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Gustav Hemwall circa 1990-1995
Gustav Hemwall circa 1990-1995
Prolotherapy is also known as "proliferation therapy," "regenerative injection therapy," or "proliferative injection therapy". It involves injecting an otherwise non-pharmacological and non-active irritant solution into the body, generally in the region of tendons or ligaments for the purpose of strengthening weakened connective tissue and alleviating musculoskeletal pain. The precise mechanism or mechanisms of action for prolotherapy agents is currently unclear.
The concept of creating irritation or injury to stimulate healing has been recorded as early as Roman times where hot needles were poked into the shoulders of injured gladiators. Prolotherapy use began in the 1930s and was originally used in the treatment of ligamentous laxity. In the 1950s Dr. George S. Hackett, a general surgeon in the United States, began performing injections of irritant solutions in an effort to repair joints and hernias. This practice is what would eventually evolve into modern day prolotherapy. He was joined in this practice by Gustav Anders Hemwall in the 1950s. In 1955, Dr. Hemwall became acquainted with George Hackett at an American Medical Association meeting and started practicing prolotherapy. Dr. Hemwall was regarded as an expert in prolotherapy.
Prolotherapy involves the injection of an irritant solution into a joint space, weakened ligament, or tendon insertion to relieve pain. Most commonly, hyperosmolar dextrose (a sugar) is the solution used; glycerine, lidocaine (a commonly used local anesthetic), phenol, and sodium morrhuate, a derivative of cod liver oil extract are other commonly used agents. The injection is administered at joints or at tendons where they connect to bone.
Prolotherapy treatment sessions are generally given every two to six weeks for several months in a series ranging from 3 to 6 or more treatments. Many patients receive treatment at less frequent intervals until treatments are rarely required, if at all.
Relative contraindications include:
Patients receiving prolotherapy injections have reported generally mild side effects including: mild pain and irritation at the injection site (often within 72 hours of the injection), numbness at the injection site, or mild bleeding. Pain from prolotherapy injections is temporary and is often treated with acetaminophen or in rare cases opioid medications; NSAIDs are not usually recommended, but are occasionally used in patients with pain refractory to other methods of pain control. Theoretical adverse events of prolotherapy injection include lightheadedness, allergic reactions to the agent used, bruising, infection, or nerve damage. However, allergic reactions to sodium morrhuate are rare. Rare cases of back pain, neck pain, spinal cord irritation, pneumothorax, and disc injury have been reported at a rate comparable to that of other spinal injection procedures.
Three randomized controlled trials found that prolotherapy by itself is inadequate for chronic low-back pain, but can be beneficial when used with other low back pain treatment modalities such as spinal manipulation or corticosteroid injections. These studies, however were based on treating non specific back pain, not the indicated tendonosis. They also were not provided in locations specific for the patient's pathology but rather at predetermined points.
Of the five studies we reviewed, three found that prolotherapy injections alone were not an effective treatment for chronic low-back pain and two found that a combination of prolotherapy injections, spinal manipulation, exercises, and other treatments can help chronic low-back pain and disability. Minor side effects such as increased back pain and stiffness were common but short-lived. Based on these five studies, the role of prolotherapy injections for chronic low-back pain is still not clear.
More recently, a 2009 systematic review of the medical literature evaluated the efficacy of injection therapies including prolotherapy in the treatment of lateral epicondylosis. The authors concluded that the current body of evidence for prolotherapy and other injection therapies suggests that these therapies may benefit patients with lateral epicondylosis, but could not make definitive conclusions due to the limited evidence available. A 2010 systematic review concluded moderate evidence exists to support the use of prolotherapy injections in the management of pain in lateral epicondyalgia; the authors also concluded that prolotherapy was no more effective than eccentric exercise in the treatment of achilles tendinopathy.
Again in 2012, a systematic review and meta-analysis of seventeen trials studying various injection therapies including glucocorticoids, botulinum toxin, autologous blood, platelet-rich plasma, polidocanol, glycosaminoglycan, prolotherapy, and hyaluronic acid found that prolotherapy and hyaluronic acid injection therapies were more efficacious than placebo when treating lateral epicondylosis. Of the studies evaluated, one of ten glucocorticoid trials, one of five trials for autologous blood or platelet-rich plasma, one trial of polidcanol, and one trial of prolotherapy met the criteria for low risk of bias. The authors noted that few of the reviewed trials met the criteria for low risk of bias and that there is a need for more well-controlled trials.
Major medical insurance policies view prolotherapy as an investigational or experimental therapy with an inconclusive evidence base. Consequently, they currently do not provide coverage for prolotherapy procedures. Medicare reviewers in 1999 determined at that time that practitioners had not provided "any scientific evidence on which to base a [different] coverage decision," and so retained Medicare's current coverage policy to not cover prolotherapy injections for chronic low back pain, but expressed willingness to reconsider if presented with results of "further studies on the benefits of prolotherapy."