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Treatment of myofascial trigger points in common shoulder disorders by physical therapy: A randomized controlled trial [ISRCTN75722066]

Treatment of myofascial trigger points in common shoulder disorders by physical therapy: A... Background: Shoulder disorders are a common health problem in western societies. Several treatment protocols have been developed for the clinical management of persons with shoulder pain. However available evidence does not support any protocol as being superior over others. Systematic reviews provide some evidence that certain physical therapy interventions (i.e. supervised exercises and mobilisation) are effective in particular shoulder disorders (i.e. rotator cuff disorders, mixed shoulder disorders and adhesive capsulitis), but there is an ongoing need for high quality trials of physical therapy interventions. Usually, physical therapy consists of active exercises intended to strengthen the shoulder muscles as stabilizers of the glenohumeral joint or perform mobilisations to improve restricted mobility of the glenohumeral or adjacent joints (shoulder girdle). It is generally accepted that a-traumatic shoulder problems are the result of impingement of the subacromial structures, such as the bursa or rotator cuff tendons. Myofascial trigger points (MTrPs) in shoulder muscles may also lead to a complex of symptoms that are often seen in patients diagnosed with subacromial impingement or rotator cuff tendinopathy. Little is known about the treatment of MTrPs in patients with shoulder disorders. The primary aim of this study is to investigate whether physical therapy modalities to inactivate MTrPs can reduce symptoms and improve shoulder function in daily activities in a population of chronic a-traumatic shoulder patients when compared to a wait-and-see strategy. In addition we investigate the recurrence rate during a one-year-follow-up period. Methods/Design: This paper presents the design for a randomized controlled trial to be conducted between September 2007 – September 2008, evaluating the effectiveness of a physical therapy treatment for non-traumatic shoulder complaints. One hundred subjects are included in this study. All subjects have unilateral shoulder pain for at least six months and are referred to a physical therapy practice specialized in musculoskeletal disorders of the neck-, shoulder-, and arm. After the initial assessment patients are randomly assigned to either an intervention group or a control-group (wait and see). The primary outcome measure is the overall score of the Dutch language version of the DASH (Disabilities of Arm, Shoulder and Hand) questionnaire. Discussion: Since there is only little evidence for the efficacy of physical therapy interventions in certain shoulder disorders, there is a need for further research. We found only a few studies examining the efficacy of MTrP therapy for Page 1 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 shoulder disorders. Therefore we will perform a randomised clinical trial of the effect of physical therapy interventions aimed to inactivate MTrPs, on pain and impairment in shoulder function in a population of chronic a-traumatic shoulder patients. We opted for an intervention strategy that best reflects daily practice. Manual high velocity thrust techniques and dry-needling are excluded. Because in most physical therapy interventions, blinding of the patient and the therapist is not possible, we will perform a randomised, controlled and observer-blinded study. Trial Registration: This randomized clinical trial is registered at current controlled trials ISRCTN75722066. num toxin, followed by ergonomic advises, active Background Shoulder pain is a common health problem in western exercises, postural correction, and relaxation (with or societies. There are substantial differences in reported without biofeedback)[17,18]. Over the years, MTrPs are prevalence in the general population. The one-year preva- increasingly accepted in the medical literature. Clinical, lence of shoulder disorders has been reported to range histological, biochemical and electrophysiological from 20% to 50%. This wide range is strongly influenced research has provided biological plausibility for the exist- for example by the definition of shoulder disorders, ence of MTrPs [19-24]. including or excluding limited motion, age, gender and anatomic area [1-3]. Of all shoulder patients who attend MTrPs are defined as exquisitely tender spots in discrete primary care physicians 50% recover within 6 months, taut bands of hardened muscle that produce symptoms meaning they do not seek any medical help after the first [25,26]. A previous study showed that MTrPs can be episode[1,4-6]. Chronicity and recurrence of symptoms detected reliably by trained physiotherapists [27]. Palpa- are common [7,8]. According to the guidelines of the tion is still the only reliable method to diagnose myofas- Dutch College of General Practioners [9], the recom- cial pain clinically. In reviews addressing the efficacy of mended management of shoulder symptoms starts with interventions in shoulder patients, MTrP therapy and educational information about the natural course of myofascial pain are rarely mentioned [15]. However, shoulder pain combined with the advise to avoid irritat- some published case studies suggest that treatment of ing and loading activities. The use of analgesics or NSAIDs MTrPs in shoulder patients may be beneficial [28-31]. is recommended for the first two weeks. When no recov- ery occurs within two weeks, subacromial or intra-articu- The primary aim of this study is to investigate the effec- lar injection therapy with corticosteroids are administered tiveness of inactivation of MTrPs in shoulder muscles by and eventually repeated. Finally, physical therapy is only physical therapy on symptoms and functioning of the recommended after a 6-week period when there are func- shoulder in daily activities in a population of chronic a- tional limitations (specifically an activating and time-con- traumatic shoulder patients when compared to a wait- tingent approach). International guidelines for shoulder and-see strategy. In addition, we investigate the recurrence pain, including the Clinical Guideline of Shoulder pain of rate during a one-year-follow-up period. the American Academy of Orthopaedic Surgeons [10] and the Shoulder Guideline of the New Zealand Guidelines Methods/Design Group[11] differ more or less from the Dutch guidelines An examiner-blinded randomized controlled trial will be in classification, recommended interventions and time- conducted, which has been approved by the ethics com- line, and order of interventions. Scientific evidence from mittee of the Radboud University Nijmegen Medical Cen- randomized clinical trials, meta-analyses or systematic tre, the Netherlands [CMO 2007/022]. reviews for either the efficacy of multimodal rehabilita- tion, injection therapy, medication, surgery or physical Participants/Study sample therapy or the order of application of commonly used Between September 2007 and September 2008, all con- therapies is lacking [12-16]. secutive patients referred to a physical therapy practice specialized in the treatment of individuals with muscu- An alternative approach to the management of persons loskeletal disorders of the neck, shoulder and arm are with shoulder problems consists of a treatment aimed at potential study participants. The referring physicians inactivating MTrPs and eliminating factors that perpetuate include general practioners, orthopaedic surgeons, neu- them. MTrPs may be inactivated by manual techniques rologists and physiatrists. Patients are eligible if they have (such as compression on the trigger point or other mas- unilateral shoulder complaints (described as pain felt in sage techniques), cooling the skin with ethyl chloride the shoulder or upper arm) for at least six months. The spray or with ice-cubes followed by stretching of the patients present with persistent shoulder pain that has not involved muscle, trigger point needling using an acupunc- spontaneously recovered. The patients are between 18 and ture needle, or injection with local anaesthetics or Botuli- 65 years old. Because the questionnaires are in the Dutch Page 2 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 language, subjects must understand written and verbal Intervention Dutch. Patients who have been diagnosed (prior to the The patients in the intervention group will be treated by a referral) with shoulder instability, shoulder fractures, sys- physical therapist once a week for a maximum period of temic diseases (such as rheumatoid arthritis, Reiter's syn- 12 weeks. All participating physiotherapists are experi- drome, diabetes), or who's medical history or enced in treating patients with long-lasting shoulder examination suggests neurological diseases, or other symptoms and patients with MTrPs and myofascial pain, severe medical or psychiatric disorders will be excluded especially in the upper part of the body. They are trained from the study. The project leader will check all the avail- and skilled in the identification of MTrPs and received a able information from referral letters, additional informa- certification in manual trigger point therapy. The treat- tion from the general practitioner and from the patients. ment starts with inactivation of the active (pain produc- All eligible patients will be informed of the study and will ing) MTrPs by using manual techniques (compression on be invited to participate. Patients who are willing to par- the trigger point, manual stretching of the trigger point ticipate will be asked to review and sign the written area and the taut band) combined with "intermittent cold informed consent. application by using ice-cubes followed by stretching the muscle" according to Travell [32] to further inactivate the Measurements MTrPs. Manual pressure will decrease the sensitivity of the Before randomization, all participants will be assessed painful nodule in the muscle while other massage tech- during an individual baseline test session. They will com- nique will mobilize and stretch the contracted muscle plete a battery of questionnaires and tests, determining fibres. The application of the ice-cubes has a desensitizing data on social, demographic, and physical factors, and effect, and makes it easier to stretch shoulder muscles. baseline values for the outcome measures. In addition, Each treatment session will end with a heat application to subjects will complete the DASH, RAND-36-dutch lan- increase the circulation of the involved muscles. guage version, and passive range of motion tests of the shoulder (PROM). During the initial assessment, MTrPs Patients will be advised to do stretching exercises and will will be identified, based on compression-produced pain be taught to perform these correctly by means of surface- that is recognized by patients as their own shoulder pain. electromyography-assisted stretching[33,34]. Further- If no MTrPs are detected, the subjects will be excluded more they will be advised to perform relaxation exercises, from the study. All measurements will be performed by and to applyheat (like a hot shower, hot packs) several the same independent observer, who is not employed by times (at least twice) a day. If there is abnormal measura- the physical therapy practice (This is to create optimal ble higher electromyographic activity in the upper trape- blinding of the observer, who is now not able to recognise zius muscle (measured by surface Electromyography the subjects). The observer is trained in identifying MTrPs (sEMG) using a Myomed 932 [Enraf Nonius, Delft, the and has several years of clinical experience in MTrP ther- Netherlands]) during standing and/or sitting [35], relaxa- apy. The observer participated in a former reliability study tion exercises will be performed using a portable myo- of MTrP palpation. The baseline measurements will be at feedback device (Myotrac I, Thought Technology, Quebec, T0, the second measurement (T1) will be 6 weeks after the Canada). Abnormal sEMG activity is defined as a con- first assessment session, the third (T2) will be 12 weeks stantly measured value above 1%–5% of the maximally after the first assessment session. All measurements [see voluntary contraction [36-39], which is in general above box 1] will be performed outside the physical therapy 10 microvolt, during several minutes and the patient is practice to assure that the observer will not recognise any not able to relax the muscle spontaneously or on request. of the study participants when they come to the physical Finally, all patients will receive ergonomic recommenda- therapy practice for their treatment. After this first assess- tions, andinstructions to assume and maintain "good" ment, the patients will be randomly assigned to one of posture [40,41]. Manual high velocity thrust techniques two groups: the intervention group or the control group. of the cervical spine and the shoulder and dry needling are The patients in the control group will stay on the waiting excluded from the treatment protocol, because not all par- list and will not receive any treatment. They are allowed to ticipating physical therapists are skilled to perform these use over-the-counter painkillers during this 12-week techniques. The content of each session may vary as it period. After 6 weeks and 12 weeks, respectively, they will depends on the findings during the first treatment session be examined by the same blinded observer. After 12 weeks and the results of the previous treatment sessions. Thus, they will receive the same physical therapy program as the there are differences in the content of the individual treat- experimental group [see Figure 1]. The initial trial ends ments, but within the limits of the treatment protocol. after 12 weeks, but 6 months and 12 months after the start of the experimental intervention shoulder function of the Stoprule subjects will be re-evaluated with the DASH-Dutch lan- The treatment ceases when the patient is completely guage version. symptom-free or the patient and the therapist agree that Page 3 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 orthopedic surgeon, neurologist general practioner or Physiatrist presentation at physiotherapy practice refused n= excluded n= included, first assessment, checking health status for exclusion criteria and randomisation control group n= physiotherapy group n= wait and see for 12 weeks assessment after 6 weeks n= n= final assessment after 12 weeks n= n= drop outs and drop outs and withdrawals n= withdrawals n= r Figure 1 ecruitment and experimental plan recruitment and experimental plan. treatment will not further benefit the patient, although Expectations regarding treatment outcome their participation in the study will prolong. If patients At the start of the trial (T0) both the patients and physical decide that they no longer wish to participate in the study therapists will complete a questionnaire regarding the they are free to withdraw from the study at any moment. anticipated treatment outcome. Control of intervention integrity Setting To enhance the integrity of this complex intervention, The study will be conducted in a physical therapy practice every week all participating physical therapists will discuss specialized in management of persons with musculoskel- the content of each therapy session with the researcher etal disorders of the neck, shoulder and arm. After ran- (CB) without mentioning names or other information domisation every patient assigned to the experimental which will assure the blinding of the independent group will be treated by the same physical therapist. researcher (CB). After 6 and 12 weeks, the patients of the intervention group will interviewed about the content of Objectives the received treatment sessions to assure that all patients In the current study we will test the following hypothesis will be treated according to the protocol. If patients are (H0). not treated according to the protocol, they will be identi- fied and participation may be discontinued. A physical therapy treatment to inactivate MTrPs within a three months' period is as effective as a "wait and see" approach of patients with chronic shoulder complaints in a three month period. Page 4 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 Population characteristics of 100 by subtracting one and multiplying by 25. The  To identify potential confounding factors, demographic transformation is done to make the score easier to com- information for all subjects will be collected including pare to other measures using a 0–100 scale. A higher score age, gender, education, occupation, sports and leisure indicates greater disability. activities, duration of the complaints, and type of onset, among others. [(sum of n responses)−1] DASH disability/sympton score = × 25  The Dutch language version of the RAND-36 item Health Survey will be used for base line characteristics of where n is equal to the number of completed responses. the study population. The RAND-36, which is almost identical to the MOS SF-36 [42], scores the functional sta- Scoring is on a 5-point Likert scale from no difficulty (0 tus and quality of life and is widely used for screening points) to very difficult (5 points). The range of the total health status in medical, social and epidemiological score is from 0 to 100, where 0 means no symptoms research. The RAND-36 consists of 36 items divided into (pain, tingling, weakness or stiffness) and no difficulty in 8 subscales concerning physical functioning, role limita- performing daily activities, while 100 means extreme, tions due to physical health, role limitations due to emo- severe symptoms and unable to perform any daily activity. tional problems, energy and fatigue, emotional well- Content and face validity of the DASH were confirmed by being, social functioning, pain, general health perception a variety of experts of the American Academy of Orthopae- and health change. This questionnaire is considered to be dic Surgeons (AAOS), the council of Musculoskeletal Spe- a reliable instrument for comparing groups (internal con- ciality Societies (COMSS) and the institute for Work and sistency Cronbach's alpha > 0.70). The test-retest stability Health (Toronto, Ontario, Canada) throughout the devel- is sufficient (0.58 – 0.82) and the questionnaire is respon- opment process [44]. sive when scoring after at least 4 weeks. The construct validity was estimated by comparing the RAND-36 with Its internal consistency was excellent (Cronbach's alpha = other Health questionnaires (like the Nottingham Health 0.96) during field-testing. The test-retest reliability was Profile [NHP] and the Groninger Activities Restriction excellent (ICC = 0.92 and 0.96) in two studies [45,46] 2.1 Scale [GARS]. There are significant correlations between and satisfactory in one study (Pearson 0.98 and kappa the subscales of the RAND-36 and the subscales of the 0.67). The minimal detectable Change (MDC) was calcu- NHP (correlation coefficient 0.42 – 0.69). The correlation lated in a population of 172 patients with several upper coefficient between the subscale physical functioning and limb disorders (Osteoarthritis, Carpal Tunnel syndrome, the GARS is 0.65. A higher score (maximum is 100 points) Rotator Cuff syndrome, Rheumatoid Arthritis and Tennis defines a more favourable health status. Elbow) [47]. The Minimal Detectable Change (MDC) var- ied between 10.70 (at 90% confidence level) and 12.75  The Beck Depression Inventory (BDI) is used to discrim- (at 95% confidence level). The DASH demonstrated to be inate between patients with major depression and those a responsive questionnaire. without or with minor depressive feelings. The BDI is included because depression may be a confounding fac- The inter- and intra-observer reliability is good to excel- tor. The BDI is widely accepted and used in clinical and lent (intra-observer reliability Pearson r = 0.96 to 0.98; experimental research and its predictive value is rated as ICC = 0.91 to 0.96; Inter-observer agreement Cohen's good. A BDI-score equally or higher than 21 indicates a kappa = 0.79). major depression (specificity 78.4%) [43]. The construct validity was estimated by comparing the Outcomes DASH to several other questionnaires. The correlation The following outcome parameters will be used: with other instruments like the SPADI (Shoulder Pain and Disability Index) is good (Pearson's r = 0.82 to 0.88). The Primary DASH questionnaire is one of the best among 16 other The overall score of the DASH (Disability of Arm Shoulder questionnaires for shoulder symptoms [48]. and Hand) questionnaire – Dutch language version will be used as the primary outcome measure. The DASH is a Secondary multidimensional (physical, emotional and social) 30- An independent examiner will perform the following item self-report measure focussing on physical function tests. pain and other symptoms. At least 27 of the 30 items must be completed for a score to be calculated. The assigned  The total number of shoulder muscles with MTrPs will values for all completed responses are simply summed be counted and compared to the baseline measurement and averaged. This value is then transformed to a score out findings. Page 5 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107  Passive range of motion of the shoulder will be meas- 0°. The observer than performs elevation until pain limits ured by an handheld digital inclinometer (The Saunders the range of motion or the extreme of the range is reached. group Inc, Chaska, MN). The range of motion of the non- Then the inclinometer is placed against the medial side of painful shoulder will be used as reference [49,49,50]. the upper arm near the elbow. The range of motion is Because the normal range of motion differs from one indi- recorded in degrees. The normal range of motion is vidual to another, we focus on improvement of limited between 165° and 180° range of motion during the experiment (both experimen- tal group and control group).  For the measurement of internal rotation the patient is in a prone position. The shoulder is 90° abduction, and For the measurement of passive external rotation, the the forearm is in neutral position. This position is defined patient is in a supine position, with the shoulder in 0° of as the position of 0°. The observer than performs internal abduction and rotation, the elbow flexed at 90° and the rotation until pain limits the range of motion or the forearm in a neutral position. This position is defined as extreme of the range is reached. The sensor is placed the position of 0°. The observer then performs external against the volar side of the forearm. The normal range of rotation until pain limits the range of motion or the motion is 70° extreme of the range is reached. The inclinometer is placed against the volar side of the forearm. This range of motion  For the measurement of horizontal adduction the is recorded in degrees. The normal range of motion for patient is in a supine position. The arm is in 90° abduc- external rotation is between 70° and 90°. tion. This position is defined as the position of 0°. The observer performs adduction, while the arm stays in the For the measurement of passive glenohumeral abduc- vertical plane, until pain limits the range of motion or the tion, the patient is seated upright, and the position of 0° extreme of the range is reached. The normal range of is defined as the upper arm is in a neutral position. While motion is 135° palpating the lower angle of the scapula with the thumb, the examiner elevates the upper arm of the patient until  Finally the total number of treatment sessions will be the scapula begins to rotate or pain limits further motion. counted. This is done by an assistant, who is not involved The inclinometer is placed against the lateral side of the in the study by using the administration-software of the upper arm near the elbow. The range of motion is practice [see Table 1]. recorded in degrees. The normal range of motion is 90°. Sample size For the measurement of passive elevation (through flex- The initial sample size is based on the assumption that the ion), the patient is in the supine position with the arm overall score of the primary outcome measure DASH along the side. This position is defined as the position of shows a mean improvement of 15 points [SD = 22] [51]. Table 1: Overview of variables Variable T0 Baseline T1 After 6 wk T2 After 12 wk Measured by Age* X Interview Gender* X Interview Work X Interview Dominant side affected X Interview Duration of the complaints* X Interview DASH DLV X X X Questionnaire Use of medication X X X Interview Use of other therapy X X X Interview Work % X X X Interview Improvement (percentage of perceived improvement) X X Interview Number of involved muscles X X X Assessment No. of treatment sessions X Assessment Health status for baseline comparison X RAND-36 DLV Existence and severity of symptoms of depression X Beck Depression Inventory Shoulder Passive ROM XX X Goniometry • flexion X X X • abduction X X X • external rotation X X X • internal rotation X X X • cross body adduction X X X *Age, gender and duration of the complaints seem to be important prognostic variables [53]. Page 6 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 To test the null hypothesis of equality of treatment at α = of our knowledge, few studies of the efficacy of MTrP ther- .05 with 90% power and assuming a uniform dropout rate apy are published. We choose for an intervention strategy of 5%, it was calculated that 52 patients in each group that best reflects daily practice. We excluded manual high would be sufficient. velocity thrust techniques and intramuscular MTrP release by dry needling, because these interventions are not com- Randomization monly used by Dutch physical therapists and not all par- After inclusion the patients will be randomly assigned to ticipating therapists were skilled to perform these either the intervention group or the "wait and see" group. techniques at the beginning of the study. In most physical The randomisation will be performed by an assistant not therapy interventions, blinding of the patient and the otherwise involved in the study by generating random therapist is not possible. The observers will be blinded for numbers using computer software. Stratification or block- the allocation procedure. The results of this trial will be ing strategies will not be used. presented as soon as they are available. Informed consent Competing interests The patients will be informed about the study prior to the The author(s) declare that they have no competing inter- first assessment and will be asked to give written informed ests. consent. Authors' contributions Blinding All authors read, edited and approved the final manu- Blinding of the patients or the physical therapists, who are script. CB is the lead investigator, and developed the involved in the treatment, is impossible due to the treat- design of the study, will carry out data-acquisition, analy- ment characteristics. sis, interpretations, and prepared as primary author the manuscript. MW and RO were responsible for the design, An independent observer will collect baseline data and project supervision and writing of the manuscript. JF will outcome data. The independent observer is blinded. The assist in carrying out data acquisition and was involved in successfulness of the blinding procedure will be evaluated preparing the study design and in writing the manuscript. by asking the observer to which group she believes the subjects belong. Acknowledgements The authors like to thank Jan Dommerholt, physical therapist for his assist- ance and critical analysis of this paper. 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Wolfe F, Simons DG, Fricton J, Bennett RM, Goldenberg DL, Gerwin 47. Beaton DE, Davies AM, Hudak P, McConnell S: The DASH (Disa- R, Hathaway D, McCain GA, Russell IJ, Sanders HO, .: The fibromy- bilities of the Arm, Shoulder and Hand) outcome measure: algia and myofascial pain syndromes: a preliminary study of What do we know about it now? British Journal of Hand Therapy tender points and trigger points in persons with fibromyal- 2001, 6:109-118. gia, myofascial pain syndrome and no disease. J Rheumatol 48. Bot SD, Terwee CB, van der Windt DA, Bouter LM, Dekker J, de Vet 1992, 19:944-951. HC: Clinimetric evaluation of shoulder disability question- 26. Gerwin RD, Shannon S, Hong CZ, Hubbard D, Gevirtz R: Interrater naires: a systematic review of the literature. Ann Rheum Dis reliability in myofascial trigger point examination. Pain 1997, 2004, 63:335-341. 69:65-73. 49. Clarkson HM: Joint Motion and Function Assessment. A research-based 27. Bron C, Wensing M, Franssen JLM, RAB O: Interobserver Reliabil- practical Guide 1st edition. Philadelphia;Baltimore, Lippincott, Williams ity of Palpation of Myofascial Trigger Points in Shoulder Mus- & Wilkins; 2005. cles. Journal Manual Manipulative Therapy 2007, 15:in press. 50. A.F.de W, Heemskerk MA, Terwee CB, Jans MP, Deville W, van 28. Ingber RS: Shoulder impingement in tennis/racquetball play- Schaardenburg DJ, Scholten RJ, Bouter LM: Inter-observer repro- ers treated with subscapularis myofascial treatments. Arch ducibility of measurements of range of motion in patients Phys Med Rehabil 2000, 81:679-682. with shoulder pain using a digital inclinometer. BMC Muscu- 29. Weed ND: When shoulder pain isn't bursitis. The myofascial loskelet Disord 2004, 5:18 [http://]. pain syndrome. Postgrad Med 1983, 74:97-2, 104. 51. Gummesson C, Atroshi I, Ekdahl C: The disabilities of the arm, 30. Grosshandler SL, Stratas NE, Toomey TC, Gray WF: Chronic neck shoulder and hand (DASH) outcome questionnaire: longitu- and shoulder pain. Focusing on myofascial origins. Postgrad dinal construct validity and measuring self-rated health Med 1985, 77:149-8. change after surgery. BMC Musculoskelet Disord 2003, 4:11. 31. Bron C, Franssen JLM, de Valk BGM: Een posttraumatische 52. Altman DG: Practical statistics for medical research first edition. Chap- schouderklacht zonder aanwijsbaar letsel. Ned Tijdschrift v Fys- man & Hall; 1991. iotherapie 2001:97-102. 53. Thomas E, van der Windt DA, Hay EM, Smidt N, Dziedzic K, Bouter 32. JG T, DG S: Myofascial Pain and Dysfunction. The Trigger Point Manual. LM, Croft PR: Two pragmatic trials of treatment for shoulder The lower extremities. Volume II. first edition. Baltimore, Lippincott, disorders in primary care: generalisability, course, and prog- Williams and Wilkins; 1999. nostic indicators. Ann Rheum Dis 2005, 64:1056-1061. 33. Neblett R, Gatchel RJ, Mayer TG: A clinical guide to surface- EMG-assisted stretching as an adjunct to chronic muscu- Pre-publication history loskeletal pain rehabilitation. Appl Psychophysiol Biofeedback 2003, The pre-publication history for this paper can be accessed 28:147-160. 34. Neblett R, Mayer TG, Gatchel RJ: Theory and rationale for sur- here: face EMG-assisted stretching as an adjunct to chronic musc- uloskeletal pain rehabilitation. Appl Psychophysiol Biofeedback 2003, 28:139-146. http://www.biomedcentral.com/1471-2474/8/107/pre 35. Franssen JLM: Handboek oppervlakte-elektromyografie. First edition. pub Edited by: Franssen JLM. Utrecht, De Tijdstroom; 1995. Page 8 of 8 (page number not for citation purposes) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Musculoskeletal Disorders Springer Journals

Treatment of myofascial trigger points in common shoulder disorders by physical therapy: A randomized controlled trial [ISRCTN75722066]

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Springer Journals
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Copyright © 2007 by Bron et al; licensee BioMed Central Ltd.
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Medicine & Public Health; Orthopedics; Rehabilitation; Rheumatology; Sports Medicine; Internal Medicine; Epidemiology
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10.1186/1471-2474-8-107
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17983467
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Abstract

Background: Shoulder disorders are a common health problem in western societies. Several treatment protocols have been developed for the clinical management of persons with shoulder pain. However available evidence does not support any protocol as being superior over others. Systematic reviews provide some evidence that certain physical therapy interventions (i.e. supervised exercises and mobilisation) are effective in particular shoulder disorders (i.e. rotator cuff disorders, mixed shoulder disorders and adhesive capsulitis), but there is an ongoing need for high quality trials of physical therapy interventions. Usually, physical therapy consists of active exercises intended to strengthen the shoulder muscles as stabilizers of the glenohumeral joint or perform mobilisations to improve restricted mobility of the glenohumeral or adjacent joints (shoulder girdle). It is generally accepted that a-traumatic shoulder problems are the result of impingement of the subacromial structures, such as the bursa or rotator cuff tendons. Myofascial trigger points (MTrPs) in shoulder muscles may also lead to a complex of symptoms that are often seen in patients diagnosed with subacromial impingement or rotator cuff tendinopathy. Little is known about the treatment of MTrPs in patients with shoulder disorders. The primary aim of this study is to investigate whether physical therapy modalities to inactivate MTrPs can reduce symptoms and improve shoulder function in daily activities in a population of chronic a-traumatic shoulder patients when compared to a wait-and-see strategy. In addition we investigate the recurrence rate during a one-year-follow-up period. Methods/Design: This paper presents the design for a randomized controlled trial to be conducted between September 2007 – September 2008, evaluating the effectiveness of a physical therapy treatment for non-traumatic shoulder complaints. One hundred subjects are included in this study. All subjects have unilateral shoulder pain for at least six months and are referred to a physical therapy practice specialized in musculoskeletal disorders of the neck-, shoulder-, and arm. After the initial assessment patients are randomly assigned to either an intervention group or a control-group (wait and see). The primary outcome measure is the overall score of the Dutch language version of the DASH (Disabilities of Arm, Shoulder and Hand) questionnaire. Discussion: Since there is only little evidence for the efficacy of physical therapy interventions in certain shoulder disorders, there is a need for further research. We found only a few studies examining the efficacy of MTrP therapy for Page 1 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 shoulder disorders. Therefore we will perform a randomised clinical trial of the effect of physical therapy interventions aimed to inactivate MTrPs, on pain and impairment in shoulder function in a population of chronic a-traumatic shoulder patients. We opted for an intervention strategy that best reflects daily practice. Manual high velocity thrust techniques and dry-needling are excluded. Because in most physical therapy interventions, blinding of the patient and the therapist is not possible, we will perform a randomised, controlled and observer-blinded study. Trial Registration: This randomized clinical trial is registered at current controlled trials ISRCTN75722066. num toxin, followed by ergonomic advises, active Background Shoulder pain is a common health problem in western exercises, postural correction, and relaxation (with or societies. There are substantial differences in reported without biofeedback)[17,18]. Over the years, MTrPs are prevalence in the general population. The one-year preva- increasingly accepted in the medical literature. Clinical, lence of shoulder disorders has been reported to range histological, biochemical and electrophysiological from 20% to 50%. This wide range is strongly influenced research has provided biological plausibility for the exist- for example by the definition of shoulder disorders, ence of MTrPs [19-24]. including or excluding limited motion, age, gender and anatomic area [1-3]. Of all shoulder patients who attend MTrPs are defined as exquisitely tender spots in discrete primary care physicians 50% recover within 6 months, taut bands of hardened muscle that produce symptoms meaning they do not seek any medical help after the first [25,26]. A previous study showed that MTrPs can be episode[1,4-6]. Chronicity and recurrence of symptoms detected reliably by trained physiotherapists [27]. Palpa- are common [7,8]. According to the guidelines of the tion is still the only reliable method to diagnose myofas- Dutch College of General Practioners [9], the recom- cial pain clinically. In reviews addressing the efficacy of mended management of shoulder symptoms starts with interventions in shoulder patients, MTrP therapy and educational information about the natural course of myofascial pain are rarely mentioned [15]. However, shoulder pain combined with the advise to avoid irritat- some published case studies suggest that treatment of ing and loading activities. The use of analgesics or NSAIDs MTrPs in shoulder patients may be beneficial [28-31]. is recommended for the first two weeks. When no recov- ery occurs within two weeks, subacromial or intra-articu- The primary aim of this study is to investigate the effec- lar injection therapy with corticosteroids are administered tiveness of inactivation of MTrPs in shoulder muscles by and eventually repeated. Finally, physical therapy is only physical therapy on symptoms and functioning of the recommended after a 6-week period when there are func- shoulder in daily activities in a population of chronic a- tional limitations (specifically an activating and time-con- traumatic shoulder patients when compared to a wait- tingent approach). International guidelines for shoulder and-see strategy. In addition, we investigate the recurrence pain, including the Clinical Guideline of Shoulder pain of rate during a one-year-follow-up period. the American Academy of Orthopaedic Surgeons [10] and the Shoulder Guideline of the New Zealand Guidelines Methods/Design Group[11] differ more or less from the Dutch guidelines An examiner-blinded randomized controlled trial will be in classification, recommended interventions and time- conducted, which has been approved by the ethics com- line, and order of interventions. Scientific evidence from mittee of the Radboud University Nijmegen Medical Cen- randomized clinical trials, meta-analyses or systematic tre, the Netherlands [CMO 2007/022]. reviews for either the efficacy of multimodal rehabilita- tion, injection therapy, medication, surgery or physical Participants/Study sample therapy or the order of application of commonly used Between September 2007 and September 2008, all con- therapies is lacking [12-16]. secutive patients referred to a physical therapy practice specialized in the treatment of individuals with muscu- An alternative approach to the management of persons loskeletal disorders of the neck, shoulder and arm are with shoulder problems consists of a treatment aimed at potential study participants. The referring physicians inactivating MTrPs and eliminating factors that perpetuate include general practioners, orthopaedic surgeons, neu- them. MTrPs may be inactivated by manual techniques rologists and physiatrists. Patients are eligible if they have (such as compression on the trigger point or other mas- unilateral shoulder complaints (described as pain felt in sage techniques), cooling the skin with ethyl chloride the shoulder or upper arm) for at least six months. The spray or with ice-cubes followed by stretching of the patients present with persistent shoulder pain that has not involved muscle, trigger point needling using an acupunc- spontaneously recovered. The patients are between 18 and ture needle, or injection with local anaesthetics or Botuli- 65 years old. Because the questionnaires are in the Dutch Page 2 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 language, subjects must understand written and verbal Intervention Dutch. Patients who have been diagnosed (prior to the The patients in the intervention group will be treated by a referral) with shoulder instability, shoulder fractures, sys- physical therapist once a week for a maximum period of temic diseases (such as rheumatoid arthritis, Reiter's syn- 12 weeks. All participating physiotherapists are experi- drome, diabetes), or who's medical history or enced in treating patients with long-lasting shoulder examination suggests neurological diseases, or other symptoms and patients with MTrPs and myofascial pain, severe medical or psychiatric disorders will be excluded especially in the upper part of the body. They are trained from the study. The project leader will check all the avail- and skilled in the identification of MTrPs and received a able information from referral letters, additional informa- certification in manual trigger point therapy. The treat- tion from the general practitioner and from the patients. ment starts with inactivation of the active (pain produc- All eligible patients will be informed of the study and will ing) MTrPs by using manual techniques (compression on be invited to participate. Patients who are willing to par- the trigger point, manual stretching of the trigger point ticipate will be asked to review and sign the written area and the taut band) combined with "intermittent cold informed consent. application by using ice-cubes followed by stretching the muscle" according to Travell [32] to further inactivate the Measurements MTrPs. Manual pressure will decrease the sensitivity of the Before randomization, all participants will be assessed painful nodule in the muscle while other massage tech- during an individual baseline test session. They will com- nique will mobilize and stretch the contracted muscle plete a battery of questionnaires and tests, determining fibres. The application of the ice-cubes has a desensitizing data on social, demographic, and physical factors, and effect, and makes it easier to stretch shoulder muscles. baseline values for the outcome measures. In addition, Each treatment session will end with a heat application to subjects will complete the DASH, RAND-36-dutch lan- increase the circulation of the involved muscles. guage version, and passive range of motion tests of the shoulder (PROM). During the initial assessment, MTrPs Patients will be advised to do stretching exercises and will will be identified, based on compression-produced pain be taught to perform these correctly by means of surface- that is recognized by patients as their own shoulder pain. electromyography-assisted stretching[33,34]. Further- If no MTrPs are detected, the subjects will be excluded more they will be advised to perform relaxation exercises, from the study. All measurements will be performed by and to applyheat (like a hot shower, hot packs) several the same independent observer, who is not employed by times (at least twice) a day. If there is abnormal measura- the physical therapy practice (This is to create optimal ble higher electromyographic activity in the upper trape- blinding of the observer, who is now not able to recognise zius muscle (measured by surface Electromyography the subjects). The observer is trained in identifying MTrPs (sEMG) using a Myomed 932 [Enraf Nonius, Delft, the and has several years of clinical experience in MTrP ther- Netherlands]) during standing and/or sitting [35], relaxa- apy. The observer participated in a former reliability study tion exercises will be performed using a portable myo- of MTrP palpation. The baseline measurements will be at feedback device (Myotrac I, Thought Technology, Quebec, T0, the second measurement (T1) will be 6 weeks after the Canada). Abnormal sEMG activity is defined as a con- first assessment session, the third (T2) will be 12 weeks stantly measured value above 1%–5% of the maximally after the first assessment session. All measurements [see voluntary contraction [36-39], which is in general above box 1] will be performed outside the physical therapy 10 microvolt, during several minutes and the patient is practice to assure that the observer will not recognise any not able to relax the muscle spontaneously or on request. of the study participants when they come to the physical Finally, all patients will receive ergonomic recommenda- therapy practice for their treatment. After this first assess- tions, andinstructions to assume and maintain "good" ment, the patients will be randomly assigned to one of posture [40,41]. Manual high velocity thrust techniques two groups: the intervention group or the control group. of the cervical spine and the shoulder and dry needling are The patients in the control group will stay on the waiting excluded from the treatment protocol, because not all par- list and will not receive any treatment. They are allowed to ticipating physical therapists are skilled to perform these use over-the-counter painkillers during this 12-week techniques. The content of each session may vary as it period. After 6 weeks and 12 weeks, respectively, they will depends on the findings during the first treatment session be examined by the same blinded observer. After 12 weeks and the results of the previous treatment sessions. Thus, they will receive the same physical therapy program as the there are differences in the content of the individual treat- experimental group [see Figure 1]. The initial trial ends ments, but within the limits of the treatment protocol. after 12 weeks, but 6 months and 12 months after the start of the experimental intervention shoulder function of the Stoprule subjects will be re-evaluated with the DASH-Dutch lan- The treatment ceases when the patient is completely guage version. symptom-free or the patient and the therapist agree that Page 3 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 orthopedic surgeon, neurologist general practioner or Physiatrist presentation at physiotherapy practice refused n= excluded n= included, first assessment, checking health status for exclusion criteria and randomisation control group n= physiotherapy group n= wait and see for 12 weeks assessment after 6 weeks n= n= final assessment after 12 weeks n= n= drop outs and drop outs and withdrawals n= withdrawals n= r Figure 1 ecruitment and experimental plan recruitment and experimental plan. treatment will not further benefit the patient, although Expectations regarding treatment outcome their participation in the study will prolong. If patients At the start of the trial (T0) both the patients and physical decide that they no longer wish to participate in the study therapists will complete a questionnaire regarding the they are free to withdraw from the study at any moment. anticipated treatment outcome. Control of intervention integrity Setting To enhance the integrity of this complex intervention, The study will be conducted in a physical therapy practice every week all participating physical therapists will discuss specialized in management of persons with musculoskel- the content of each therapy session with the researcher etal disorders of the neck, shoulder and arm. After ran- (CB) without mentioning names or other information domisation every patient assigned to the experimental which will assure the blinding of the independent group will be treated by the same physical therapist. researcher (CB). After 6 and 12 weeks, the patients of the intervention group will interviewed about the content of Objectives the received treatment sessions to assure that all patients In the current study we will test the following hypothesis will be treated according to the protocol. If patients are (H0). not treated according to the protocol, they will be identi- fied and participation may be discontinued. A physical therapy treatment to inactivate MTrPs within a three months' period is as effective as a "wait and see" approach of patients with chronic shoulder complaints in a three month period. Page 4 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 Population characteristics of 100 by subtracting one and multiplying by 25. The  To identify potential confounding factors, demographic transformation is done to make the score easier to com- information for all subjects will be collected including pare to other measures using a 0–100 scale. A higher score age, gender, education, occupation, sports and leisure indicates greater disability. activities, duration of the complaints, and type of onset, among others. [(sum of n responses)−1] DASH disability/sympton score = × 25  The Dutch language version of the RAND-36 item Health Survey will be used for base line characteristics of where n is equal to the number of completed responses. the study population. The RAND-36, which is almost identical to the MOS SF-36 [42], scores the functional sta- Scoring is on a 5-point Likert scale from no difficulty (0 tus and quality of life and is widely used for screening points) to very difficult (5 points). The range of the total health status in medical, social and epidemiological score is from 0 to 100, where 0 means no symptoms research. The RAND-36 consists of 36 items divided into (pain, tingling, weakness or stiffness) and no difficulty in 8 subscales concerning physical functioning, role limita- performing daily activities, while 100 means extreme, tions due to physical health, role limitations due to emo- severe symptoms and unable to perform any daily activity. tional problems, energy and fatigue, emotional well- Content and face validity of the DASH were confirmed by being, social functioning, pain, general health perception a variety of experts of the American Academy of Orthopae- and health change. This questionnaire is considered to be dic Surgeons (AAOS), the council of Musculoskeletal Spe- a reliable instrument for comparing groups (internal con- ciality Societies (COMSS) and the institute for Work and sistency Cronbach's alpha > 0.70). The test-retest stability Health (Toronto, Ontario, Canada) throughout the devel- is sufficient (0.58 – 0.82) and the questionnaire is respon- opment process [44]. sive when scoring after at least 4 weeks. The construct validity was estimated by comparing the RAND-36 with Its internal consistency was excellent (Cronbach's alpha = other Health questionnaires (like the Nottingham Health 0.96) during field-testing. The test-retest reliability was Profile [NHP] and the Groninger Activities Restriction excellent (ICC = 0.92 and 0.96) in two studies [45,46] 2.1 Scale [GARS]. There are significant correlations between and satisfactory in one study (Pearson 0.98 and kappa the subscales of the RAND-36 and the subscales of the 0.67). The minimal detectable Change (MDC) was calcu- NHP (correlation coefficient 0.42 – 0.69). The correlation lated in a population of 172 patients with several upper coefficient between the subscale physical functioning and limb disorders (Osteoarthritis, Carpal Tunnel syndrome, the GARS is 0.65. A higher score (maximum is 100 points) Rotator Cuff syndrome, Rheumatoid Arthritis and Tennis defines a more favourable health status. Elbow) [47]. The Minimal Detectable Change (MDC) var- ied between 10.70 (at 90% confidence level) and 12.75  The Beck Depression Inventory (BDI) is used to discrim- (at 95% confidence level). The DASH demonstrated to be inate between patients with major depression and those a responsive questionnaire. without or with minor depressive feelings. The BDI is included because depression may be a confounding fac- The inter- and intra-observer reliability is good to excel- tor. The BDI is widely accepted and used in clinical and lent (intra-observer reliability Pearson r = 0.96 to 0.98; experimental research and its predictive value is rated as ICC = 0.91 to 0.96; Inter-observer agreement Cohen's good. A BDI-score equally or higher than 21 indicates a kappa = 0.79). major depression (specificity 78.4%) [43]. The construct validity was estimated by comparing the Outcomes DASH to several other questionnaires. The correlation The following outcome parameters will be used: with other instruments like the SPADI (Shoulder Pain and Disability Index) is good (Pearson's r = 0.82 to 0.88). The Primary DASH questionnaire is one of the best among 16 other The overall score of the DASH (Disability of Arm Shoulder questionnaires for shoulder symptoms [48]. and Hand) questionnaire – Dutch language version will be used as the primary outcome measure. The DASH is a Secondary multidimensional (physical, emotional and social) 30- An independent examiner will perform the following item self-report measure focussing on physical function tests. pain and other symptoms. At least 27 of the 30 items must be completed for a score to be calculated. The assigned  The total number of shoulder muscles with MTrPs will values for all completed responses are simply summed be counted and compared to the baseline measurement and averaged. This value is then transformed to a score out findings. Page 5 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107  Passive range of motion of the shoulder will be meas- 0°. The observer than performs elevation until pain limits ured by an handheld digital inclinometer (The Saunders the range of motion or the extreme of the range is reached. group Inc, Chaska, MN). The range of motion of the non- Then the inclinometer is placed against the medial side of painful shoulder will be used as reference [49,49,50]. the upper arm near the elbow. The range of motion is Because the normal range of motion differs from one indi- recorded in degrees. The normal range of motion is vidual to another, we focus on improvement of limited between 165° and 180° range of motion during the experiment (both experimen- tal group and control group).  For the measurement of internal rotation the patient is in a prone position. The shoulder is 90° abduction, and For the measurement of passive external rotation, the the forearm is in neutral position. This position is defined patient is in a supine position, with the shoulder in 0° of as the position of 0°. The observer than performs internal abduction and rotation, the elbow flexed at 90° and the rotation until pain limits the range of motion or the forearm in a neutral position. This position is defined as extreme of the range is reached. The sensor is placed the position of 0°. The observer then performs external against the volar side of the forearm. The normal range of rotation until pain limits the range of motion or the motion is 70° extreme of the range is reached. The inclinometer is placed against the volar side of the forearm. This range of motion  For the measurement of horizontal adduction the is recorded in degrees. The normal range of motion for patient is in a supine position. The arm is in 90° abduc- external rotation is between 70° and 90°. tion. This position is defined as the position of 0°. The observer performs adduction, while the arm stays in the For the measurement of passive glenohumeral abduc- vertical plane, until pain limits the range of motion or the tion, the patient is seated upright, and the position of 0° extreme of the range is reached. The normal range of is defined as the upper arm is in a neutral position. While motion is 135° palpating the lower angle of the scapula with the thumb, the examiner elevates the upper arm of the patient until  Finally the total number of treatment sessions will be the scapula begins to rotate or pain limits further motion. counted. This is done by an assistant, who is not involved The inclinometer is placed against the lateral side of the in the study by using the administration-software of the upper arm near the elbow. The range of motion is practice [see Table 1]. recorded in degrees. The normal range of motion is 90°. Sample size For the measurement of passive elevation (through flex- The initial sample size is based on the assumption that the ion), the patient is in the supine position with the arm overall score of the primary outcome measure DASH along the side. This position is defined as the position of shows a mean improvement of 15 points [SD = 22] [51]. Table 1: Overview of variables Variable T0 Baseline T1 After 6 wk T2 After 12 wk Measured by Age* X Interview Gender* X Interview Work X Interview Dominant side affected X Interview Duration of the complaints* X Interview DASH DLV X X X Questionnaire Use of medication X X X Interview Use of other therapy X X X Interview Work % X X X Interview Improvement (percentage of perceived improvement) X X Interview Number of involved muscles X X X Assessment No. of treatment sessions X Assessment Health status for baseline comparison X RAND-36 DLV Existence and severity of symptoms of depression X Beck Depression Inventory Shoulder Passive ROM XX X Goniometry • flexion X X X • abduction X X X • external rotation X X X • internal rotation X X X • cross body adduction X X X *Age, gender and duration of the complaints seem to be important prognostic variables [53]. Page 6 of 8 (page number not for citation purposes) BMC Musculoskeletal Disorders 2007, 8:107 http://www.biomedcentral.com/1471-2474/8/107 To test the null hypothesis of equality of treatment at α = of our knowledge, few studies of the efficacy of MTrP ther- .05 with 90% power and assuming a uniform dropout rate apy are published. We choose for an intervention strategy of 5%, it was calculated that 52 patients in each group that best reflects daily practice. We excluded manual high would be sufficient. velocity thrust techniques and intramuscular MTrP release by dry needling, because these interventions are not com- Randomization monly used by Dutch physical therapists and not all par- After inclusion the patients will be randomly assigned to ticipating therapists were skilled to perform these either the intervention group or the "wait and see" group. techniques at the beginning of the study. In most physical The randomisation will be performed by an assistant not therapy interventions, blinding of the patient and the otherwise involved in the study by generating random therapist is not possible. The observers will be blinded for numbers using computer software. Stratification or block- the allocation procedure. The results of this trial will be ing strategies will not be used. presented as soon as they are available. Informed consent Competing interests The patients will be informed about the study prior to the The author(s) declare that they have no competing inter- first assessment and will be asked to give written informed ests. consent. Authors' contributions Blinding All authors read, edited and approved the final manu- Blinding of the patients or the physical therapists, who are script. CB is the lead investigator, and developed the involved in the treatment, is impossible due to the treat- design of the study, will carry out data-acquisition, analy- ment characteristics. sis, interpretations, and prepared as primary author the manuscript. MW and RO were responsible for the design, An independent observer will collect baseline data and project supervision and writing of the manuscript. JF will outcome data. The independent observer is blinded. The assist in carrying out data acquisition and was involved in successfulness of the blinding procedure will be evaluated preparing the study design and in writing the manuscript. by asking the observer to which group she believes the subjects belong. Acknowledgements The authors like to thank Jan Dommerholt, physical therapist for his assist- ance and critical analysis of this paper. 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