ReActiv8-A
Research type
Research Study
Full title
Investigation of the ReActiv8 Implantable Stimulation System for Chronic Low Back Pain (ReActiv8-A)
IRAS ID
149412
Contact name
Fred Ecklund
Contact email
Sponsor organisation
Mainstay Medical Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
The purpose of this Clinical 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. The new therapy is delivered by an investigational device called the ReActiv8. Being investigational, it is only available to patients taking part in this trial. The information collected in this study may be used as part of an application to gain approval to sell the system commercially in Europe.
Specialized exercises to activate certain muscles in the back are often used as a therapy for people with chronic low back pain. While the exercises are effective for some people, many people find it difficult if not impossible to perform the exercises. Mainstay Medical has developed the ReActiv8 implantable stimulator to deliver small electrical stimulation pulses to the nerve that supplies certain back muscles, thereby causing the muscles to contract. It is hoped that these electrically induced muscle contractions may provide similar effect to voluntary muscle contractions.
The therapy consists of low-level electrical stimulation delivered via a thin wire (lead) placed inside the body next to a nerve located 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 IPG is a small metal can that includes a battery and some specialised electronics. Two leads are placed (one each left and right side) and connected to the IPG. The IPG is externally programmable with a Programmer. The patient controls the electrical stimulation with an external device (Activator) or magnet. Stimulation is delivered (under the patinet's control) typically for up to one hour a day in two sessions of 30 minutes each, morning and evening.
The leads and IPG are placed with a minor surgical procedure.REC name
North East - York Research Ethics Committee
REC reference
14/NE/1001
Date of REC Opinion
24 Jul 2014
REC opinion
Further Information Favourable Opinion