Tag Archives: Prolotherapy

Prolotherapy

Nonsurgical reconstructive therapy ó also referred to as “prolotherapy” or “proliferative therapy” ó evolved out of a treatment pioneered by H. I. Biegeleisen called “sclerotherapy,” which was originally (and still is) used to treat varicose veins. Prolotherapy involves the injection of an “irritant” solution into the area where ligaments are weak and/or damaged. Over the next few days, cells called “macrophages,” literally big eaters, are attracted into the area by the presence of this irritant solution. Once they arrive, these macrophages pick up the irritant solution and carry it away for disposal (they are the garbage men of the body). As the macrophages are finishing their job, the body sends in “fibroblasts,” literally connective tissue builders, to lay down fibrous tissue wherever they detect damage to connective tissue such as ligaments.

Of course, prolotherapy can be used on any weakened ligament or tendon in the body. The determining factor is the doctor’s skill in introducing the needle to exactly the right locaiton. Knees, hips, elbows, shoulders, in fact every joint in the body can develop problems which can be addressed with prolotherapy.

The doctor’s job is to introduce the irritant solution into the places where ligaments are weak or damaged. If properly placed, this causes the repair of ligaments. This new supporting structure pulls the vertebrae back into close relationship with each other correcting instability and therefore putting an end to inflammation. When inflammation disappears, so does pain! Stability is restored along with mobility.

A single treatment with prolotherapy will cost around $200. Usually not more than ten to fifteen treatments are necessary to bring a typical back pain or neck pain syndrome under control.

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The term “prolotherapy” is a derivation of “proliferative injection therapy” and is also known as sclerotherapy. The practice of prolotherapy is used by doctors of osteopathy and other physicians to treat a number of different types of chronic pain. Prolotherapy consists of a series of intraligamentous and intratendinous injections of solutions in trigger points near the pained area to induce the proliferation of new cells.

Proponents of this treatment suggest that looseness in the supporting ligaments and tendons around the joints causes the pain, inducing the muscles to contract against the ligament and irritate the nerve endings. The physicians using this treatment method for low back pain believe the ligament laxity to be concentrated in the sacroiliac joint. During a physical examination a physician will identify trigger points generally in the muscles overlying the sacroiliac joint. The physician then may inject proliferant substances into the supporting ligament and tendon tissue.

The practice of sclerotherapy or prolotherapy to produce dense fibrous tissue in an effort to strengthen the attachment of ligaments and tendons is not new. Forms of this therapy apparently date back to Hippocrates, however, prolotherapy recently found favor with osteopaths following the teachings of George Hackett, MD, who in 1939 began using a local injectable irritant to initiate the healing process. It was Dr. Hackett who coined the term “prolotherapy” because sclerotherapy implied scar formation, which, according to Dr. Hackett, did not occur with prolotherapy. Nevertheless, both processes use trigger point injections to form new cells in an effort to support weakened muscles. Although the method has been in use for some time, to date there is no strong clinical evidence to support the efficacy of the treatment.

Prolotherapy injections are intended to mimic the natural healing process by causing an influx of fibroblasts that synthesize collagen at the injection site, leading to the formation of new ligament and tendon tissue. The newly produced collagen is intended to support the injured or loosened ligaments, creating a more stable and strong muscle base, in the process, alleviating pain.

There are three classes of proliferant solutions used to initiate inflammation: chemical irritants (e.g. phenol), osmotic shock agents (e.g. hypertonic dextrose and glycerin), and chemotactic agents (e.g. morrhuate sodium, a fatty acid derivative of cod liver oil). The two studies supplied by the requestor used a dextrose-glycerine-phenol solution.

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What is known about prolotherapy outcomes for back pain?
Reported success rates range from 80%-90% when performed by a physician trained in the prolotherapy procedure. Many of these reports are based on anecdotal evidence from the physicians themselves. Studies have not yet connected positive outcomes for back pain and healing to prolotherapy.

The anecdotal reports suggest improvements such as:

* Reduction or elimination of back pain
* Increased strength of the ligament, tendon or joint capsule
* Reduced recurrence of injury to the treated site
* Improved or return to normal function

Factors that may be key for a successful outcome include:

* Proper diagnosis of the location of the sprain or strain
* Willingness of the patient to complete follow-up therapy
* Clinical skill of the physician in performing the injection

Finally, it is important to note that nobody knows exactly what happens in prolotherapy. There is no objective medical evidence, and no histology has been published as to what goes on when injection is placed into the painful soft tissues.

Non-Surgical Ligament Reconstruction

Is it impossible to have a healthcare system that is driven by profits to also be focused on inexpensive and permanent solutions?

When reports on ESPN this week revealed that some US Olympic Ski Team members left the country and went where they could use what is considered ìalternativeî treatments for relief of their injuries and pains, it once again elevated the question of why Medical insurance and workmans comp in the U.S. wonít cover procedures like that.

In many cases, these treatments prove markedly more effective than traditional therapies. The treatment called prolotherapy, used to strengthen weakened ligaments, is widely accepted and used in other countries with national health care systems, including Canada.
Prolotherapy has been considered ìinvestigationalî for 70 years by the Medicare board; insurance companies will cover it when Medicare decides to cover it.

The practice of prolotherapy is used by both medical doctors (MDís) and osteopathic physicians (DOís), such as Dr. Jo Ann Douglas of Colorado Osteopathic & Sports Medicine, to treat several different types of chronic pain. It may be the latest alternative therapy to hit the sports medicine scene.

Doctors are using the treatment successfully for tennis elbow, Achilles tendonitis, patellar tendonitis, back problems, and other common sports injuries. Prolotherapy is also effective in cases of arthritis, fibromyalgia, whiplash, and chronic pain in the neck, back, shoulder, ankle, and sciatica. It relieves disk problems unresponsive to more conservative treatment.

According to Dr. Douglas, there are approximately 600 licensed physicians in the U.S. that perform this procedure. ìProlotherapy treats the cause of the problem; that is, instability. We inject a solution into the ligament or tendon where it attaches to the bone, which stimulates the bodyís own healing response by creating blood flow to the area, recruiting immune system cells that clean the area, and construction cells (fibroblasts) that rebuild the tissues.

ìThis is the exact opposite of the current standard of care, which treats pain and inflammation with anti-inflammatories. Prolotherapy promotes the bodyís inflammatory process so that the body can heal itself. In most cases, commonly prescribed anti-inflammatory medications and drastic measures like surgery or joint replacement may not help, and often hinder or even prevent the healing process.î

According to Dr. Douglas, ìmany patients do not understand why insurance companies will not reimburse for this technique. In many cases it may save the patient from chronic pain management or surgery, which would save money for insurance companies and Medicare as well as treat the cause of the problem for the patient.î

The federal government hears issues from large special interest groups loud and clear. The drug companies, surgeons and chiropractors are heard; whereby the 600 doctors who perform prolotherapy are a very small voice in the healthcare system. In fact, they were not heard at all until Olympic Athletes went to Mexico to get prolotherapy.
Vioxx was covered by insurance, even though it had risks. Surgeons continually change their methods and the new surgery techniques are covered by Medicare and insurances. Secondly, surgeons use cortisone for temporary relief even though cortisone has been proven to cause ligament and tendon deterioration, which may only lead to surgery.
X-rays and MRIís do not always reveal injuries. The number of qualified doctors specifically trained to administer prolotherapy is growing. There are training programs at medical schools now that teach this technique, including how to properly diagnose these injuries.

Although medical doctors who do prolotherapy will continue to be few until more evidence accumulates, osteopaths like Dr. Douglas have a long track record with the procedure.

Each injection treatment varies in cost, ranging from less than $100 for smaller joints to several hundred dollars for larger or more complex joints such as those in the neck and back. Most people need 4-6 treatments ó usually administered in a series of injections three weeks apart ó to stabilize the joint

WHY ISN’T PROLOTHERAPY COVERED BY MEDICAL INSURERS?
Modern allopathic medical research demands that therapies be proven by double-blind methods. This means that neither the patient nor the physician know which therapy is used. For medications, the pills can easily be made to look alike, and a sugar pill used as a placebo is presumed to have no therapeutic value.

For procedures like prolotherapy and most surgeries, there is no adequate placebo. Cortisone cannot be used as a placebo because cortisone can only be injected 3 times a year; typically, prolotherapy requires 4-6 treatments.

The Medicare board wants more data to show the effectiveness of prolotherapy. Drug companies pay for research when it is profitable. They are unlikely to pay for research on prolotherapy because this would not be a profitable venture. In fact, drug companies and surgeons would profit less if prolotherapy would be more widely used, since fewer people would need pain medication and they could avoid expensive surgeries or complications from surgeries.

Dr. Douglas can be contacted through her Website (www.mycodo.com) which further explains this procedure.

Jo Ann Douglas, M.S,D.O.
Board Certified by the American Osteopathic Board of Neuromusculoskeletal Medicine
Colorado Osteopathic & Sports Medicine

Prolotherapy In Denver

DR. JO ANN DOUGLAS is nationally Board Certified by the American Osteopathic Association in Neuromusculoskeletal Medicine. She graduated from University of New England College of Osteopathic Medicine (UNECOM) in Biddeford, Maine in 1998, completing her rotating internship at Saint Vincent Hospital in Worcester, MA and her neuromusculoskeletal residency at UNECOM in 2001. Dr. Douglas is one of the first osteopathic physicians to be trained in prolotherapy as part of the Post-Doctoral Residency Training Program for Board Certification in Musculoskeletal Medicine. Prior to osteopathic medical school, Dr. Douglas attained her M.S. Degree in Exercise Science from the University of Massachusetts, where she worked for several years as an athletic trainer and exercise physiologist for the womens athletic teams.
At her current facility, Colorado Osteopathic and Sports Medicine, which has two convenient locations in Lakewood, CO (minutes from Denver) and Breckenridge, CO, Dr. Douglas specializes in treatment of the musculoskeletal system with (OMT) Osteopathic Manipulative Treatment (for restrictions/hypomobility) and Prolotherapy (for instability/hypermobility). She treats both the spine and the extremities.
Many recurrent problems are often interrelated; yet physicians not specially trained in osteopathic medicine, prolotherapy and OMT often overlook the fact that physical symptoms can demonstrate a connection between various physical problems in the body. As a result of her training and experience with patients, Dr. Douglas has a high success rate in assessing the connection between the various parts of the body. Her extensive knowledge in musculoskeletal functioning and its interconnected relationship with the entire body allows Dr. Douglas to use prolotherapy to simultaneously treat back pain, shoulder pain, rotator cuff tears, chronic ankle sprains, tennis elbow, migraine headaches, scoliosis, degenerative disc disease, TMJ, arthritis, herniated disc, and tendonitis (a few of the many complications associated with musculoskeletal problems). For example, prolotherapy can be used to stabilize a chronic ankle problem that may be contributing to back pain because of the body’s tendency to compensate. Or even more dramatic, a persistent migraine headache can improve because of decreased muscle tension in the neck, shoulders and back resulting from the compensation for the same ankle instability!

www.mycodo.com

Sugar treatments for chronic musculoskeletal pain

News 10 has an article about Prolotherapy, which is use a dextrose (sugar water) solution, which is injected into the ligament or tendon where it attaches to the bone. This causes a localized inflammation in these weak areas which then increases the blood supply and flow of nutrients and stimulates the tissue to repair itself.

Part of the theory is the injections cause an inflammation that causes healing, and anti-inflammatory drugs stop healing process.

They also list this link to Magaziner Center in Cherry Hill, N.J. and a phone number at Information on Prolotherapy Injections for Chronic Pain: (856) 424-8222

History of Medicare’s Prolotherapy Coverage Policy

The Coverage Issues Manual (CIM) ’35-13, “Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents – Not Covered,” states that the medical effectiveness of these therapies has not been verified by scientifically controlled studies, and therefore, cannot be covered by the Social Security Act, ‘1862(a)(1), as a “reasonable and necessary” treatment. This policy of non-coverage along with an erroneous Administrative Law Judge (ALJ) opinion issued in favor of Irwin Abraham, MD, in December 1997, on behalf of a Medicare beneficiary, prompted Dr. Abraham to request a national coverage decision reversing the current policy of non-coverage.

Prolotherapy was last examined for coverage by the Health Care Financing Administration (HCFA) in September 1992. The request had been generated by a beneficiary claiming a benefit from the prolotherapy treatments she had been receiving. HCFA received a number of anecdotal accounts of significant benefit derived from prolotherapy treatments, but when a literature search was conducted it failed to produce any scientifically sound studies on which to base a coverage decision.

The ALJ decision in favor of Dr. Abraham was based on Dr. Abraham’s ability to successfully bill HCFA under the CPT code 20550, “Injection, tendon sheath, ligament, trigger points or ganglion cyst” in the past. However, after the carrier identified the treatment of Dr. Abraham’s patient as prolotherapy, the carrier denied further payment. The ALJ reasoned that because the treatment had been paid for in the past, the carrier was estopped from further payment for the same procedure on the same patient who claims a benefit from the treatment. The ALJ further reasoned that payment for this treatment in the past and the teaching of this method in some medical schools is sufficient evidence that HCFA had modified its policy regarding prolotherapy. Unfortunately, the ALJ did not address the possibility that the carrier had mistakenly paid for the treatment before recognizing it as the non-covered prolotherapy. Furthermore, because the carrier failed to submit evidence that prolotherapy was indeed experimental and investigational, the ALJ determined that without advance notice to the beneficiary that the procedure was non-covered, Medicare would cover the treatment as reasonable and necessary.



HCFA conducted a new electronic literature search using MEDLINE and Ovid. The results only provided editorial articles devoid of any new scientific research. Also, HCFA staff searched the internet and contacted the American Association of Osteopaths for a complete list of current scientific evidence on the efficacy of prolotherapy. None of these efforts produced significant evidence to support the coverage request.

Analysis of Scientific Evidence

In light of the aforementioned ALJ decision, Dr. Abraham’s confusion regarding the policy here is just; however, an ALJ decision is neither binding nor precedent setting on HCFA’s national coverage decisions. Dr. Abraham supplied HCFA with five articles, two of which are clinical trials that support his request for coverage of prolotherapy. Neither of these articles contain sufficient evidence to persuade HCFA to alter the policy now in place.



The Ongley et al. article: “A New approach to the Treatment of Chronic Low Back Pain,” published in The Lancet, July 1987, studied 81 patients with chronic low back pain with an average duration of ten years in a double-blinded study to compare prolotherapy injections with a non-proliferant injectable course of therapy. Forty of the 81 patients received a regimen of forceful spinal manipulation and injections of a dextrose-glycerine-phenol solution. The 41 patients in the placebo group received less extensive initial local anesthesia (<10 ml 0.5% lignocaine compared with infiltration of 60 ml 0.5% lignocaine in treatment group), a non-forceful manipulation and saline as a substitute for the proliferant used in the experimental group. Also, the experimental group on the first day received a regimen including infiltration of triamcinolone (an anti-inflammatory) into the gluteus medius origin, whereas the placebo group only received lignocaine into the gluteus medius origin. The program included exercises in both groups to encourage the synthesis of the new cells with existing connective tissue. While the authors concluded that "the experimental regimen is a safe and effective treatment for chronic low back pain that has not responded to other conservative forms of treatment," they write earlier in the body of the results section of the paper that "(i)ndependent evaluation of physical signs revealed no significant differences between the groups after treatment."


The Ongley study fails to support the coverage of prolotherapy for a number of reasons. The authors report a subjective improvement in pain amelioration, but they fail to supply any persuasive objective criteria on which to base a coverage decision that must be grounded in scientifically valid evidence. Even the authors acknowledge in their conclusion “(f)uture studies may be needed to analyse [sic] the relative import of each component of the overall procedure.” Since the authors chose to provide the participants with manipulation, exercises and anesthesia in addition to the proliferant and saline injections, it is difficult, if not impossible, to isolate the component of the treatment which gave the participants the reported relief.




Establishing a link between the subjective improvement in pain management and a particular regimen is problematical because the participants in the experimental group received a different preparation course with more anesthesia and a forceful manipulation as opposed to the placebo group’s faux manipulation. Since the study did not treat the proliferant injections as a single variable, there is no way to positively identify prolotherapy as the cause of the pain relief rather than the forceful manipulation. Also, because Medicare currently covers forceful manipulation and massage therapy by a qualified provider, HCFA would need evidence that the addition of another variable, such as prolotherapy, to a patient’s course of treatment would provide greater benefit than that which is currently covered. Furthermore, even if the results concluded that the benefit in pain reduction could be positively attributed to prolotherapy, the sample size of 81 patients is really an insufficient number on which to base a positive national coverage decision.




The more recent study submitted by Dr. Abraham also falls short of the requisite level of evidence needed for a national coverage decision. The Klein et al. study, “A Randomized Double-Blind Trial of Dextrose-Glycerine-Phenol Injections for Chronic, Low Back Pain” published in 1993, fails in much the same way as the Ongley study before it. Again, the number of participants is small; therefore it would be difficult to use the results in support of a newly crafted national coverage decision.

The Klein study was comprised of 79 patients, 39 of which were placed in the proliferant group. Thirty of 39 patients in the proliferant group achieved a 50% or greater diminution in subjective pain or disability. The control group was not a true placebo because “the patients received four of the five active interventions of the full treatment regimen and demonstrated statistically significant within-group improvements compared to baseline disability and pain scores.” Twenty-one of 40 patients in the placebo group reported a 50% or greater diminution in subjective pain and disability scores. A response of more than 50% of patients in the control group reporting improvement suggests that an actual treatment effect rather than a pure placebo response occurred. Even the authors note, “(t)he interventions shared by both treatment groups, including exercises, injection of local anesthetics, repeated needling, and manipulation may all enhance the success of the procedure, but the relative contribution of each intervention requires further study.”

The authors identify that further studies are needed to show greater improvement in treating pain with prolotherapy because “the statistical significance was only borderline” when the experimental group was compared to the control group. Also, “objective testing of range of motion, isometric strength, and velocity of movement showed significant improvements in both groups following treatment, but did not favor either” the proliferant or the control group. Further, “the MRI and CT scans showed significant abnormalities in both groups, but these did not correlate with subjective complaints and were not predictive of response to treatment.”

A total of 160 patients studied over the past twelve years, with only 79 of the patients receiving the proposed treatment, is not a large enough sample to support a change in the coverage policy. More studies with larger control and experimental groups must be evaluated using regimens designed to isolate variables and correlate them to positive results. Ideally, these studies would consist of improvements in both objective and subjective measurement tools. However, substantial and statistically significant improvements in subjective pain scores could be persuasive if HCFA could attribute the patient benefit to the prolotherapy regimen.

ClinicalTrials.gov shows an closed study “Joint Injections for Osteoarthritic Knee Pain” to determine whether prolotherapy can decrease pain and disability from knee osteoarthritis.

Saline Injections for Chronic Low-Back Pain

In a controlled 6 month trial, 110 subjects with nonspecific low-back pain (average duration, 14 years) were randomized to have repeated prolotherapy with 20% glucose/0.2% lidocaine (lignocaine) or normal saline injections into tender lumbo-pelvic ligaments. Subjects were also randomized to a program of flexion/extension exercises or to normal activity. With follow-up through 12 months in 96% of subjects and through two years in 80% of subjects.

Throughout the trial, injections resulted in significant and sustained reductions in pain. However, prolotherapy injections were no more effective than saline injections, and the exercise program did not confer any additional benefit over normal activity.

At 12 months, more than 50% reduction in pain from baseline occurred in 46% of the prolotherapy group vs. 36% of the saline group, and in 41% of the exercise group vs. 39% of the normal activity group. More than 50% reduction in disability occurred in 42% of the prolotherapy group vs. 36% of the saline group, and in 36% of the exercise group vs. 38% of the normal activity group. None of these differences were statistically significant.