Objective. To evaluate the benefits and harms of selected interventional procedures for acute and chronic pain that are not currently covered by the Centers for Medicare & Medicaid Services (CMS) but are relevant for and have potential utility for use in the Medicare population, or that are covered by CMS but for which there is important uncertainty or controversy regarding use. Data sources. Electronic databases (Ovid® MEDLINE®, PsycINFO®, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews) to April 12, 2021, reference lists, and submissions in response to a Federal Register notice. Review methods. Using predefined criteria and dual review, we selected randomized controlled trials (RCTs) for 10 interventional procedures and conditions that evaluated pain, function, health status, quality of life, medication use, and harms. Random effects meta-analysis was conducted for vertebral compression fracture; otherwise, outcomes were synthesized qualitatively. Effects were classified as small, moderate, or large using previously defined criteria. Results. Thirty-seven randomized trials (in 48 publications) were included. Vertebroplasty (13 trials) is probably more effective at reducing pain and improving function in older (>65 years of age) patients, but benefits are small (less than 1 point on a 10-point pain scale). Benefits appear smaller (but still present) in sham-controlled (5 trials) compared with usual care controlled trials (8 trials) and larger in trials of patients with more acute symptoms; however, testing for subgroup effects was limited by imprecision. Vertebroplasty is probably not associated with increased risk of incident vertebral fracture (10 trials). Kyphoplasty (2 trials) is probably more effective than usual care for pain and function in older patients with vertebral compression fracture at up to 1 month (moderate to large benefits) and may be more effective at >1 month to ≥1 year (small to moderate benefits) but has not been compared against sham therapy. Evidence on kyphoplasty and risk of incident fracture was conflicting. In younger (below age for Medicare eligibility) populations, cooled radiofrequency denervation for sacroiliac pain (2 trials) is probably more effective for pain and function versus sham at 1 and 3 months (moderate to large benefits). Cooled radiofrequency for presumed facet joint pain may be similarly effective versus conventional radiofrequency, and piriformis injection with corticosteroid for piriformis syndrome may be more effective than sham injection for pain. For the other interventional procedures and conditions addressed, evidence was too limited to determine benefits and harms. Conclusions. Vertebroplasty is probably effective at reducing pain and improving function in older patients with vertebral compression fractures; benefits are small but similar to other therapies recommended for pain. Evidence was too limited to separate effects of control type and symptom acuity on effectiveness of vertebroplasty. Kyphoplasty has not been compared against sham but is probably more effective than usual care for vertebral compression fractures in older patients. In younger populations, cooled radiofrequency denervation is probably more effective than sham for sacroiliac pain. Research is needed to determine the benefits and harms of the other interventional procedures and conditions addressed in this review.
Blinding in trials of interventional procedures is possible and worthwhile
