STOP - START With Rotator Cuff-related Shoulder Pain (RCRSP) Study
Sponsored by Sussex Community NHS Foundation Trust
About this trial
Last updated 2 years ago
Study ID
331819
Status
Not yet recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 90 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 2 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- • 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:
1. Near normal passive range of shoulder flexion / abduction / external rotation
2. 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.
3. 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.
4. 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.
5. 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.
6. Presence of a painful arc of movement.
Exclusion Criteria
- 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.