Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2021-02-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physiotherapist-led exercise

Structured and progressive physiotherapist-led exercise programme. Reflective of current guidance for exercise programmes for people with rotator cuff disorders, an individualised programme developed in relation to the participant's specific goals will be prescribed by the physiotherapist and supported over approximately six contact sessions across a 12-week period.

Group Type EXPERIMENTAL

Physiotherapist-led exercise

Intervention Type OTHER

A programme of physiotherapist-led exercise over approximately 12 weeks.

Surgical repair

Surgical repair of the rotator cuff plus usual post-operative rehabilitation.

Group Type ACTIVE_COMPARATOR

Surgical repair

Intervention Type PROCEDURE

Surgical repair of the rotator cuff plus usual post-operative rehabilitation

Interventions

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Physiotherapist-led exercise

A programme of physiotherapist-led exercise over approximately 12 weeks.

Intervention Type OTHER

Surgical repair

Surgical repair of the rotator cuff plus usual post-operative rehabilitation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No