As an occupational specialist and also having worked in orthopedic practices, Dr. Trangle as well as his colleagues are experienced in evaluating a variety of orthopedic cases from the simple spinal sprain and strain to the more complex disability cases involving disc herniation, degenerative disc disease, as well as other joint issues, rotator cuff tendinopathy, epicondylitis, patellofemoral epicondylitis, and other joint pathology; these are routine parts of evaluation and proffered opinions. Newer types of treatments and their acceptance often are reviewed for purposes of payment, litigation and relevancy. One such example would be prolotherapy.
Prolotherapy is the term used for non-surgical ligament reconstruction, and it is also claimed to be a permanent treatment for chronic pain. Prolotherapy is derived from the Latin word “proli” which means to regenerate or rebuild. “Prolo” is short for proliferation, because the treatment is supposed to lead to the proliferation (growth, formation) of new ligament tissue in areas where it has become weak.
Prolotherapy, or proliferation therapy, is the injection of a solution to stimulate the growth of new cells to heal painful areas. Ligaments are the most common sites for injection although muscles and tendons can also be treated.
Proliferation, of course, means “rapid production.” Prolotherapy is described as a process of rapid production of collagen and cartilage. Collagen is a naturally occurring protein in the body that is a necessary element for the formation of new connective tissue-the tissues that hold skeletal infrastructure together. These tissues include tendons, ligaments, muscle fascia and joint capsular tissue.
In the United States the current number of practitioners actively practicing Prolotherapy is unknown, but it estimated the number may be in thousands (Rabago, 2010).
The National Institute of Health (NIH) describes Prolotherapy as a complementary alternative medical therapy (CAM). Both the Centers for Medicare and Medicaid Services and the Veteran’s Administration reviewed Prolotherapy literature for low back pain and all musculoskeletal indications, and came to the conclusion that there is no conclusive evidence regarding its efficacy in the management of the conditions (Rabago, 2010). Hence, neither recommends third party payment for Prolotherapy. Some private insurers are said to be covering Prolotherapy for selected indications and clinical circumstances, but most patients pay out-of-pocket (Rabago, 2010).
A randomized controlled trial of efficacy intra-articular Prolotherapy in comparison to steroid injection for sacroiliac joint pain, concluded that intra-articular Prolotherapy provided significant relief for sacroiliac joint pain and its effects lasted longer than those of steroid injections (Kim, 2010).
A study of the treatment of chronic low-back pain and a one-year or greater follow up of the study population, suggested that Prolotherapy using a variety of proliferants can be an effective treatment for low back pain from presumed ligamentous dysfunction for some patients when performed by a skilled practitioners (Watson, 2010).
A pilot study of the efficacy of Prolotherapy for lateral epicondylitis concluded that Prolotherapy was well tolerated and effectively decreased elbow pain, as well as improved strength testing in subjects with refractory lateral epicondylitis compared to control group injections (Scarpone, 2008).
A prospective descriptive study of the use of Prolotherapy in the sacroiliac joint and follow up at 3, 12, and 24 months showed positive clinical symptomatic outcomes in the patients—76% at 3 months; 76% at 12, and 32% at 24 months (Cusi, 2010).
A systematic review of randomized controlled studies on the efficacy and safety of corticosteroids injections and other injections for management of tendinopathy, in which the authors searched eight databases without language, publication, or date restrictions. Forty one out of the 3824 studies met the inclusion criteria. The authors concluded that despite the effectiveness of corticosteroids injections in the short term, non-corticosteroids might be of benefit for long-term treatment of lateral epicondylitis. The authors advised against the generalization of the response to the injections because of variation in effect between sites of tendinopathy (Commbes, 2010).
A systematic review of randomized controlled and quasi randomized controlled trails that compared Prolotherapy injections to control injections alone or in combination with other treatments, which measure pain or disability before and after intervention concluded that there is conflicting evidence regarding the efficacy of Prolotherapy injections for patients with chronic low back pain alone. When combined with spinal manipulation and exercise, and other co-interventions, Prolotherapy may improve chronic low-back pain (Dagenais, 2007) & (Yelland, 2004).
A critical review of the literature by Dagenais, et al., (2005), concluded that Prolotherapy describes variety of treatment approaches rather than a specific protocol. Furthermore, the authors claimed, although results from clinical studies available indicated that the treatment may be effective in reducing spinal pain; there was a great variation found in the injection and treatment protocols used in the studies, thereby precluding definitive conclusion (Dagenais S. H., 2005)
Based on the above evidence, the variation of the treatment and the treatment protocols, there is no adequate clinical epidemiological evidence to support the efficacy and safety of Prolotherapy in the treatment of chronic low back pain and in general, the treatment of any musculoskeletal conditions.
There is little evidence, and few studies directed at shoulder degenerative conditions, that show efficacy of such injections.
More evidence exists for the efficacy of epicondylitis, but even in this application, the evidence is mixed as to its curative potential.
Because of the still yet lack of sufficient and convincing evidence of efficacy of this procedure, it still is regarded as an experimental procedure with unproven value and as such, it is not generally covered by insurance companies as a reimbursable procedure.
References are available upon request.