ReActiv8-B, Revision B
Research type
Research Study
Full title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
IRAS ID
194827
Contact name
Diane Burnside
Contact email
Sponsor organisation
MLL US Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
The ReActiv8-B is an international, multi-center, prospective, randomized, sham controlled, blinded trial with an adaptive statistical design. The ReActiv8 neurostimulator is a small implantable device which stimulates the nerves responsible for contraction of the most important muscles, stabilizing the low back.
The purpose of the study is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with chronic low back pain and no prior surgery when used in conjunction with medical management. Patients with chronic back pain who have failed at least medical management and physical therapy and meet all study eligibility criteria can be implanted with the ReActiv8 neurostimulator. A 1:1 randomization will occur post-implantation. For patients enrolled to the Treatment arm the ReActiv8 will be implanted and configured to deliver stimulation at a subject-appropriate level. For patients enrolled to the Control arm the ReActiv8 will be implanted as well, but will deliver minimal stimulation. All patients (both in treatment and control group) will be required to deliver stimulation for 60 minutes per day in two sessions of 30 minutes each.
The hypothesis of the study is that in patients with chronic low back pain and no prior surgery with unsatisfactory pain relief despite medical management, episodic electrical stimulation of the medial branch of the dorsal ramus nerves to cause contraction of the lumbar multifidus muscles can lead to relief of low back pain and the disabling effects of back pain.REC name
North East - York Research Ethics Committee
REC reference
16/NE/0346
Date of REC Opinion
14 Dec 2016
REC opinion
Further Information Favourable Opinion