Pain medicine

Evaluating the Statistical Robustness of Randomized Controlled Trials of Spinal Cord Stimulation for Pain through the Use of Fragility Index

AnesthesiologyPublished Systematic review of randomised controlled trials

Authors' conclusion

This study suggests that the majority of RCTs investigating primary pain outcomes after SCS therapy are robust with relatively high fragility scores.

Study context

Population
Randomized controlled trials (RCTs) assessing spinal cord stimulation (SCS) for any chronic pain indication
Participants
30 RCTs
Outcome
Trial-specific fragility index for the prespecified pain primary outcomes of RCTs
Methodological detailsfragility index analysis
  • Fragility index analysis

Pooled result

As reported in the abstract

Fragility index, primary outcome of all trials

Median fragility index across the primary outcome of all trials

5.45

IQR 3.00 to 11.45

Further pooled results

Fragility by outcome type, primary vs secondary pain outcomes, and conflict of interest

No statistical difference between dichotomous vs continuous outcomes
P = 0.710
No statistical difference between primary vs secondary pain outcomes
P = 0.771
No statistical difference between presence vs absence of trial conflict of interest
P = 0.753

Fragility index by SCS indication (subgroup)

Persistent spinal pain syndrome type 2, median (IQR)
8.00 (2.80 to 12.60)
Painful diabetic neuropathy, median (IQR)
6.00 (3.00 to 11.80)
Complex regional pain syndrome, median (IQR)
7.20 (4.62 to 81.50)
Mixed etiologies, median (IQR)
9.00 (3.00 to 38.00)
Other etiologies, median (IQR)
3.00 (1.00 to 8.55)

Original publication

Evaluating the Statistical Robustness of Randomized Controlled Trials of Spinal Cord Stimulation for Pain through the Use of Fragility Index. Anesthesiology. Published 1 December 2025. doi:10.1097/aln.0000000000005876

Composed by AI from the published abstract and checked against it. How Briefs are made →

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