The REACH Trial: Randomised Evaluation of rehabilitation after ACute proximal Humerus fracture

Background

Approximately 24,000 people suffer a proximal humerus fracture in the UK each year, resulting in sudden life-changing reductions in physical function. Most people have non-surgical management, with a sling being applied initially. Shoulder pain and stiffness are prolonged after this injury. Standard practice is to refer patients for physiotherapy, involving 4 to 8 clinic appointments. However, people report finding it difficult to attend physiotherapy. Driving is not possible after this  injury and public transport can be a struggle. To attend appointments people become reliant on family, friends and carers. Physiotherapy represents the largest healthcare cost for patients treated non-surgically. Provision of high-quality advice to support self-directed rehabilitation could be an alternative to attending physiotherapy appointments. Enabling people to manage their own recovery

could be less of a burden for patients and use less healthcare resources, research in other areas suggest patients find this approach acceptable.

Aim

The aim of this multi-centre, randomised non-inferiority trial is to compare the clinical and cost-effectiveness of a self-directed rehabilitation programme versus physiotherapist-supervised rehabilitation (standard care) for adults with a proximal humerus fracture.

Study design

Multi-centre, non-inferiority randomised trial with an internal pilot and parallel economic evaluation.

Setting

Trauma/physiotherapy departments at a minimum of 24 NHS hospitals.

Patients

Adults with non-surgically managed proximal humerus fractures.

Randomisation

1:1 allocation, within four weeks of fracture, using a centralised computer randomisation service using minimisation stratified by age (<50/≥50) and recruitment centre

Comparison

Physiotherapist-supervised rehabilitation (standard care).

Intervention

Self-directed rehabilitation (provision of high-quality self-management advice by a trained health professional and a workbook and website with a set of exercises that can be progressed independently).

Primary outcome

Oxford Shoulder Score (OSS)

Secondary outcomes

PROMIS Upper Extremity Function, Self-Efficacy for Exercise Scale, complications, resource use and EQ-5D-5L. Data will be collected from hospital records and participant questionnaires at baseline, 2, 4 and 6 months.

Sample size

Primary outcome data provided by 970 participants at 6 months will provide 90% power and 2.5% (1-sided) significance to detect whether self-directed rehabilitation is non-inferior to standard supervised rehabilitation, based on a non-inferiority margin of 2.5 agreed with clinical and patient stakeholder representatives. Allowing 20% loss to follow-up yields an overall sample size of 1214

(607 per arm).

Primary analysis

Mixed-effects linear regression model with adjustments for stratification factors, sex and baseline (pre-injury) score and incorporating data from all time points.

Health economic evaluation

A prospective economic evaluation, conducted from NICE’s recommended NHS and personal social services perspective.