Ongoing Clinical Studies
ReActiv8-A Clinical Trial
The ReActiv8-A clinical trial is an international, multi-centre, prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three-month endpoint after activation of stimulation and compared to baseline prior to implant. Results from the first 47 patients enrolled in the ReActiv8-A Clinical Trial supported the CE-Marking of the system. Further details can be obtained at: https://clinicaltrials.gov/ct2/show/NCT01985230
ReActiv8-B Clinical Trial
The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit. Patients will then be followed for up to 5 years to assess the durability of response.
The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms at the 120-day primary outcome assessment visit. Secondary/supplemental endpoints analyses include reduction from baseline in pain as measured by both mean reduction in pain and percent pain relief (PPR), change from baseline in disability, change from baseline in quality of life, subject global impression of change, clinician global impression of change, patient treatment satisfaction and pain resolution. The Clinical Trial is designed to provide what is referred to as Level 1 Evidence of safety and efficacy of ReActiv8, which may be used to support applications for favourable reimbursement in the USA. Further details can be obtained at: https://clinicaltrials.gov/show/NCT02577354
ReActiv8-A Results Summary
The ReActiv8-A international multicenter clinical trial (N=47) shows clinically important and statistically significant improvement in low back pain¹ , disability² and quality of life³ at 90 days, 180 days and 1 year.
Forty-seven subjects were implanted in 9 centers in Europe and Australia. Key inclusion criteria included disabling Chronic Low Back Pain (CLBP, NRS ≥6 and ≤9) despite a minimum of 90 days of medical management including at least physical therapy and drugs, no identifiable spine pathology as a likely cause, no prior spine surgery, and no indications for spine surgery or spinal cord stimulation. Subjects were asked to administer stimulation in two 30 minute sessions per day for a minimum of 90 days.
At enrolment, average duration of low back pain was 14± 10 years; average age was 44± 11 years, and 55% of subjects were female and 45% male. The majority of subjects (70%) were regularly taking opioids at baseline. All reported improvements were significant (p<0.001 ).
Conclusion: Electrical stimulation to reactivate the lumbar multifidus appears to be an effective treatment option for subjects with refractory CLBP and no indications for surgery.
- 1 Dworkin, R.H. et al (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. The Journal of Pain, 9(2), 105-21.
- 2 Ostelo, R. W. et al (2008). Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine, 33(1 ), 90-4.
- 3 Soer, R. et al (2012). Clinimetric properties of the EuroQol-50 in patients with chronic low back pain. Spine Journal, 12(11 ), 1035-1039.