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

NCT06107127 | Not Yet Recruiting

• 1 other identifier: 331819
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Is it important to measure pain-free force when treating people with RCRSP?
2. 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

Keywords

rotator cuff

Outcome Measures

Primary Outcomes (1)

• Shoulder pain and disability index

  The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

  10 to 12 weeks

Study Arms (2)

Researcher 1

ACTIVE COMPARATOR

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.

Procedure: STOP

Researcher 2

ACTIVE COMPARATOR

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.

Procedure: STOP

Interventions

STOP PROCEDURE

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.

Researcher 1; Researcher 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Shoulder pain of at least 3-month duration.
• Minimal resting pain
• Pain reproduced during resisted testing in shoulder abduction and/or external rotation.
• Diagnosis of rotator cuff-related shoulder pain (RCRSP) suggested by at least 3 of the following tests being positive:
• Near normal passive range of shoulder flexion / abduction / external rotation
• Pain may or may not be present during active shoulder external rotation when tested at 0° of shoulder abduction but will increase with resisted\* external rotation.
• Pain may or may not be present during active shoulder external rotation when tested at 90° of shoulder abduction but will increase with resisted external rotation.
• Pain may or may not be present during active shoulder abduction when tested through range but will increase with resisted abduction (plane of scapula, elbow extended, forearm in mid prone) at 45° and / or 90° and / or 150° and / or end-range.
• Pain may or may not be present during active shoulder flexion when tested through range but will increase with resisted flexion (elbow extended, forearm in mid prone) at 45° and / or 90° and / or 150° and / or end-range.
• Presence of a painful arc of movement.

You may not qualify if:

• Known calcific tendinopathy, based on previous imaging.
• Patients with clinical signs of massive rotator cuff tears as defined by presence of gross weakness of rotator cuff muscles in the absence of pain.
• Other shoulder disorders e.g., frozen shoulder, severe osteoarthritis, fracture, acromioclavicular joint pathology, history of shoulder dislocation.
• Shoulder external rotation less than 45 degrees or 50% of the opposite side.
• Undergone previous shoulder surgery on same side.
• Symptomatic cervical spine pathology, defined as reproduction of neck, shoulder or upper limb symptoms with active physiological cervical spine movement of any of the following movements in isolation or in combination: flexion, extensions: rotation (left and / or right), side flexion (left and / or right).
• Presence of significant co-morbidity e.g., neurological disorders, rheumatoid arthritis, unstable diabetes, unstable blood pressure
• Current carcinoma, TB, or HIV
• Unlikely to be able to perform required clinical assessment tasks.
• Inability to understand written or spoken English language.

Sponsors & Collaborators

• Sussex Community NHS Foundation Trust: lead

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 30, 2023

Record last verified: 2023-10