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Meta-Analysis
. 2019 Jul 1;20(7):1281-1293.
doi: 10.1093/pm/pny154.

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review

Wayne B Jonas  1 , Cindy Crawford  2 , Luana Colloca  3 , Levente Kriston  4 , Klaus Linde  5 , Bruce Moseley  6 , Karin Meissner  7   8
Affiliations
Meta-Analysis

Are Invasive Procedures Effective for Chronic Pain? A Systematic Review

Wayne B Jonas et al. Pain Med. .

Abstract

Objective: To assess the evidence for the safety and efficacy of invasive procedures for reducing chronic pain and improving function and health-related quality of life compared with sham (placebo) procedures.

Design: Systematic review with meta-analysis.

Methods: Studies were identified by searching multiple electronic databases, examining reference lists, and communicating with experts. Randomized controlled trials comparing invasive procedures with identical but otherwise sham procedures for chronic pain conditions were selected. Three authors independently extracted and described study characteristics and assessed Cochrane risk of bias. Two subsets of data on back and knee pain, respectively, were pooled using random-effects meta-analysis. Overall quality of the literature was assessed through Grading of Recommendations, Assessment, Development, and Evaluation.

Results: Twenty-five trials (2,000 participants) were included in the review assessing the effect of invasive procedures over sham. Conditions included low back (N = 7 trials), arthritis (4), angina (4), abdominal pain (3), endometriosis (3), biliary colic (2), and migraine (2). Thirteen trials (52%) reported an adequate concealment of allocation. Fourteen studies (56%) reported on adverse events. Of these, the risk of any adverse event was significantly higher for invasive procedures (12%) than sham procedures (4%; risk difference = 0.05, 95% confidence interval [CI] = 0.01 to 0.09, P = 0.01, I2 = 65%). In the two meta-analysis subsets, the standardized mean difference for reduction of low back pain in seven studies (N = 445) was 0.18 (95% CI = -0.14 to 0.51, P = 0.26, I2 = 62%), and for knee pain in three studies (N = 496) it was 0.04 (95% CI = -0.11 to 0.19, P = 0.63, I2 = 36%). The relative contribution of within-group improvement in sham treatments accounted for 87% of the effect compared with active treatment across all conditions.

Conclusions: There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain. Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.

Keywords: Meta-analysis; Pain; Placebo; Sham; Surgery; Systematic Review.

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Figures

Figure 1
Figure 1
PRISMA flow diagram. RCT = randomized controlled trial.
Figure 2
Figure 2
A) Individual between-group effects of invasive treatments compared with sham procedures. B) Meta-analysis for arthritis and low back pain. CI = confidence interval; ES = effect size.
Figure 3
Figure 3
Relative contribution of within-group improvement in sham treatments to improvement in active treatment. *For arthritis, the improvement was larger for the sham treatments than for the active treatments.
See this image and copyright information in PMC

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