Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial
Primary result · Holistic respondersResult — go to the resultAbsolute risk difference 22.4% 95% CI 6.4%–38.4%Authors' conclusion
The results of this study suggest that closed-loop spinal cord stimulation can provide sustained clinically meaningful improvements in multiple domains and provide holistic improvement in the long-term for patients with chronic refractory pain.
Study context
- Population
- Patients with chronic refractory pain
- Participants
- 67 vs 67
- Comparison
- ECAP-controlled closed-loop vs open-loop spinal cord stimulation
- Closed-loopn = 67
- Open-loopn = 67reference
- Primary endpoint
- Holistic treatment response (at least one minimal clinical important difference in all domains impaired at baseline: pain intensity, physical function, health-related quality of life, sleep quality, emotional function)
- Follow-up
- 24 months
Methodological detailsmulticentre, participant, investigator, and outcome assessor-blinded, parallel-arm
- Multicentre
- Participant, investigator, and outcome assessor-blinded
- Parallel-arm
Primary result
Holistic responders
Absolute risk difference
22.4%
95% CI 6.4%–38.4%
P = 0.012
By group
Closed-loop vs Open-loop
absolute risk difference 22.4% (95% CI 6.4%–38.4%); P = 0.012
As reported in the abstract
Further findings
| Outcome | Mean difference (95% CI) | P value | |
|---|---|---|---|
| Cumulative responder score (total minimal clinical important differences across all domains) · 24 monthsSignificantly greater for closed-loop at all time points | 3.4 (1.3–5.5) | P = 0.002 | |
| −50510Difference (linear scale) |
Accuracy of neural activation
- Three times more accurate in closed-loop
- P < 0.001 at all time points
Original publication
Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. Published 25 July 2023. doi:10.
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