Title: A multicentre randomised controlled trial of spinal cord stimulation plus usual care vs. usual care alone in the management of refractory angina: A feasibility & pilot study
Funder: Department of Health (England)

Abstract: Background There is an increasing number of patients with ‘refractory angina’ (RA) who are unsuitable for revascularization. RA patients experience severe pain leading to frequent hospitalisation and poor levels of health-related quality of life (HRQoL) RA patients are offered a number of therapies (e.g. anti-angina drugs, sympathectomy, and analgesics). The evidence base for many of these treatments is limited. A number of small RCTs have shown spinal cord stimulation (SCS), a minimally invasive neuromodulation technique, to be a promising treatment of RA. A NICE technology appraisal of SCS in 2008 called for a pragmatic UK-based trial of SCS for RA patients. We wish to undertake a pilot controlled trial in preparation for a definitive; appropriately powered multicentre randomised controlled trial. Aims This proposal has two main aims: 1. To assess the current NHS management of RA patients. 2. To conduct a pilot randomised controlled trial of SCS (‘SCS group’) plus usual care versus usual care (‘UC group’) alone. Specific objectives of this pilot trial are: i. To assess recruitment, uptake and retention of subjects in both groups. ii. To assess the feasibility and acceptability of SCS treatment from the point of view of patients and referring physicians. iii. To assess the feasibility and acceptability of standardising usual care from the point of view of patients and referring physicians. iv. To test the feasibility and acceptability of the proposed trial outcome measures in both groups. Plan of Investigation Aim 1: A questionnaire will be mailed to cardiothoracic and pain departments across all UK NHS hospitals. This will contain questions seeking: (1) the number of RA patients treated in the last 12-months and details of their medical treatment; (2) the views of medical staff on the suitability of SCS as a treatment option for RA and (3) their willingness to participate in a multicentre trial of SCS. Aim 2: We will randomise 45 RA patients stratified across 3 English NHS hospitals to either the SCS or UC group. Patients will be followed up for 6 months. We will evaluate: patient willingness to be randomised, time taken to recruit patients, feasibility and acceptability of proposed outcome measures and estimate the between group effect size at 6-months. Potential Impact RA has substantial burden in terms of reduced patient HRQoL and increased healthcare costs. A recent systematic review and meta-analysis by one of the applicants has shown that SCS improves HRQoL of RA patients and may reduce healthcare costs (1). However, trials of SCS to date have been small, poor quality and do not reflect usual care in UK. A NICE technology appraisal in 2008 concluded that although the evidence suggests that there may be groups of people with RA who could benefit from SCS, there was currently insufficient evidence on patient and economic benefit. An adequately powered pragmatic multi-centre RCT is therefore urgently needed. This application seeks to undertake the necessary feasibility and pilot research in order to determine whether such a trial can be taken forward.


Research activity codes: 5.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: CARDIOVASCULAR