TRU-BURST
Research type
Research Study
Full title
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome.
IRAS ID
316297
Contact name
Stefano Palmisani
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study is designed to prove BurstDR-SCS therapy as superior when compared to sham stimulation for patients with Failed Back Surgery Syndrome (FBSS).
All patients to be approached for this study will have already been identified to receive a BurstDR-SCS system by their Doctor as part of their standard care.
Patients who consent to this study will receive the BurstDR-SCS system as part of their standard of care, but for the purpose of this study they agree to be randomized to either a 'treatment arm' or a 'sham arm' at the post-implant 1-month follow up visit. Patients allocated to receive 'sham treatment' will have their BurstDR-SCS system switched off before they leave clinic at the post-implant 1-month follow up visit, whilst for patients who have been allocated to the treatment arm the device will remain active. To preserve blinding, the patient controller app will be issued to all patients which will look exactly the same for everyone, but for people in the sham arm the app will not connect to their implanted Burst-DR SCS device.
We also wish to collect patient-reported outcome data throughout the study by asking patients to complete questionnaires through an app on an iPhone, and by asking the participant to wear a wearable biosensor (Fitness watch or fitness ring). Collecting data in this manner replaces traditional paper questionnaires and written diaries.
The iPhones and biosensors to be used in this study will be provided by the sponsor for the patient to use for the duration of the study.
REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0104
Date of REC Opinion
24 Aug 2022
REC opinion
Further Information Favourable Opinion