Tag Archives: treatments

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

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

Agreement form recommended for use before opioid treatment is prescribed

I understand that Dr ____________ is prescribing opioid medication to assist me in managing chronic pain that has not responded to other treatments. The risks, side effects, and benefits have been explained to me, and I agree to the following conditions of opioid treatment. Failure to adhere to these conditions will result in discontinuing the medication.

  1. The medication must be safe and effective. The goal is to use the lowest dose that is both safe and effective.
  2. The medication must assist me to function better. If my activity level or general function gets worse, the medication will be changed or discontinued.
  3. I will participate in other treatments that Dr ____________ recommends and will be ready to taper or discontinue the opioid medication as other effective treatments become available.
  4. I will take my medications exactly as prescribed and will not change the medication dosage or schedule without Dr ____________’s approval.
  5. I will keep regular appointments at the pain clinic.
  6. One doctor. All opioid and other controlled drugs for pain must be prescribed only by Dr __________.
  7. If I have another condition that requires the prescription of a controlled drug (narcotics, tranquilizers, barbiturates, or stimulants) or if I am hospitalized for any reason, I will inform the pain clinic within one business day.
  8. I will designate one pharmacy where all my prescriptions will be filled.
  9. I understand that lost or stolen prescriptions will not be replaced, and I will not request early refills.
  10. I agree to abstain from all illegal and recreational drugs and will provide urine or blood specimens at the doctor’s request to monitor my compliance.

    Signature: ___________________________________

    Date: _______________________________________

    Signature: ___________________________________

    Date: _______________________________________
    (Chronic Pain Management staff)

Principles of opioid maintenance analgesia for chronic pain

  1. Successful management of chronic pain usually does not require the use of opioids; however, some patients with chronic pain can benefit from long-term opioid maintenance analgesia (OMA). These patients function better, maintain improved pain control with acceptable side effects, and continue to use their medications in a responsible, reliable manner.
  2. In some patients, pain cannot be managed with long-term use of opioids. Pain control is marginal, function does not improve, side effects may prohibit ongoing therapy, or the patient’s abilityto keep medication use under control is poor or erratic.
  3. Opioids are rarely adequate as the sole treatment for complex chronic pain, which usually requires a multimodal and often a multidisciplinary approach.
  4. OMA for chronic pain is neither a patient’s right nor a privilege. It is one treatment approach that may be chosen by mutual agreement between patient and physician.
  5. Candidates for OMA should:
    • Have an established diagnosis that is concordant with moderate to severe pain
    • Be reliable patients who are known to the physician and are expected to be compliant with the treatment protocol
    • Have exhausted reasonable alternative treatments and be open to new ments in the future
    • Not be using illegal drugs
    • Not be pregnant or likely to become pregnant during the course of treatment
  6. Patients with a history of addiction or poor impulse control are at increased risk for failing to comply with an OMA regimen.
  7. For daily pain, long-acting opioids taken on a fixed schedule are generally preferred for OMA. Limited quantities of nonopioids or shorter-acting opioids are acceptable for breakthrough pain in some cases.
  8. For episodic pain, limited quantities of opioid analgesics may be prescribed as needed.
  9. Meperidine hydrochloride is a poor choice for OMA because of metabolite toxicity with repeated dosing.
  10. For patients initiating OMA, a signed agreement outlining expectations and responsibilities is recommended (see box below). Failure to comply with the agreement should result in discontinuation of OMA or actions to ensure compliance in the future.
  11. Continuation of OMA depends on the following five factors:
    • The medication is safe with acceptable side effects.
    • The medication is effective; that is, pain is reduced and function and quality of life are improved.
    • The patient is a reliable and responsible participant in the treatment program.
    • The condition causing pain persists.
    • No specific or better alternative treatments are available.
  12. The physician’s responsibilities for OMA include:
    • Initial assessment of the pain problem, including relevant medical, psychological, and social factors
    • Scheduling regular office visits for reassessing pain and related conditions; monitoring safety, efficacy, and compliance; and managing side effects
    • Being prepared to continue OMA when it is working
    • Being prepared to taper and discontinue OMAwhen it is not working
    • Thorough documentation of the responsibilities listed
  13. Techniques for monitoring compliance include:
    • Conducting patient interviews
    • Checking patient’s compliance with appoint-ments
    • Obtaining collateral information from family members, other physicians, nurses, and pharmacists
    • Obtaining pharmacy profiles
    • Scheduling drug screens
  14. When discontinuing OMA, the weaning schedule depends on daily dosage and duration of treatment. No weaning is needed when opioids havebeen used occasionally; daily opioid use may re-quire weaning that ranges from 10 days to a few months.
  15. Referral to a pain specialist for consideration of OMA is warranted when:
    • The cause of pain is unclear
    • Behavioral, psychological, and social factors complicate the pain problem
    • The physician is unsure what additional treatment may be effective, or how to administer such treatment

Adapted, with permission, from Fairview Pain Management Center, Minneapolis.

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.

The agony that won’t go away

Christine Doyle hears the plight of sufferers of chronic pain and examines possible new treatments

Sharp pain, such as that suffered when accidentally touching a hot oven, is acute and unbearable.

A speedy reaction is a basic survival instinct. Imagine the sensation lingering for months, even years, and you begin to have an idea of what people with chronic pain have to endure.

More than one in 10 people in Britain live with long-term pain, and many feel that their plight is largely unrecognised and under-treated. Despite the increasing number of pain clinics offering a mix of physical, psychological and complementary approaches, surveys suggest that only one in four patients sees a pain specialist.

to continue read more here on telegraph.co.uk

Can narcotics be used effectively to treat chronic pain?

Iíve already indicated that the use of opioids is controversial in essentially all settings. Debate still persists about medicating terminal patients, so you can imagine how heated the discussion becomes for treating chronic pain, a setting in which there is no end in sight and where complaints often appear to be out of proportion to accompanying physical signs or x-ray findings. Regrettably, most of todayís cure-oriented physicians still do not understand chronic pain. Since it has only been recently that, stimulated by hordes of frustrated patients, a few physicians have even developed the courage to ask questions about chronic pain and opioids, it is not surprising that answers are still elusive.

This question is actually probably best regarded as two related questions: (1) are opioids effective in relieving chronic pain, and (2) if so, when (if ever) is their use appropriate? The bad news is that the ultimate answer to whether opioids are effective in the long term will only be answered with certainty with controlled clinical trials which have not even yet been proposed. Since it would be unethical to allow patients to suffer while awaiting this data, we need to be asking what is known that will help guide todayís treatment safely?

The good news is that there has been increasing experience with using opioids to treat chronic pain due to a variety of causes. While still not as reliable as a controlled trial, data from this experience can be cautiously applied to many of todayís patients with chronic pain. It appears that opioids effectively reduce pain over long intervals in a proportion of patients with chronic pain without intolerable side effects or problems with addiction. One key point here is that as long as the source of pain persists, pain can often be reduced but rarely if ever is it eliminated. Thus, if treatment is to even have a chance at success, patients must maintain realistic expectations, such as a 50% reduction in pain severity. Another key point relates to side effects: in fact, most patients will experience side effects when opioids are first started or their dose is changed, but when medications are started in low doses, are only gradually increased, and with reliance on long-acting formulations side effects can usually be resolved or minimized. Most patients will continue to experience low level side effects as long as opioid therapy is ongoing, but this may represent a reasonable tradeoff if pain is severe. While opioids may produce dangerous respiratory depression when used erratically, this almost never occurs with carefully supervised use. Nausea, sedation and itch are common at first, but usually resolve over time. Constipation is an ongoing difficulty that can and must be prevented with activity, diet and regular gentle laxative use. Because fatigue so commonly accompanies chronic pain, most patients cannot tolerate high doses of opioids, and thus must be satisfied with partial relief. In other words, while opioids are helpful in some cases, they donít eliminate chronic pain: patients continue to have ongoing, but lower grade symptoms, with some good and some bad days. These drugs are not a panacea, but simply represent one of the many tools at our disposal to help make chronic pain more bearable. Moreover, opioids are usually not a first line treatment, and work best when integrated with other drug treatments like antidepressants, anti-inflammatories, muscle relaxants and anticonvulsants, as well as with non-drug therapies like physical therapy, distraction and relaxation training.

Neuropathic pain

Neuropathic pain – a type of chronic pain in people for which there are few effective treatments – is the result of injury- or disease-related damage to nerve fibres. Even after surrounding tissue has healed, the damaged nerve fibres continue to send pain signals to the brain, according to background information in the article.

Neuropathy often results in numbness, abnormal sensations called dysesthesias and allodynias that occur either spontaneously or in reaction to external stimuli, and a characteristic form of pain, called neuropathic pain or neuralgia, that is qualitatively different from the ordinary nociceptive pain one might experience from stubbing a toe or hitting a finger with a hammer.

Neuropathic pain is usually perceived as a steady burning and/or “pins and needles” and/or “electric shock” sensations. The difference is due to the fact that “ordinary” pain stimulates only pain nerves, while a neuropathy often results in the firing of both pain and non-pain (touch, warm, cool) sensory nerves in the same area, producing signals that the spinal cord and brain do not normally expect to receive.