a manual physical therapy approach versus subacromial

A manual physical therapy approachversus subacromial corticosteroidinjection for treatment of shoulderimpingement syndrome: a protocol fora randomised clinical trial

Daniel I Rhon,1 Robert E Boyles,2 Joshua A Cleland,3 David L Brown4

ABSTRACTIntroduction: Corticosteroid injections (CSI) area recommended and often-used first-line interventionfor shoulder impingement syndrome (SIS) in primarycare and orthopaedic settings. Manual physical therapy(MPT) offers a non-invasive approach with negligiblerisk for managing SIS. There is limited evidence tosuggest significant long-term improvements in pain,strength and disability with the use of MPT, and thereare conflicting reports from systematic reviews thatquestion the long-term efficacy of CSI. Specifically, theprimary objective is to compare the effect of CSI andMPT on pain and disability in subjects with SIS at12 months.

Design: This pragmatic randomised clinical trial willbe a mixed-model 235 factorial design. Theindependent variables are treatment (MPT and CSI)and time with five levels from baseline to 1 year. Theprimary dependent variable is the Shoulder Pain andDisability Index, and the secondary outcome measuresare the Global Rating of Change and the Numeric PainRating Scale. For each ANOVA, the hypothesis ofinterest will be the two-way group-by-time interaction.

Methods and analysis: The authors plan to recruit104 participants meeting established impingementcriteria. Following examination and enrolment, eligibleparticipants will be randomly allocated to receivea pragmatic approach of either CSI or MPT. The MPTintervention will consist of six sessions, and the CSIintervention will consist of one to three sessions. Allsubjects will continue to receive usual care. Subjectswill be followed for 12 months.

Dissemination and ethics: The protocol wasapproved by the Madigan Army Medical CenterInstitutional Review Board. The results may have animpact on clinical practice guidelines. This study wasfunded in part by the Orthopaedic Physical TherapyProducts Grant through the American Academy ofOrthopaedic Manual Physical Therapists.

Trial Registration: http://clinicaltrials.gov/NCT01190891.

To cite: Rhon DI, Boyles RE,Cleland JA, et al. A manualphysical therapy approachversus subacromialcorticosteroid injection fortreatment of shoulderimpingement syndrome:a protocol for a randomisedclinical trial. BMJ Open2011;1:e000137.doi:10.1136/bmjopen-2011-000137

< Prepublication history forthis paper is available online.To view these files pleasevisit the journal online (http://bmjopen.bmj.com).

Received 12 April 2011Accepted 3 June 2011

This final article is availablefor use under the terms ofthe Creative CommonsAttribution Non-Commercial2.0 Licence; seehttp://bmjopen.bmj.com

For numbered affiliations seeend of article.

Correspondence toDr Daniel Rhon;[email protected]

ARTICLE SUMMARY

Article focus- Shoulder pain is a common symptom in patients

seeking healthcare for musculoskeletalcomplaints.

- Corticosteroid injections (CSI) are a commonfirst-line intervention for shoulder pain in primarycare settings, but their long-term efficacy has notbeen established.

- The long-term efficacy of manual physicaltherapy and CSI will be evaluated and comparedfrom baseline out to 1 year after enrollment.

Key messages- Manual physical therapy has been shown to

provide improvements in pain and function inpatients with shoulder impingement but has notbeen directly compared with CSI.

- Understanding which interventions have betterlong-term outcomes may be instrumental inhelping improve clinical practice guidelines forthe management of shoulder impingementsyndrome.

Strengths and limitations of this study- This randomised controlled study will compare

the effectiveness of a manual physical therapyapproach to a corticosteroid injection in patientswith shoulder impingement.

- This is a pragmatic study evaluating twointerventions that are standard practice andhave been shown to be effective for shoulderimpingement.

- Even as a single blinded randomised clinical trialthere is no true control group, and we cannotstate whether true a cause-and-effect relation-ship exists.

- Owing to the pragmatic nature of the study, theintervention will not be standardised, whichcould make it difficult for clinicians to replicate.

- The lack of a gold standard with the diagnosis ofshoulder impingement makes this populationdifficult to study.

Rhon DI, Boyles RE, Cleland JA, et al. BMJ Open 2011;1:e000137. doi:10.1136/bmjopen-2011-000137 1

Open Access Protocol

group.bmj.com on April 10, 2018 - Published by http://bmjopen.bmj.com/Downloaded from

http://bmjopen.bmj.com/

http://group.bmj.com

INTRODUCTIONShoulder impingement is among the most commonfunction-limiting disorders of the musculoskeletalsystem.1 2 The point prevalence of shoulder symptomshas been reported to range from 20 to 33%,3 and theincidence of shoulder complaints in the general popu-lation is increasing.4 Furthermore, several authors havereported low rates of perceived recovery (patient reportsof ‘being cured’) for patients with a new episode ofshoulder pain.4e7 Less than 25% of patients with a firstepisode of shoulder pain may recover and be symptom-free after 3 months.5 Recovery rates at 18 months havebeen reported only between 49% and 59%,5 6 8 and 25%of patients with shoulder or neck pain experience atleast one episode of recurrence within 12 months.9

These findings suggest that shoulder pain can berecurrent and frequently progresses to the chronic stage.A comprehensive manual physical therapy (MPT)

approach, including both thrust and non-thrust tech-niques and reinforcing mobility exercises, is a commonintervention for patients presenting with a primaryreport of shoulder pain.1 9e16 This comprehensiveapproach has shown improvement in shoulder symp-toms with mobilisation and manipulation techniquestargeted to the thoracic spine, cervicothoracic spine, ribcage and acromioclavicular joints,9 12 in addition to theglenohumeral joint. A recent systematic review by Hoet al17 stated there was no clear evidence to suggestadditional benefits of manual therapy to other inter-ventions for shoulder impingement, indicating the needfor further high-quality research. That systematic reviewwas conducted through January of 2007, excluding somemore recent trials discussed below.In a trial by Bergman et al,10 patients with a primary

report of shoulder pain were randomly assigned toreceive usual medical care for their shoulder symptomsfrom their primary care physicians or usual care plusmanipulative therapy (UMC+MT) directed at the cervi-cothoracic spine and rib cage for a maximum of sixtreatment sessions. The group that received manipula-tive therapy reported increased rates of ‘full recovery’,and improved disability out to 52 weeks.10 In a trial byBang and Deyle,9 significant improvements in functionand pain with the use of an MPT approach, consisting ofmanual techniques and reinforcing exercises, were seenout at 2 months. Two other studies compared the useof manual mobilisation techniques in addition toa comprehensive offering of various therapeutic modal-ities and exercise, and showed improved outcomes in thegroups that received mobilisations in addition to theircomprehensive programme.10 18 Several other studieshave looked at a less pragmatic approach to manualtherapy by breaking down the manual therapy approachinto several subcomponents.18 19 No evidence for harmwith using this intervention has been reported.Corticosteroids injections are a common intervention

for symptoms from shoulder impingement and have alsobeen shown to be an effective treatment for shoulder

pain. They are one of the most common procedures forthe management of shoulder pain used by orthopaed-ists, rheumatologists and general practitioners,20 with96% of clinicians in a recent survey stating that CSI is anefficacious treatment option for rotator cuff pathology.21

Conflicting evidence in the literature suggests theirefficacy in the management of shoulder impingement isnot well established.22e27 A recent meta-analysis byArroll and Goodyear-Smith23 evaluating the efficacy ofCSI for painful shoulder conditions (included rotatorcuff tendonitis and adhesive capsulitis) concluded thatsubacromial injections are probably effective forimprovement of rotator cuff tendonitis when comparedwith placebo or non-steroidal anti-inflammatory drugs,but that there is still insufficient evidence to determinethe extent of their effectiveness. Five studies comparedsubacromial injection with placebo and showed signifi-cantly better results then placebo in all studies,28 butonly three of those studies were specifically for shoulderimpingement. The determination of effectiveness wasbased on dichotomising results into success and non-success based on the terms that included ‘responder,’‘decreased pain’ and ‘remission.’A recent Cochrane review24 and a meta-analysis by

Gaujoux-Viala et al26 indicated that steroid injectionswere not more effective than non-steroidal anti-inflam-matory drugs in the treatment of shoulder and elbowtendonitis. Another review by Koester et al27 found ninerandomised clinical trials comparing subacromial corti-costeroid injection with placebo in patients with rotatorcuff disease and concluded that subacromial corticoste-roid injection is not effective for the treatment of rotatorcuff disease. It has been reported that the variablesuccess with subacromial CSI may be due to inaccuracyof the clinician in terms of approach (posterior oranterolateral),29 tendon penetration30 and/or inconsis-tencies in dose.23

Specific aimThe aim was to determine if there is any clinicallysignificant difference in outcomes of pain and disabilitybetween subjects with shoulder impingement syndromethat receive MPT compared with CSI at 1 year.

TRIAL DESIGN AND METHODSThe study will be a randomised clinical trial. The inde-pendent variables are treatment (MPT and CSI) andtime with five levels from baseline out to 1 year. Theprimary dependent variable (DV) is the Shoulder Painand Disability Index (SPADI). The secondary DVs arethe Global Rating of Change (GRC) and the NumericPain-Rating Scale (NPRS). Figure 1 demonstrates theflow of subjects through the trial. This will be a trialassessing pragmatic delivery of two common interven-tions, and will report results following CONSORTguidelines for pragmatic trials.31 The current SPIRITguidelines for creating protocols for randomised clinicaltrials were followed.32

2 Rhon DI, Boyles RE, Cleland JA, et al. BMJ Open 2011;1:e000137. doi:10.1136/bmjopen-2011-000137

Pragmatic care for shoulder impingement; protocol for an RCT




ParticipantsWe will recruit 104 subjects, male and female, betweenthe ages of 18 and 65 years with a primary complaint ofshoulder pain through the Physical Therapy departmentsat Madigan Army Medical Center as well as the outlyingprimary care clinics on the military installation. They willbe recruited through the referral source to PhysicalTherapy from outlying clinics (Family Practice, Ortho-paedics and Primary Care clinics). If recruitment targetsare not being met, flyers with information about thestudy may be distributed for potential subjects to enquireabout, as patients in this setting have direct access tophysical therapy care and do not need a referral source.

Inclusion criteria:1. Age 18 and older.2. Read, write, and speak English.3. Eligible for healthcare at a military medical treatment

facility.4. Primary complaint of shoulder pain (glenohumeral

region).5. Meets diagnostic criteria for shoulder impingement

(mentioned below).

Exclusion criteria:1. History of a shoulder injection for the current

episode of pain.2. History of shoulder dislocation, subluxation, frac-

ture, adhesive capsulitis the glenohumeral joint orcervical/shoulder/upper back surgery.

3. Isolated acromioclavicular joint (ACJ) pathology.The only location of symptoms is localised specificallywith one finger directly over the ACJ and nowhereelse, and reproduced only with ACJ palpation by theexaminer.

4. Full-thickness rotator cuff tears (evidenced by MRIand/or positive lag signs).

5. Presence of cervical radiculopathy, radiculitis, orreferral from cervical spine.

6. Total baseline SPADI score not <20% (to preventa ceiling effect with treatment).

7. History of breast cancer on the involved side.8. Prior MPT treatment to the involved limb for the

current episode of pain.9. Military service members pending a medical evalua-

tion board, physical evaluation board or equivalentdischarge process, or in medical hold to determinelong-term disposition. For non-military personnel,anyone who is pending or undergoing any litigationfor their injury.

10. Contraindications or precautions to receiving a corti-costeroid injection (history of allergies, adversereactions, history of multiple injections in that areaeven if not within last 30 days, uncontrolled diabetesmellitus, pregnancy, etc).

11. Unable to give informed consent to participate inthe study.

12. Unable to come into the clinic for regular treatmentover the course of the following month.

Diagnostic criteria for entry:To be included in the study, participants are required

to have:1. Pain with one of the two tests in category I; and2. Pain with one test from either category II or category

III.with ‘pain’ being defined as reproduction of the usual

pain that the subject experiences that makes up thenature of their complaint.Category I: impingement signs:

1. Passive overpressure at full shoulder flexion with thescapula stabilised.

2. Passive internal rotation at 908 of shoulder flexion inthe scapular plane and in progressive degree ofhorizontal adduction.Category II: active shoulder abduction:Active shoulder abductionCategory III: resisted break tests:

1. Abduction2. Internal rotation3. External rotationThese criteria have been used in previous clinical trials

to classify patients with shoulder impingementsyndrome.17 23

RandomisationOnce the baseline examination is completed, a secondinvestigator blind to the baseline examination willopen the randomisation envelope indicating the

Figure 1 Proposed recruitment flow of the study. CSI,corticosteroid injection; GRC, Global Rating of Change; NPRS,Numeric Pain Rating Scale; MPT, Manual Physical Therapy;SPADI, Shoulder Pain and Disability Index.






patient’s treatment group assignment that correspondsto the patient’s unique identification number. Arandom-number generator will be used to establishrandomisation lists prior to the initiation of the study.Individual randomisation assignments will be concealedaccording to the following procedure. The groupassignment will be recorded on a label that is affixed toa 3.535 inch index card. This card will be folded in halfsuch that the label with the patient‘s group assignmentwill be on the inside of the fold. The folded index cardwill then be placed inside the envelope, and the enve-lope will be sealed. This will prevent the possibility of thetherapist holding the envelope up to the light andvisualising the patient’s treatment group assignmentthrough a sealed yet transparent envelope.

BlindingOwing to the nature of this study, it is not possible toblind the patient or the clinician providing the inter-vention to the treatment received. The clinicianperforming the screening, baseline and follow-upmeasurements, and outcome assessments will be blindedto the patient’s treatment group assignment. Patientswill be instructed not to discuss the intervention receivedwith the clinician when reporting for their follow-upappointments unless medically necessary. Incidence ofunmasking will be recorded.

InterventionsBoth treatment options are standard-of-care interventions.Their allocation and dosage are described in table 1.

Manual physical therapyAt the first session, the examiner will perform a stand-ard clinical examination in order to determine theappropriate application and delivery of MPT (appendix 1)to the entire shoulder, spine, and adjacent joints. Thegoal of MPT is to improve the quality of motion anddecrease the pain associated with motion at the targetjoint and soft tissue. For our purposes, we define ourMPT as the combination of manual techniques toinclude joint mobilisations (both thrust and non-thrusttechniques), soft-tissue mobilisations, manual stretchesand contracterelax techniques, along with the exercisesthat help reinforce those techniques. We feel this isconsistent not only with other shoulder trials, but alsowith other MPT trials.9 33e35 The application oftechniques will not be based on a regimented protocolthat is identical for each patient, but rather tailoredspecifically to the impairments identified during the

clinical examination. We feel this approach is pragmaticand consistent with the actual delivery of MPT in theclinical setting.The examiner will provide an initial intervention of

MPT that is targeted to impairments found during theinitial clinical examination (the patient will return fora maximum total of six treatment sessions over thefollowing 3 weeks). Each session will last approximately30 min. The subjects will receive some of the protocolexercises (appendix 2) to augment the joint mobi-lisations, which will collectively make up the MPTintervention.The clinicians providing the MPT are two fellowship-

trained orthopaedic manual physical therapists, whoboth received training in the same 18-month programme,to ensure consistency with delivery of this interventionapproach.

Corticosteroid injectionThe examiner will perform a standardised clinicalexamination and health screening in order to confirmthe absence of contraindications to steroid injection.The subject will then receive an injection in the suba-cromial space of the symptomatic shoulder by a seniorSports Medicine Fellowship Trained Family Physician(appendix 3). The subject will also receive a handoutexplaining the effects of the steroid injection and how tomanage any potential flare-ups or ensuing pain, anda handout describing pendulum exercises for the subjectto perform. The physician will spend approximately30 min with each subject explaining the rationale for theinjection, relevant anatomy, performing the procedureand reviewing the pendulum exercises.The subject can receive up to a total of two shoulder

injections with a minimum of 1 month between injec-tions if they are not getting relief of symptoms with theinitial injection. This will be dictated by patient prefer-ence and the approval/recommendation of the physi-cian performing the injection procedure, as this wouldrepresent a pragmatic approach commensurate withstandard practice.

Outcome measuresThe primary DV will be the SPADI, and the secondaryDVs will be the GRC and the NPRS.

Shoulder Pain and Disability IndexSPADI is a 100-point, 13-item self-administered ques-tionnaire, divided into two subscales: a five-item painsubscale and an eight-item disability subscale. Williams

Table 1 Treatment allocation and dosage

Intervention Subjects needed DosageFollow-up time points(months)

Corticosteroid injection N¼52 One initially; option for a totalof three within first 6 months

1, 3, 6, 12

Manual physical therapy N¼52 Six sessions 1, 3, 6, 12






et al have shown that the SPADI is responsive to changeand accurately discriminates between patients who areimproving or worsening.36 A high testeretest reliabilityand internal consistency for this instrument has beenreported.37 A recent systematic review identifieda minimal detectable change of 18 points and a mini-mally clinically important difference (MCID) of 8e13points.38 The validity and responsiveness to change ofSPADI have been described in physical therapy, as well asprimary- and secondary-care settings.39

Because disability will be used as an outcome ofinterest, it is important to ensure a moderate level ofdisability will be present at the inception of the treat-ment. Thus, patients will be required to have at leasta baseline SPADI score of 20 points (average of pain anddisability subscales). A score of 0 indicates no pain orfunctional limitation with the described activities.

Global Rating of Change questionnaireThe GRC questionnaire is an instrument that measuresoverall changes in the quality of life of the subject.40 Theuse of a GRC is a common, feasible and useful methodfor assessing outcome,41 and has been shown to bea valid measurement of change in patient status in otherpain populations.42 A change in score of three ratingpoints (+3) has been established as clinically significantin the patients perception of quality of life.41 TheGRC has 15 possible choices, with 0 being equal to nochange, �1 to �7 indicating a negative change and +1to +7 indicating a positive change.

Numeric Pain-Rating ScaleAn 11-point pain-rating scale ranging from 0 (no pain)to 10 (worst imaginable pain) will be used to assess painintensity in the shoulder.43 This scale has been demon-strated to be reliable and generalisable, and to haveinternal consistency in measures of clinical and experi-mental pain sensation intensity.44 45 A change of at leastthree points has been suggested as the MCID for theNPRS in patients with shoulder pain.46

Justification of sample sizeThe calculations were based on detecting a 12-point (or9.2% changedbased on reported MCID range of 8e13points)38 difference in the SPADI with a standard devi-ation of 10 points, a two-tailed test and an a level ¼0.05.This generates a sample size of 43 subjects per group.Allowing for a conservative dropout or loss to follow-uprate of approximately 20%, we will recruit 104 subjectsinto the study. Planning for a larger loss to follow-up rateis deemed necessary in this military population wherefollow-up at 1 year can be challenging with multipledeployments and changes in duty station around theworld. This sample size will yield greater than 80% powerto detect both statistically significant and clinicallymeaningful changes in the other outcome variables.Sample-size estimation was performed with G*Powersoftware, V 3.1.2.47

Data analysisDescriptive statistics will be run on the demographic data(age, gender, race, etc) and health characteristics of thestudy population to include measures of centraltendency (means, medians other percentiles) anddispersion (standard deviations, ranges) which will becomputed for continuous data for summary. Frequencydistributions will be estimated for categorical data.Graphical displays including histograms and box plotswill be produced. Transformations will be sought forvariables to be included in further analyses to ensuredistributional assumptions are met.We will examine the primary aim using a linear mixed

model with repeated measures to account for thecorrelation among repeated observations from the samepatient. Time (baseline, 1, 3, 6 and 12 months) andtreatment group (MPT and CSI) will be modelled asfixed effects, with the SPADI questionnaire as theprimary dependent variable. A separate model will beconstructed in a similar fashion with pain (NPRS) andthe GRC as the DV. The hypothesis of interest will be thegroup-by-time interaction. Treatment effects will becalculated from the between-group differences inchange score from baseline to 1, 3, 6 and 12 months. Nopatients will be removed from the analysis for lack ofadherence to treatment procedures. Missing data pointswill be estimated in the mixed model analyses usingrestricted maximum likelihood ratio estimation with 100iterations. If one treatment is shown to be superior tothe other, supplemental analyses will be performed bydichotomising groups based on minimal clinicallyimportant differences of 13% for the SPADI.45 This willallow computation of absolute risk reduction, relativerisk reduction and number needed to treat (with asso-ciated 95% CIs) using failure to obtain clinically mean-ingful benefit as the event of interest. The level ofsignificance for all analyses will be a priori established at0.05 using a two-tailed test.Because of potential crossover between groups, data

will be analysed using both per-protocol and intention-to-treat principles. The per-protocol analyses will onlyinclude patients who completed the study in the groupto which they were randomly assigned. The intention-to-treat analyses will include all patients who were rando-mised at baseline regardless if they crossed over. Dataanalysis will be conducted using SPSS for Windows V 16.

Trial organisation and monitoringThe investigative team includes the authors listed in thisprotocol, in addition to three other licensed physicaltherapists who will assist with subject screening, datacollection, subject follow-up and data entry. The principalinvestigator will manage data flow and perform audits ofthe procedures, enrolment and treatment throughoutthe entire process of the study. The associate investigatorswill monitor the data-collection process and data integritywith periodic evaluation performed continually duringthe course of the data-collection phase.






DISCUSSIONThis randomised clinical trial will be the first study thatdirectly compares the short- and long-term effects of animpairment-based MPT approach and CSI for patientswith shoulder impingement syndrome. The results ofthis study may help to establish best clinical practiceguidelines for this patient population.

ETHICAL CONSIDERATIONS AND DISSEMINATIONAll interventions provided in this study are consideredstandard of care and could be given to a patient as partof their treatment plan even if they were not part of thisstudy. An ethics review will be conducted by MadiganArmy Medical Center and monitored by the US ArmyMedical Department Clinical Investigation RegulatoryOffice to ensure compliance with federal regulations forprotection of human medical research subjects. Thisclinical trial was registered with http://clinicaltrials.gov/with a registration number of NCT01190891.

PUBLICATION POLICYThe results of the trial will be published in an appro-priate journal regardless of outcome. We will report theresults following the CONSORT statement with therecommended extension for pragmatic trials.31

PROJECTED TIMETABLE FOR TRIALMarch 2010dprotocol approved by the WesternRegional Medical Command Institutional Review Board.June 2010dsubject enrolment begins.June 2011dfirst subject completes 1-year follow-up.July 2011dsubject enrolment complete.July 2012dlast subject completes 1-year follow-up.December 2012ddata entry and analysis complete.June 2013dpublication with study results submitted

for publication.

Author affiliations:1Department of Physical Medicine, Madigan Army Medical Center, Tacoma,Washington, USA2School of Physical Therapy, University of Puget Sound, Tacoma, Washington,USA3School of Physical Therapy, Franklin Pierce University,Concord, NewHampshire, USA4Department of Family Medicine, Madigan Army Medical Center, Tacoma,Washington, USA

Correction notice The “To cite: .” information and running footer in thisarticle have been updated with the correct volume number (volume 1).

Funding This study is funded in part by the Orthopaedic Physical TherapyProducts Grant through the American Academy of Orthopaedic ManualPhysical Therapists.

Competing interests None.

Ethics approval Ethics approval was provided by the Madigan Army MedicalCenter Institutional Review Board.

Contributions DIR conceived the idea for the project and is the PI. All authorscontributed to writing and reviewing the protocol, as well as reviewing andsubmitting the protocol for publication. JAC provided advice with statistical

and methods design. DIR and REB will provide all the direct interventions forthe MPT group. DLB will perform all the injections for the CSI group.

Provenance and peer review Not commissioned; externally peer reviewed.

REFERENCES1. Conroy DE, Hayes KW. The effect of joint mobilization as

a component of comprehensive treatment for primary shoulderimpingement syndrome. J Orthop Sports Phys Ther 1998;28:3e14.

2. Warner JJ, Micheli LJ, Arslanian LE, et al. Patterns of flexibility, laxity,and strength in normal shoulders and shoulders with instability andimpingement. Am J Sports Med 1990;18:366e75.

3. Pope DP, Croft PR, Pritchard CM, et al. Prevalence of shoulder painin the community: the influence of case definition. Ann Rheum Dis1997;56:308e12.

4. Bot SD, van der Waal JM, Terwee CB, et al. Predictors of outcome inneck and shoulder symptoms: a cohort study in general practice.Spine (Phila Pa 1976) 2005;30:E459e70.

5. Croft P, Pope D, Silman A. The clinical course of shoulder pain:prospective cohort study in primary care. Primary Care RheumatologySociety Shoulder Study Group. BMJ 1996;313:601e2.

6. van der Windt DA, Koes BW, Boeke AJ, et al. Shoulder disorders ingeneral practice: prognostic indicators of outcome. Br J Gen Pract1996;46:519e23.

7. Winters JC, Jorritsma W, Groenier KH, et al. Treatment of shouldercomplaints in general practice: long term results of a randomised,single blind study comparing physiotherapy, manipulation, andcorticosteroid injection. BMJ 1999;318:1395e6.

8. Winters JC, Sobel JS, Groenier KH, et al. The long-term course ofshoulder complaints: a prospective study in general practice.Rheumatology (Oxford) 1999;38:160e3.

9. Bang MD, Deyle GD. Comparison of supervised exercise with andwithout manual physical therapy for patients with shoulderimpingement syndrome. J Orthop Sports Phys Ther 2000;30:126e37.

10. Bergman GJ, Winters JC, Groenier KH, et al. Manipulative therapy inaddition to usual medical care for patients with shoulder dysfunctionand pain: a randomized, controlled trial. Ann Intern Med2004;141:432e9.

11. Winters JC, Sobel JS, Groenier KH, et al. Comparison ofphysiotherapy, manipulation, and corticosteroid injection for treatingshoulder complaints in general practice: randomised, single blindstudy. BMJ 1997;314:1320e5.

12. Boyles RE, Ritland BM, Miracle BM, et al. The short-term effects ofthoracic spine thrust manipulation on patients with shoulderimpingement syndrome. Man Ther 2009;14:375e80.

13. Galgano RC. Manipulative therapy for patients with shouldersymptoms. Ann Intern Med 2005;142:226; author reply 26e7.

14. Haddick E. Management of a patient with shoulder pain and disability:a manual physical therapy approach addressing impairments of thecervical spine and upper limb neural tissue. J Orthop Sports PhysTher 2007;37:342e50.

15. Kachingwe AF, Phillips B, Sletten E, et al. Comparison of manualtherapy techniques with therapeutic exercise in the treatment ofshoulder impingement: a randomized controlled pilot clinical trial.J Man Manip Ther 2008;16:238e47.

16. Senbursa G, Baltaci G, Atay A. Comparison of conservativetreatment with and without manual physical therapy for patients withshoulder impingement syndrome: a prospective, randomized clinicaltrial. Knee Surg Sports Traumatol Arthrosc 2007;15:915e21.

17. Ho CY, Sole G, Munn J. The effectiveness of manual therapy in themanagement of musculoskeletal disorders of the shoulder:a systematic review. Man Ther 2009;14:463e74.

18. Yiasemides R, Halaki M, Cathers I, et al. Does passive mobilization ofshoulder region joints provide additional benefit over advice andexercise alone for people who have shoulder pain and minimalmovement restriction? A randomized controlled trial. Phys Ther2011;91:178e89.

19. Chen JF, Ginn KA, Herbert RD. Passive mobilisation of shoulderregion joints plus advice and exercise does not reduce pain anddisability more than advice and exercise alone: a randomised trial.Aust J Physiother 2009;55:17e23.

20. Gruson KI, Ruchelsman DE, Zuckerman JD. Subacromial corticosteroidinjections. J Shoulder Elbow Surg 2008;17(1 Suppl):118Se30S.

21. Alvarez CM, Litchfield R, Jackowski D, et al. A prospective, double-blind, randomized clinical trial comparing subacromial injection ofbetamethasone and xylocaine to xylocaine alone in chronic rotatorcuff tendinosis. Am J Sports Med 2005;33:255e62.

22. Akgun K, Birtane M, Akarirmak U. Is local subacromial corticosteroidinjection beneficial in subacromial impingement syndrome? ClinRheumatol 2004;23:496e500.

23. Arroll B, Goodyear-Smith F. Corticosteroid injections for painfulshoulder: a meta-analysis. Br J Gen Pract 2005;55:224e8.






24. Buchbinder R, Green S, Youd JM. Corticosteroid injections forshoulder pain. Cochrane Database Syst Rev 2003;(1):CD004016.

25. Cummins CA, Sasso LM, Nicholson D. Impingement syndrome:temporal outcomes of nonoperative treatment. J Shoulder ElbowSurg 2009;18:172e7.

26. Gaujoux-Viala C, Dougados M, Gossec L. Efficacy and safety ofsteroid injections for shoulder and elbow tendonitis: a meta-analysisof randomized controlled trials. Ann Rheum Dis 2009;68:1843e9.

27. Koester MC, Dunn WR, Kuhn JE, et al. The efficacy of subacromialcorticosteroid injection in the treatment of rotator cuff disease: Asystematic review. J Am Acad Orthop Surg 2007;15:3e11.

28. Adebajo AO, Nash P, Hazleman BL. A prospective double blinddummy placebo controlled study comparing triamcinolonehexacetonide injection with oral diclofenac 50 mg TDS in patients withrotator cuff tendinitis. J Rheumatol 1990;17:1207e10.

29. Henkus HE, Cobben LP, Coerkamp EG, et al. The accuracy ofsubacromial injections: a prospective randomized magneticresonance imaging study. Arthroscopy 2006;22:277e82.

30. Borick JM, Kurzweil PR. Magnetic resonance imaging appearance ofthe shoulder after subacromial injection with corticosteroids canmimic a rotator cuff tear. Arthroscopy 2008;24:846e9.

31. Zwarenstein M, Treweek S, Gagnier JJ, et al. Improving the reportingof pragmatic trials: an extension of the CONSORT statement. BMJ2008;337:a2390.

32. Anon. Strengthening the credibility of clinical research. Lancet2010;375:1225.

33. Deyle GD, Allison SC, Matekel RL, et al. Physical therapy treatmenteffectiveness for osteoarthritis of the knee: a randomized comparisonof supervised clinical exercise and manual therapy procedures versusa home exercise program. Phys Ther 2005;85:1301e17.

34. Deyle GD, Henderson NE, Matekel RL, et al. Effectiveness of manualphysical therapy and exercise in osteoarthritis of the knee. Arandomized, controlled trial. Ann Intern Med 2000;132:173e81.

35. Hoeksma HL, Dekker J, Ronday HK, et al. Comparison of manualtherapy and exercise therapy in osteoarthritis of the hip:a randomized clinical trial. Arthritis Rheum 2004;51:722e9.

36. Williams JW Jr, Holleman DR Jr, Simel DL. Measuring shoulderfunction with the Shoulder Pain and Disability Index. J Rheumatol1995;22:727e32.

37. Michener LA, Leggin BG. A review of self-report scales for theassessment of functional limitation and disability of the shoulder.J Hand Ther 2001;14:68e76.

38. Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulderfunction: a systematic review of four questionnaires. Arthritis Rheum2009;61:623e32.

39. Roach KE, Budiman-Mak E, Songsiridej N, et al. Development ofa shoulder pain and disability index. Arthritis Care Res 1991;4:143e9.

40. Juniper EF, Guyatt GH, Willan A, et al. Determining a minimalimportant change in a disease-specific Quality of Life Questionnaire.J Clin Epidemiol 1994;47:81e7.

41. Jaeschke R, Singer J, Guyatt GH. Measurement of health status.Ascertaining the minimal clinically important difference. Control ClinTrials 1989;10:407e15.

42. Fritz JM, Irrgang JJ. A comparison of a modified Oswestry Low BackPain Disability Questionnaire and the Quebec Back Pain DisabilityScale. Phys Ther 2001;81:776e88.

43. Jensen MP, Turner JA, Romano JM. What is the maximum numberof levels needed in pain intensity measurement? Pain1994;58:387e92.

44. Jensen MP, McFarland CA. Increasing the reliability and validity ofpain intensity measurement in chronic pain patients. Pain1993;55:195e203.

45. Price DD, Bush FM, Long S, et al. A comparison of painmeasurement characteristics of mechanical visual analogue andsimple numerical rating scales. Pain 1994;56:217e26.

46. Michener LA, Snyder AR, Leggin BG. Responsiveness of the numericpain rating scale in patients with shoulder pain and the effect ofsurgical status. J Sport Rehabil 2011;20:115e28.

47. Faul F La-G BA. G* Power. In.48. Rhon D, Hando B. Evidence Based OMT 1.1 ed. Available at http://

itunes.apple.com/us/app/evidence-based-omt/id414629908?mt¼12(accessed 22 Mar 2011).






APPENDIX 1Manual physical therapy manual techniques.48

Represents the majority of the techniques used, but is not inclusive or representative of all of them.






APPENDIX 2Home exercise programme handout for MPT group






APPENDIX 3Corticosteroid injection procedures

PAGE fraction trail=1212 Rhon DI, Boyles RE, Cleland JA, et al. BMJ Open 2011;1:e000137. doi:10.1136/bmjopen-2011-000137





clinical trialsyndrome: a protocol for a randomised treatment of shoulder impingementsubacromial corticosteroid injection for A manual physical therapy approach versus

Daniel I Rhon, Robert E Boyles, Joshua A Cleland and David L Brown

doi: 10.1136/bmjopen-2011-0001372011 1: BMJ Open

http://bmjopen.bmj.com/content/1/2/e000137Updated information and services can be found at:

These include:

References http://bmjopen.bmj.com/content/1/2/e000137#ref-list-1

This article cites 45 articles, 11 of which you can access for free at:

Open Access

.http://creativecommons.org/licenses/by-nc/2.0/legalcode and http://creativecommons.org/licenses/by-nc/2.0/with the license. See:

properly cited, the use is non commercial and is otherwise in compliance distribution, and reproduction in any medium, provided the original work isCommons Attribution Non-commercial License, which permits use, This is an open-access article distributed under the terms of the Creative

serviceEmail alerting

box at the top right corner of the online article. Receive free email alerts when new articles cite this article. Sign up in the

CollectionsTopic Articles on similar topics can be found in the following collections

(345)Rehabilitation medicine

Notes

http://group.bmj.com/group/rights-licensing/permissionsTo request permissions go to:

http://journals.bmj.com/cgi/reprintformTo order reprints go to:

http://group.bmj.com/subscribe/To subscribe to BMJ go to:


http://bmjopen.bmj.com/content/1/2/e000137

http://bmjopen.bmj.com/content/1/2/e000137#ref-list-1

http://creativecommons.org/licenses/by-nc/2.0/

http://creativecommons.org/licenses/by-nc/2.0/legalcode

http://bmjopen.bmj.com//cgi/collection/bmj_open_rehabilitation_medicine

http://group.bmj.com/group/rights-licensing/permissions

http://journals.bmj.com/cgi/reprintform

http://group.bmj.com/subscribe/



a manual physical therapy approach versus subacromial

Documents