Comparison of percutaneous 60-day peripheral nerve stimulation of the lumbar medial branches to usual care with standard interventional management for chronic low back pain-a multicenter pragmatic randomized controlled trial (RESET).

OBJECTIVE

Management of refractory chronic low back pain (CLBP) includes a range of treatments (eg, physical therapy, injections, ablations, neurostimulation, surgery) with varying utilization and effectiveness. This pragmatic randomized controlled trial (RCT) evaluated the effectiveness of one treatment option, percutaneous 60-day peripheral nerve stimulation (PNS), compared to usual care with standard interventional management for CLBP.

METHODS

Two hundred thirty patients with CLBP were randomized in a 1:1 ratio to Group 1 (percutaneous 60-day PNS) or Group 2 (physician-directed usual care with standard interventional management). The Primary Clinical Endpoint evaluated the proportion of participants with ≥50% reductions in CLBP at 3 months post-treatment compared to baseline.

RESULTS

At the Primary Endpoint, a greater proportion of participants receiving percutaneous 60-day PNS (55%; n = 112; 95% confidence interval [CI] = 45-65) experienced ≥50% pain relief compared to usual care with standard interventional management (26%; n = 110; 95% CI = 17-34; P < .001). Concordant with the Primary Endpoint, percutaneous 60-day PNS also produced greater improvements in patient-centric secondary endpoints, including disability, pain interference, health-related quality of life, and analgesic consumption. Reductions in pain and resulting improvements in function were sustained through 6 months with percutaneous 60-day PNS.

CONCLUSIONS

This prospective multicenter pragmatic RCT met its Primary Clinical Endpoint and found that more participants with CLBP reported pain relief at 3 months after receiving percutaneous 60-day PNS as compared to usual care with standard interventional management. Participants treated with 60-day PNS showed greater reductions in pain and more substantial improvements in functional outcomes through 6 months.

CLINICALTRIALS.GOV: NCT04246281; Primary funding: Department of Defense (DoD), with additional funding needed to complete the study provided by the study's sponsor, SPR.The protocol is available on ClinicalTrials.gov. The statistical analysis plan and results will be made available within 12 months of the study's completion.