title: Intraligamentous injection of sclerosing solutions (prolotherapy) for spinal pain: a critical review of the literature.
abstract: BACKGROUND
  The injection of various solutions aimed at producing a sclerosing effect has been used to treat soft tissues injuries (eg, inguinal hernia) for more than 100 years. In the 1930s, this treatment approach was applied to injured joints in an attempt to stimulate connective tissue repair. Although several studies have been published about this method of treatment for various orthopedic and spinal indications (termed prolotherapy), its use remains controversial.
  
  
  OBJECTIVE
  To conduct a critical review of the literature on prolotherapy for spinal pain.
  
  
  METHODS
  Critical review of the literature.
  
  
  METHODS
  Computerized medical literature databases (Medline, CINAHL, Mantis, Cochrane Central Register of Controlled Trials) were searched to uncover all published information about the use of sclerosing injections in humans with spinal pain disorders. Search results were reviewed for relevance, and information was abstracted from full-text articles.
  
  
  RESULTS
  Our search uncovered almost 200 reference materials in various media related to prolotherapy, including 31 clinical studies related to spinal pain. There were 26 observational cohorts and 5 randomized clinical trials (RCTs). Indications in these studies were low back pain (22), neck pain (3), cervical headaches (3) and dorsal or thoracic pain (3). A total of 20 sclerosing solutions were used in these studies; the most common was a mixture of dextrose 12.5%, glycerin 12.5%, phenol 1.25% and lidocaine 0.25%. Wide variations were found in treatment protocols, such as dose, number of treatments and use of adjunct therapies. Most cohort studies were only of moderate quality and varied greatly in the substances injected and the use of co-interventions. Most clinical studies reported positive results such as decreased pain or disability, although differences between treatment and control groups did not always reach statistical significance. Commonly reported adverse reactions to this treatment include temporary postinjection pain and stiffness. A handful of more serious adverse events were reported in the 1950s and 1960s with stronger or unknown solutions.
  
  
  CONCLUSIONS
  Prolotherapy describes a variety of treatment approaches rather than a specific protocol. Results from clinical studies published to date indicate that it may be effective at reducing spinal pain. Great variation was found in the injection and treatment protocols used in these studies that preclude definite conclusions. Future research should focus on those solutions and protocols that are most commonly used in clinical practice and have been used in trials reporting effectiveness to help determine which patients, if any, are most likely to benefit from this treatment.
authors.affiliation: Department of Environmental Health, Science, and Policy, University of California, Irvine, CA 92697, USA. Simon@CamResearch.com
authors.forename: Simon
authors.initials: S
authors.lastname: Dagenais
authors.forename: Scott
authors.initials: S
authors.lastname: Haldeman
authors.forename: James R
authors.initials: JR
authors.lastname: Wooley
mesh_terms: D002986:Clinical Trials as Topic; D000529:Complementary Therapies; D006801:Humans; D007278:Injections, Spinal; D008022:Ligaments / Q000187:drug effects*; D010146:Pain / Q000188:drug therapy*; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D013131:Spine / Q000187:drug effects*; D016896:Treatment Outcome
chemical_list: D012597:Sclerosing Solutions