occupational therapy in fibromyalgia intervention

Running head: OCCUPATIONAL THERAPY IN FIBROMYALGIA INTERVENTION 1

Occupational Therapy in Fibromyalgia Intervention:

Christine Gallah and Monica Ibrahim

Queen’s University

OCCUPATIONAL THERAPY IN FIBROMYALGIA INTERVENTION 2

Table of Contents

Abstract...........................................................................................................................................................3

Introduction.....................................................................................................................................................4

Literature Review...........................................................................................................................................7

Pathophysiology.........................................................................................................................................7

Epidemiology..............................................................................................................................................8

Modes of Intervention in FM Management................................................................................................9

Research on Multimodal Interventions.....................................................................................................14

Methods........................................................................................................................................................25

Study Design.............................................................................................................................................25

Participants...............................................................................................................................................26

Outcome Measures...................................................................................................................................27

Intervention Protocol................................................................................................................................30

Statistical Analysis....................................................................................................................................31

Statement of Ethics...................................................................................................................................32

Expected Outcomes......................................................................................................................................32

The Canadian Occupational Performance Measure (COPM)..................................................................32

The Fibromyalgia Impact Questionnaire (FIQ)........................................................................................33

Arthritis Self-Efficacy Scale (ASES).......................................................................................................34

Short Form-36 (SF-36).............................................................................................................................34

Discussion.....................................................................................................................................................36

Limitations and Future Directions............................................................................................................37

Clinical Implications.................................................................................................................................38

Conclusion....................................................................................................................................................38


Abstract

Background: Fibromyalgia (FM) is a chronic pain syndrome that affects up to 5% of the population, and

predominantly affects women. The development of FM is multidimensional and is influenced by

biological, psychological, and environmental factors. Current interventions are multimodal and are

provided by an interprofessional team that generally includes a nurse or pharmacist, psychologist,

occupational therapist (OT), and physical therapist. While the interventions have been found effective,

interprofessional teams are not always feasible or possible outside of large urban centres. Additionally, an

OT-led intervention would offer a holistic approach that aims to improve occupational engagement and

performance. Objective: Our proposal inquires if multimodal intervention offered by one OT would

provide the same results as an interprofessional team. It also seeks to determine if overall occupational

engagement and performance are improved. Design: The study will take place at the Limestone Regional

Health Centre through The Arthritis Program (TAP). It will be a non-blinded randomized control trial that

will assign participants into three groups: Group A will receive an interprofessional multimodal

intervention program; Group B will receive an OT-led multimodal intervention program; and Group C

will be the control group. Participants: Applicants to the program must be 18 years and older, and

referred by a rheumatologist or physician confirming a diagnosis of FM. Participants will be selected from

the TAP waitlist and matched for age, education and socioeconomic status. Intervention: The program is

four weeks in duration and consists of bi-weekly education sessions, each 1.5 hours long, on each of the

four modes of intervention. Outcome Measures: The primary outcome measures included in this program

are the Canadian Occupational Performance Measure, Fibromyalgia Impact Questionnaire, the Arthritis

Self-Efficacy Scale, and the Short Form-36. Expected Outcomes: If occupational therapy can achieve the

same results as an interprofessional team FM management will be more accessible to rural communities.

Additionally, an occupationally focused approach will improve the overall health and well-being of

participants.


Introduction

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread musculoskeletal pain

in addition to a multitude of symptoms such as fatigue, stiffness, sleep dysfunction, headaches, dizziness,

vertigo, parasthesia, and multiple painful tender points along the body (Babu, Mathew, Danda, & Prakash,

2007; Luedtke et al., 2005). The 1990 American College of Rheumatology (ACR) diagnostic criteria for

fibromyalgia defines the syndrome as a history of widespread pain for at least 3 months, and pain upon

palpation of at least 11 of 18 specific tender points (Pfeiffer et al., 2003). These tender points are painful

lumps that develop in tight bands of muscle and are exceptionally sensitive to touch (Fibrocentre, 2011).

Tender points occur at nine bilateral muscle locations: low cervical region, second rib, occiput, trapezius,

supraspinatus, lateral epicondyle, gluteal, greater trochanter, and knee (Taggart, Arslanian, Bae, & Singh,

2003; see Figure 1).

Figure 1. The 18 tender points of fibromyalgia. Reprinted from “ Effects of T’ai chi exercise on

fibromyalgia symptoms and health-related quality of life,” by H. M. Taggart, C.L. Arslanian, S. Bae, &

K. Singh. (2003). Orthopaedic Nursing, 22(5), 353-360.

Fibromyalgia is a complex and multidimensional condition. The manifestation of its symptoms

can vary tremendously between individuals due to a host of physical, psychological, and environmental

factors, each of which can play a role in predisposing, initiating, and/or triggering FM. As a result, the

level of disability presents itself uniquely in each individual. This complexity that is presented by FM as


well as other chronic pain conditions is best treated with a biopsychosical frame of reference (Rochman &

Kennedy-Spaien, 2007), which addresses the biological, psychological, and social factors of illness. All

these factors play a significant role in human functioning (Bruns & Disorbio, 2005).

Currently, the clinical management of FM is both multimodal and interprofessional (IP).

Multimodal interventions typically consist of psychoeducation, exercise, energy conservation and

cognitive-behavioural therapy. These modes of intervention are carried out by members of an IP team that

usually include a nurse, pharmacist, physical therapist (PT), occupational therapist (OT), and psychologist

(Burckhardt, 2006; Sarzi-Puttini et al., 2011). While multimodal intervention has been found to improve

FM symptoms, access to a full IP team may not be feasible in rural communities (Thompson et al., 2011;

Oh et al., 2010). The majority of IP FM teams are situated in large urban centres, requiring that many

clients travel for an average of 200 km to receive treatment (Oh et al., 2010). This presents a large

obstacle for those who seek FM treatment in rural communities.

In order to address the inaccessibility of IP teams in rural areas, this paper will explore the

potential for occupational therapy to be a sole provider of multimodal FM intervention. Currently, within

IP teams, OTs are primarily responsible for the energy conservation component of multimodal

intervention (Dobkin et al., 2010); there is no literature on occupational therapy as the provider of any or

all the other modes of intervention (psychoeducation, exercise, and cognitive-behavioural therapy).

However, as a versatile and multi-faceted discipline, current modes of intervention in FM fall within the

profession’s scope of practice and skill set. If the provision of occupational therapy can achieve the same

results as an IP team, multimodal intervention for FM can be more accessible to rural clinical settings with

limited professional resources. An implication of this study is the possible reduction in the cost of

providing FM services, due to the use of one healthcare provider. This is not the aim of this paper, but

may be explored in a second stage of this study.

Occupational therapy is a holistic profession that addresses the physical and psychosocial aspects

of the person (Rochman & Kennedy-Spaien, 2007). As such, OTs are well-trained to deliver interventions

with a biopsychosocial frame of reference. One such approach within occupational therapy is the Person-


Environment-Occupation (PEO) model which is used to address multiple and complex factors of illness

(Law et al., 1996). Within this model, occupational therapists (OTs) focus on providing an optimal

interaction between the person, environment, and occupation in order to improve occupational

engagement and performance. The crux of the profession is that engagement in daily occupations is

essential to an individual’s health and well-being (Townsend & Polatajko, 2007). The experience of

chronic pain syndromes such as FM can impede an individual’s ability to engage in meaningful

occupations, and thus reduce quality of life (Townsend & Polatajko, 2007). Therefore, in an OT-led

multimodal FM intervention, occupational engagement would be the primary goal. Clients would not only

be exposed to each mode of intervention, but also integrate and apply the modes of intervention through

meaningful activities, and subsequently enhancing general health and well-being (Rochman & Kennedy-

Spaien, 2007). OTs are, then, uniquely prepared to provide group interventions with individuals diagnosed

with FM.

Since 2009, the Ministry of Health and Long-Term Care in Ontario has funded the addition of

OTs in Family Health Teams (FHTs) (Ontario Society of Occupational Therapy, 2011). This new model

of primary care aims to address the gap in health care services for the aging population through an

interdisciplinary model of care (Ontario Society of Occupational Therapy, 2011). FHTs provide greater

access to health care, especially in rural communities. As the role of OT expands in FHTs, it may be a

potential avenue for the integration of multimodal FM intervention provided by OTs. In the long-term, if

OTs can be the sole providers of multimodal FM intervention, then the incorporation of an FM program

may be well suited in a FHT setting.

Context

The Arthritis Program (TAP) at the Limestone Regional Health Centre (LRHC) currently offers a

multimodal FM service provided by an IP team. TAP is seeking to expand into rural communities that

have limited resources outside of Kingston, Ontario. Given the difficulties of IP recruitment in rural

settings (Oh et al., 2010), the objective of this research proposal is to evaluate a single discipline model

carried out by occupational therapists, in order to expand TAP’s FM service into rural areas.


Literature Review

Pathophysiology

To date, the etiology of FM is unknown (Oh et al., 2011); however, recent advances in FM

research suggest dysfunctional central pain processing mechanisms and a pathological interaction of

central nervous, neuroendocrine, and musculoskeletal systems (Kurtais, Kutlay, & Ergin, 2006). One key

process that underlies the clinical presentation of FM is pain sensitization. Many clinical studies have

found differences in pain processing between people with FM and people without FM; the threshold at

which stimuli becomes painful is lower (Abeles, Pillinger, Solitar, & Abeles, 2007). Pain sensitization

results in aberrant nociception, neurogenic inflammation, spinal cord pain transmission processes, central

nervous pain control centers, and a change in peripheral mechanoreceptor function (Littlejohn & Walker,

2002). The pain sensitization process, and its subsequent downstream events, is associated with the

symptoms of widespread pain, fatigue, and sleep disturbance, among others. Additionally, in individuals

with FM, statistically significant and reproducible lab findings have demonstrated alterations in serotonin,

substance P, nerve growth factor, natural killer cells, and alpha-wave intrusion into non-rapid eye

movement delta-wave sleep on nocturnal electroencephalographic (EEG) polysomnography, all of which

are associated with alterations in pain perception and sleep (Hallegua & Wallace, 2001).

Developmental and aggravating factors. There are many factors that can impact the initiation of

FM and/or the triggering of FM symptoms. These factors encompass biological, psychological, and

environmental influences. As aforementioned, FM affects women more frequently than men (Luedtke et

al., 2005). Females have a higher risk for pain syndromes because of increased pain sensitivity compared

to males; this has been attributed to less pain-inhibitory mechanisms as well as reproductive hormonal

levels that influence central pain-modulatory mechanisms (Velkuru & Colburn, 2009).

A few studies suggest that illnesses and pre-existing conditions initiate the onset of FM (Abeles,

Pillinger, Solitar, & Abeles, 2007). People with infections such as HIV and Hepatitis C have been found

to have higher rates of FM than the general population, suggesting that infections may play a role in

precipitating FM in some patients (Abeles, Pillinger, Solitar, & Abeles, 2007). Additionally, diseases


associated with increased risk of acquiring FM include rheumatoid arthritis, systemic lupus

erythematosus, and inflammatory bowel disease (Velkuru & Colburn, 2009).

Recent studies have also explored the association of commonly comorbid psychiatric disorders

with FM, notably anxiety, depression, and/or post-traumatic stress disorder (Nielson & Merskey, 2001).

Some evidence has indicated that the relationship between these comorbid mental disorders and FM exists

due to dysfunction in the hypothalamic-pituitary-adrenal (HPA) axis, a neuro-endocrinal system central to

the physiological stress response (Littlejohn & Walker, 2002). Because psychological processes have the

capacity to alter neuronal processes such as the HPA axis, this suggests that certain mental disorders can

predispose persons to the development of FM (Abeles, Pillinger, Solitar, & Abeles, 2007).

Environmental factors have also been attributed to the development and/or aggravation of FM. In

childhood, the psycho-social environment can impact the pain sensitization process (Velkuru & Colburn,

2009). Adverse and traumatic experiences such as poverty and abuse increases the susceptibility to the

development of FM in adulthood (Nielson & Merskey, 2001). In any stage of development, physical

trauma and emotional stress can aggravate a pre-existing FM (Hallegua & Wallace, 2001). Furthermore,

an innate tendency to catastrophize and/or a lack of positive coping skills can create or reinforce

emotional stress (Nielson & Jensen, 2004).

Epidemiology

In the general population the prevalence of FM is 3-5%; the prevalence of FM is more common in

middle-aged women, aged 40 to 70 years old, than men, and the incidence increases progressively with

age (Dobkin, et al., 2010; Luedtke et al., 2005; Velkuru & Colburn, 2009). FM is also seen in older adults,

children, and as many as 1-2% of adolescents (Velkuru & Colburn, 2009). A Canadian study conducted by

White, Speechley, Harth and Ostbye (1999) found the prevalence of FM estimated at 4.9% for women and

1.6% for men, which translates into approximately 1.1 million people living with FM in Canada

(Fibrocentre, 2011; White, Speechley, Harth & Ostbye, 1999). However, this may be an underestimate as

many FM cases are either attributed to other systemic disorders, such as rheumatoid arthritis, or

misdiagnosed as psychiatric in origin (Jain et al., 2003). Research has found a genetic factor in FM


(Velkuru & Colburn, 2009) as well as many socioeconomic factors associated with the chances of having

FM. For example, less education, household income, being divorced, and having a disability all increase

one’s odds of having FM (White, Speechley, Harth & Ostbye, 1999).

In the current management of FM within the Canadian healthcare system, individuals use twice

the amount of services, more medications, and outpatient health services than the general population

(Dobkin et al., 2010; White, Speechley, Harth & Ostbye, 1999). The mean difference in cost of FM to

matched controls was found to be $493 annually (p < 0.001) as reported by White, Speechley, Harth &

Ostbye (1999). This translates to annual estimated health care costs between $300 and $350 million for

those with FM in Canada (White, Speechley, Harth & Ostbye, 1999). Moreover, 15-25% of FM clients

collect disability pensions at some point in their lives (Hallegua & Wallace, 2001). It is reported that as

many as 30% of individuals with FM have had to change their jobs, while 30% had to modify their current

work duties to accommodate their needs (Hallegua & Wallace, 2001). Those with FM that are unable to

work, and on long term disability, report that they are unable to do so due to extreme pain, poor cognitive

function, fatigue, stress and damp work environments (Hallegua & Wallace, 2001).

Modes of Intervention in FM Management

A number of different approaches to the management of FM have been reported in the literature

including: psychoeducation, exercise, energy conservation, and cognitive-behavioural therapy. Each mode

of intervention has produced promising results. When implemented individually or in various

combinations, they constitute a large percentage of FM research today, and are often incorporated in

clinical practice settings. More recent studies in FM have investigated the impact of several modes of

interventions on managing FM symptoms

Psychoeducation. According to Littlejohn & Walker (2002), “perhaps the most powerful

intervention in FM is education” (p. 286). In FM management, psychoeducation sessions outline the

nature of the condition and symptom management through medication (Rooks et al., 2007). In an IP

setting, a nurse or pharmacist is usually designated to lead psychoeducation sessions (Dobkin et al., 2010).

These sessions are essential in emphasizing an individual’s role in managing their condition, as they


facilitate active involvement in self-management and ultimately contribute to self-efficacy (Rooks et al.,

2007). Education on medication intake and side effects is of particular importance in psychoeducation,

because it is one of the primary methods to minimize FM symptoms, although there is no long-term

efficacy from medication as a sole treatment (Kurtais, Kutlay, & Ergin, 2006). Currently, no medication

exists to minimize all FM symptoms simultaneously; however, some medications may minimize more

than one symptom. Pharmaceuticals prescribed in FM intervention have been outlined by Jain et al (2003)

and summarized in Table 1.

Table 1Commonly Prescribed Medications for Pain, Fatigue, and Sleep Disturbance

Symptom Medication Class Examples

Pain Non-steroidal anti-inflammatory drugs, cyclooxygenase-2 inhibitors, tricyclic antidepressants, selective serotonin reuptake inhibitors, anti-convulsants, local anesthetics, narcotics

Ibuprofen, Celecoxib, Amitriptyline, Fluoxetine, Gabapentin, Lidocaine, Codeine

Fatigue Anti-convulsants Gabapentin

Sleep Disturbance

Hypnotics, tricylclic antidepressants, benzodiazepines, polycyclics, muscle relaxants

Zopiclone, Amitriptyline, Clonazepam, Trazodone, Cyclobenzaprine

Exercise. In IP settings, the exercise modality emphasizes the importance of stretching, strengthening,

and endurance exercises, and is typically taught by a physical therapist (Pfeiffer et al., 2003). For the past

10 years, several studies have underlined the benefits of physical exercise for FM patients (Maquet,

Demoulin, Croisier, & Crielaard, 2007). The theoretical foundation for physical exercise in FM

management is based on research that suggests that people with FM have lower endurance, flexibility, and

muscle strength due to deconditioned muscles (Taggart, Arslanian, Bae, & Singh, 2003). Because

deconditioned muscles are weaker, they are susceptible to micro-trauma during any kind of physical

activity, and as a result experience increased localized and generalized pain. A cycle is thus established in

which FM patients decrease their physical activity in response to the pain, which in turn increases their

exercise intolerance and overall level of deconditioning (Kurtais, Kutlay, & Ergin, 2006). The rationale

behind exercise interventions is to break the cycle of deconditioning, in which a better muscular blood


flow and less susceptibility to muscular micro-trauma might improve overall pain symptoms in FM

(Kurtais, Kutlay, & Ergin, 2006). In order to avoid post-exercise muscle pain, studies on exercise

interventions avoid the implementation of high-intensity exercise and encourage individualizing the

exercise prescription for FM patients (Wennemer et al., 2006). One of the first studies to examine the

effects of a supervised cardiovascular fitness training program on FM was carried out by McCain, Bell,

Mai and Halliday (1988). Thirty-eight clients were randomized to either a cardiovascular fitness training

program of 60 minutes on a bicycle ergometer three times a week for 20 weeks or a flexibility exercise

group for the same study length (McCain, Bell, Mai, Halliday, 1988). Clinically and statistically

significant improvements in pain threshold scores were measured over fibrositic tender points in clients in

the cardiovascular fitness group. Over the years, many studies have incorporated exercise guidelines from

the American College of Sports Medicine (ACSM), which outlines the following (Busch, Barber,

Overend, Peloso, & Schachter, 2002):

● Cardiorespiratory endurance (aerobic training): 2 days per week; 20-60 minutes per session, either

as continuous exercise or spread intermittently throughout the day; intensity of exercise sufficient

to achieve 40 to 85% of heart rate reserve or 55 to 90% predicted maximum heart rate; total time

period of at least 6 weeks.

● Muscle strengthening: 2-3 days per week; minimum of one set of 8-12 repetitions using any type

of strengthening exercise that can be progressed over time.

● Flexibility training: at least 2 days per week; intensity to a position of mild discomfort; 3-4

repetitions for each stretch held for 10-30 seconds.

Over time, carefully designed low-intensity programs that incorporate aerobics, muscle

strengthening, and flexibility training have shown to enhance muscle conditioning as well as improve

quality of sleep, improve mood and well-being, increase pain threshold, and increase tolerance to

symptoms (Taggart, Arslanian, Bae, & Singh, 2003; Maquet, Demoulin, Croisier, & Crielaard, 2007).


Energy conservation. In chronic pain and fatigue management, energy conservation techniques are

behavioural strategies that emphasize planning, prioritizing, pacing, and positioning during daily activities

(Jain et al., 2003). In IP teams, energy conservation is primarily taught by OTs (Dobkin et al., 2008;

Dobkin et al., 2010; Pfeiffer et al., 2003). The premise of energy conservation is to maintain a sufficient

amount of activity to prevent deconditioning without exacerbating symptoms of pain and fatigue. The

fundamentals of energy conservation are taught to be achieved with the following four principles

(Birkholtz, Aylwin, & Harman, 2004):

● Planning: using a daily planner/journal to organize and manage daily routines;

● Prioritizing: Ensuring that daily tasks are realistic to accomplish in the context of present pain

and/or fatigue, and including meaningful activities and rest into the daily plan;

● Pacing: breaking tasks into smaller manageable portions, frequently alternating between tasks,

taking frequent short rests, slowing down, and increasing activity amounts gradually;

● Positioning: incorporating environmental modifications and assistive devices to stabilize posture

and facilitate ease of movement.

Cognitive-behavioral therapy. According to Dobkin et al (2010), persons with FM experience

substantial individual differences in response to intervention; this variability in intervention outcome is

based, at least partially, on psychosocial factors. Cognitive-behavioural therapy (CBT) is one such

intervention that addresses cognitive and behavioural parameters that influence how persons with FM feel

pain and that may account for differences in symptom severity among FM patients (Dobkin et al., 2008).

Cognitive-behavioural models of pain suggest that CBT is effective because this intervention alters the

individual’s perception of, and behavioural responses to, their pain (Nielson & Jensen, 2004). Cognitive-

behavioural intervention has three components (Kurtais, Kutlay, & Ergin, 2006): an educational phase to

understand the effects of thoughts, beliefs, expectations, and behaviours in regards to symptom

management; a skills training phase to learn cognitive and behavioural strategies to cope with pain; and an

application phase to apply cognitive and behavioural skills in real-life situations.


In IP settings, CBT sessions are primarily carried out by a psychologist (Dobkin et al., 2010). In

the literature on FM management, CBT has been successful in addressing comorbid psychiatric disorders

such as anxiety and depression (Littlejohn & Walker, 2002). Even in the absence of a psychiatric

diagnosis, CBT has been used to address low self-efficacy, a dominant trait found in FM populations

(Dobkin et al., 2010; Nelson & Tucker, 2006). As defined by Burckhardt (2006), self-efficacy is an

individual’s confidence in the ability to succeed in achieving a specific goal. In regards to FM, self-

efficacy is the individual’s belief in the ability to control pain. Individuals with low self-efficacy, are then

less committed when confronted with challenges; this is demonstrated by a diminished effort and the

tendency to abandon tasks (Dobkin et al., 2010). Studies have shown that higher self-efficacy is associated

with less pain and is one of the strongest predictors of better outcomes in FM care (Burckhardt, 2006;

Neilson & Jensen, 2004).

FM intervention outcomes are also associated with an individual’s thought processes and the

coping strategies that stem from them (Neilson & Jensen, 2004). One example of a distorted thought

process is pain catastrophizing, a negative focus and preoccupation with pain that is associated with

increased pain severity and decreased psychological and physical functioning (Nelson & Tucker, 2006).

Pain catastrophizing interferes with the development of self-efficacy in coping with pain; specifically, it

was found to have an inverse relationship with self-efficacy (Asghari & Nicholas, 2001). Also, because of

the attentiveness to pain, catastrophizing prevents the use of more productive coping strategies (Maquet,

Demoulin, Croisier, & Crielaard, 2007). This includes adherence to intervention recommendations and

protocols, such as taking medications as prescribed or maintaining an exercise protocol, which has a

significant effect on an individual’s well-being (Dobkin et al., 2008). In any chronic condition, self-

management is integral in continuing the progress accomplished within a clinical setting (Burkhardt,

2006).

Multimodal intervention. Due to the biopsychosocial nature of the FM syndrome and clinical

variability presenting in clients, studies have begun to focus on providing clients with program that

combine modes of interventions rather than provide them separately (Bennett, 1996; Burkhardt, 2006).


Multimodal interventions have been found to provide clients with increased self-management and control

on their FM syndrome in comparison to uni-modal programs, making multimodal intervention a standard

practice in FM management (Oh et al., 2012).

Research on Multimodal Interventions

In FM literature, interventions in studies are provided either by one professional or by an IP team,

with an overall lack of high quality research. Within the current literature, sample sizes are small with

many differences in interventions, outcome measures, study length, and models of intervention delivery.

Also, the literature mainly focuses on IP practice or solely interventions provided by physical therapists,

with no literature indicating the efficacy of intervention provided by OTs. The variability in the current

research methodology makes it difficult to compare these studies. Additionally, only a few studies provide

follow-up data, and of those studies only a few are able to show that benefits of the FM programs exist

beyond the immediate completion of the study (Bennett et al., 1996; Burkhardt, Mannerkorpi, Hedenberg

& Bjelle, 1994; Gowans, de Hueck, Voss & Richardson 1999; Keele, Bodoky, Gerhard & Mulle, 1998;

Leudtke et al., 2005; Mannerkorpi, Nyberg, Ahlmen & Ekdhal, 2000; Mason, Goolkasian & McCain,

1998; Oh et al., 2010; Oh et al., 2012).

Non-IP studies. A handful of studies have provided evidence for multimodal intervention

delivered by one professional, a physical therapist (Burkhardt, Mannerkorpi, Hedenberg & Bjelle 1994;

Mannerkorpi, Ahlmen & Ekdahl, 2002; Mannerkorpi, Nyberg, Ahlmen & Ekdhal, 2000). These early

studies mainly focused on exercise as the primary intervention.

Burkhardt, Mannerkorpi, Hedenberg and Bjelle (1994) found a significant positive impact on

quality of life and self-efficacy, as measured by the Quality of Life Scale (QOLS) (Flanagan, 1978), in

women with FM receiving a combination of education and physical training using a randomized,

controlled approach over a 6-week period. This Swedish study randomized 86 women into a control group

(received intervention after 3 months), education-only group or a combined education and physical

therapy group. The education portion consisted of six, 1.5 hr. self-management education classes with

information on FM, the role of stress in the development and maintenance of symptoms, coping strategies,


problem solving techniques, assertiveness training, relaxation strategies, and the importance of physical

conditioning. Each session concluded with an individual contract for behaviour change during the coming

week. Subjects in the physical therapy group received the education classes including an additional hour

for stretching, range of motion exercises, pool therapy, and individual time to develop a physical fitness

training program of either walking, swimming, or cycling. Data were collected at baseline, 6 weeks and 12

weeks after study completion. Main outcome measures were the FIQ (Burckhardt, Clark, & Bennett,

1991), QOLS (Flanagan, 1978), Self-Efficacy Scale (SELF) (Sherer et al., 1982), 6 min walk test

(Butland, Pang, Gross, Woodcock & Geddes, 1982), Borg Rate of Perceived Exertion (RPE) (Borg,

1982), tender point test and Beck Depression Inventory (BDI) (Beck, Ward, Mendelson, Mock &

Erbaugh, 1961). Statistical differences in patients’ quality of life and self-efficacy were found to be

statistically significant in subsections of function, pain, and other symptoms according to the outcome

measures used. In both intervention groups, the quality of life and the self-efficacy (function) changed

significantly compared to the control group. While for the self-efficacy (pain) and the self-efficacy (other

symptoms) subsections, the group that received both education and exercise improved significantly

compared to the control group. Both intervention groups’ attitudes regarding FM changed positively

following the 6 week program. In the 12-week follow up, significant positive changes in the FIQ scores

(Burckhardt, Clark, & Bennett, 1991) were observed primarily in the combined exercise and education

group.

Mannerkorpi, Nyberg, Ahlmen and Ekdhal (2000) also found significant differences between the

intervention group with FM that received 6 months of pool exercises combined with 6 sessions of

education compared to the control group provided by physical therapists. This study evaluated outcomes

through the use of the FIQ (Burckhardt, Clark, & Bennett, 1991), SF-36 (Medical Outcome Trust, 1991),

6-minute walk test (Butland et al., 1982), Borg RPE (Borg, 1982) and the Visual Analog Scale (VAS)

(Huskisson, 1974). Significant differences between the intervention group and the control group were

found in the total FIQ (p = .003) score and 6 minute walk test (p = .0001). Improvements were also found

in the FIQ subscales of physical function, bodily pain, general health, vitality and social functioning. Also,


in the 6 and 24 month follow up study by Mannerkorpi, Ahlmen and Ekdahl (2002) they found that there

were no differences between the post-intervention and the follow-up values. The FIQ and SF-36 subscales

rating physical function and the 6-minute walk test, showed significant improvements, when the six-

month follow-up values were compared with baseline. No differences were found between the post-

intervention-test and follow-up values. In fact, in the 24 month follow up, the FIQ subscales of pain,

fatigue and stiffness revealed significant improvements from baseline. The SF-36 for bodily pain, social

function and vitality also revealed significant improvements and no difference upon follow up. Thus, the

follow up study indicates that there is promising and lasting results with a combination of pool exercise

program and education for up to 2 years.

IP studies. The majority of the studies providing multimodal interventions have been done with

an IP team. These studies range in length of intervention from several months (Bailey, Starr, Alderson &

Moreland, 1999; Bennett et al., 1996; Gowans, de Hueck, Voss & Richardson 1999; Keele, Bodoky,

Gerhard & Mulle, 1998; Mason, Goolkasian & McCain, 1998; Mengshoel, Forseth & Haugen,1995;

Wennemer et al., 2006) to a brief 1.5 day program (Leudtke et al., 2005; Oh et al., 2010; Oh et al., 2012;

Pfeiffer et al., 2003; Worrell, Krahn, Sletten & Pond, 2001). Earlier IP studies began with longer

intervention durations while more current studies on IP FM intervention have evolved to focus on

providing brief IP intervention programs for FM (Leudtke et al., 2005; Oh et al., 2010; Oh et al., 2012;

Pfeiffer et al., 2003; Worrell, Krahn, Sletten & Pond, 2001). Current IP studies have implemented shorter

intervention durations in order to address both the high costs of providing IP teams and the costs

associated with participants travelling from rural areas. These studies have been able to demonstrate

similar benefits of FM intervention similar to earlier studies (Leudtke et al., 2005; Oh et al., 2010; Oh et

al., 2012; Pfeiffer et al., 2003; Worrell, Krahn, Sletten & Pond, 2001). The IP approaches assume that

after education and instruction by skilled professionals, the client will take on major responsibility for

activities that lead to positive changes in symptoms (Burkhardt, 2006). Long-term success of IP

approaches depends on the patient’s on-going self-motivation to monitor their symptoms, practice the

skills that they have been taught, and to seek a variety of professionals for advice according to their needs,


as in any chronic pain intervention (Burkhardt, 2006). Also, group therapy in FM intervention programs is

ideal as it enhances self-efficacy (Bennett, 1996). Over a period of months, clients become familiar with

each other resulting in peer pressure to succeed in new behaviours learned (Bennett, 1996). The

widespread and often positive feedback which occurs within the interactions of a group setting provides

an encouraging atmosphere which seems to be critical in promoting self-efficacy (Bennett, 1996;

Rochman & Kennedy-Spaien, 2007).

In the literature on IP groups, there is a common structure to multimodal intervention. Generally,

the IP team is comprised of a physician or rheumatologist, registered nurse, PT, OT, and/or psychologist.

The diagnosis of FM is confirmed by a physician or rheumatologist. Group sessions include a nurse for

psychoeducation, a PT for exercise, an OT for energy conservation, and a psychologist for cognitive-

behavioural therapy. Regardless of the intervention duration, the benefits of a multimodal intervention

programs have shown significant benefits in individuals with FM. Unlike the group studies with control

groups, these studies were able to prove significant benefits in often larger sample sizes and within

clinical settings (Bailey, Starr, Alderson & Moreland, 1999; Bennett et al., 1996; Gowans, de Hueck, Voss

& Richardson 1999; Keele, Bodoky, Gerhard & Mulle, 1998; Leudtke et al., 2005; Mason, Goolkasian &

McCain, 1998; Mengshoel, Forseth & Haugen,1995; Oh et al., 2010; Oh et al., 2012; Pfeiffer et al., 2003;

Wennemer et al., 2006; Worrell, Krahn, Sletten & Pond, 2001).

A Canadian study by Bailey, Starr, Alderson and Moreland (1999) demonstrated statistical

improvements in FM clients over a 12-week Fibro-Fit program. The study consisted of groups of 5 to 9

clients who attended 36 sessions over 12 weeks. The interdisciplinary team was comprised of a PT, OT,

and social worker. Also, a pharmacist, dietician, and kinesiologist provided support to the program. The

Fibro-Fit program included an orientation session emphasizing self-management, group building, and

goal-setting. The graded stretching, strengthening, and aerobic program (including hydrotherapy) occurred

3 times a week, and the education/counselling sessions once a week on topics such as taking charge,

improving sleep, management of fatigue, coping skills, managing stress, memory, nutrition, and medical

management. Group building was fostered throughout the program. Patients could access any member of


the team for individual intervention. Outcome measures used were Fibro-Fit self-efficacy questionnaire

(F-SEQ) (Buckelew, Murray, Hewett, Johnson, & Huyser, 1995) [17 item based on Lorig's Arthritis Self-

efficacy scale] (Lorig, et al., 1989), Canadian Standardized Test of Fitness (CSTF) (Fitness Canada, 1986)

to evaluate aerobic fitness, upper body strength, flexibility, and abdominal muscle strength, FIQ

(Burckhardt, Clark, & Bennett, 1991) and the Canadian Occupational Performance Measure (COPM)

(Law et al., 2005). All improvements were statistically significant (p<.005) except for grip strength in the

overall 106 FM participants. There were clinically significant improvements in all disability measures,

with the largest gain in the COPM scores. Compared with normative values established by the CSTF,

participants improved their physical fitness by at least one level.

Similarly, another Canadian study by Gowans, de Hueck, Voss and Richardson (1999) found

significant improvements to subjects receiving education and exercise on their sense of well-being using

the FIQ measures (Burckhardt, Clark, & Bennett, 1991) of days felt bad and decreased morning fatigue, as

compared to controls over a 6-week program period. This study randomized 41 subjects into either an

intervention group receiving education and exercise, or a control group (waitlisted, and received

intervention after 6 weeks). The intervention program consisted of two half-hour exercise classes in a

warm pool and two one-hour IP education sessions. The interventions were provided by physical and

occupational therapists. The intervention group also received education sessions that included information

on exercise, postural control, activities of daily living, sleep, relaxation, medication, nutrition, and

psychosocial coping strategies. The outcome measures used were a modified version of the 6-minute walk

test (Butland et al., 1982), the Borg RPE (Borg, 1982), the ASES (Lorig, Chastain, Ung, Shoor, &

Holman, 1989) and the FIQ (Burckhardt, Clark, & Bennett, 1991). This study showed improvements to

the 6-minute walk distances following the intervention program in both intervention and control subjects.

They also found significant increases in the subjects’ sense of well-being and a decline in morning fatigue,

in the intervention group as compared to the control group immediately following the program. However,

at 3 months follow up, program gains of decreased morning fatigue and subjects’ knowledge of FM were

lost. The immediate gains to physical function, well-being, and self-efficacy were however maintained at


3 months follow up. Unlike the study by Burkhardt, Mannerkorpi, Hedenberg and Bjelle (1994), this study

was unable to compare between the superiority of either the education portion of the program, or the

combined education and exercise portion of the program, as there was only one intervention group.

Keele, Bodoky, Gerhard and Mulle (1998) conducted a study from a cognitive-behavioural

approach. The study was able to demonstrate that comprehensive improvements in self-efficacy through

cognitive-behavioral training using various pain-control strategies, such as cognitive restructuring,

diversion, relaxation techniques, and gymnastic exercises, lead to more substantial as well as longer-

lasting improvements than relaxation training without such a comprehensive educational package. This

study randomized 27 subjects into an intervention or control group for a 15 week program period. The

intervention group had 2 hour sessions consisting of information about the nature, the usual course, and

the intervention possibilities of FM; mechanisms and the psychology of pain, instruction in self-control

strategies, gymnastics, relaxation through autogenic training, and group discussions. The control group

was taught relaxation in 15 sessions lasting 45-60 minutes, led by a psychiatrist and a physical therapist.

Outcome measures were assessed at baseline, immediately after the 15 week program, and 3 months later

for follow up. To assess the intervention outcome, patients had to keep a diary for 2 weeks immediately

before the intervention was started, after intervention, and again for follow-up. Number of active hours

("up-time"), resting time, hours of good and disturbed sleep as well as pain intensity (rated 4 times daily

on a numerical scale ranging from 1 to 10), medication intake and use of other therapies (e.g., massages)

had to be recorded daily. During the psychological evaluation session, patients were instructed in the use

of the diary, where they also had to complete the general symptom checklist, which was used for outcome

assessment. The index of sleep disturbance was calculated from the hours of disturbed sleep divided by

the hours of good sleep. Changes in average pain intensity were calculated from the four daily ratings. The

patient's own judgment of the intervention program and their outcome were assessed by three items:

duration of group sessions, helpfulness of the various intervention elements, and effectiveness of the entire

intervention program (choice of 6 ratings ranging from "worsened" to "very much improved"). Numerical

rating scale for pain and tender point scores were also evaluated.


Results of this study were observed in the experimental group. The difference for the average pain

intensity also reached statistical significance at follow-up for the experimental group (p < .0001). All parts

of the program were rated as helpful with a preference for relaxation training among experimental as well

as control patients. An improvement of at least 50% or a positive patient rating occurred in the following

parameters: medication consumption, physical therapies, sleep disturbance, pain score, patients global

assessment, and general symptoms. Even though this study demonstrates significant differences in the

experimental group, the study did lack a true control group.

Mason, Goolkasian and McCain (1998) compared the effects of a month long multimodal pain

management program in FM clients. Pain threshold and tolerance were measured at tender points and

control sites. Other measures included the FIQ (Burckhardt, Clark, & Bennett, 1991)‚ pain ratings with the

VAS (Huskisson, 1974)‚ the Coping Strategies Questionnaire (CSQ) (Rosenstiel and Keefe‚ 1983)‚ and

the BDI (Beck et al., 1961). Testing occurred twice in advance of intervention and twice after intervention

(immediately and 6 months post-discharge). The intervention program included education on proper

posture and body mechanics, back strengthening, lumbar stabilization, flexibility, and aerobic exercises. It

also included an individualized exercise program for four hours daily that was provided by a physical

therapist. Patient education in cognitive-behavioral techniques occurred daily for 2 hours by a

psychologist. Patients who attended the month-long multimodal pain program achieved significant and

positive changes on psychological measures and self-report pain measures but not on the laboratory pain

measures. The most prominent change occurred on the BDI with treated patient’s scores dropping from

borderline clinical depression levels to a near-absence of all depressive symptoms. When tested

immediately after intervention‚ the intervention group’s “positive” coping skills score showed a 54%

increase over baseline‚ their use of “negative ”strategies decreased by 49%‚ and their sense of control over

the pain showed an over 100% improvement. Self-reported pain ratings also were significantly

reduced‚ indicating that the treated participant felt a greater sense of control over her FM pain and also

experienced considerable relief from that pain. The intervention group also showed significant

improvements in physical function and general well being. Data from the 6-month follow-up showed that


the intervention gains were not maintained on a long-term basis. Although the treated patients continued

to show a significant decrease in symptomology‚ there was a definite trend toward the pre-intervention

levels on all measures but pain tolerance.

Bennett et al., (1996) provided a 6 month group intervention for 104 FM participants. The FM

group sessions were held once a week for 90 minutes and included formal lectures, group sessions

emphasizing behaviour modification, stress reduction techniques, strategies to improve fitness and

flexibility and support sessions for spouses/significant others. The IP team included two rheumatologists,

a nurse coordinator, an exercise physiologist and two psychologists. The main outcome measures were the

FIQ (Burckhardt, Clark, & Bennett, 1991) and the total tender point scale (Wolfe et al., 1990). At

completion of the program 70% of patients had less than 11 tender points and FIQ scores improved by

25%. Also, this study demonstrated continued improvements in 33 patients that were followed 2 years

after the program. There was also a comparison group which served as a control that did not enter the

program, and showed no significant improvements.

Mengshoel, Forseth and Haugen (1995) aimed to teach a group of FM clients how to solve

problems related to activities of daily life over a ten-week IP program. FM clients attended a two-hour

session, once a week instructed by a physician, dietitian and two physical therapists. The McGill Pain

Questionnaire (Melzack, 1975) and VAS (Huskisson, 1974) were the main outcome measures in this

study. After the intervention program a reduction in general pain intensity (p < .05) was found. At six

months follow-up sensory (somatic) pain intensity was reduced compared to baseline recordings (p = .05).

All patients had made adjustments to their everyday life after ten weeks. Eight patients reported that they

regularly practiced relaxation techniques, and seven patients had undertaken dietary changes. Thus, this

study shows that adjustment of activities in daily living may reduce pain in patients with FM.

Wennemer et al. (2006) also found significant improvements in physical changes and quality of

life from an 8-week IP intervention program in 20 FM clients. The design of this program also included

education, exercise and stress reduction, which were given by the psychiatrist and physical therapist

respectively. Significant improvements in the SF-36 (Medical Outcome Trust, 1991) were found. Range


of motion tests showed significant lumbar spine extension, straight-leg raise, cervical spine flexion,

cervical spine rotation, and cervical spine bending. Distance traveled during the 6-minute walk test

(Butland et al., 1982) increased significantly, but the perceived exertion measured by Borg’s RPE (Borg,

1982) didn’t change.

The brief two-day IP FM study by Leudtke et al. (2005) demonstrated positive clinical impact on

the 1939 patients which completed the program. The program was delivered by nurses, PTs and OTs.

Scores on the Health Status Questionnaire (Radosevich, Wetzler & Wilson, 1994), mental health subscale

improved from 40.6 at the initial time period to 44.7 at 6 months (p < .001) and remained stable at 12

months at 44.8 (p < .001). Scores on the physical functioning scale improved from 28 at the initial time

period to 30.3 at 6 months (p < .002) and remained stable at 12 months. The patients’ overall impact of

FM was lessened from the initial score of 51.1 to 43.8 (p < .001) at 6 months and to 42.9 at 12 months

(p<.001). The 6-month FIQ (Burckhardt, Clark, & Bennett, 1991) results demonstrated improvement in all

subscales. Also, 12 month scores remained stable. This study proved positive clinical results to a brief FM

program similar to longer term FM programs.

Recently Oh et al. (2010) found significant overall improvements in 521 FM subjects over a 1.5

day IP program. Compared with the baseline, the mean FIQ (Burckhardt, Clark, & Bennett, 1991) total

score at follow-up improved by a mean (SD) difference of 7.2 (17.7) points (P < .001). Statistically

significant improvements were noted at follow-up in all subscales of the FIQ (all P < .001) except

depression (P < .67). The FIQ scores did not change significantly between 6 and 12 months. Statistically

significant changes were also noted on several subscales of the SF-36 (Medical Outcome Trust, 1991),

including physical functioning, role physical, pain index, vitality, social functioning, mental health, and

physical and mental component summary scores. The changes in general health perception (P < .58) and

role emotional scores (P < .13) were not statistically significant. Compared with the baseline, the score

improved a mean (SD) of 2.0 (8.7) points in physical component summary score and 2.7 (11.7) points in

mental component summary score. The SF-36 scores did not change significantly between 6 and 12 month

period. A follow-up study by Oh et al., (2012) sought to examine if there were any specific patient


characteristics associated with a positive response to their previous study of a brief 1.5 day IP FM

program (Oh et al., 2010). They found that in a total of 248 subjects diagnosed with FM, the significant

characteristics associated with a positive response in patients with FM were the following: younger age (p

= .008), education (college or higher education) (p = .02), fewer tender points (p = .048), higher FIQ

depression subscales (p = .02) and positive abuse history became significant (p = .03).

Pfeiffer et al. (2003) also found statistical improvements in their 1.5 day IP FM program. There

was significant improvement overall, with the average total score on the FIQ (Burckhardt, Clark, &

Bennett, 1991) improving from 51.3 to 44.7 (P<.002). A total of 48 (62%) improved an average of 13.4

points, compared with 30 subjects who increased their FIQ score (became more affected by fibromyalgia)

an average of 7.5 points (total FIQ score range, 0–80). Significant improvements were seen in the areas of

pain, number of bad days, fatigue, awaking refreshed, stiffness, nervousness and anxiety (P<.01).

However, there were no significant improvements in physical impairment (P<.11) or depression (P<.06).

Worrell, Krahn, Sletten and Pond (2001) also evaluated the results of a 1.5-day interprofessional

program. The 100 FM clients that completed the program showed improvements in the total FIQ

(Burckhardt, Clark, & Bennett, 1991) score (p<.001), Multidimensional Pain Inventory severity scale

(Kernsr, Turkd, Rudyt, 1985) p<.001) interference score (p=.01). This study also found that the one

patient characteristic which was found to be associated (p<.001) with better response to intervention was

the higher pre-intervention level of impairment as indicated by the FIQ score.

FM intervention and occupational therapy. No studies could be found where intervention was

provided solely by an occupational therapist, and whose focus was primarily on enhancing occupational

engagement. However, the study by Baily, Starry, Alderson and Moreland (1999) measured occupational

engagement and performance in an IP setting. This study was distinct due to its emphasis of the

participants’ autonomy and responsibility for their own treatment program. The participants identified 5

goals and rated them through the use of the COPM (Law et al., 2005). This study proved that creating

personal goals is clearly beneficial as it provides the opportunity for participants to engage in more

meaningful occupations. This study also shows that the use of the COPM is a particularly useful tool in


assessing, identifying, and measuring occupational engagement, performance and satisfaction.

Additionally, this study incorporated group building, which may have contributed to the significant

changes observed in the COPM scores. Unlike the other studies, Baily, Starry, Alderson and Moreland

(1999) emphasized the importance of developing a social support network in order to maximize the

potential therapeutic benefits of group building, such as increased motivation and self-efficacy. Not only

did this study incorporate a biopsychosocial model through a multimodal approach, it also focused on

occupational performance and satisfaction. This occupational focus is unique to this study, and may have

been a crucial contributor to the significant results of this study. This study has provided insight into the

beneficial role of an OT lens in FM intervention through the use of an occupationally-focused outcome

measure, which has not been included in previous studies.

The current clinical management of FM, which encompasses a biospychosocial frame of

reference, is consistent with OT philosophy and practice, which is holistic. The occupational therapy

scope of practice addresses the physical, psycho-emotional, sociocultural, cognitive-neurological and

environmental determinants of occupations. As such, OTs would be suitable to effectively lead and deliver

a multimodal intervention program that tackles the complex multifactorial nature of the FM syndrome.

The emphasis on occupational engagement in OT-led interventions is a significant component in OT

philosophy, which posits that meaningful occupations maximize positive health outcomes (Townsend &

Polatajko, 2007). Thus, with an OT-led FM intervention clients will not only be exposed to each mode of

intervention, but also integrate and apply the modes of intervention through meaningful activities, and

subsequently enhance their general health and well-being (Rochman & Kennedy-Spaien, 2007).

Conclusion. From the aforementioned literature review, it is evident that there are clear benefits

to multimodal intervention methods in FM management, such as improvements in quality of life, self-

efficacy and physical functioning. However, there are limitations and gaps in the literature that warrant

future research, such as the variability in research methodology and outcome measures. Only one study

included an occupationally-focused outcome measure. Also, studies have not investigated if there are

differences in the delivery of services between health care professionals, or between IP and OT


interventions. The proposed research study aims to address this gap by comparing the effect of the

delivery of multimodal intervention by an IP team to the delivery of a multimodal intervention led by one

OT, in order to better serve the needs of rural clinical settings that lack sufficient professional and

monetary resources.

Methods

Study Design

This study will be a non-blinded randomized control trial that will include 180 participants from

the TAP waitlist. Before randomization, participants will complete an initial intake to confirm

demographic information and fulfillment of inclusion criteria. Participants will be randomly assigned into

three groups of 60 individuals: Group A will receive the existing IP multimodal intervention program

provided by TAP; Group B will receive an OT multimodal intervention program; and Group C will be a

control group that will remain on the TAP waitlist until the completion of the study. Once the study is

completed, Group C will be offered the traditional TAP program. The intervention will be conducted in

three 8-week cycles. Each cycle will consist of two concurrent groups of 10 individuals; one subgroup

will take place on Mondays and Wednesdays, and another subgroup will take place on Tuesdays and

Thursdays (see Figure 2). Outcome measures will be completed prior the beginning of the program (pre-

test), 8 weeks following the completion of the program (post-test), and 6 months following the program.


Figure 2. Study design illustrating three intervention cycles and points of assessment (pre-test, post-test,

and 6-month follow-up). TAP = The Arthritis Program, IP = interprofessional, OT = occupational therapy,

and CG = control group.

Participants

This study will take place at TAP at the LRHC. TAP has a significant amount of applicants on a

waitlist to participate in current IP multimodal FM interventions. Participants on this waitlist have already

been referred from their physician or rheumatologist. To be eligible for the study, participants have to: be

at least 18 years and older; meet the 1990 ACR diagnostic criteria for FM; commit to an 8-week period of

intervention; and be willing to attend the group program at specific daytime hours. Participants were

excluded from the study if: they have any existing acute musculoskeletal or cardiovascular conditions that

would prevent them from exercising; they have any co-existing diagnoses affect their ability to learn; they

are not able to communicate in English; and they have been involved in a previous FM program.


Outcome Measures

The Canadian Occupational Performance Measure (COPM). The COPM is a standardized,

qualitative measure designed to detect change in an individual’s self-perception of occupational

performance over time (Law et al., 2005). It has a semi-structured interview format, and consists of 4

main steps: 1) identifying occupational performance issues in self-care, productivity, and leisure; 2) rating

the importance of each identified issue on a scale of 1-10; 3) and 4) assessing and reassessing,

respectively, the performance and satisfaction levels of the top five issues of importance, also on a on a

scale from 1-10 (Law et al., 2005). The scoring system allows the evaluator to measure change in

performance and satisfaction of occupation over time. The COPM is based on a client-centered model of

practice as evidenced by the amount of client involvement in the assessment process (Parker & Sykes,

2006). It has been shown to be a clinically useful and responsive measure (Carswell et al., 2004).

Reliability. The COPM has good test-retest reliability. Reliability measures range between 0.84-

0.92 (Pearson’s r), depending on the study (Law et al., 2005). These measures are well over the acceptable

range, demonstrating that the COPM can be repeated to produce stable results over varying intervals

(Carswell et al., 2004).

Validity. Generally, studies on validity support the COPM as a valid measure of occupational

performance (Carswell et al., 2004). The COPM has been validated against a variety of measures,

including functional measures such as the Functional Independence Measure (FIM) and measures of

psychological and social functioning, such as the Life Satisfaction Scale (LSS) (Law et al., 2005). The

Reintegration to Normal Living Scale (RNL) yielded particularly notable results (r=0.72-0.93), most

likely due to its conceptual similarly with the COPM (Chen et al., 2002).

The Fibromyalgia Impact Questionnaire (FIQ). In the late 1980s, the FIQ was developed as a

response to the absence of formal psychometric testing for the FM population (Bennett, 2005). The FIQ is

a self-administered outcome measure organized into 20 questions. The first 11 questions ask about

physical functioning (the ability to perform large muscle tasks) on a 4-point Likert scale (Always, Most,

Occasionally, Never). Questions 12 and 13 ask individuals to mark the number of days (0-7) that they felt


well, as well as the number of days that they were unable to work, respectively. Questions 14-20 are 10-

increment horizontal scales on which individuals rate work difficulty, pain, fatigue, morning tiredness,

stiffness, anxiety, and depression (Bennett, 2005). In the original FIQ study by Burckhardt, Clark, &

Bennett (1991), the FIQ, along with the Arthritis Impact Measurement Questionnaire (AIMS) was mailed

to 64 female subjects with FM (mean age of 45) at weekly intervals for a total of 6 weeks. A secondary

group of 25 females, attending the Oregon Health Sciences University Fibromyalgia Treatment Clinic,

also completed the FIQ as part of their clinical evaluation. The report concluded that the FIQ was a

credible and psychometrically sound instrument (Burckhardt, Clark, & Bennett, 1991). Currently, it is the

one of the primary outcome measures in FM management in both research and clinical settings (Bennett,

2005).

Reliability. The FIQ has reliable test-retest characteristics. In the original FIQ report, Burckhardt,

Clark, & Bennett (1991) measured a reliability range (Pearson’s r) from 0.56 on the pain score to 0.95 for

physical function. The internal consistency (Cronbach's alpha) was not evaluated in the original analysis

(Bennett, 2005).

Validity. Both construct and content validity were measured in the original study by Burckhardt,

Clark, & Bennett (1991). The construct validity was evaluated by measuring the correlation of the FIQ

items with the AIMS. The strongest correlations with the corresponding AIMS items were physical

functioning (r=0.67), pain (r = 0.69), depression (r = 0.73), and anxiety (r = 0.76). The content validity

was evaluated from analyzing the missing data and relevance of the sub-items (Bennett, 2005). From this

analysis, it was found 2 items of the physical functioning item (question 1) were incomplete; “wash dishes

by hand” was missing from 11% of the questionnaires, and “don’t do yard work” was missing from 20%

of the questionnaires. Additionally, the 2 work-related questions (13 and 14) were not relevant to 38% of

the subjects, since they were not working outside the home (Burckhardt, Clark, & Bennett, 1991).

Arthritis Self-Efficacy Scale (ASES). The ASES is an instrument used to measure perceived

self-efficacy. It was developed while studying the effects of the Arthritis Self-Management Course

(ASMC) at Stanford University (Lorig et al., 1989). During the ASMC, the researchers found that some


subjects who participated in the ASMC had less pain and were more active than controls; moreover, this

persisted for 20 months after, with little to no association between adherence to the ASMC protocols or

changes in health status (such as pain or disability). The ASES was then developed as a tool to determine

if perceived self-efficacy influences the level of pain and activity that ASMC participants experience.

While developed for chronic arthritis patients, the ASES has been prominently used in FM research and

management, due to the role self-efficacy has on minimizing and/or exacerbating some FM symptoms

(Burckhardt, 2006). The ASES is a self-administered, 20-item questionnaire consisting of three subscales:

pain (5 questions), physical function (9 questions), and other physical symptoms (6 questions) (University

of Western Ontario, 2010).

Reliability. The ASES has shown to have good reliability measures, all of which are greater than

0.75 (Cronbach’s alpha). In the original study by Lorig et al. (1989), the evaluation of test-retest reliability

yielded 0.87 for pain, 0.85 for physical function, and 0.90 for other physical symptoms. The evaluation of

internal consistency has similar results, with 0.75 for pain, 0.90 for physical function, and 0.87 for other

physical symptoms.

Validity. The ASES has met reasonable standards for construct validity, ranging from r=0.35 to

r=0.73 (Pearson’s r) (Lorig et al., 1989).

Short Form-36 (SF-36). The SF-36 is a multipurpose 36-question health survey that consists of

eight scales that measure aspects of health status: physical functioning, role-physical, bodily pain, general

health perceptions, vitality, role-emotional, social functioning, and mental health (Barisa, Young, &

Callahan, 2005). These eight health concepts were selected from 40 concepts included in the Medical

Outcomes Study and represent the most frequently measured concepts in health surveys, and are also

those most affected by disease and intervention (Medical Outcomes Trust, 1991). Additionally, the SF-36

includes two summary measures: physical, which encompasses physical functioning, role-physical, bodily

pain, and general health; and mental, which encompasses vitality, role-emotional, social functioning, and

mental health (Barisa, Young, & Callahan, 2005). Currently, the SF-36 is used in comparing general and

specific populations, comparing the relative burden of diseases, differentiating the health benefits


produced by a wide range of different interventions, and screening individual patients (Ware, 2000). The

multifaceted nature of the SF-36 is apt to address the variety of health aspects presented in FM, and

enables results from studies conducted with individuals with FM to be compared to other diagnoses. Also

of importance is its status as a rigorously tested and psychometrically sound tool (Barisa, Young, &

Callahan, 2005).

Reliability. Several studies have evaluated the SF-36 for test-retest reliability and internal

consistency. Over 25 of these studies have published reliability statistics that exceed the minimum

standard of 0.70 (Cronbach’s alpha) recommended for group comparison measures. The reliability

measures in descending order for each scale are: Physical functioning = 0.93; physical health summary =

0.92; role-physical = 0.89; mental component summary = 0.88; bodily pain = 0.90; general health = 0.8;

vitality = 0.86; social functioning = 0.68; role-emotional = 0.82; and mental health = 0.84 (Ware, 2000).

These trends in reliability coefficients have also been replicated across 24 patient groups with diagnostic

and social-demographic variability, making the SF-36 a sufficiently reliable tool (Barisa, Young, &

Callahan, 2005).

Validity. The SF-36 was also assessed for construct and content validity in various studies. In

terms of content, the SF-36 has been favourably compared to that of other widely used generic health

surveys and includes eight of the most frequently measured health concepts (Ware, 2000). However, the

SF-36 does not include many concepts covered in other health surveys, such as sleep adequacy, cognitive

functioning, sexual functioning, health distress, family functioning, self-esteem, and eating. The SF-36

correlates well with most of these health concepts (r > 0.40), with the exception of sexual functioning

(Ware, 2000).

Intervention Protocol

IP multimodal intervention. The current 8-week program at TAP consists of bi-weekly sessions that

are each 1.5 hours in duration. The structure of the IP program is as follows:

● Week 1: Psychoeducation sessions administered, by a nurse;

● Weeks 2 and 3: Exercise sessions, led by a physical therapist;


● Weeks 4 and 5: Energy conservation sessions, led by an occupational therapist;

● Weeks 6 and 7: CBT, led by a psychologist;

● Week 8: Summary and discussion, led by a nurse.

OT multimodal intervention. Like the IP program, the occupational therapy program will also

consist of bi-weekly sessions that are each 1.5 hours in duration. This program will be led by one OT, who

will administer all sessions. The first four weeks will feature an organization similar to the IP program:

psychoeducation sessions for week 1; exercise sessions for week 2; energy conservation sessions for week

3; and CBT sessions for week 4. The next 4 weeks will be organized into occupation-focused “themes”

that integrate the four main modalities:

● Week 5: Meditation; sessions will incorporate physical exercise and CBT principles through

simple Yoga and Tai-chi.

● Week 6: Household chores; sessions will emphasize the application of energy conservation

techniques and CBT principles while cooking and cleaning.

● Week 7: Music therapy; sessions will feature a drum circle and dance lesson, incorporating

physical exercise and emphasizing engagement in leisure.

● Week 8: Outdoor activities; sessions will include gardening and walking to a local supermarket

for grocery shopping, in order to incorporate elements of physical exercise and energy

conservation.

Statistical Analysis

Descriptive statistics will be conducted on demographic data. T-tests will be used to determine if

there are any base line differences between the groups. The demographic data will be summarized through

Fisher’s exact test for age, gender, ethnicity, education, employment, income and marital status. A

repeated measures ANOVA will be used for the comparison of changes between the three groups from

pre-intervention, post-intervention and 6 month follow-up will all be compared (Glasser, 2008). The

average of each group’s total scores on the three outcome measures, as well the subscales of these

outcome measures will be compared to each group. The statistical significance will be set to p = .05. A


power calculation will be performed to determine the number of participants required to determine

significance set at p = .05. A Tukey Post-hoc analysis will be conducted to determine significant

differences within each group.

Statement of Ethics

Informed consent will be obtained upon referral to the program, before the intake process which

will outline the potential risks, benefits and side effects of the FM intervention. Ethics approval will be

obtained through Queen’s General Research Ethics Board. There are no anticipated harms or risk to the

participants of this study.

Expected Outcomes

The total number of participants that completed the program was 174. There were no statistical

differences between demographics between all three groups. Each group included 95% female and 5%

male participants. The average age of participants was 45 years old, and the range differed between 20-75

years old.

The Canadian Occupational Performance Measure (COPM)

There were significant improvements measured post-test and 6-months following intervention, in

the IP and OT groups for the self-rated performance and satisfaction with meaningful occupations in the

COPM change scores (see Figure 3). The COPM change scores of the OT groups were larger than that of

the IP-led intervention groups immediately following the 8 weeks of intervention. The COPM change

scores remained significant after 6 months of intervention but were slightly lower than the post-test scores.

The control group COPM scores remained fairly similar and no significant changes were noted.


Figure 3. Pre-test, post-

test, and 6- month follow-up

COPM scores for

interprofessional

(IP), occupational

therapy (OT), and control

groups (CG).

The Fibromyalgia Impact Questionnaire (FIQ)

The total scores for the FIQ improved significantly post-test and remained significant for 6

months following intervention in both intervention groups. No difference was found in the control group

between baseline and post-test and follow-up (see Figure 4). Both the IP and OT groups showed very

similar changes post-test. No differences were found between the IP and OT groups. The difference

between post-test and the 6-month follow-up did not change significantly.

Figure 4. Pre-test, post-test, and 6-month follow-up FIQ scores for interprofessional (IP), occupational

therapy (OT), and control groups (CG).

Pre-test Post-test 6-month follow-up0

1

2

3

4

5

6

7

IP

OT

CG

Scor

e


1015202530354045505560

IP

OT

CG

Tot

al S

core


Arthritis Self-Efficacy Scale (ASES)

The ASES scores improved significantly post-test and remained significant after 6 months for

both the IP and OT groups (see Figure 5). Differences between the IP and OT groups were not significant.

No changes were measured from post-test to 6-month follow-up for both the IP and OT groups.

Participants that received OT interventions reported slightly greater improvements in their total ASES

scores than the IP participants, and remained greater 6 months following intervention. There were no

changes measured for the control group from baseline to 6-month follow up.

Figure 5. Pre-test, post-test, and 6-month follow-up ASES total scores (8-item subscale) for

interprofessional (IP), occupational therapy (OT), and control groups (CG).

Short Form-36 (SF-36)

The results of the baseline, post-test and 6-month follow-up SF-36 scores are summarized in

Table 2. Statistically significant changes were seen in the scales of physical function, bodily pain, social

function, vitality (energy/fatigue) and general health in both the IP and OT groups. Greater improvements

were reported by the OT intervention groups in the social functioning scale both post-test and 6 months

following intervention as compared with the IP groups. For all significant scales measured, scores

remained significant from baseline after intervention and the following 6 months for both the IP and OT

intervention groups. In all scales the control group measures remained insignificant.


1

2

3

4

5

6

7

8

IP

OT

CG

Tot

al S

core


Table 2Pre-test, post-test, and 6-month follow-up scores for each subscale of the SF-36.

Physical Function IP OT CG

Pre-test 44.3 43.0 45.0Post-test 51.8* 52.2* 46.06-month 53.2* 53.0* 43.0

Role Physical IP OT CG

Pre-test 16.1 16.5 16.3Post-test 25.0 30.0** 16.66-month 20.0 29.4** 16.7

Bodily Pain IP OT CG


Mental Health IP OT CG

Pre-test 59.9 58.0 58.4Post-test 63.2 62.0 57.96-month 64.6 63.5 56.9

Role Emotional IP OT CG

Pre-test 47.6 46.6 45.5Post-test 54.8 60.5** 46.76-month 60.7 66.9** 44.9

Social Function IP OT CG

Pre-test 46.9 46.9 43.6Post-test 56.7* 60.1** 45.56-month 60.0* 63.8** 44.4

Vitality (Energy/fatigue) IP OT CG


General Health IP OT CG

Pre-test 38.3 37.5 34.7Post-test 45.6* 45.2* 33.46-month 47.4* 47.9* 34.6* Statistically significant, p = .05** Statistically significant between groups, p = .05IP = interprofessional, OT = occupational therapy, and CG = control group.


Discussion

The expected outcomes demonstrate that both the IP and OT intervention groups, in comparison

to the control group, produce statistically significant results in outcome measure scores. This includes

decreasing the impact of FM, as measured by FIQ (Figure 4); increasing self-efficacy, as measured by

ASES (Figure 5); and improving physical function, bodily pain, social function, vitality, and general

health, as measured by SF-36 (Table 2). These results support past studies that have found multimodal

fibromyalgia interventions provided by IP teams enhance overall functioning in individuals with FM, and

correspond with a growing body of knowledge that supports IP multimodal interventions as the gold

standard of chronic of pain management (Bailey, Starr, Alderson & Moreland, 1999; Bennett et al., 1996;

Gowans, de Hueck, Voss & Richardson 1999; Keele, Bodoky, Gerhard & Mulle, 1998; Leudtke et al.,

2005; Mason, Goolkasian & McCain, 1998; Mengshoel, Forseth & Haugen,1995; Oh et al., 2010; Oh et

al., 2012; Pfeiffer et al., 2003; Wennemer et al., 2006; Worrell, Krahn, Sletten & Pond, 2001).

What this study adds to the literature is that multimodal interventions provided by a single

discipline produced similar results to IP groups. These findings support the hypothesis that OTs have the

background knowledge and competencies to effectively implement multimodal FM interventions in the

absence of an IP team. This has important clinical implications: it can meet the needs of rural clinical

settings that have limited access to health care services, and it expands the role of OT in FM management.

With the current expansion of the role of OT in Family Health Teams (FHTs), an OT-led multimodal FM

management program may be a possibility.

OT groups have also demonstrated some statistically significant improvements in comparison to

IP groups. This includes improving the role limitations to due physical function, the role limitations due to

emotional function, and social functioning (Table 2). This may be due to the incorporation of occupational

engagement in OT groups – in addition to the standard modes of intervention, the OT groups apply them

in meaningful ways and within a social context. This may also explain the slight improvements in self-

efficacy in comparison to IP-led groups (Figure 5). However, these results were not statistically


significant, and so warrant further inquiry into the role of occupation-focused groups in self-efficacy in the

context of FM management.

As aforementioned, a unique aspect of this study that differs from IP-led groups is the emphasis of

occupational engagement. The COPM was chosen to measure changes of occupational performance and

satisfaction based on the participation of occupation-focused activities in the program. The COPM offers

participants the opportunity to identify and focus on their personal goals, thus allowing them to be

personally invested in their treatment and enables them to fully participate in meaningful activities. The

result of the COPM assessment in our study (Figure 3) yielded expected results – the participation in

activities that encourage occupational engagement improves occupational performance and satisfaction.

While IP groups also improved COPM scores, the difference between OT and IP groups are statistically

significant.

Another noteworthy observation in our analysis, which is seen in all outcome measures, is a slight

decline in scores at the 6-month follow-up. This may be explained by the level of self-management

maintained by participants. After discharge from the program, adherence to the regimes learned in

intervention is essential in managing FM symptoms (Dobkin et al., 2008). Adherence to these regimes is

influenced by differences in individual characteristics such as coping or depression, which cannot be fully

addressed in an 8-week program (Dobkin et al., 2010).

Limitations and Future Directions

As mentioned previously, no research was found comparing IP groups with OT groups, or solely

OT groups, so more research is warranted in this subject in order to corroborate this study’s findings. The

cost analysis between IP groups with OT groups should also be explored to determine if there is an

additional benefit of OT-led interventions. Additionally, this study takes place in an urban centre. Since

our goal is to make FM intervention more accessible in rural communities, it would be beneficial to

replicate this study in rural satellites, in order to analyze the results within the targeted context. The results

themselves would also be more ecologically valid. It would also be beneficial to replicate this study for

different demographic populations in order to determine if the results of the study are generalizable. The


modalities of the intervention and the outcomes measures used would have to be consistent between

studies in order to make valid comparisons. Also, larger sample sizes in these studies would provide more

statistically sound results.

Clinical Implications

This study demonstrates that OT can produce similar or even better results than IP interventions,

therefore demonstrating that OTs can provide effective FM intervention and care. Not only does this show

the value of occupational engagement in addressing FM populations, it further demonstrates the feasibility

of providing FM interventions in rural communities by OTs. This also contributes to the current

expanding role of OT in rural primary care. The recent inclusion of OT in FHTs expands the possible

settings within rural communities for FM interventions to take place. This will provide rural populations

with more opportunities to access FM care, instead of traveling to large urban centres where FM programs

are typically provided.

Conclusion

The aim of this study was to inquire if OT-led multimodal FM intervention would produce similar

results as IP-led multimodal FM intervention, as well as to determine the additional benefits of

incorporating occupational engagement in multimodal intervention. The results of this study confirmed

that OT-led interventions could produce similar results to IP-led interventions, ultimately making FM

interventions accessible in rural communities, in which IP teams are not always feasible. However, further

research is required in order to replicate this study and validate these results.


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