Rehabilitation following rotator cuff repair Musculoskeletal Diseases
Conditions
Interventions
Control (reflective of current UK practice): participants will receive one treatment session with a physiotherapist after surgery where they will be advised to immobilise their arm in a sling for four
Sponsors
University of Keele
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with a non-traumatic symptomatic tear of the RC and listed for surgical repair 2. RC tear confirmed by ultrasound or MRI 3. Aged = 18 years 4. Patients screened by the surgeon as suitable to participate (an opt-out scheme will be implemented whereby all patients under the care of a surgeon who is participating in the trial will be eligible unless the surgeon states otherwise in the medical notes at the time of listing for surgery) 5. Able to return to the recruiting centre or affiliated site for the initial outpatient follow-up physiotherapy appointment 6. Access to a mobile phone and willing and able to receive and respond to SMS text messages 7. Able to understand English
Exclusion criteria
Exclusion criteria: 1. Traumatic RC tears (e.g. sudden onset of shoulder pain and weakness following a fall), given the different care pathways for such patients (these patients are typically fast-tracked to surgery) 2. Patients who are unable to give full informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of recruitment, retention and acceptability of the RaCeR intervention assessed using the following outcomes: 1. Numbers of: potentially eligible and eligible patients, invited, seen in pre-operative assessment clinic, consent rates collected via screening and randomisation logs at screening and baseline timepoints 2. Number of eligible patients found subsequently not to have a RC tear at surgery (indicating false positive scan) collected via a Post-operative Case Report Form at 0 weeks 3. Feasibility of recruiting participating centres and numbers of additional centres who are interested in participating in the main trial collected via expressions of interest (ongoing) 4. Rate of retention in the trial, including response rates to questionnaires and individual measures (including resource use) and SMS text messages collected via SMS weekly from 0-12 weeks from surgery and self-report questionnaires at 6 and 12 weeks 5. Intervention fidelity and adherence, using physiotherapist-completed case report forms at 0, 2, 4, 6, 8 and 12 weeks and patient-completed personal exercise diaries at 4 weeks 6. Determining the primary outcome measure for the main trial by assessing and comparing sensitivity to change of the measures and other statistical properties to support sample size derivation, comparing follow-up rates of different methods of data capture (questionnaire at 6 and 12 weeks/SMS text weekly between 0-12 weeks) and of individual measures, and evaluating which outcome measures best reflect the patients' rehabilitation goals, identified from the qualitative interviews between 0-4 weeks 7. Participant satisfaction with the interventions on a five-point ordinal scale: Very Satisfied/Satisfied/Neutral/Dissatisfied/Very Dissatisfied via self-report questionnaires at 6 and 12 weeks 8. Patient and clinician views about the acceptab | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes will be measured as follows: 1. Pain and disability assessed using the Oxford Shoulder Score (OSS) and Shoulder Pain & Disability Index (SPADI) at baseline, 6 weeks’ post-surgery by post and 12 weeks’ post-surgery in person, during a follow-up clinic visit or postal questionnaire with telephone call for minimum data collection if no response to postal questionnaire 2. Health related quality of life assessed using the EQ-5D-5L at baseline, six weeks’ post-surgery by post and 12 weeks’ post-surgery in person, during a follow-up clinic visit or postal questionnaire 3. Global change question at 6 weeks’ post-surgery by post and 12 weeks’ post-surgery in person, during a follow-up clinic visit or postal questionnaire with telephone call for minimum data collection if no response to postal questionnaire 4. Pain in the last week (derived from the OSS) using weekly SMS text messages for 12 weeks (post-surgery) based on a 0-4 numerical rating scale (NRS) with anchors of ‘No pain’ (0) to ‘Unbearable pain’ (4) 5. Disability relating to work or activity interference due to the shoulder problem in the last week (derived from the OSS) using weekly SMS text messages for 12 weeks (post-surgery) based on a 0-4 NRS with anchors of 'Not at all' (0) to 'Totally' (4) 6. Days lost from work due to the shoulder problem at 6 weeks’ post-surgery via postal questionnaire and 12 weeks’ post-surgery via questionnaire completed during a follow-up clinic visit 7. Time taken to return to driving, if applicable, via questionnaire at 6 and 12-week follow-up 8. Number and type of adverse events; e.g. post-procedural exacerbation of pain, for up to 12 weeks’ post-randomisation via patient self-report questionnaire at six and 12 weeks’ post-surgery and via surgeon, physiotherapist or GP report 9. Integrity of surgical repair assessed using a | — |
Countries
United Kingdom
Contacts
Public ContactStephanie Butler-Walley
Outcome results
None listed