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STOP - START With Rotator Cuff-related Shoulder Pain (RCRSP) Study

NCT06107127 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-10-30

No results posted yet for this study

Summary

Shoulder pain is the third most common type of musculoskeletal (MSK) disorder for which people seek medical care. Roughly 70% of all shoulder pain can be accounted for by one condition, namely rotator ruff-related shoulder pain (RCRSP). Despite limited research it is thought that a lack of pain-free force production of certain shoulder muscles is a key finding in those with RCRSP. Strengthening exercise appears to be an important treatment for RCRSP. However, there remains uncertainty regarding the optimal choice of exercise. It has been suggested essential to target the rotator cuff muscles. Despite this claim, exercise specific to these muscles has not been compared to exercise that specifically avoids significant rotator cuff recruitment. A clearer understanding could result in more effective treatment, and improved exercise adherence.

Key questions that this research aims to answer are:

1. Is it important to measure pain-free force when treating people with RCRSP?
2. Is it more effective to target the rotator cuff muscles than not when using exercise to treat RCRSP? To attempt to answer these questions this study will be split into two trials. Patients referred to Sussex Community NHS Foundation trust for treatment of RCRSP will be screened by a Physiotherapist for eligibility and those interested will be asked to give consent to participate. Trial 1 will involve participants attending a one-off 45-minute assessment. Data collection will run over a 6-month period. Participants in Trial 2 will be required to attend a minimum of 10 (or maximum of 12) 45-minute exercise sessions over a 12-16-week period. Trail 2 will last approximately 18 months, with outcomes being recorded when participants finish their exercise sessions and at 6 and 12 months after the date they started the trial.

Conditions

  • Musculoskeletal Diseases

Interventions

PROCEDURE

STOP

Using their symptomatic arm participants will be asked to push against a fixed force dynamometer (hand held force gauge), starting with a low level of effort and gradually increasing their effort stopping either at the point that they start to feel pain or when they feel they have pushed as forcefully as they can.

Sponsors & Collaborators

  • Sussex Community NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2027-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107127 on ClinicalTrials.gov