Interventional Treatments for Acute and Chronic Pain: Systematic Review

Project Summary Title and Description

Interventional Treatments for Acute and Chronic Pain: Systematic Review
Structured Abstract 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 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 one 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, occipital nerve stimulation for headache may be more effective than usual care for disability and headache days 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.
Pacific Northwest Evidence-based Practice Center
Authors of Report
Roger Chou, MD Rongwei Fu, PhD Tracy Dana, MLS Miranda Pappas, MA Erica Hart, MST Kimberly M. Mauer, MD
Methodology description
Systematic Review
PMID: 34524764 The data for this project was prospectively entered into SRDR+.
Funding Source
Agency for Healthcare Research and Quality

Key Questions

1. Key Question 1: What are the effectiveness and harms of selected interventional procedures (vertebral augmentation procedures, cooled or pulsed radiofrequency ablation, intradiscal and facet joint platelet-rich plasma, intradiscal methylene blue, intradiscal ozone, sphenopalatine block, occipital nerve stimulation, piriformis injection, and peripheral nerve stimulation) versus placebo, a sham procedure, or no interventional procedure for Medicare beneficiaries with pain? a. How do the effectiveness and harms vary according to demographic (age, sex, race/ethnicity), clinical (type of pain, severity of pain, prior treatments, medical and psychiatric co-morbidities), and technical factors (variations in techniques, intensity, frequency, dose, and number of treatments)?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

Allogeneic mesenchymal precursor cells treatment for chronic low back pain associated with degenerative disc disease: a prospective randomized, placebo-controlled 36-month study of safety and efficacyAmirdelfan, K.; Bae, H.; McJunkin, T.; DePalma, M.; Kim, K.; Beckworth, W. J.; Ghiselli, G.; Bainbridge, J. S.; Dryer, R.; Deer, T. R.; Brown, R. D.2020
Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trialBerenson, J.; Pflugmacher, R.; Jarzem, P.; Zonder, J.; Schechtman, K.; Tillman, J. B.; Bastian, L.; Ashraf, T.; Vrionis, F.; Cancer Patient Fracture Evaluation, Investigators2011
Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized follow-up, controlled trialBlasco, J.; Martinez-Ferrer, A.; Macho, J.; San Roman, L.; Pomes, J.; Carrasco, J.; Monegal, A.; Guanabens, N.; Peris, P.2012
A randomized trial of vertebroplasty for painful osteoporotic vertebral fracturesBuchbinder, R.; Osborne, R. H.; Ebeling, P. R.; Wark, J. D.; Mitchell, P.; Wriedt, C.; Graves, S.; Staples, M. P.; Murphy, B.2009
Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraineCady, R. K.; Saper, J.; Dexter, K.; Cady, R. J.; Manley, H. R.2015
Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fracturesChen, D.; An, Z. Q.; Song, S.; Tang, J. F.; Qin, H.2014
Botulinum toxin type A use in piriformis muscle syndrome: a pilot studyChilders, M. K.; Wilson, D. J.; Gnatz, S. M.; Conway, R. R.; Sherman, A. K.2002
Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebo-controlled trialClark, W.; Bird, P.; Gonski, P.; Diamond, T. H.; Smerdely, P.; McNeil, H. P.; Schlaphoff, G.; Bryant, C.; Barnes, E.; Gebski, V.2016
Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint painCohen, S. P.; Hurley, R. W.; Buckenmaier, C. C., 3rd; Kurihara, C.; Morlando, B.; Dragovich, A.2008
Prospective, multicenter, randomized, double-blinded, partial crossover study to assess the safety and efficacy of the novel neuromodulation system in the treatment of patients with chronic pain of peripheral nerve originDeer, T.; Pope, J.; Benyamin, R.; Vallejo, R.; Friedman, A.; Caraway, D.; Staats, P.; Grigsby, E.; Porter McRoberts, W.; McJunkin, T.; Shubin, R.; Vahedifar, P.; Tavanaiepour, D.; Levy, R.; Kapural, L.; Mekhail, N.2016
Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fracturesFarrokhi, M. R.; Alibai, E.; Maghami, Z.2011
Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trialFiranescu, C. E.; de Vries, J.; Lodder, P.; Venmans, A.; Schoemaker, M. C.; Smeets, A. J.; Donga, E.; Juttmann, J. R.; Klazen, C. A. H.; Elgersma, O. E. H.; Jansen, F. H.; Tielbeek, A. V.; Boukrab, I.; Schonenberg, K.; van Rooij, W. J. J.; Hirsch, J. A.; Lohle, P. N. M.2018
BOTOX and physical therapy in the treatment of piriformis syndromeFishman, L. M.; Anderson, C.; Rosner, B.2002
Electrophysiologically identified piriformis syndrome is successfully treated with incobotulinum toxin a and physical therapyFishman, L. M.; Wilkins, A. N.; Rosner, B.2017
Sciatica: treatment with intradiscal and intraforaminal injections of steroid and oxygen-ozone versus steroid onlyGallucci, M.; Limbucci, N.; Zugaro, L.; Barile, A.; Stavroulis, E.; Ricci, A.; Galzio, R.; Masciocchi, C.2007
Vertebroplasty vs. SHAM for Treating Osteoporotic Vertebral Compression Fractures: A Double Blind RCTHansen, EJ; Simony, A; Carreon, L; Rousing, R; Tropp, H; Andersen, MO2019
Comparative Study between Treatment of Lumbar Disc Herniation with Intra Discal Ozone and Transforaminal Steroid Injection versus Steroid Injection onlyHaseeb, Abd El Shafy Ahmed; Abd El Hares, Abd El Hameed; Abd El Moez, Khaled Mohamed; Mustafa, Ashraf Ismail; Ahmed, Osama Eid Ahmed2019
A multicenter randomized controlled trial on the efficacy of intradiscal methylene blue injection for chronic discogenic low back pain: the IMBI studyKallewaard, J. W.; Wintraecken, V. M.; Geurts, J. W.; Willems, P. C.; van Santbrink, H.; Terwiel, C. T. M.; van Kleef, M.; van Kuijk, S. M. J.2019
A randomized trial of vertebroplasty for osteoporotic spinal fracturesKallmes, D. F.; Comstock, B. A.; Heagerty, P. J.; Turner, J. A.; Wilson, D. J.; Diamond, T. H.; Edwards, R.; Gray, L. A.; Stout, L.; Owen, S.; Hollingworth, W.; Ghdoke, B.; Annesley-Williams, D. J.; Ralston, S. H.; Jarvik, J. G.2009
Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trialKlazen, C. A.; Lohle, P. N.; de Vries, J.; Jansen, F. H.; Tielbeek, A. V.; Blonk, M. C.; Venmans, A.; van Rooij, W. J.; Schoemaker, M. C.; Juttmann, J. R.; Lo, T. H.; Verhaar, H. J.; van der Graaf, Y.; van Everdingen, K. J.; Muller, A. F.; Elgersma, O. E.; Halkema, D. R.; Fransen, H.; Janssens, X.; Buskens, E.; Mali, W. P.2010
A randomized, double-blind, prospective study comparing the efficacy of continuous versus pulsed radiofrequency in the treatment of lumbar facet syndromeKroll, H. R.; Kim, D.; Danic, M. J.; Sankey, S. S.; Gariwala, M.; Brown, M.2008
Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: A prospective multicenter international randomized controlled studyLeali, P. T.; Solla, F.; Maestretti, G.; Balsano, M.; Doria, C.2016
Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint painMcCormick, Z. L.; Choi, H.; Reddy, R.; Syed, R. H.; Bhave, M.; Kendall, M. C.; Khan, D.; Nagpal, G.; Teramoto, M.; Walega, D. R.2019
Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled studyMisirlioglu, T. O.; Akgun, K.; Palamar, D.; Erden, M. G.; Erbilir, T.2015
Percutaneous pulsed radiofrequency treatment of dorsal root ganglion for treatment of lumbar facet syndromeMoussa, W. M.; Khedr, W.; Elsawy, M.2020
Ozone nucleolysis in the management of prolapsed lumbar intervertebral disc in reducing pain and disability: a randomized controlled studyNilachandra, L.; Darendrajit, L.; Joy Singh, Ak.; Kanti, R.K.; Shibu, B.; Tripti, S.2016
A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint painPatel, N.; Gross, A.; Brown, L.; Gekht, G.2012
A randomized placebo-controlled trial of intradiscal methylene blue injection for the treatment of chronic discogenic low back painPeng, B.; Pang, X.; Wu, Y.; Zhao, C.; Song, X.2010
Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized studyRousing, R.; Andersen, M. O.; Jespersen, S. M.; Thomsen, K.; Lauritsen, J.2009
Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility studySaper, J. R.; Dodick, D. W.; Silberstein, S. D.; McCarville, S.; Sun, M.; Goadsby, P. J.; Investigators, Onstim2011
Occipital nerve stimulation for chronic migraine: a randomized trialSerra, G.; Marchioretto, F.2012
Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: results from a randomized, multicenter, double-blinded, controlled studySilberstein, S. D.; Dodick, D. W.; Saper, J.; Huh, B.; Slavin, K. V.; Sharan, A.; Reed, K.; Narouze, S.; Mogilner, A.; Goldstein, J.; Trentman, T.; Vaisman, J.; Ordia, J.; Weber, P.; Deer, T.; Levy, R.; Diaz, R. L.; Washburn, S. N.; Mekhail, N.2012
A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint painTekin, I.; Mirzai, H.; Ok, G.; Erbuyun, K.; Vatansever, D.2007
Lumbar intradiskal platelet-rich plasma (PRP) injections: A prospective, double-blind, randomized controlled studyTuakli-Wosornu, Y. A.; Terry, A.; Boachie-Adjei, K.; Harrison, J. R.; Gribbin, C. K.; LaSalle, E. E.; Nguyen, J. T.; Solomon, J. L.; Lutz, G. E.2016
Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS studyVoormolen, M. H.; Mali, W. P.; Lohle, P. N.; Fransen, H.; Lampmann, L. E.; van der Graaf, Y.; Juttmann, J. R.; Jansssens, X.; Verhaar, H. J.2007
Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trialWardlaw, D.; Cummings, S. R.; Van Meirhaeghe, J.; Bastian, L.; Tillman, J. B.; Ranstam, J.; Eastell, R.; Shabe, P.; Talmadge, K.; Boonen, S.2009
Percutaneous vertebroplasty versus conservative treatment in aged patients with acute osteoporotic vertebral compression fractures: a prospective randomized controlled clinical studyYang, E. Z.; Xu, J. G.; Huang, G. Z.; Xiao, W. Z.; Liu, X. K.; Zeng, B. F.; Lian, X. F.2016

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