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BACKGROUND: Previous studies detailing the clinical and histologic effects of sclerosing solutions in rabbit ear and other animal vein models have provided information comparing the effects of various concentrations of hypertonic saline with and without dextrose (Sclerodex), polidocanol, scleremo (chromated glycerin), and sodium tetradecyl sulfate. OBJECTIVE: To observe short-term histologic changes of sclerosing solutions in vitro in large diameter human vein. METHODS: Human saphenous vein segments were obtained following cardiac bypass procedures. Several types of sclerosing solutions, including 23.4% hypertonic saline, 1% polidocanol, and 3% sodium tetradecyl sulfate, were allowed continuous contact with the vessel wall for 10 minutes. Test vein segments were immediately fixed and observed for histologic changes compared with normal saline controls. RESULTS: Endothelium was rapidly destroyed by all tested sclerosing solutions. Vessel wall necrosis occurred quickly with the extent determined by the sclerosing solution. Destructive potential of 3% sodium tetradecyl sulfate greatly exceeded that of 23.4% hypertonic saline or 1% polidocanol, in agreement with previous animal studies. CONCLUSION: Direct toxic effects of sclerosing agents may be compared in a constant, reproducible environment with this in vitro model.
BACKGROUND CONTEXT: 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. PURPOSE: To conduct a critical review of the literature on prolotherapy for spinal pain. STUDY DESIGN/SETTING: 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. CONCLUSION: 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.
A double-blind study was conducted to assess the influence of a sclerosing solution on rabbit medial collateral ligaments (MCL) in situ. It was shown that repeated injections of 5% sodium morrhuate into the MCL and its bony attachments significantly increased its bone-ligament-bone junction strength, ligament mass and thickness when compared to saline-injected controls. Morphometric analysis of electron micrographs showed a highly significant corresponding increase of the collagen fibril diameters in the experimental ligament compared against the control MCL. These composite findings suggested that the sclerosing solution had a significant influence on dense connective tissue at the insertion sites. The mechanisms for these changes are uncertain and are the basis for future investigations.
OBJECTIVE: To study the side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain. DESIGN: Practitioner postal survey. SETTING: Postal survey of practitioners of prolotherapy for back and neck pain in the United States and Canada. PARTICIPANTS: A sample of prolotherapy practitioners from 2 professional organizations were surveyed about their training and experience, use of specific treatment procedures, estimated prevalence of side effects, and adverse events related to prolotherapy for back and neck pain. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Prevalence of side effects and adverse events. RESULTS: Surveys were completed by 171 practitioners (response rate, 50%). Ninety-eight percent held medical degrees, and 83% were board certified in various disciplines. Respondents had a median of 10 years of experience, during which they had treated a median of 500 patients and given a median of 2000 treatments. Side effects with the highest median estimated prevalence were pain (70%), stiffness (25%), and bruising (5%). There were 472 reports of adverse events, including 69 that required hospitalization and 5 that resulted in permanent injury secondary to nerve injury. The vast majority (80%) were related to needle injuries such as spinal headache (n = 164), pneumothorax (n=123), temporary systemic reactions (n = 73), nerve damage (n = 54), hemorrhage (n = 27), nonsevere spinal cord insult (ie, meningitis, paralysis, spinal cord injury) (n = 9), and disk injury (n = 2). CONCLUSIONS: Side effects related to prolotherapy for back and neck pain, such as temporary postinjection pain, stiffness, and bruising, are common and benign. Adverse events related to prolotherapy for back and neck pain are similar in nature to other widely used spinal injection procedures. Further study is needed to fully describe the adverse event profile of prolotherapy for back and neck pain.
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