The TRIAL-STIM Study
DOES A SCREENING TRIAL FOR SPINAL CORD STIMULATION IN PATIENTS WITH CHRONIC PAIN OF NEUROPATHIC ORIGIN HAVE CLINICAL UTILITY AND COST-EFFECTIVENESS?
South Tees Hospitals NHS Foundation Trust
PB-PG-0815-20028, RfPB Ref
Duration of Study in the UK
2 years, 8 months, 0 days
Spinal Cord Stimulation (SCS) is a National Institute for Health and Care Excellence (NICE) recommended treatment for severe nerve pain. SCS involves implanting a wire through the skin and into the spine; this then attaches to a battery placed under the skin of the stomach. Electric pulses transmitted via this wire to the nerves provide pain-relief. This therapy is only recommended for use in the NHS if patients report pain-relief from a ‘trial’ (or test) stimulation where a temporary implanted spine wire is attached to an external battery.
Patients can test the system at home for up to 4-weeks. Those expressing 50 percent or more pain-relief are offered a permanent implanted battery. Although test stimulation is a widely accepted part of clinical practice the scientific evidence for its use is lacking. It is possible that a proportion of patients who fail to experience pain-relief during trial would experience pain-relief after a permanent implant. Trials expose patients to an increased risk of infection, pain and increased costs.
Therefore, research is needed to answer:
1. Is patients’ response to trial SCS stimulation predictive of long-term pain-relief success?
2. How do the pain levels and quality-of-life of patients receiving permanent SCS implant (or not) following trial stimulation compare to those patients receiving a permanent implant without undergoing trial stimulation?
3. Is using a SCS trial prior to permanent SCS implant a more cost-effective way to manage patients than providing a permanent implant without trial stimulation?
We plan to allocate by chance, 100 consenting SCS candidates in three UK centres to either receive a permanent implant following successful test stimulation or a permanent implant without test stimulation. Patients will have their levels of pain, health-related quality-of-life, and costs assessed by questionnaire before being allocated to the two conditions and then at three and six-months.
North East - Tyne & Wear South Research Ethics Committee
Date of REC Opinion
4 Apr 2017
Further Information Favourable Opinion