Clinical trial NCT04175184: Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain
Official title: The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Shoulder Pain
Keywords: rotator cuff pain
mobilisation with movement
exercises
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, placebo-controlled, with a parallel group design
Primary purpose: TREATMENT

Brief summary: Rotator cuff related pain is considered the main source of musculoskeletal shoulder pain that affects function and produces pain on movement. Amongst the existing physiotherapeutic management approaches, exercise therapy has been recognized as the first line approach. The use of manual therapy in the management of this condition has been debated and studies have shown contradictory results. A specific manual therapy approach, mobilisation with movement (MWM), seems promising in this population as it aims to improve pain-free range of motion and includes active engagement of the participant.

Detailed description: Rotator cuff related pain is a term that includes a diversity of shoulder conditions known as: subacromial impingement syndrome, rotator cuff tendinitis/tendinopathy, rotator cuff tear, bursitis. The use of a broader term is useful as the diagnostic accuracy of special orthopaedic tests have been widely criticised and are unable to identify pathognomonic sources of symptoms in people presenting with shoulder pain. Additionally, even though diagnostic imaging is capable of identifying pathology in patients with rotator cuff related pain, studies demonstrate that their correlation with clinical presentation is questionable.

Shoulder pain is one of the most common sources of musculoskeletal pain that might affect up to 20% of the population. Additional important epidemiological data concerning shoulder pain is the fact that approximately 40% of people complaining of shoulder pain will still be symptomatic after six months. Physiotherapy has an important role in the management of rotator cuff related pain and exercise is the main therapeutic approach when considering pain and functional restriction,

Mobilisation with movement (MWM) is one alternative musculoskeletal approach that focuses on improving active pain-free range of motion. This concept of treatment incorporates a passive accessory glide produced by the clinician, followed by an active movement executed by the patient. Different studies have suggested positive effects of MWM in patients complaining of shoulder pain. On the other hand, other studies reported no superior effects when using MWM in their studies. Several methodological aspects might have influenced this discrepancy in results, such as population, dosage and type of MWM utilized, follow-up period and outcome measures. Due to this uncertainty, the current research aims to further explore the inclusion of MWM to an exercise programme in patients with rotator cuff related pain.

Eligibility criteria: Inclusion Criteria:

* Unilateral shoulder pain of atraumatic origin.
* Complaining of shoulder pain for at least six weeks.
* Scoring at least 3 out 10 on a numeric pain rating scale (0- no pain; 10- worst pain imaginable).
* Pain on active shoulder movement
* Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, painful arc, resisted external rotation, empty or full can.
* Participants referred by a specialist under the diagnosis of subacromial impingement syndrome, rotator cuff tendinopathy, partial rotator cuff tears, subacromial pain, bursitis.

Exclusion Criteria:

* Shoulder pain following a traumatic event.
* History compatible with complete rotator cuff and biceps rupture.
* Adhesive capsulitis.
* History of dislocation.
* Glenohumeral osteoarthritis.
* Cancer
* Systemic, local or self-immune inflammatory conditions.
* Previous shoulder or neck surgery.
* Familiar pain provoked by neck movements.
* Presence of radicular signs.
* Use of corticosteroids over the past six months.
* Diagnosis of fibromyalgia.
* Participants with clinical depression
* Participants under treatment for her/his shoulder condition.

Primary outcomes:
measure: Shoulder Pain Disability Index (SPADI).
timeFrame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
measure: Visual Analogue Scale (VAS) for pain.
timeFrame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Secondary outcomes:
measure: Active pain-free range of motion.
timeFrame: Changes from baseline and study completion (5 weeks).
measure: Pain pressure threshold
timeFrame: Changes from baseline and study completion (5 weeks).
measure: Global rating scale of change (GROC)
timeFrame: Through study completion and 4 weeks follow-up.
measure: Expectations of physiotherapy
timeFrame: Change at 3 weeks of treatment from baseline
Other outcomes:
measure: Chronic Pain Self-Efficacy Scale
timeFrame: Baseline
Locations:
city: São Leopoldo
country: Brazil
facility: Albrecht - Clínica Integrada de Reabilitação
state: Rio Grande Do Sul
city: Taquara
country: Brazil
facility: Faculdades Integradas de Taquara
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Marcelo Faria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: is it time for a new method of assessment? Br J Sports Med. 2009 Apr;43(4):259-64. doi: 10.1136/bjsm.2008.052183. Epub 2008 Oct 6.
citation: Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, Cook C. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med. 2008 Feb;42(2):80-92; discussion 92. doi: 10.1136/bjsm.2007.038406. Epub 2007 Aug 24.
citation: Hegedus EJ, Cook C, Lewis J, Wright A, Park JY. Combining orthopedic special tests to improve diagnosis of shoulder pathology. Phys Ther Sport. 2015 May;16(2):87-92. doi: 10.1016/j.ptsp.2014.08.001. Epub 2014 Aug 10.
citation: Gismervik SO, Drogset JO, Granviken F, Ro M, Leivseth G. Physical examination tests of the shoulder: a systematic review and meta-analysis of diagnostic test performance. BMC Musculoskelet Disord. 2017 Jan 25;18(1):41. doi: 10.1186/s12891-017-1400-0.
citation: Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI of symptomatic and asymptomatic full-thickness rotator cuff tears. A comparison of findings in 100 subjects. Acta Orthop. 2010 Jun;81(3):361-6. doi: 10.3109/17453674.2010.483993.
citation: Minagawa H, Yamamoto N, Abe H, Fukuda M, Seki N, Kikuchi K, Kijima H, Itoi E. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village. J Orthop. 2013 Feb 26;10(1):8-12. doi: 10.1016/j.jor.2013.01.008. eCollection 2013.
citation: Schwartzberg R, Reuss BL, Burkhart BG, Butterfield M, Wu JY, McLean KW. High Prevalence of Superior Labral Tears Diagnosed by MRI in Middle-Aged Patients With Asymptomatic Shoulders. Orthop J Sports Med. 2016 Jan 5;4(1):2325967115623212. doi: 10.1177/2325967115623212. eCollection 2016 Jan.
citation: Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017 Nov 21;18(1):469. doi: 10.1186/s12891-017-1827-3.
citation: Picavet HS, Schouten JS. Musculoskeletal pain in the Netherlands: prevalences, consequences and risk groups, the DMC(3)-study. Pain. 2003 Mar;102(1-2):167-78. doi: 10.1016/s0304-3959(02)00372-x.
citation: Karel YHJM, Verhagen AP, Thoomes-de Graaf M, Duijn E, van den Borne MPJ, Beumer A, Ottenheijm RPG, Dinant GJ, Koes BW, Scholten-Peeters GGM. Development of a Prognostic Model for Patients With Shoulder Complaints in Physical Therapist Practice. Phys Ther. 2017 Jan 1;97(1):72-80. doi: 10.2522/ptj.20150649.
citation: Abdulla SY, Southerst D, Cote P, Shearer HM, Sutton D, Randhawa K, Varatharajan S, Wong JJ, Yu H, Marchand AA, Chrobak K, Woitzik E, Shergill Y, Ferguson B, Stupar M, Nordin M, Jacobs C, Mior S, Carroll LJ, van der Velde G, Taylor-Vaisey A. Is exercise effective for the management of subacromial impingement syndrome and other soft tissue injuries of the shoulder? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):646-56. doi: 10.1016/j.math.2015.03.013. Epub 2015 Apr 1.
citation: Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
citation: Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
citation: Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernandez-de-las-Penas C, Alburquerque-Sendin F. Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. J Manipulative Physiol Ther. 2015 May;38(4):245-52. doi: 10.1016/j.jmpt.2014.12.008. Epub 2015 Apr 30.
citation: Teys P, Bisset L, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on range of movement and pressure pain threshold in pain-limited shoulders. Man Ther. 2008 Feb;13(1):37-42. doi: 10.1016/j.math.2006.07.011. Epub 2006 Oct 27.
citation: Satpute KH, Bhandari P, Hall T. Efficacy of Hand Behind Back Mobilization With Movement for Acute Shoulder Pain and Movement Impairment: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2015 Jun;38(5):324-34. doi: 10.1016/j.jmpt.2015.04.003. Epub 2015 Jun 20.
citation: Guimaraes JF, Salvini TF, Siqueira AL Jr, Ribeiro IL, Camargo PR, Alburquerque-Sendin F. Immediate Effects of Mobilization With Movement vs Sham Technique on Range of Motion, Strength, and Function in Patients With Shoulder Impingement Syndrome: Randomized Clinical Trial. J Manipulative Physiol Ther. 2016 Nov-Dec;39(9):605-615. doi: 10.1016/j.jmpt.2016.08.001. Epub 2016 Nov 6.
citation: Lirio Romero C, Torres Lacomba M, Castilla Montoro Y, Prieto Merino D, Pacheco da Costa S, Velasco Marchante MJ, Bodes Pardo G. Mobilization With Movement for Shoulder Dysfunction in Older Adults: A Pilot Trial. J Chiropr Med. 2015 Dec;14(4):249-58. doi: 10.1016/j.jcm.2015.03.001. Epub 2015 Nov 24.
citation: Martins J, Napoles BV, Hoffman CB, Oliveira AS. The Brazilian version of Shoulder Pain and Disability Index: translation, cultural adaptation and reliability. Rev Bras Fisioter. 2010 Nov-Dec;14(6):527-36. English, Portuguese.
citation: Kolber MJ, Vega F, Widmayer K, Cheng MS. The reliability and minimal detectable change of shoulder mobility measurements using a digital inclinometer. Physiother Theory Pract. 2011 Feb;27(2):176-84. doi: 10.3109/09593985.2010.481011. Epub 2010 Aug 8.
citation: Cools AM, De Wilde L, Van Tongel A, Ceyssens C, Ryckewaert R, Cambier DC. Measuring shoulder external and internal rotation strength and range of motion: comprehensive intra-rater and inter-rater reliability study of several testing protocols. J Shoulder Elbow Surg. 2014 Oct;23(10):1454-61. doi: 10.1016/j.jse.2014.01.006. Epub 2014 Apr 13.
citation: Satpute K, Hall T, Kumar S, Deodhar A. A new method of measuring shoulder hand behind back movement: Reliability, values in symptomatic and asymptomatic people, effect of hand dominance, and side-to-side variability. Physiother Theory Pract. 2016 Oct;32(7):520-7. doi: 10.1080/09593985.2016.1222041. Epub 2016 Sep 12.
citation: Paul TM, Soo Hoo J, Chae J, Wilson RD. Central hypersensitivity in patients with subacromial impingement syndrome. Arch Phys Med Rehabil. 2012 Dec;93(12):2206-9. doi: 10.1016/j.apmr.2012.06.026. Epub 2012 Jul 10.
citation: Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
citation: Chester R, Jerosch-Herold C, Lewis J, Shepstone L. Psychological factors are associated with the outcome of physiotherapy for people with shoulder pain: a multicentre longitudinal cohort study. Br J Sports Med. 2018 Feb;52(4):269-275. doi: 10.1136/bjsports-2016-096084. Epub 2016 Jul 21.
citation: SALVETTI, M. G.; PIMENTA, C. A. M. Validação da Chronic Pain Self-Efficacy Scale para a Língua Portuguesa. Rev Psiq Clín, v. 32, n. 4, p. 202, 2005
citation: Baeske R, Hall T, Silva MF. The inclusion of mobilisation with movement to a standard exercise programme for patients with rotator cuff related pain: a randomised, placebo-controlled protocol trial. BMC Musculoskelet Disord. 2020 Nov 12;21(1):744. doi: 10.1186/s12891-020-03765-6.