Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain

Shoulder Pain Clinical Trial

Official title:

The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04175184
• Other study ID #: 10534119.5.0000.5345
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2020
• Source: Federal University of Health Science of Porto Alegre
• Contact: Rafael Baeske, PhD student
• Phone: +55 51 981702422
• Email: rbaeske[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Pain

Intervention

Other:
• Mobilisation with Movement
MWM is a pain-free manual therapy procedure that aims to restore full active pain-free range of motion. It consists of an accessory movement performed by the therapist followed by an active movement executed by the patient. The accessory glide might be produced by the therapist´s hands or by a belt. Minor changes in the amount of force or direction of the glide are common to produce better results. The MWM procedures will be used pragmatically in this study. Therefore, several attempts might be needed to produce the outcome desired. In the case of the shoulder, they can be applied to the glenohumeral joint, scapulothoracic joint, acromioclavicular joint, cervical and thoracic spines and the rib cage. The decision making process in this study will be based on the outcome observed. The procedure that produced the greatest improvement in active pain-free range of motion will be the one used on that occasion.
• Sham Mobilisation with Movement
Sham MWM is a comparator procedure used in this research to control for placebo related mechanisms of action. This procedure has already been used in previous research (Delgado-Gil et al 2015). Briefly, the therapist will stand opposite to the affected shoulder, he/she will place the thenar eminence of the anterior hand on the skin in front of the humeral head, while the posterior hand will rest on the scapula. Both hands will just lightly rest on the skin, no accessory glide will be performed to the humeral head. Then, the participant will move his/her shoulder in the direction previously selected. Shall the procedure elicit pain-free full range of motion, the participant will move their shoulder ten times. Otherwise, the movement should be performed up to the onset of symptoms.

Locations

Country	Name	City	State
Brazil	Albrecht - Clínica Integrada de Reabilitação	São Leopoldo	Rio Grande Do Sul
Brazil	Faculdades Integradas de Taquara	Taquara	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (26)

Abdulla SY, Southerst D, Côté 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. — View 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. — View 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. — View Citation

Delgado-Gil JA, Prado-Robles E, Rodrigues-de-Souza DP, Cleland JA, Fernández-de-las-Peñas C, Alburquerque-Sendín 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. — View Citation

Gismervik SØ, Drogset JO, Granviken F, Rø 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. Review. — View Citation

Guimarães JF, Salvini TF, Siqueira AL Jr, Ribeiro IL, Camargo PR, Alburquerque-Sendín 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. — View 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. Review. — View 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. Epub 2007 Aug 24. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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;(6):CD012224. doi: 10.1002/14651858.CD012224. Review. — View 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. — View 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. — View 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

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. — View 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. — View 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. — View 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. Review. — View 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. Epub 2006 Oct 27. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic Pain Self-Efficacy Scale	Self-efficacy is considered an important predictor of patients with shoulder pain (Chester et al, 2018). The domains of pain (5 questions) and function (9 questions) of the chronic pain self-efficacy scale will be used in this study (Salvetti & Pimenta, 2005). Values range from 10 to 100, higher values indicate greater self-efficacy.	Baseline
Primary	Shoulder Pain Disability Index (SPADI).	SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).	Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Primary	Visual Analogue Scale (VAS) for pain.	VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).	Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Secondary	Active pain-free range of motion.	Active pain-free range of motion will be assessed for flexion, abduction (Kolber et al, 2011), external rotation (Cools et al, 2014) and hand behind back (Satpute et al, 2016). An inclinometer (Baseline, Enterprises Inc) will be used to measure the ranges of motion.; All measurements will be conducted to the onset of pain.	Changes from baseline and study completion (5 weeks).
Secondary	Pain pressure threshold	Measurements will be collected at three different sides: 5 cm distal to the lateral border of the acromion on both sides over the deltoid muscle, and 10 cm distal to the tibiofemoral joint line, over the tibialis anterior muscle on the unaffected side (Paul et al, 2012). A calibrated digital algometer (Wagner instruments, model FPX 25) will be used to assess the pain pressure threshold.; An interval of 30 seconds will be respected between measurements.	Changes from baseline and study completion (5 weeks).
Secondary	Global rating scale of change (GROC)	GROC is designed to measure a patient's improvement or deterioration over time as a result of an intervention.The amplitude of this difference is scored on a numerical or visual analogue scale. In this research a 15 point scale will be used (Kamper et al, 2009).	Through study completion and 4 weeks follow-up.
Secondary	Expectations of physiotherapy	The scale to be used in this study to assess expectation has been previously used in patients with shoulder disorders (Chester et al, 2018). Participants will answer the following question: "How much do you expect your shoulder problem to change as a result of physiotherapy treatment?. Please circle one box only".; Possible answers are: Completely recover, Much improve, Slightly improve, No change, Slightly worse, Much worse, Worse than ever.	Change at 3 weeks of treatment from baseline