Prolotherapy

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Editors-In-Chief: Robert G. Schwartz, M.D. [4], Piedmont Physical Medicine and Rehabilitation, P.A.; Dean Reeves, M.D., Clinical assistant/associate professor at the 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 [5]

Please Join in Editing This Page and Apply to be an Editor-In-Chief for this topic: There can be one or more than one Editor-In-Chief. You may also apply to be an Associate Editor-In-Chief of one of the subtopics below. Please mail us [6] to indicate your interest in serving either as an Editor-In-Chief of the entire topic or as an Associate Editor-In-Chief for a subtopic. Please be sure to attach your CV and or biographical sketch.

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.

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 to invasive arthroscopic surgery. This is an important alternative, especially when ligamentous structures are involved. The unique role of prolotherapy is highlighted when taking into consideration the effectiveness of arthroscopy. A double-blind placebo-controlled study on arthroscopic surgery for osteoarthritis of the knee was published in the New England Journal of Medicine in July 2002 and concluded that the group that received actual arthroscopic surgery did not report better function or pain than the placebo group."[1]

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)[2][3][4].

As of April 2005, doctors at the Mayo Clinic began supporting prolotherapy. Robert D. Sheeler, MD (Medical Editor, Mayo Clinic Health letter) first learned of prolotherapy through C. Everett Koop’s interest in the treatment. Mayo Clinic doctors list the areas that are most likely to benefit from prolotherapy treatment: ankles, knees, elbows, and sacroiliac joint in the low back. They report that "unlike corticosteroid injections — which may provide temporary relief — prolotherapy involves improving the injected tissue by stimulating tissue growth."[5]

While identifing a clearly delinated population of back pain patients in the literature can be quite challenging, an evidence-based medicine review[6] of prolotherapy for low back pain concluded: "There is conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-back pain. If used alone, prolotherapy injections do not have a role in the treatment of chronic low-back pain. When combined with other treatments, they may give prolonged partial relief of pain and disability." More studies are currently underway (see Ongoing study section below).

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.[7] Allen R Banks, Ph.D., has described in detail the theory behind prolotherapy in "A Rationale for Prolotherapy".[7] Robert G. Schwartz, MD has also published a biochemical literature review on the topic "Prolotherapy: A Literature Review and Retrospective Study"[7].

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. [8]

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: Needling Effect Issues

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)


A Cochrane review of the medical literature as of January 2004 on the efficacy of prolotherapy injections in adults with chronic low-back pain[6] found four controlled trials, all measuring pain and disability levels at six months. The review concluded:

"There is conflicting evidence regarding the efficacy of prolotherapy injections in reducing pain and disability in patients with chronic low-back pain. Conclusions are confounded by clinical heterogeneity amongst studies and by the presence of co-interventions." "... in the presence of co-interventions, prolotherapy injections were more effective than control injections, more so when both injections and co-interventions were controlled concurrently."

The review also noted: "[m]inor side effects from the treatment, such as increased back pain and stiffness, were common but short-lived." ("Stiffness" is an expected short-lived side effect, as the goal is to cause irritation and the corresponding body reaction of temporary inflammation and repair.)

More recently Lyftogt J. [Prolotherapy for recalcitrant lumbago. Australasia Musculoskeletal Med. 2008; 13 (5):18-20] published that ninety percent of patients with recalcitrant lumbago reported more then 50% improvement after prolotherapy. Long term follow up results were not stated. In addition, Rabago et al. [A systematic review of prolotherapy for chronic musculoskeletal pain. Clin J Sport Med. 2005 Sep;15(5):376-80] noted: "Two [randomized controlled trials] on osteoarthritis reported decreased pain, increased range of motion, and increased patellofemoral cartilage thickness after prolotherapy."

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").[9]

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).[10]

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).[11]

See also

References

  1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12110735 "A controlled trial of arthroscopic surgery for osteoarthritis of the knee" N Engl J Med 2002 Jul 11;347(2):81-8, Moseley JB; O'Malley K; Petersen NJ; Menke TJ; Brody BA; Kuykendall DH; Hollingsworth JC; Ashton CM; Wray NP
  2. "Second Annual Prolotherapy Research Forum" (PDF).
  3. March Darrow, Prolotherapy: Living Pain Free, Protex Press, ISBN-13: 978-0971450325
  4. Ross A. Hauser, Marion A. Hauser, Prolo Your Pain Away, Beulah Land Press, ISBN-13: 978-0966101096
  5. Mayo Clinic (2005). "Alternative treatments: Dealing with chronic pain". Mayo Clinic Health Letter. 23 (4).
  6. 6.0 6.1 [1] Cochrane Collaboration
  7. 7.0 7.1 "A Rationale for Prolotherapy".
  8. "The History of Prolotherapy". Retrieved 2007-08-26. In 1955, at an American Medical Association meeting, Dr. Gustav Hemwall was astonished to see so many doctors at one particular exhibit. The presenter was talking about a very successful treatment for chronic low back pain. Nothing was worse at the time for Dr. Hemwall than having a chronic low back pain patient come to him, because the treatments he was able to offer were not very successful. The doctor doing the presentation was George S. Hackett, M.D., and he was discussing the technique of Prolotherapy. Once the crowd diminished, Dr. Hemwall asked Dr. Hackett how he could learn the treatment described in his book, Ligament and Tendon Relaxation Treated by Prolotherapy. Dr. Hemwall went to Dr. Hackett's office in Canton, Ohio, to learn the technique. Dr. Hemwall became so proficient at administering the technique that Dr. Hackett would later refer patients to him. Prolotherapy owes a great debt to Dr. Hemwall. Between 1955 until his retirement in 1996, he was the main instructor and proponent of Prolotherapy in the United States. He was not a researcher but a clinician, and perhaps the world's greatest Prolotherapist. He treated more than 10,000 patients world wide and collected data on 8,000 of these patients. In 1974, Dr. Hemwall presented his largest survey of 2,007 Prolotherapy patients to the Prolotherapy Association.
  9. [2] HCFA Decision Memorandum
  10. [3] Clinicaltrials.Gov, Joint Injections for Osteoarthritic Knee Pain, web page last updated October 16, 2006
  11. http://clinicaltrials.gov/ct2/show?cond=%22Tennis+Elbow%22&rank=3 Clinicaltrials.Gov, Efficacy Study of Prolotherapy vs Corticosteroid for Tennis Elbow

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