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

Not Applicable

Completed

• Conditions: Shoulder Pain; Rotator Cuff Injuries

• Registration Number: NCT04175184
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-21
• Study First Posted: 2019-11-22
• Study Start: 2020-09-01
• Status Verified: 2023-11
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder Pain Disability Index (SPADI).	Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.	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).
Visual Analogue Scale (VAS) for pain.	Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.	VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).

Secondary Outcome Measures

Name	Time	Method
Pain pressure threshold	Changes from baseline and study completion (5 weeks).	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.
Global rating scale of change (GROC)	Through study completion and 4 weeks follow-up.	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).
Active pain-free range of motion.	Changes from baseline and study completion (5 weeks).	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.
Expectations of physiotherapy	Change at 3 weeks of treatment from baseline	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.

Trial Locations

Locations (2)

Albrecht - Clínica Integrada de Reabilitação; 🇧🇷 São Leopoldo, Rio Grande Do Sul, Brazil

Faculdades Integradas de Taquara; 🇧🇷 Taquara, Rio Grande Do Sul, Brazil