Prolotherapy

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Editors-In-Chief: Robert G. Schwartz, M.D. [3], Piedmont Physical Medicine and Rehabilitation, P.A.; Dean Reeves, M.D., Clinical assistant/associate professor University of Kansas Medical School, Dept of Physical Medicine and Rehabilitation 1986-2015; Felix Linetsky, M.D., Clinical Associate Professor, Department of Osteopathic Principles and Practice, Nova Southeastern College of Osteopathic Medicine [4]

Note for recent edits Captcha has been blocking external links so additional references have been placed after each paragraph until administration can correct that. See support desk comment "When editing, asking to type two words in a box that does not exist" (Dr Reeves)

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Overview

Prolotherapy ("Proliferative Injection Therapy") involves injecting an otherwise non-pharmacological and non-active proliferant or 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. Prolotherapy has enjoyed increased acceptance within the medical community, especially in light of the focus being given to regenerative medicine as a discipline. Eighteen randomized controlled trials were found on PubMed as of June, 2017. (see Evidence Based Medicine section below)

Prolotherapy can be distinguished from sclerotherapy. Sclerotherapy is the use of injections of caustics into the veins, in vascular surgery and dermatology, to remove varicose veins and other vascular irregularities. Prolotherapy is the use of injections in tendons or ligaments to correct connective tissue weakness and reduce musculoskeletal pain. Prolotherapy is also called "proliferation therapy" and "regenerative injection therapy."

Prolotherapy is often used as an alternative in the presence of chronic pain involving ligaments and tendons, as chronic changes in ligaments and tendons are primarily degenerative in nature rather than primarily inflammatory, with the term "tendinopathy" rather than "tendinitis" preferred. (Scott 2015). Prolotherapy is also used as an alternative in the presence of chronic pain involving joints, which histologic findings similarly primarily degenerative. Lack of benefit in general with anti-inflammatory approaches on the clinical course of osteoarthritis is emphasized by a recent clinical trial of saline versus steroid (triamcinolone) injection in knee osteoarthritis showing unequivocal acceleration of cartilage loss with quarterly injection of steroid for 2 years in comparison with a saline control injection, reported in JAMA. (McAlindon 2017)

Scott A, Backman LJ, Speed C. Tendinopathy: Update on Pathophysiology. J Orthop Sports Phys Ther 2015;45:833-41. McAlindon TE, LaValley MP, Harvey WF, Price LL, Driban JB, Zhang L, et al. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA 2017;317:5283

Arthroscopic surgery of the knee is, however, rarely performed for the indication of osteoarthritis, but rather for mechanical tears or disruptions of cartilaginous tissue. Prolotherapy is not intended to address this type of problem. Doctors and surgeons have given numerous accounts of successful treatment for knee injuries, shoulder separation, and typical injuries to golfers (epicondylitis, shoulder strain, lower back strain and injury, hip and knee injury).

In 2005, Robert D. Sheeler, MD (Medical Editor, Mayo Clinic Health letter), who first learned of prolotherapy through C. Everett Koop’s interest in the treatment, listed ankles, knees, elbows, and sacroiliac joint in the low back as areas most likely to benefit from prolotherapy treatment and stated that "unlike corticosteroid injections — which may provide temporary relief — prolotherapy involves improving the injected tissue by stimulating tissue growth." Stimulation of tissue growth was then confirmed by Mayo Clinic researchers (Biomechanics Laboratory, Division of Orthopedic Research, and Department of Neurology),(Oh 2008, Yoshii 2009, Yoshii 2011, Yoshii 2014), who performed one open-label and three blinded studies using rabbits; each study with a saline control injection, to determine the effect of injection of 10% dextrose. They demonstrated that 10% dextrose injection, compared to saline injection, resulted in a increase in total energy absorption and tensile load tolerated before rupture, and thickening of injected ligament tissue. This tissue growth, histologically, was normal tissue. This result was significant enough that they proposed use of dextrose injection to create carpal tunnel syndrome for research by intentionally thickening the transverse carpal ligament equivalent in the rabbit, producing compression of the median nerve.

Prolotherapy in clinical practice

Prolotherapy involves the injection of either an irritant or proliferant solution into the area where connective tissue has been weakened or damaged through injury or strain. Many solutions are used, including Dextrose, Lidocaine (a commonly used local anesthetic), Phenol (an alcohol), Glycerine, Cod Liver Oil extract or Sodium Morrhuate . The injection is placed onto ligament, into joint capsules or where tendon connects to bone. Many points may require injection. The Injected solution causes the body to heal itself through the process of inflammation and repair. In the case of weakened or torn connective tissue, induced inflammation and release of growth factor at the site of injury may result in a 40% strengthening of the attachment points.

Most clinicians say that at least three injections, done at 2-3 week intervals, are required to accomplish this result. In addition, patients may receive treatment beyond the initial three injections until treatments are required only every several years, if at all. Allen R Banks, Ph.D., has described in detail the theory behind prolotherapy in "A Rationale for Prolotherapy". Robert G. Schwartz, MD has also published a biochemical literature review on the topic "Prolotherapy: A Literature Review and Retrospective Study"[6].

History

Injections of irritant solutions were performed in the late 1800’s to repair hernias and in the early 1900’s for jaw pain due to temporomandibular (jaw) joint laxity. Dr. George Hackett, MD developed the technique of prolotherapy in the 1940’s. Dr. Gustav Hemwall was a pioneer, beginning his studies and treatments in the 1950s and continuing until the mid 1990s. In his study of almost 10,000 prolotherapy cases, Dr. Hackett found that over 99 percent of the patients found relief from their chronic pain.

Guidelines used by practitioners as indicators for prolotherapy

• Recurrent swelling or fullness involving a joint or muscular region
• Popping, clicking, grinding, or catching sensations with movement
• A sensation of the “leg giving way” with associated back pain
• Temporary benefit from chiropractic manipulation or manual mobilization that fails to ultimately resolve the pain
• Distinct tender points and “jump signs” along the bone at tendon or ligament attachments
• Numbness, tingling, aching, or burning, referred into an upper or lower extremity
• Recurrent headache, face pain, jaw pain, ear pain
• Chest pain with tenderness along the rib attachments on the spine or along the front of the chest
• Spine pain that does not respond to surgery, or whose origin is not clear or consistent based on extensive studies

Evidence based medicine

General Narrative Review Articles 2005 to 2011

The first comprehensive review article on safety and potential efficacy of prolotherapy was published in 2005. (Rabago 2005) On the basis of 34 case reports or case series, 2 nonrandomized controlled trials, and 6 RCTs, prolotherapy was considered “safe when performed by an experienced clinician” but “conclusive data for prolotherapy as a treatment for musculoskeletal pain was lacking”. Since 2010 there has been an acceleration in publication of randomized controlled trials (RCTs) for dextrose prolotherapy and both general and specific systematic reviews. A 2011 review noted growing evidence to recommend use in tendinopathies and early evidence of benefit in osteoarthritis. (Distel 2011)

General Narrative Reviews 2012 to Present and Strength of Recommendations

In the field of general practice, a practical way to consider the merit of employing a specific treatment for a specific condition was developed by Ebell et al,(Ebell 2004) and has been increasingly utilized. It is called the Strength of Recommendation Taxonomy and is composed of 3 assessments, study quality (bias), study quantity (and number of subjects), and study consistency (do studies agree?). Strength of recommendations were included as part of narrative reviews beginning with Covey at al (Covey 2015) who assigned a level A strength of recommendation (SOR) (recommendation based on consistent and good-quality patient-oriented evidence) for dextrose prolotherapy for knee osteoarthritis and level B SOR (recommendation based on inconsistent or limited-quality patient-oriented evidence) for Achilles tendinopathy, lateral epicondylosis, Osgood Schlatter disease, and plantar fasciosis. Two 2016 general review articles expanded level B strength of recommendations to include low back/sacroiliac pain and rotator cuff tendinopathy. (Reeves 2016, Hauser 2016) A SOR for the use of prolotherapy in acute pain, myofascial pain or as first-line therapy, cannot be determined based on current literature. (Hauser 2016) It is important to keep in mind, when considering the assignment of strength of recommendation, that a single RCT cannot lead to a level A SOR recommendation. Thus despite a single high quality study the SOR will only be B (recommendation based on inconsistent or limited-quality patient-oriented evidence). In a field in which research is virtually all self-funded, with no proprietary interest, studies will accumulate slowly and a level B recommendation may mean a "poor quantity" of studies or low patient numbers, rather than "poor quality".

Back pain/Sacroiliac Pain Articles: Treatment Comparison Trials Rather Than Placebo Trials Due to Extensive Needling Effects

A 2007 review of prolotherapy in adults with chronic low-back pain found unclear evidence of effect. (Dagenais 2007) A 2009 review mentioned prolotherapy but did not review the studies and deferred to the 2007 review.(Staal 2009) There was tentative evidence of benefit when used with other low back pain treatments. (Distel 2001) These prior reviews focused primarily on phenol-containing solutions, which have declined in use in favor of hypertonic dextrose which is less inflammatory and better studied. (Rabago 2017) More recent reviews of dextrose-only studies interpreted the dextrose-only controlled trials as treatment comparison studies in that the first study (Yelland 2003) utilized a control with substantial needling effect on multiple occasions and both saline and dextrose groups had a persistent benefit with "greater than 50% pain reduction in 46% and 36% of dextrose and saline groups respectively at 12 months," (Reeves 2016) and the second study favored dextrose over steroid injection (triamcinolone) for injection of the SI joint.(Kim 2010) Recent reviews conclude that evidence of benefit remains tentative (level B) for dextrose prolotherapy in low back/sacroiliac pain based on two favorable but inconsistent treatment comparison studies. (Reeves 2016. Hauser 2016)

Criticism

While many major medical insurance policies cover the treatment, not all do. Twenty years ago (After a 1999 review of the medical evidence) Medicare declined prolotherapy coverage for chronic low back pain (citing that prolotherapy "was last examined for coverage by the Health Care Financing Administration (HCFA) in September 1992").

Ongoing Study

Knee injuries

A randomized, double-blind, placebo control study is currently recruiting patients to determine whether prolotherapy can decrease pain and disability from knee osteoarthritis. This study is Sponsored by the National Center for Complementary and Alternative Medicine (NCCAM).

Tennis elbow

A randomized, double-blind, placebo control study is currently recruiting patients to determine whether prolotherapy can be an effective treatment for lateral epicondylitis (tennis elbow).

See also

• Pin firing
• Gustav Hemwall

External links

• Prolotherapy.org is a source for extensive articles, diagrams and other resources related to prolotherapy.
• Prolotherapy.com - a source for information on nonsurgical ligament reconstruction
• American Association of Orthopaedic Medicine is a non-profit organization that promotes prolotherapy.
• "CAM Prolotherapy Project". 2006-08-06. Retrieved 2006-08-06.