Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover
Authors' conclusion
SCS relieved pain and resulted in clinically significant improvements in functional disability and health-related quality of life in patients with non-surgical, refractory back pain with or without accompanying leg pain.
Study context
- Population
- Patients with non-surgical, refractory back pain (with or without leg pain)randomized
- Participants
- 147 patients
- Comparison
- Spinal cord stimulation (SCS)+conservative medical management (CMM) vs CMM alone
- SCS+CMMn = 79
- CMM alonen = 68reference
- Primary endpoint
- Proportion with ≥50% overall pain relief without an increase in mean daily opioid use
- Follow-up
- 3 months
Methodological detailsprospective, multicentre, crossover option at 3 months
- Prospective
- Multicentre
- Crossover option at 3 months
Primary result
As reported in the abstract
Study responders (≥50% pain relief without increase in mean daily opioid use)
P < 0.0001
Further findings
| Outcome | SCS+CMM | CMM alone | P value |
|---|---|---|---|
| Change in Oswestry Disability Index score · 3 months | −27.5 ± 15.9 points | −7.2 ± 9.9 points | P < 0.0001 |
| Change in EQ-5D-5L index score · 3 months | 0.247 ± 0.164 points | 0.031 ± 0.151 points | P < 0.0001 |
Durability of SCS benefits · 12 months
- Benefits of SCS sustained until the 12-month visit
Safety
- Patients with SCS-related serious adverse events
- 7
- Implant site infections resulting in explant
- 5 (3.6%)
Original publication
Spinal cord stimulation plus conventional medical management versus conventional medical management alone for severe, non-surgical, refractory back pain: a randomized clinical trial followed by crossover. Reg Anesth Pain Med. Published 5 October 2025. doi:10.
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