Prospective, double-blind, randomized placebo-controlled trials in interventional spine: what the highest quality literature tells us.

BACKGROUND CONTEXT: The prospective, double-blind, randomized, placebo-controlled study design is essential in the interventional spine literature to truly evaluate whether or not a procedure is effective.

PURPOSE: This article will critically evaluate the highest quality interventional spine literature with strict interpretation of the results of these trials.

STUDY DESIGN: Review article.

METHODS: Extensive Medline/Pubmed searches and searches of the large review articles on the major interventional spine topics were performed to find all prospective, double-blind, randomized placebo-controlled trials in the English language interventional spine literature.

RESULTS: Fluoroscopically-guided lumbosacral transforaminal epidural corticosteroid injections are effective in the treatment of acute/subacute lumbosacral radicular pain, and in preventing future surgeries. Injection of corticosteroid or Sarapin on the cervical or lumbar medical branch nerves is not effective. When done with proper technique, percutaneous radiofrequency lumbar and cervical medial branch neurotomy are both effective. Intraarticular sacroiliac joint corticosteroid injections are effective in patients with spondyloarthropathy. IDET is modestly effective in the treatment of lumbosacral discogenic pain in carefully selected patients. Percutaneous radio frequency neurotomy of the ramus communicans is effective in the treatment of lumbosacral discogenic pain. No firm conclusions can be drawn about cervical epidural corticosteroid injections, lumbosacral epidural corticosteroid injections for the treatment of chronic radicular pain, cervical or lumbosacral intraarticular zygapophysial joint corticosteroid injections for the treatment of degenerative zygapophysial joint pain, or intradiscal corticosteroid injections.

CONCLUSIONS: The prospective, double-blind, randomized placebo-controlled trials in the interventional spine literature demonstrate efficacy from several different procedures when properly performed on appropriate patients. Other procedures have been shown to lack efficacy, while inconclusive evidence exists from multiple other interventional spine procedures. Further details are discussed in the text.