Multifidus Stimulation study (MUST)
Research type
Research Study
Full title
A prospective single arm pilot study to investigate the brain and multifidus muscle response through Positron Emission Tomography (PET) in patients with low back pain receiving Reactiv8 stimulation.
IRAS ID
254110
Contact name
Vivek Mehta
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Multifidus stimulation (MS) therapy consists of low-level electrical stimulation delivered via a flexible thin wire (lead) placed inside the body next to the nerve in the lower back. The lead is connected to an implantable pulse generator (IPG) that is typically placed under the skin above the buttocks. The new therapy is delivered by an implantable device called the ReActiv8 that activates the multifidus muscles.
The aim of this study is to investigate the effect of a new therapy for chronic low back pain in people who have not responded to physical therapy and medication. We will investigate the dynamic brain and whole body imaging in pain using PET scan in patients who have undergone successful Reactiv8 implantation. Also we will investigate the response to these stimulator settings on health related quality of life using validated questionnaires.
REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/0740
Date of REC Opinion
21 Jul 2020
REC opinion
Further Information Favourable Opinion