Evoked compound action potential (ECAP)-controlled closed-loop versus open-loop spinal cord stimulation (SCS) for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial
Primary result · ≥50% reduction in overall back and leg pain intensityResult — go to the resultDifference 28.4% 95% CI 12.8%–43.9%Authors' conclusion
This long-term evaluation with objective measurement of SCS therapy demonstrated that ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months.
Study context
- Population
- Chronic, intractable back and leg pain refractory to conservative therapy
- Comparison
- ECAP-controlled closed-loop SCS vs fixed-output open-loop SCS
- Primary endpoint
- ≥50% reduction in overall back and leg pain
- Follow-up
- 36 months
Methodological detailsmulticentre, participant-blinded, investigator-blinded, outcome assessor-blinded, parallel-arm, Enrolled January 2017 to February 2018; follow-up through 36 months
- Multicentre
- Participant-blinded, investigator-blinded, outcome assessor-blinded
- Parallel-arm
- Enrolled January 2017 to February 2018; follow-up through 36 months
Primary result
As reported in the abstract
≥50% reduction in overall back and leg pain intensity
Difference
28.4%
95% CI 12.8%–43.9%
P < 0.001
By group
CL-SCS vs OL-SCS
difference 28.4% (95% CI 12.8%–43.9%); P < 0.001
Further findings
| Outcome | CL-SCS | OL-SCS | Difference (95% CI) | P value | |
|---|---|---|---|---|---|
| ≥80% reduction in overall back and leg pain intensity · 36 months | 49.3% | 31.3% | 17.9 (1.6%–34.2%) | P = 0.032 | |
| −2002040Difference (linear scale) |
Holistic treatment responders · 36 months
Holistic treatment responders · 36 months
- Greater cumulative responder score with CL-SCS
Other patient-reported outcomes · 36 months
- Clinically meaningful improvements from baseline in both groups, greater with CL-SCS
Neural activation and accuracy
- Greater neural activation and accuracy with CL-SCS
Safety
Adverse events
- No differences between CL-SCS and OL-SCS groups
Explants due to loss of efficacy
- None observed in the CL-SCS group
Original publication
ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. Published 27 August 2023. doi:10.
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