Diagnostic utility of medial branch blocks for ReActiv8 response
Research type
Research Study
Full title
A pilot study to assess the diagnostic utility of lumbar facet medial branch blocks for identifying responders to stimulation of the medial branch of the dorsal ramus in chronic low back pain patients
IRAS ID
295749
Contact name
Ganesan Baranidharan
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
ISRCTN Number
ISRCTN12101415
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Chronic low back pain is a common disorder that can have significant impact on the lives of patients. Treatment options include physiological therapy, psychological therapy and medication, which can have limited effectiveness. The multifidus muscle plays an important role in stabilising the lower back. The ReActiv8 device involves electrically eliciting contractions of the multifidus muscle to improve its strength over time and to help relieve pain. However, like most treatments, some patients respond more readily than others. This pilot study aims to explore whether responses to medial branch blocks help with predicting the amount of benefit patients receive when treated with the ReActiv8 device.
Up to 70 patients with chronic mechanical low back pain will be recruited across 3 medical centres to undergo two medial branch injections. Patients who then agree to go ahead with the ReActiv8 therapy will receive insertion of the device and be placed in one of three groups, according to the amount of pain relief they experienced from the medial branch injections.
Group 1: more than 60% pain relief from both injections.
Group 2: more than 60% pain relief from either one of the injections.
Group 3: less than 60% pain relief to both injections.
There will be a maximum of 15 patients per group.Patients will be follow-up 1, 3, 6 and 12 months after the ReActiv8 device has been activated.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0130
Date of REC Opinion
3 Jun 2021
REC opinion
Further Information Favourable Opinion