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Published on: June 26, 2018
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Implanted spinal neuromodulation interventions for chronic pain in adults
Neil E O'Connell1, Michael C Ferraro2,3, William Gibson4
1Department of Health Sciences, Centre for Health and Wellbeing Across the Lifecourse, Brunel University London, Uxbridge, UK.
The Cochrane Database of Systematic Reviews
|December 2, 2021
Summary
Spinal neuromodulation (SNMD) may offer pain relief when combined with other treatments, but evidence is limited and low-certainty. Spinal cord stimulation (SCS) alone showed minimal benefit against placebo, with risks of complications and serious adverse events.
Area of Science:
- Neurology and Pain Management
- Clinical Trial Analysis
- Health Technology Assessment
Background:
- Implanted spinal neuromodulation (SNMD) techniques, including spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS), are used for refractory chronic pain.
- These interventions involve implanting electrodes near the spinal cord or dorsal root ganglion and using electrical stimulation to reduce pain intensity.
Purpose of the Study:
- To evaluate the efficacy, effectiveness, adverse events, and cost-effectiveness of implanted SNMD interventions for chronic pain.
- To synthesize evidence from randomized controlled trials (RCTs) comparing SNMD with placebo, no treatment, or usual care.
Main Methods:
- A systematic literature search was conducted across multiple databases (CENTRAL, MEDLINE, Embase, Web of Science) and clinical trial registries up to September 2021.
- Included were RCTs involving participants aged 18+ with chronic non-cancer, non-ischemic pain, comparing SNMD interventions with control groups or as add-on therapy.
- Primary outcomes were pain intensity and adverse events; secondary outcomes included disability, medication use, quality of life, and economic outcomes. Risk of bias and certainty of evidence (GRADE) were assessed.
Main Results:
- Fifteen published studies (908 participants) and 20 ongoing studies were included; all evaluated SCS, with no eligible published studies on DRGS.
- SCS versus placebo showed a small, potentially not clinically important, short-term reduction in pain intensity (very low certainty evidence).
- SCS as an add-on therapy showed potentially clinically important pain reduction at short- and medium-term follow-up (low to very low certainty evidence). Device-related complications (lead failure, infection, reoperation) and serious adverse events, including death, were reported with very low certainty evidence.
Conclusions:
- The evidence suggests SCS alone may not offer clinically significant pain relief compared to placebo, with limited certainty.
- SNMD interventions, when added to conventional management, may provide clinically important pain benefits, though evidence quality is low to very low.
- SNMD is associated with significant risks, including device complications and serious adverse events, with high uncertainty regarding their precise incidence.
