evidence grid: purpose of research elements: major findings … · 2018-09-07 · design:...

27
Evidence Grid: Article citation in APA format Level of evidence Purpose of study/research questions Research elements: - Design - Sampling method - Sample size - Brief description of interventions (if any) - Outcomes measured Major findings relevant to project Critique of validity, bias and significance for your project Andrasik, F. (2010). Biofeedback in headache: An overview of approaches and evidence. Cleveland Clinic Journal of Medicine, 77(3), 72-76. doi: 10.3949/ccjm.77.s3.13 Level of Evidence: I Purpose: This article reviews the supportive evidence for each category of biofeedback approaches to headache therapy Design: Systematic Review Sampling Methods: Review of all relevant published studies from: National Institutes of Health, the Canadians Headache Society, the American Psychological Association, the Society of Pediatric Psychology, the Association for Applied Psychophysiology and Biofeedback, and the US Headache Consortium. Sampling Size: A, B, or C evidence quality were reviewed. -The findings from studies and reviews conclude that: 1. Various forms of biofeedback are effective for migraine and tension- type headache, 2. Outcomes with biofeedback rival outcomes with medication therapy, 3. Combining medication and biofeedback can enhance outcomes, 4. Outcomes from biofeedback are similar to those obtained with other behavioral approaches, 5. The outcome effects from biofeedback seem to endure for extended periods, and 6. Although biofeedback has been shown to be effective for a number of patients, some patients do not achieve significant relief. Weaknesses: - Sample size Strengths: - The review question is clearly stated. - The search strategy was effective and appropriate databases were used. - Reviews methods are consistent in findings. - Biofeedback has led to improvements in headache therapy for children and adults. Significance for this project: - Includes evidence that consistently show improvement of outcomes. - Recommendations made for future research include an increase in training

Upload: others

Post on 25-May-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Evidence Grid: Article citation in APA format Level of evidence

Purpose of study/research questions

Research elements: - Design - Sampling method - Sample size - Brief description of interventions (if any) - Outcomes measured

Major findings relevant to project

Critique of validity, bias and significance for your project

Andrasik, F. (2010). Biofeedback in headache: An overview of approaches and evidence. Cleveland Clinic Journal of Medicine, 77(3), 72-76. doi: 10.3949/ccjm.77.s3.13 Level of Evidence: I

Purpose: This article reviews the supportive evidence for each category of biofeedback approaches to headache therapy

Design: Systematic Review Sampling Methods: Review of all relevant published studies from: National Institutes of Health, the Canadians Headache Society, the American Psychological Association, the Society of Pediatric Psychology, the Association for Applied Psychophysiology and Biofeedback, and the US Headache Consortium. Sampling Size: A, B, or C evidence quality were reviewed.

-The findings from studies and reviews conclude that: 1. Various forms of biofeedback are effective for migraine and tension-type headache, 2. Outcomes with biofeedback rival outcomes with medication therapy, 3. Combining medication and biofeedback can enhance outcomes, 4. Outcomes from biofeedback are similar to those obtained with other behavioral approaches, 5. The outcome effects from biofeedback seem to endure for extended periods, and 6. Although biofeedback has been shown to be effective for a number of patients, some patients do not achieve significant relief.

Weaknesses: - Sample size Strengths: - The review question is clearly stated. - The search strategy was effective and appropriate databases were used. - Reviews methods are consistent in findings. - Biofeedback has led to improvements in headache therapy for children and adults. Significance for this project: - Includes evidence that consistently show improvement of outcomes. - Recommendations made for future research include an increase in training

Page 2: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Intervention: Evaluation of the general use of biofeedback-assisted relaxation techniques were reviewed. Outcomes Measured: The reviews and studies have consistently shown that outcomes for the individual treatments are similar in magnitude and that the combination of both behavioral and pharmacological treatment leads to even greater effects

sessions

Baillie, L. E., Gabriele, J. M., & Penzien, D. B. (2013). A systematic review of behavioral headache interventions with an aerobic exercise component. American Headache Society. (54), 40-53. doi: 10.1111/head.12204. Level of Evidence: I

Purpose: To evaluate studies using behavioral headache interventions with an aerobic exercise component and compare to the use of pharmacological treatments only.

Design: Systematic Review Sampling Method: Databases such as PubMed, Medline and PsychInfo were used to search for studies that offered and recommended exercise as a part of multidisciplinary treatment for headaches. Only articles that were written in English and published in

- Incorporation of exercise into behavioral headache treatments appears to be promising. - Further study is needed to evaluate the unique role of exercise in treatment programs - None of the studies found that the intervention was associated with worse outcomes at post-treatment, or compared with control groups. - Inclusion of exercise in headache treatment does

Weaknesses: - Small sample size. Strengths: - The review question is clearly stated. - The search strategy was effective. - Comprehensive search methods and appropriate databases were used. - Review methods are documented within each study. Significance for this project:

Page 3: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

academic journals were included in the search. Sample Size: 9 studies, 2 of which were randomized controlled trials, 2 were non-randomized, and 5 studies described results of a single-group intervention. Interventions: Incorporations of exercise into behavioral headache treatments to include: exercise dose, delivery format of the exercise intervention, session supervision, type of exercise, and non-exercise treatment factors. Outcomes Measured: Evaluation of headache frequency, headache intensity, number of headache days, disability, quality of life, depression, medication use, and doctor visits.

not appear to be harmful. - Exercise is associated with improved cardiovascular fitness which may be reason to include it in behavioral headache treatments (relationship between exercise and headache variables is not yet understood) - Participants indicated that they found the exercise component to be the most helpful aspect of the treatment program. - Positive outcomes for secondary variables were reported (i.e. quality of life) decreased disability and decreased depression.

- The improvements that could be made to conduct a better application of evidence - There were recommendations made for future research: 1. More RCT’s needed; the design is essential to establishing the effectiveness of a given treatment and 2. Reporting of outcomes for specific headache diagnosis should be for individual headache types. - Regarding the exercise treatments, there should have been more information to help determine the effectiveness of physical activity on headaches, and more specific guidelines should have been established for exercise regime.

Campbell, J. K., Penzien, D. B. & Wall, E. M. (2012). Purpose: Focus Design: Evidence- - Long-term goals for using Weaknesses:

Page 4: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Evidence-based guidelines for migraine headache: Behavioral and physical treatments. US Headache Consortium. Retrieved from http://tools.aan.com/professionals/practice/pdfs/gl0089.pdf Level of Evidence: I

evidence-based treatment recommendations for behavioral and physical therapies currently used for acute treatment or prevention of migraine with headache guidelines.

based clinical practice guidelines based on systematic reviews Sampling Method: Empirical evidence limited to studies in the AHCPR technical review. Only published literature on reported randomized, control trials, published in English and evaluated adult migraine patients. Sample Size: 39 controlled trials of behavioral treatments for migraines Interventions: Controlled trials of behavioral or physical treatments aimed at the prevention of migraine headaches or relief of symptoms included relaxation training, biofeedback training, cognitive-behavioral therapy, hypnosis, and various combinations of these interventions.

these treatment methods for migraine prevention include: decrease frequency and severity of headache, decreased headache related disability, decreased reliance on non-tolerated pharmacological treatments, personal control of migraine, and decreased headache-related stress. - Improvements were noted with each type of therapy. - Involving the patient in developing a management plan is critical to success of the treatment. Set realistic goals and recognize success. - Relaxation training obtained a statistically significant and moderately large effect size of 0.55. - Hypnosis demonstrated improvement over control meds but not different than a biofeedback/relaxation therapy. - Biofeedback showed 37% improvement but no long-term clinical benefit. - Acupuncture showed a reduction of 53% in frequency of disabling headache. - Cervical manipulation – post scores were

- The sample of studies included in the meta-analysis could include bias. - Small sample size. Strengths: - Focus is aimed on evidence-based treatment recommendations for behavioral and physical therapies used for treatment or prevention of migraines. - Includes comparisons of behavioral treatments with drug treatments, this is a big portion of my project. Significance to this project: - Since the focus on this project is evaluating the addition of non-pharmaceutical techniques in addition to pharmaceutical therapy only. - This article supports the theory that behavioral therapy in combination with pharmacological therapy can have a

Page 5: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Outcomes Measured: Goals are focused on reduction of migraine headaches. Behavioral and physical interventions are used for preventing migraines rather than alleviating symptoms once the migraine has begun. The interventions can be used in combination with pharmacological therapy.

significantly better than pre-treatment scores for headache frequency, severity, and disability, but not for duration.

better overall outcome in relation to migraine headaches.

Chaibi, A., & Tuchin, P. (2011). Manual therapies for migraine: A systemic review. J Headache Pain. (12), 127-133. doi: 10.1007/s10194-011-0296-6. Level of Evidence: I

Purpose: To assess the efficacy of manual therapies on migraine.

Design: Systematic Review Sampling Method: Databases such as CINAHL, Cochrane, Medline, Ovid and PubMed were searched. All RCTs written in English using manual therapy on migraine were evaluated. The evaluation of covered study population, intervention, measurement of effect, data presentation and

- Massage therapy included 26 participants with chronic migraine: American study showed massage therapy had a significantly effect on pain intensity. Pain intensity was reduced 71%. New Zealand study showed migraine frequency was significantly reduced while intensity was unchanged. -Physical therapy included female migraineurs with frequent attacks: American study showed reduction in headache severity.13% had 50%

Weaknesses: - Regarding the studies, there should have been more specific criteria for patients to be included, this allowed for different results. - Some RCTs included a control group and some did not, therefore the interpretation is not straightforward. - The methodological quality has room for improvement. - Type 2 errors could have occurred.

Page 6: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

analysis. The maximum score is 100 points and ≥ 50 points considered to be methodology of good quality. Sample Size: 7 RCT studies, 2 massage therapy studies, 1 physiotherapy study, 4 chiropractic spinal manipulative therapy studies. Interventions: Massage therapy, physical therapy, and chiropractic spinal manipulative treatment were introduced as treatment for patients and evaluation of at least one migraine outcome measure was studied (pain intensity, frequency, or duration). Outcomes Measured: Evaluation of at least one migraine outcome such as pain intensity, frequency, or duration was measured.

reduction or more in mean headache severity in the physical therapy group and 51% had 50% reduction or more in mean headache severity in the relaxation group. - Chiropractic spinal manipulation therapy showed: Australian study included migraineurs diagnosed by neurologist who experiences reduction in attack frequency. American study included migraineurs diagnosed by chiropractor that experienced reduction in intensity and frequency. -Each study included comparison of therapy with use of prophylactic treatment (propanol and topiramate) Massage therapy – 27-28% showed therapeutic gain in frequency verses 6,16, and 29% therapeutic gain by prophylactic treatment with topiramate. Physiotherapy – 50% reduction in migraine intensity verses 23-49% in prophylactic treatment with topiramate and 44% with propranolol.

Strengths: - The review question is clearly stated. - The search strategy was effective. - Comprehensive search methods and appropriate databases were used. - Review methods are documented within each study. Strengths: - Improvements that could be made to conduct a better application of evidence - There were recommendations made for future research: well-conducted RCTs without the many methodological shortcomings of the evaluated RCTs on manual therapies. - Studies should follow clinical trial guidelines from the International Headache Society.

Page 7: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Chiropractic Spinal Manipulative Therapy (CSMT) showed reduction in migraine frequency across the board equivalent to topiramate 100mg/day and the efficacy is equivalent to that of propranolol.

Estemalik, E., & Tepper, S. (2013). Preventive treatment in migraine and the new US guidelines. Neuropsychiatric Disease and Treatment. (9), 709-720. doi: 10.2147/NDT.S33769. Level of Evidence: I

Purpose: To establish a set of guidelines, not only to when to start preventative treatment for headaches, but on selection of preventative for patients.

Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method: 2012 guidelines on preventative medications for migraines, clinical studies, and technical reports were searched. Sample Size: 4 class studies that included random control trials comparing assessments Interventions: Preventative medication therapy was used in each class studied. Outcomes Measured: A new set of guidelines with an evidence review on

- The set of guidelines published in 2012 gave a Level A rating to valproate, topiramate, metoproplol, Petasites, propranolol, timolol, and for short-term menstrual migraine prevention – frovatriptan. - Preventative medication therapy was rated as follows: Level A-established effective, Level B: probably effective, Level C: possibly effective, Level U: inadequate or conflicting data to support or refute use, and Other: treatments that are established as possibly or probably effective. Of the Antiepileptic drugs: divalproex sodium/sodium valprotate and topiramate proved effective in treatments (Level A). Of the Antidepressant drugs – Venlafaxine proved as effective as amitriptyline

Weaknesses: Total number of studies have been few with regards to preventative medications in migraine headaches. Strengths: This review was based on guidelines that were presented in 2000 and reevaluated with new results. Significance to this project: This article gives supportive evidence that preventative therapy is a way to decrease episodes of headache.

Page 8: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

preventative medications was published. A second set of guidelines provided evidence of NSAIDs, herbs, minerals and vitamins for prevention of episodic migraine.

in preventative medication for migraines (Level B). Of the Antihypertensive drugs – Lisinopril and candesartan are possibly effective in migraine prevention (Level C). Of the Betablockerspropranolol and metoprolol were shown to be effective (Level A). Calcium channel blockers – have been downgraded as not effective (Level U). Triptans – Frovatriptan, zolmitriptan and naratriptan were shown to be effective in short-term prevention of menstrual related migraines (Level A). NSAIDs, herbals preparations, minerals vitamins, and others ranged from all levels. - When starting medications they should be started at a low dose, raised to optimal dosage as needed, and continued for 2-3 months. - Patients should keep a headache journal to assess progress of treatment and headaches. - Selection of medication should be based on level of evidence for efficacy,

Page 9: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

adverse effect profile, and patient comorbidities. - Patients should be educated about medication.

Rocket, F., de Oliveria, V., Chaves, M., de S Perla, A., Perry, I. (2012). Dietary aspects of migraine trigger factors. Nutrition Reviews. 70(6), 337-356. doi: 10.1111/j.1753-4887.2012.00468.x Level of Evidence: I

Purpose: To evaluate evidence in literature that substantiates the existence of dietary trigger factors in the prophylactic management of patients with migraines.

Design: Systemic Review of Meta-analysis Sampling Methods: Review of all relevant published studies from: PubMed, SciELO databases for descriptors that are cross-listed with migraine, headache, and cephalalgia. Sampling Size: 45 articles were evaluated; 16 population studies, 12 involved interventions or analyzed observational prospective cohorts, and 17 were retrospectively studies. Intervention: Evaluation of the articles about studies conducted were categorized as follows: 1. Population studies of the association of

- 30 dietary items were explored, 7 were addressed experimentally (ice water, ice cream, ice, reduced lipid intake, chocolate, fasting, red wine, and water deprivation.

- Most significant precipitating factor in studies was fasting or skipping meals.

- Dietary factors are reported at a significantly higher frequency by those with migraines than by patients with other types of headaches.

- 18 studies analyzed showed higher frequencies of reports of foods as trigger factors of migraine crises in patients that have migraines with aura than patients with other migraine types.

- 26 studies were evaluated on alcohol as a factor. One study showed heavy

Weaknesses: - There were no medium or long term studies that restricted exposure to previously identified precipitating factors and monitored the subsequent effects. - Some studies conflicted others in results. - Lack of evidence from controlled studies. Strengths: - Comprehensive search methods and appropriate databases were used. - This review evaluates precipitating factors in the management of migraineurs. Significance to this project: - The data found in this review highlight the importance of recognizing precipitating dietary factors or factors in

Page 10: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

migraines with food habits or with prevalence of dietary trigger factors, 2. Studies involving dietary intervention or observational prospective cohorts, and 3. Studies that, although considered transversal, were reported retrospectively in terms of trigger factors with migraine populations. Outcomes Measured: 8 out of the 16 population studies identified dietary precipitating factors associated with migraines. The reviews and studies have shown that dietary intake can possibly trigger migraine headaches.

consumption of alcoholic beverages is significantly associated with migraines and tension-type headaches.

- 7 studies addressed chocolate as a trigger. One study showed frequencies of 19.2%-22.5% among migraine sufferers report chocolate as a precipitating factor.

- 12 studies identified caffeine consumption or caffeine withdrawal as a migraine crisis trigger.

- 7 studies considered citrus fruits and vegetables and citrus fruits showed as a significant factor

- 3 studies showed an association between fatty foods and migraines.

- 4 studies included fluid deprivation or low consumption of fluids as a factor, only one of these studies indicated it not being a factor.

- 7 studies on the consumption of ice cream or ice water addressed it as a factor.

- 12 studies on milk, cheese, and other dairy

the management of migraines.

Page 11: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

products indicated no negative dietary impact.

- 3 studies on meat and eggs were reviewed and considered them a factor.

- 8 studies were used to identify other dietary factors. MSG, aspartame, sodas, walnuts, and sugar was determined a factor.

- One study found that reduction of migraines was seen among groups with diets rich in fiber.

Spouse-Blum, A., Gabriel, A., Brown, J., & Yee, M. (2013). Randomized control trial: Targeted neck cooling in the treatment of the migraine patient. Hawaii Journal of Medicine & Public Health. 72(7), 237-241. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/23901394 Level of Evidence: I

Purpose: To determine if cold therapy/neck cooling treatment is effective at decreasing participant pain levels.

Design: Randomized controlled, crossover clinical trial Experimental Sampling Method: Participants were recruited from the general public through posters, local media, and physician referral then screened to insure they met inclusion criteria. Participants were randomized into one of two arms frozen (treatment), and non-frozen (control). Sample Size: 55 individuals

Results from study include: - 25.5% of

participants met HIS criteria for migraine with aura, 74.5% met criteria for migraine without aura.

- 85.5% were female

- Participants were between the ages of 19-64 with a mean age of 43.1 +/- 11.4 years.

- Reported frequency of migraine attacks varied from less than one per month to daily

Weaknesses: - Limitations include: selection bias due to recruitment from facilities, small size of study, variability of placement of neck wrap since it was place by the participant themselves, targeted neck cooling is intended for headaches with a vascular component, diagnostic criteria could have allowed for false-positives in inclusion of study, and non-blinded assessments involved in subjective

Page 12: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Interventions: All participants were educated on how to use a ice pack on their neck at onset of migraine and then recorded data in migraine diary on the following time intervals: onset, 15 minutes, 30 minutes and one hour after occurrence of migraine and using neck wrap upon onset of migraine. The wrap was worn for 30 minutes then removed. Outcomes Measured: Headache pain was significantly decreased with the application of cold therapy.

with a median frequency of 5.5 attacks per month.

- Mean pain scores at each time interval for both treatment and control arms were 2.83 +/- 0.26 frozen, compared to 2.61 +/- 0.25 non-frozen.

- Treatment arm reported a max pain decrease in pain at 30 minutes, 31.8% +/- 15.2% pain decrease over onset.

- Participants without aura reported a decrease at 30 minutes of 39.3% +/- 13.4% and those with aura a decrease of 11.2% +/- 43.8%.

- When neck wrap was removed pain improvement fell to 27.3% +/- 17.5% at one hour.

- The control arm reported a 31.5%

measurement scales. Strengths: - The results of data acknowledge that cold therapy can affect migraine pain levels. Significance to this project: - The data found in this study confirmed that application of a frozen neck wrap at the onset of migraine targeting the carotid arteries at the neck specifically reduced pain in participants with migraine headaches. - Cold therapy can assist in reducing migraine pain as well as confirm that more research and clinical trials need to be done.

Page 13: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

+/- 20.0% increase in pain at 30 minutes, and increased severity to 35.4% +/- 24.1% at one hour.

Anderson, R. E., & Seniscal, C. (2006). A comparison of selected osteopathic treatment and relaxation for tension-type headaches. American Headache Society, (46), 1273-1280. doi: 10.1111/j.1526-4610.2006.00535.x. Level of Evidence: II

Purpose: To compare the effects of osteopathic treatment and progressive muscular relaxation (PMR) exercises on patients with tension-type headache (TTH) to other methods via research.

Design: Randomized control Trial/ True Experimental Sampling Method: Convenience Sample, Patients were randomly assigned by the treating practitioner to a control (n=12) and a experimental group (n=14) Sample Size: 29 individuals Interventions: All participants were given a headache diary two weeks before the start of the study and maintained 6-7 weeks. Patients were to fill out the diary 4 times per day (mealtime and bedtime) rating the headache on a 6-point scale (0-no headache to 5-

- Outcome was that patients in the experimental group, who did home relaxation exercises and received 3 osteopathic treatments had significantly less frequent headaches than those patients in the control group. - The Control group reported a 15.6% improvement compared to 57.5% improvement from the experimental group. - Treatment group had an increase in headache free days, decreased intensity and decrease in headache frequency. - This study demonstrated that selected osteopathic manual techniques combined with home-based relaxation exercises significantly decreased the frequency of tension-type headaches more than relaxation alone.

Weaknesses: - Small sample size. - One person dropped out and two people were dropped due to incompletion. - One location. Strengths: - True experimental design, randomized control trial. Significance for this project: - This study demonstrated that osteopathic techniques combined with home relaxation techniques can significantly decrease the frequency of TTH more than relaxation techniques alone. - This project discusses the use of not only one method of treatment but combining treatments is more effective.

Page 14: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

intense headache). After two weeks, all patients were given an audiotape and typed instructions on PMR exercises that they were to do at home for 20 minutes and begin recording a relaxation diary. Patients in the experimental group received osteopathic treatments once a week for 3 weeks from the treating practitioner Outcomes Measured: Headache frequency and intensity; Headache free days

Calhoun, A. & Ford, S. (2007). Behavioral sleep modification may revert transformed migraine to episodic migraine. American Headache Society, (47), 1178-1183. doi: 10.1111/j.1526-4610.2007.00780.x Level of Evidence: II

Purpose: To assess the impact of behavioral sleep modifications (BSM) on transformed migraine (TM).

Design: small randomized, single blind, placebo-controlled pilot study. Sampling Methods: Participants completed a packet of information. Baseline self-report information regarding headache frequency, severity, chronicity, sleep characteristics,

- By the second visit, the BSM group reported a statistically significant reduction in headache frequency and intensity. - The BSM group was more likely to have reverted to episodic migraine, while no member of the placebo group reverted to episodic migraine. - By the third visit, 48.5% of the individuals who had received sleep instructions

Weaknesses: - 10 participants dropped out, leaving 36 evaluable subjects. - Limitations include its single-blinded design, which permits the possibility that unblended staff could have been conveyed to the subjects and influenced the outcome. Strengths: - This behavioral trial

Page 15: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

demographics, BMI, and medication use was assessed through patient report. Sampling Size: 43 women with TM. Intervention: Patients were randomized to receive either behavioral sleep instructions or placebo behavioral instructions in addition to usual medical care. Patients recorded headaches in standardized diaries. Outcomes Measured: Analysis found that a targeted behavioral sleep invention was associated with improvement in headache frequency, headache index, and with reversion to episodic migraine in women with TM.

had reverted to episodic migraine. - Adherence to BSM instructions was strongly related to with headache improvement. - Only one participant who adhered to BSM instructions did not revert to episodic migraine. - Among those who were nonadherent with 3 or more instructions, none reverted. - All subjects were instructed to taper or discontinue overused medications. At baseline, 74.4% of the participants were overusing acute agents. By the 12th week (final visit), medication overuse was eliminated in all participants who reverted to episodic migraine, as well as in 60% of those participants who did not revert.

suggests that BSM may be an effective, noninvasive adjunctive treatment for TM. - It is suggested for future studies the use of a double-blind methodology would be beneficial. Significance for this project: - Studies have often supported a link between sleep disruptions and headache chronicity. - This study demonstrated that BSM can be beneficial and can have an impact on TM.

Lawler, S. & Cameron, L. (2006). A randomized, controlled trial of massage therapy as a treatment for migraine. Ann Behav Med, 32(1), 50-59.

Purpose: Design a RCT to assess the effects of massage therapy on migraine

Design: Randomized Controlled Trial Sampling Methods: Migraine sufferers

- Most common triggers of attacks were physical and emotional stressors. -Most common triggers

Weaknesses: - This study did not take place in the U.S. - Limitations may be

Page 16: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Level of Evidence: II

experiences as well as on sympathetic arousal, stresses and coping processes, and sleep behavior in individuals with migraine conditions.

(N = 47) were randomly assigned to massage or control conditions and the within-subjects factor of assessment time over a 13- week period. Baseline phase (4 weeks prior to the first massage session), Intervention phase (6 weeks during massage sessions), and the Follow-up phase (3 weeks after the last massage session). Sampling Size: 48 individuals (40 women, 8 men) ranging from 12 to 60 years in age. Intervention: Migraine sufferers were assigned to either massage or control conditions. The massage participants received a 45-minute massage and the control participants were instructed to keep daily headache diaries of headache

indicated by the participants with ratings of “often”:64% the end of a busy or stressful time, 62% overtiredness, 55% long gaps between meals or insufficient food, 53% worry, 53% muscle tension in the neck and shoulders, 40% depression, 38% alcohol, 34% bright lights, and 34% flashing or flickering lights. - Heart rates and state anxiety scores decreased significantly from pre-massage to post-massage in all 6 sessions. - Cortisol decreased over time. - The massage therapy group did not report improvements in perceived stress or coping efficacy and instead reported sustained levels of these factors over the study. - The control group reported a significant decrease in coping efficacy at the end of the intervention - Massage therapy did not influence sleep quantity but did lead to improvements in sleep quality during the intervention and follow-up

seen due to the RCT used a no-treatment control group that could have created negative effects due to the disappointments from participants who were assigned to the control condition. - Further research is needed to compare treatments. - When using pen and paper diaries it is hard to verify that entries were completed at appropriate times and present a potential for error. Strengths: - This study provides evidence that massage therapy can have beneficial effects on migraine experiences and sleep for individuals with migraines. Significance for this project: - Massage therapy significantly reduced migraine frequency both during the 6 weeks of massage therapy as well as

Page 17: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

frequency and intensity, medication use, and sleep behavior to help gain an understanding of potential triggers and medication outcomes. Baseline measures of migraine characteristics and medication used were collected. Pre-massage and Post-massage measures focused on anxiety state, heart rate, and cortisol levels were measured before and after the first and last massage session. Daily diary measurements were rated 4 times a day. Long-term measures were aimed at stress and coping. Outcomes Measured: Findings support the use of massage therapy as a nonpharmacologic treatment for individuals suffering from migraines.

phases. - Simple effects analyses revealed that the massage group exhibited decreases in migraine frequency and increases in sleep quality in baseline while the control group reported no change. -Simple effects analyses reveled that the control group exhibited decreases in coping efficacy over time and the massage group reported no change.

during the 3 weeks following the end of therapy.

Slavin-Spenny, O., Lumley, M., Thakur, E., Navedal, D., Purpose: To Design: Randomized - Four central findings: Weaknesses:

Page 18: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

& Hijazi, A. (2013). Effects of anger awareness and expression training versus relaxation training on headaches: A randomized trial. Ann Behav Med. 46(2), 181-192. doi: 10.10007/s12160-013-9500-z Level of Evidence: II

develop and test anger awareness and expression training (AAET) on people with headaches.

controlled trial. Sampling Methods: randomized to AAET, relaxation training (RT), or a wait-list control (1:1:1) ratio Assessed affect during sessions, and process and outcome variables at baseline and 4 weeks after treatment. Sampling Size: 147 college students (N=147) who a. experienced headaches several times per month or more frequently, b. rated their typical headache as “moderate” or “severe” in intensity, and c. desired to engage in a stress management treatment for chronic headaches. Intervention: Participants were assigned to either of two intervention conditions. Session 1 had an intervention immediately, then returned the same

1.A brief group-based intervention that enhanced awareness, experience, and adaptive expression of anger reduced-related outcomes (frequency, severity, duration, disability) after 4 weeks 2. A matched comparison intervention that taught various relaxation skills also was effective in improving headache outcomes 3. The two interventions differentially influenced processes, including in-session arousal and affect valence, as well as assertiveness, alexithymia, and emotional processing which supports the proposal that theses two interventions have different mechanisms and 4. Despite their uniqueness, the outcomes of the two interventions are very similar.

- The sample was of college students not patients in clinical care. Strengths: - Screened thousands of students to identify the sample, which has a mean headache frequency and pain level that were clinically substantial. Significance for this project: - Enhancing anger awareness and expression may improve chronic headaches; not more than RT. - It is suggested that researchers should study which patients are most likely to benefit from emotional expression versus emotional reduction approaches to chronic pain.

Page 19: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

day and time 1 and 2 weeks later for intervention. Session 2 and 3.Intervention participants rated their affect before and after each of the three sessions and returned 6 weeks after the baseline (4weeks after session 3) for the post-treatment assessment of process and outcome measures. Participants assigned to the wait-list control condition were dismissed after completing baseline measures and returned 6 weeks later for the post-treatment assessment. AAET: Session 1 was taught that stress triggers or exacerbates headaches, inhibiting emotions. Session 2 learned to communicate anger adaptively by identifying stressful interpersonal events in their lives when

Page 20: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

anger should be experienced and Session 3 involved trouble shooting difficulties in assertive communication experienced by participants for a difficult interpersonal situation. RT: Session 1 taught that stress can trigger or exacerbate headaches, were taught progressive muscle relaxation exercises and given a CD. Session 2 the therapist explored any difficulties engaging in progressive muscle relaxation and taught deep breathing relaxation as well as relaxation exercises. Session 3 taught guided imagery relaxation and examined how to incorporate relaxation into daily routines. Wait-list Control: Participants received no

Page 21: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

intervention but were invited to request an intervention after completing the post-treatment assessment. Participants in the two intervention conditions rated three affect dimensions at the beginning and end of each of the three sessions, using a pictorial version of Self-Assessment Manikin of 1-9. Outcomes Measured: Participants rated headache frequency, severity and duration, disability, and psychological symptoms.

Smith, T., Nicholson, R., & Banks, J. (2010). Migraine education improves quality of life in a primary care setting. Headache. 50(1), 600-612. doi: 10.1111/j.1526-4610.2010.01618.x Level of Evidence: II

Purpose: Evaluate the effectiveness of the Mercy Migraine Management Program (MMMP) an educational program for physicians and patients.

Design: Randomized controlled trial. Sampling Methods: Open-label, prospective study. Sampling Size: 284 participated in the MMMP, 228 provided data. Intervention: MMMP provided

- 46% of all participants reported a 5-% or greater reduction in headache frequency.

- The percentage of participants experiencing a >50% reduction in headache

Weaknesses: - Limitations included lack of control condition, lack of parallel comparison group that did not receive the educational intervention. Strengths: - This study provides

Page 22: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

Provider Education and Training via a 2-hour continuing education program. The program covered 4 concepts: 1.impact recognition diagnosis of headache, 2. Benefits of early abortive intervention, especially with migraine specific medications, 3. Effective preventive regimens, and 4. Nonpharmacological management. Overall goal was to educate providers how to equip their patients with tools needed to manage migraines on a daily basis. Once the providers were educated and given educational materials to pass along to their patients, the providers would then inform patients of the study and individuals interested in participating were

frequency increased steadily over the 12 months, suggesting a lasting effect on the MMMP.

- McNemar’s test conducted with significance level for comparisons was adjusted to P<.008.

- HIT-6 scores were significantly greater for those with High Worry compared to those with Low Worry at 3-months after baseline.

- Participants reported headache related disability decreased and quality of life improved during the study.

- Improvements were seen in a low-cost, easy-to-administer educational program.

- Patients worried less about their headaches over

evidence that providers having an increased knowledge regarding headache therapy can have a positive effect on patient care. - Providers taking the time to educate their patients on all aspects of treatment for headaches can achieve greater satisfaction amongst their patient population. Significance for this project: - Patients that participated in this study reported a decrease in headaches, less disability, an improved quality of life, less worry, increased self-efficacy, and greater satisfaction with their migraine treatment. - Outcomes were achieved in a low-cost, easy-to-administer educational program.

Page 23: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

recruited. Data about headache frequency, headache related disability using the HIT-6, migraine specific quality of life (MSQ), worry about headaches, self-efficacy for managing headaches, ER visits for headaches, and satisfaction with care at 4 time points over 12 months (baseline, 3 months, 6 months, 12 months). Outcomes Measured: Patients that participated in the MMMP reported improvements in their headache frequency as well as cognitive and emotional aspects of headache management.

time. - A low-cost, easy-

to-administer intervention can have a positive perception of care and increase satisfaction levels.

- Increased knowledge about migraine and management skills can lessen the burdens of disease.

-

Adams, J., Barbery, G. & Lui, C. (2012). Complementary and adult medicine use for headache and migraine: A critical review of the literature. American Headache Society, (53), 459-473. doi: 10.1111/j.1526-4610.2012.02271.x Level of Evidence: III

Purpose: Evaluate research findings on Complementary and Alternative Medicine (CAM) use among patients who have headaches and migraines.

Design: Systematic Review Sampling Methods: A comprehensive search of literature in CINAHL, MEDLINE, AMED, and Health Sources was conducted. Only

- Individuals with severe headache conditions are more likely to use CAM - 50% of adults in the US have used CAM in the last 12 months - Mind-body therapies such as meditation, breathing exercise, and yoga are the

Weaknesses: - Bias may have occurred due to this review only being conducted in English language publications. - Studies to date about this topic have been weak, further research

Page 24: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

peer-reviewed articles published in English reporting empirical research findings of CAM use among individuals with headaches or migraines. Sampling Size: 12 papers were included in this review. Intervention: Data was synthesized on: 1. How to identify the relevant studies that examine the use of CAM among individuals with headaches 2. Analysis on the equality of studies 3. Summarize key findings into theme-based analysis. Outcomes Measured: Analysis showed CAM use among people with headaches and migraines to be considered a treatment option for these individuals.

most common CAM used by US respondents with migraine or severe headaches - CAM users seek CAM concurrent with or following a general physician visit - 80% of the respondents did not relinquish their use of prescribed medications while using CAM. - One of the main reasons for using CAM reported in this study were “general wellness/disease prevention” and “to improve/enhance energy - Results suggest that CAM is used at a substantial rate among individuals with headaches and migraines. - Acupuncture, massage, chiropractic, and homeopathy were the most common therapies reported as used by those suffering from headache -National health survey showed 50% of US adults with migraines or severe headaches have used CAM at least once over the last year. In Canada 19% of people with migraines visited a CAM practitioner in the

is recommended that utilize both quantitative and qualitative methods to address if CAM is effective, safe, and responsive to those who suffer from headaches and migraines. Strengths: - Evidence showed that a majority of CAM users in the US seek CAM concurrent with or following a general practitioner visit. Significance for this project: - This project focuses on using combined therapies to decrease headache symptoms and this review reported that individuals who suffer from headaches and migraines are aware of different modalities of treatment such as CAM and there is evidence that supports individuals using CAM concurrently with conventional medicine to achieve a

Page 25: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

last year.

better quality of life.

Lieba-Samal, D., Seidel, S., Frantal, S., & Wöber, C. (2012). Knowledge about and use of pharmacological and non-pharmacological headache therapies. Wiener klinische Wochenschrift. (124), 716-722. doi: 10.1007/s00508-012-0250-x. Level of Evidence: IV

Purpose: To analyze knowledge and use of pharmacological and non-pharmacological therapies in headache patients and find out if when these treatments are used together are they beneficial.

Design: Correlational study Sampling Method/Size: Convenience, 114 consecutive patients referred by a neurologist that were asked to fill out a comprehensive questionnaire regarding 23 compounds for acute treatment, 21 prophylactic drugs, and 30 complementary and alternative treatments; before their first appointment at an outpatient headache clinic. Interventions: The questionnaire asked about biographical data, medical history, characteristics of headaches, past diagnostic and therapeutic measures, knowledge about and use of non-

- With 82% of patients having any knowledge about alternative treatments, 75% have stated that they have used at least one. - Of the patients who took part in this study; 92% of patients knew at least one acute therapy, 62% knew at least one pharmaco-prophylaxis, 80% knew one non-pharmacological treatment. 87% of migraine patients who experience 4 or more disabling headaches days per month only 41% had taken triptans, and 19% had taken first choice migraine prophylaxis for a minimum of 3 months. 75% of the patients have used complementary or alternative treatments. - Major findings in this study were: 1. Prophylactic pharmacological headache treatment is heavily underused in primary and secondary care 2. There is a strong need for continuing education of professionals dealing with headache patients.

Weaknesses: - This study took place in Austria, not in the U.S. - There is not enough information regarding alternative treatments. - The main problem with alternative treatments is that studies are either lacking entirely or their quality is poor. Strengths: -Comprehensive questionnaire includes patient reported data regarding patient knowledge on different treatments available for headaches/migraines and if the patients have made use of the different treatments. Significance for this project: - Since this focus for this project is aimed at educating patients and providers on the use of non-pharmaceutical techniques in addition to pharmaceutical

Page 26: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

pharmacological and alternative headache therapies (acupuncture, massage, exercise, autogenic training). Outcomes Measured: Knowledge about pharmacological and non-pharmacological therapies

techniques to help reduce headache frequency, this article supports that more education is needed for patient understanding regarding pharmacological administration, which is important when comparing outcomes.

Wells, R. & Loder, E. (2012). Mind/Body and behavioral treatments: The evidence and approach. Headache. 52(2), 70-75. doi: 10.1111/j.1526-4610.2012.02238.x Level of Evidence: VI

Purpose: To address most common questions about nondrug treatment options from the perspective of patients.

Design: Narrative Review Sampling Method/Size: Retrieval of 355 studies assessing the impact of behavioral interventions on migraines, with 39 meeting criteria in mind/body and behavioral treatments toward promoting health. Interventions: Review of meta-analysis assessing the impact of behavioral interventions on migraines. Outcomes Measured: The reviews have consistently shown

- The findings conclude that: 1. Relaxation training, thermal feedback with relaxation, electromyography biofeedback, and cognitive behavioral therapy (CBT) led to a 32-49% reduction in headache frequency/index vs. than wait-list controls. 2. Of the biofeedback studies, the biggest improvements were for headache frequency and perceived self-efficacy, with the effects stable over 17 months of follow up. 3. Both pharmacological and non-pharmacological trials has a comparable 43% reduction in the migraine index.

Weaknesses: - Low level of evidence

Strengths: - The review question is clearly stated.

- The search strategy was effective. Headache literature databases were used. The National Institute of Health’s National Center for Complementary and Alternative Medicine defines mind/body therapies as “Practices that focus on the interactions among the brain, mind, body, and behavior with the intent to use the mind to affect physical functioning

Page 27: Evidence Grid: Purpose of Research elements: Major findings … · 2018-09-07 · Design: Evidence-based clinical practice guidelines based on systematic reviews Sampling Method:

that outcomes for the mind/body and behavioral treatments are similar in positive outcomes and that the combination of both behavioral and pharmacological treatment leads to better overall health status.

- Major findings in this study were: Research suggests that mind/body and behavioral treatments may decrease the frequency of migraine or tension type headaches by 35-50%, an effect size comparable with those observed in medication trials but with fewer side effects than drugs. Most of the benefit seems to occur in those who combine medications with nonpharmacological treatments.

and promote health. - Review methods are documented within each study.

Significance for this project: - The significance of the potential for reducing headache impact and helping an individual gain a sense of personal control in their own treatment. - The authors explain that it is difficult to answer questions about nondrug therapies without knowledge and awareness of the variety of options and having research to support their use.

- Recommendations made for future research include the need to further clarify and address all the questions typically asked by headache patients in a clinical setting.