Clinical trial NCT04027205: Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff
Official title: Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff: a Multi-site Pilot and Feasibility Randomised Controlled Trial (the SPeEDy Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Rotator Cuff Tear
Lead sponsor: Keele University
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University Hospitals of Derby and Burton NHS Foundation Trust
name: University Hospitals, Leicester
name: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
name: University Hospitals of North Midlands NHS Trust
name: University Hospitals Coventry and Warwickshire NHS Trust
name: Airedale NHS Foundation Trust
name: Liverpool University Hospitals NHS Foundation Trust
name: University Hospital Birmingham NHS Foundation Trust
First posted: 2019-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.

Detailed description: Tears of the rotator cuff are a significant cause of shoulder pain. Rates of surgical repair have risen approximately 200% over the last 20 years across Europe and the USA. 9 189 repairs were undertaken in 2015/ 2016 in the NHS. The cost of surgery ranges from £2 897 to £5 593 meaning that direct NHS treatment costs alone are £26.6 to £51.4 million annually.

If a patient is suspected of having a traumatic rotator cuff tear, then guidance from the British Elbow and Shoulder Society and British Orthopaedic Association suggests this is a 'red flag' needing urgent surgical opinion. But, this guidance is open to question. Three randomised controlled trials (RCT) (n = 252) have been synthesised in a systematic review which concluded that surgery is not more effective than conservative care for rotator cuff tears. But, of the 252 patients included, only 40 (16%), were diagnosed with traumatic tears. Hence, there is a dearth of randomised evidence to inform decision-making.

Given uncertainty about the comparative effectiveness of surgery and considering the cost, risk, for example infection, there is an urgent need to carry out high-quality research in this area.

Research Question: In patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future multicentre RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair in terms of clinical outcomes but is more cost-effective.

Research Design: Two-arm, parallel group, pilot and feasibility RCT with nested Quintet Recruitment Intervention (QRI) and qualitative interviews.

Setting: Eight NHS hospitals.

Objectives:

1. Determine feasibility of recruiting and retaining patients,
2. Identify barriers and facilitators to recruitment and retention, including patient and clinician equipoise and proportion and reasons for treatment cross-over (reflective of known challenges in surgical RCTs),
3. Estimate the number of potential and willing sites for the future main trial.

Participants: Adults with traumatic tears of the rotator cuff, eligible for surgery.

Intervention/ control: Participants will be allocated on a 1:1 ratio, stratified by tear size to: 1) Structured and progressive physiotherapist-led exercise; 2) Surgical repair and usual post-operative rehabilitation.

Key feasibility outcomes: 1) Numbers of patients screened, eligible, approached, consenting, randomised, and accepting allocation; 2) Rate of retention and follow-up; 3) Feasibility of recruiting participating sites; 4) Participant satisfaction.

Key clinical outcomes: 1) Shoulder pain and function (Oxford Shoulder Score): Quality of life (EQ-5D-5L) at baseline, three, and six months.

Health economic outcomes: Health care resource use and days lost from work over six-months.

Sample size: 76 participants.

Analysis: Analysis will focus on process outcomes (recruitment, retention, and treatment cross-over). Means and confidence intervals of clinical outcomes will be calculated only to inform the sample size calculation for the future main trial.

The QRI will use targeted methods including interviews with clinicians and patients, audio-recording of recruitment appointments and document review to understand and then develop an action plan to optimise recruitment and informed consent. Semi-structured qualitative interviews will explore treatment acceptability and the data will be analysed thematically.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (≥18 years)
2. Diagnosed with a symptomatic tear of the rotator cuff following a traumatic incident thought to be of sufficient force to induce a tear.
3. Rotator cuff tear confirmed by diagnostic ultrasound or MRI scan undertaken as part of routine diagnostic work-up
4. Eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
5. Able to return to the participating NHS hospital or associated orthopaedic and physiotherapy services (where physiotherapists have been trained in trial interventions) for post-operative rehabilitation or the programme of physiotherapist-led exercise.
6. Able to understand English.

Exclusion Criteria:

1. Not eligible for rotator cuff repair surgery or a programme of physiotherapist-led exercise as determined by the attending clinician (surgeon or physiotherapist, where appropriate)
2. Patients who are unable to give full informed consent.

Primary outcomes:
measure: Numbers of patients screened, number eligible, number approached, number consenting, number randomised, and number accepting allocation
timeFrame: Over recruitment period, 15 months
measure: Numbers of participants continuing in allocated treatment
timeFrame: Six months
measure: Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
timeFrame: Three months post-randomisation
measure: Follow-up response rates to questionnaires (including Oxford Shoulder Score and EQ-5D-5L)
timeFrame: Six months post-randomisation
measure: Determination of zone of clinical equipoise
timeFrame: Over recruitment period, 15 months
measure: Treatment cross-over
timeFrame: Six months
measure: Participant satisfaction with the interventions: five-point ordinal scale
timeFrame: Six months
Secondary outcomes:
measure: Pain and disability assessed using the Oxford Shoulder Score (OSS)
timeFrame: Three and six months post-randomisation
measure: Health related quality of life assessed using the EQ-5D-5L
timeFrame: Three and six months post-randomisation
measure: Days lost from work due to the shoulder problem
timeFrame: Three and six months post-randomisation
measure: Time taken to return to driving
timeFrame: Three and six months post-randomisation
Other outcomes:
measure: Number of recruiting participating sites and numbers of additional sites who are interested in participating in the main trial
timeFrame: Whole study period, 36 months
measure: Number and type of adverse events
timeFrame: Up to six months post-randomisation
Locations:
city: Derby
country: United Kingdom
facility: University Hospital of Derby & Burton NHS
Study officials:
affiliation: Manchester Metropolitan University
name: Chris Littlewood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Littlewood C, Wade J, Butler-Walley S, Lewis M, Beard D, Rangan A, Bhabra G, Kalogrianitis S, Kelly C, Mehta S, Singh HP, Smith M, Tambe A, Tyler J, Foster NE. Protocol for a multi-site pilot and feasibility randomised controlled trial: Surgery versus PhysiothErapist-leD exercise for traumatic tears of the rotator cuff (the SPeEDy study). Pilot Feasibility Stud. 2021 Jan 7;7(1):17. doi: 10.1186/s40814-020-00714-x.
citation: Littlewood C, Astbury C, Bush H, Gibson J, Lalande S, Miller C, Pitt L, Tunnicliffe H, Winstanley R. Development of a physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy study. Physiotherapy. 2021 Jun;111:66-73. doi: 10.1016/j.physio.2020.07.008. Epub 2020 Aug 3.