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

NCT04175184 | Completed DMC

• 1 other identifier: 10534119.5.0000.5345
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Rotator Cuff Injuries; Shoulder Pain

Keywords

rotator cuff pain; mobilisation with movement; exercises

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (4)

• Active pain-free range of motion.

  Changes from baseline and study completion (5 weeks).

• Pain pressure threshold

  Changes from baseline and study completion (5 weeks).

• Global rating scale of change (GROC)

  Through study completion and 4 weeks follow-up.

• Expectations of physiotherapy

  Change at 3 weeks of treatment from baseline

Other Outcomes (1)

• Chronic Pain Self-Efficacy Scale

  Baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

1. Exercise programme: 2-3 sets of 10-15 repetitions of shoulder girdle and glenohumeral strengthening exercises performed in different positions in addition to three stretching exercises. 2. Mobilisation with movement (MWM): the participant and physiotherapist will decide one movement more functionally relevant to the patient. Afterwards, attempts of MWM will be applied to different joints in order to identify one particular MWM that improves significantly the movement previously selected. Then, one set of six to ten repetitions will be applied. This process of pragmatically using MWM will be conducted in every session, but from the second session onwards, two to three sets of ten repetitions will be applied, with an interval of sixty seconds between sets. In case of failure to identify an MWM that improves the movement significantly, the patient decides which one seemed to be best and one set of six repetitions will be applied to the onset of discomfort.

Other: Mobilisation with Movement

Placebo group

SHAM COMPARATOR

1. The exercise programme is exactly the same as the experimental group. 2. Sham MWM: the participant and physiotherapist will decide together one movement that is more functionally relevant to the patient. Afterwards, a sham MWM (Delgado-Gil et al 2015) will be applied and the movement previously selected will be repeated six times in the first consultation. The participant will be informed that he/she should move to the onset of symptoms, if they occur.This process will be conducted in every session, but from the second session onwards, two to three sets of 10 repetitions will be applied, with an interval of sixty seconds between sets. In case the sham MWM failed to improve the movement significantly, one set of six repetitions will be applied only.

Other: Sham Mobilisation with Movement

Interventions

Mobilisation with Movement OTHER

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.

Also known as: MWM, Mobilization with movement

Experimental group

Sham Mobilisation with Movement OTHER

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.

Also known as: sham MWM, sham Mobilization with movement

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (2)

Albrecht - Clínica Integrada de Reabilitação

São Leopoldo, Rio Grande do Sul, 93020-080, Brazil

Location

Faculdades Integradas de Taquara

Taquara, Rio Grande do Sul, 95612-150, Brazil

Location

Related Publications (28)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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  BACKGROUND

• Baeske R, Hall T, Dall'Olmo RR, Silva MF. In people with shoulder pain, mobilisation with movement and exercise improves function and pain more than sham mobilisation with movement and exercise: a randomised trial. J Physiother. 2024 Oct;70(4):288-293. doi: 10.1016/j.jphys.2024.08.009. Epub 2024 Sep 25.

  PMID: 39327172 DERIVED

• 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.

  PMID: 33183274 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Motor Activity

Interventions

Movement

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marcelo Faria, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of participants: participants will be unaware about the specificities of the group allocation. The inclusion of a sham mobilisation with movement (MWM) procedure has the aim to mask the manual therapy procedure. For a naive participant, it is unlikely that he/she might be able to discern the real MWM from the sham MWM. In addition, participants will be requested to avoid discussing the interventions received with the outcome assessor. A scale ranging from "treatment under investigation" to "I don´t know" will be used to assess blinding of participants. Blinding of outcome assessor: this research assistant will only be responsible for conducting the outcome assessments. He/she will be unaware of group allocation and will also be requested not to discuss any specifics about the treatment programmes with the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized clinical trial, placebo-controlled, with a parallel group design

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 22, 2019
• Study Start: September 1, 2020
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: October 15, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)