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Clinical Trials/NCT04175184
NCT04175184
Completed
Not Applicable

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

Federal University of Health Science of Porto Alegre2 sites in 1 country70 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Injuries
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
70
Locations
2
Primary Endpoint
Shoulder Pain Disability Index (SPADI).
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 11, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Rafael Baeske

Principal investigator

Federal University of Health Science of Porto Alegre

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.
  • 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.

Outcomes

Primary Outcomes

Shoulder Pain Disability Index (SPADI).

Time Frame: 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.

Time Frame: 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 Outcomes

  • 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.)
  • Active pain-free range of motion.(Changes from baseline and study completion (5 weeks).)
  • Expectations of physiotherapy(Change at 3 weeks of treatment from baseline)

Study Sites (2)

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