Musculoskeletal DiseasesNCT06107127
STOP - START With Rotator Cuff-related Shoulder Pain (RCRSP) Study
A study testing STOP in people with Musculoskeletal Diseases, run by Sussex Community NHS Foundation Trust.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- STOP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: 2 RCTS: Investigate the Relationship Between Pain-free Shoulder Abduction and External Rotation Force and Pain and Disability - Assess the Effectiveness of Two Different Forms of Exercise Treatment
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:
- Is it important to measure pain-free force when treating people with RCRSP?
- 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.
Read the detailed description
The aims of this study are to
- investigate the relationship between pain-free shoulder abduction and external rotation force and pain and disability in those with RCRSP, and
- to assess the effectiveness of two different forms of exercise aimed at reducing pain and disability in patients with RCRSP.
The key questions that this research aims to answer are:
- Is pain-free shoulder force testing in patients with RCRSP using portable hand-held dynamometer reliable?
- Do reductions in pain-free force using this method correlate with severity of shoulder pain and disability?
- When treating RCRSP using resistance training (RT) exercise to specifically target the rotator cuff is compared to resistance training designed to avoid a significant contribution from these muscles, are there differences in outcome?
- What factors might mediate the changes in outcome in these two groups? The design is a randomised controlled trial. Trial 1 Participants will be allocated to one of two groups. Group one will be allocated researcher no. one and group two will be allocated to researcher no. two. Relevant tests will then be carried out. The two groups will then swap researcher and be tested again. The test: 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. Participants will be advised to rest for 1 minute before repeating this process a total of three times. All three measures will be recorded, and a mean will be calculated. The same procedure will then be carried out on their asymptomatic shoulders. A ten-minute break will follow, and the process will be repeated with the second assessor. This ensures that the order in which patients are assessed cannot influence the results. Once measured, the difference in pain-free force between symptomatic and asymptomatic shoulders will be described in terms of an index (a score reported as a percentage). Outcome measures will be taken once the session is over. Pain-free shoulder force index. Shoulder pain and disability index. Trial 2 Participants will be allocated in to one of the two exercise programme intervention groups. Participants will be asked to complete a minimum of ten sessions of exercise over a sixteen week period from when they start.
Group 1 - Participants will perform resistance exercises that involve pushing against a weighted pulley machine.
Exercise intensity will be progressed over each session as participants become accustomed to the stimulus involved.
Group 2 - Participants will perform resistance exercises that involve pulling against a weighted pulley machine.
Exercise intensity will be progressed over each session as participants become accustomed to the stimulus involved. Outcome measures will be taken once all sessions have been completed, and at 6 and 12 months.
Outcome measures are: Shoulder pain and disability index. Pain-free shoulder force index (if considered reliable during Trial 1).
- Conditions
- Musculoskeletal Diseases
- Being tested
- STOP
- Keywords
- rotator cuff
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: STOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sussex Community NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107127
- Sponsor's protocol ID
- 331819
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2 RCTS: Investigate the Relationship Between Pain-free Shoulder Abduction and External Rotation Force and Pain and Disability - Assess the Effectiveness of Two Different Forms of Exercise Treatment
- ClinicalTrials.gov ID
- NCT06107127
- Acronym / sponsor ID
- 331819
- Conditions
- Musculoskeletal Diseases
- Keywords
- rotator cuff
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sussex Community NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it important to measure pain-free force when treating people with RCRSP?
- 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.
Detailed description
The aims of this study are to
- investigate the relationship between pain-free shoulder abduction and external rotation force and pain and disability in those with RCRSP, and
- to assess the effectiveness of two different forms of exercise aimed at reducing pain and disability in patients with RCRSP.
The key questions that this research aims to answer are:
- Is pain-free shoulder force testing in patients with RCRSP using portable hand-held dynamometer reliable?
- Do reductions in pain-free force using this method correlate with severity of shoulder pain and disability?
- When treating RCRSP using resistance training (RT) exercise to specifically target the rotator cuff is compared to resistance training designed to avoid a significant contribution from these muscles, are there differences in outcome?
- What factors might mediate the changes in outcome in these two groups? The design is a randomised controlled trial. Trial 1 Participants will be allocated to one of two groups. Group one will be allocated researcher no. one and group two will be allocated to researcher no. two. Relevant tests will then be carried out. The two groups will then swap researcher and be tested again. The test: 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. Participants will be advised to rest for 1 minute before repeating this process a total of three times. All three measures will be recorded, and a mean will be calculated. The same procedure will then be carried out on their asymptomatic shoulders. A ten-minute break will follow, and the process will be repeated with the second assessor. This ensures that the order in which patients are assessed cannot influence the results. Once measured, the difference in pain-free force between symptomatic and asymptomatic shoulders will be described in terms of an index (a score reported as a percentage). Outcome measures will be taken once the session is over. Pain-free shoulder force index. Shoulder pain and disability index. Trial 2 Participants will be allocated in to one of the two exercise programme intervention groups. Participants will be asked to complete a minimum of ten sessions of exercise over a sixteen week period from when they start.
Group 1 - Participants will perform resistance exercises that involve pushing against a weighted pulley machine.
Exercise intensity will be progressed over each session as participants become accustomed to the stimulus involved.
Group 2 - Participants will perform resistance exercises that involve pulling against a weighted pulley machine.
Exercise intensity will be progressed over each session as participants become accustomed to the stimulus involved. Outcome measures will be taken once all sessions have been completed, and at 6 and 12 months.
Outcome measures are: Shoulder pain and disability index. Pain-free shoulder force index (if considered reliable during Trial 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Researcher 1 | Active comparator | Procedure: STOPUsing 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 2 | Active comparator | Procedure: STOPUsing 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Age 18 years or older
Key exclusion criteria (10 listed)
- Known calcific tendinopathy, based on previous imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STOPUsing 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 or surgery | Researcher 1, Researcher 2 |
Primary outcome
Shoulder pain and disability index
Time frame: 10 to 12 weeks
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing STOP in people with Musculoskeletal Diseases, run by Sussex Community NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain and disability index (time frame: 10 to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.