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.
The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will 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.