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Cure/no cure????

Posted by Pauline on 9/11/03 at 21:41 (129664)

What does all this mean and where to the Roles and Maudsley percentages come from???? No one seems to agree on the figures or the cure. I guess you just pick the numbers that meet your needs. Doctors pick one set/ insurance companies use another.

Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Indications

Assessment Program
Volume 18, No. 5
August 2003

Executive Summary
This Assessment evaluates whether extracorporeal shock wave treatment (ESWT) improves health outcomes for patients with musculoskeletal conditions that are unresponsive to conservative treatment.

Chronic musculoskeletal conditions include a wide range of inflammatory and degenerative conditions of the musculoskeletal system. These disorders sometimes respond poorly to conservative treatments such as rest, medications, physical therapy, and/or corticosteroid injections. Surgery is an option, but involves recovery time and possible morbidity. ESWT may be an alternative for musculoskeletal conditions that are not responsive to conservative measures.

ESWT delivers shock waves via a device that is similar to that used for renal lithotripsy. The mechanism of action of ESWT for musculoskeletal conditions is not well understood. The shock waves generated by ESWT may disrupt calcific deposits, increase the diffusion of cytokines across vessel walls, stimulate angiogenesis, and/or promote new bone formation. One or more of these mechanisms may operate to aid in the healing process.

ESWT can theoretically be applied to a large number of musculoskeletal conditions. A broad literature search was performed to capture all potential indications. Published prospective trials comparing ESWT to placebo or an alternative treatment were selected for inclusion in this review of evidence. Studies meeting the selection criteria have been published for only 3 indications: plantar fasciitis (with or without a heel spur), tendinitis of the shoulder, and tendinitis of the elbow.

The main outcomes evaluated in the treatment of chronic musculoskeletal conditions are improvements in pain and function (e.g., activity). These outcomes are influenced by nonspecific effects (e.g., placebo response, natural history, regression to the mean). Pain and functional outcomes should be evaluated in randomized, controlled trials that maintain adequate blinding of treatment assignment. The purpose of blinding is to prevent knowledge of which treatment is given from influencing the assessment of the success of the treatment. The gold standard is double-blinding, which means that
neither the patient nor the physician examining the patient knows which treatment was given.

This Assessment updates the December 2001 TEC Assessment, which concluded that ESWT met the TEC criteria for treatment of chronic plantar fasciitis. At that time, the published evidence consisted of 3 randomized, controlled trials, only 1 of which was double-blinded. There are now 2 additional randomized, double-blind trials, one of which found that ESWT was no more effective than placebo for plantar fasciitis.1 The purpose of this Assessment is to reassess the evidence on ESWT for plantar fasciitis and to update the evidence on ESWT for other musculoskeletal indications.

Based on the available evidence, the Blue Cross and Blue Shield Medical Advisory Panel made the following judgments about whether ESWT meets the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) criteria for musculoskeletal indications.

1. The technology must have final approval from the appropriate governmental
regulatory bodies.

There are currently 3 ESWT devices approved by the U.S. Food and Drug Administration (FDA). The Ossatron® device (HealthTronics, Marietta, GA.), an electrohydraulic delivery system, was approved by the FDA on July 20, 2000, for patients with chronic proximal plantar fasciitis that has failed to respond to conservative management. The Epos™ Ultra (Dornier, Germering, Germany), an electromagnetic delivery system, was approved on January 15, 2002, for similar indications. The SONOCUR® Basic (Siemens, Erlangen, Germany) also uses an electromagnetic delivery system and was approved for tendinitis of the elbow (lateral epicondylitis) on July 19, 2002.

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

Plantar Fasciitis. The scientific evidence does not permit conclusions concerning the effect of the technology on health outcomes of plantar fasciitis. The literature on ESWT for plantar fasciitis is the most robust body of evidence of any of the indications considered in this Assessment. There are 3 randomized double-blind, placebo-controlled trials that together include over 600 patients. Two of these trials (HealthTronics, Dornier) report a statistically significant improvement in pain measures, but the improvement is small and not generally accompanied by improvement in activity or use of pain medication. The third trial (Buchbinder) reported that ESWT was no better than placebo.

Overall, the results of the trials are inconclusive. If ESWT provided a clinically significant
improvement in plantar fasciitis, one would expect consistent improvement across multiple ways of measuring pain and function (e.g., morning pain, use of pain medications, ability to walk without pain). But the results of various measures within studies and across studies do not give a consistent picture.

The HealthTronics trial (n=293) found improvement in pain on first walking in the morning as reported by the patient. There was also improvement in the investigator assessment of pain caused by applying pressure to the heel. But there was no difference between ESWT and placebo in the patients' self-assessment of the distance and time they were able to walk without heel pain. There was also no difference between ESWT and placebo in the proportion of patients who reported talking no pain medication.
The Dornier trial (n=150) reported that ESWT improved the mean pain on first walking compared to placebo; however, there was no difference in proportion of patients achieving at least a 60% improvement in pain. The difference between ESWT and placebo was statistically significant on the Roles and Maudsley Scale, but not on the AOFAS Ankle-Hindfoot Score or SF-12 health status questionnaire.
The Buchbinder trial (n=166) found no difference between ESWT and placebo in any outcome measure: self-reported pain (overall pain, morning pain, pain with activity); self-reported walking time; Maryland Foot Score; Problem Elicitation Technique; SF-36 health status questionnaire.
Because the above conclusion is a reversal of the 2001 TEC Assessment on ESWT for plantar fasciitis, the evidence bases for the 2001 and 2003 Assessments are compared in the following paragraphs.

2001 Evidence Base

The evidence for the 2001 TEC Assessment consisted of the HealthTronics trial and 2 smaller randomized, controlled trials that were single-blinded (n=96). Median duration of plantar fasciitis was 18 months in the HealthTronics trial and 8.4 and 9 months in the smaller trials. The HealthTronics trial used high-energy shock waves given in one session, while the 2 smaller studies used lower-energy shock waves given in multiple sessions.

The main outcome reported in the HealthTronics trial was a composite measure derived from 4 individual pain and activity scales measured at 12 weeks' follow-up. Treatment success was defined as meeting all 4 of these criteria: 1) improvement in investigator assessment of pain caused by applying pressure to the heel; 2) improvement in pain on first walking in the morning as reported by the patient; 3) improvement in the patients' self-assessment of the distance and time they were able to walk without heel pain; and 4) no pain medication for the past 2 weeks.

This composite measure was difficult to interpret because the difference between ESWT and placebo was statistically significant even though 2 of the 4 component measures were not. However, the result of the composite measure was accepted for two reasons. First, HealthTronics explained that the measure had been defined a priori and was intended as a conservative measure. This allayed concerns that the composite measure might have been chosen after the investigators knew that half the outcome measures were not statistically significant. Second, the 2 smaller trials reported results of various pain and activity measures that were highly statistically significant. Although single-blind trials are known to somewhat overestimate outcome compared to double-blind trials, the results of the 2 smaller trials appeared to substantiate that ESWT resulted in clinically significant improvements in patients who have chronic plantar fasciitis.

2003 Evidence Base

Two additional randomized double-blind trials (Dornier, Buchbinder) are now available. Although all 5 trials used a placebo control, there was a remarkable difference in percent improvement reported for the control arm in the 3 double-blind trials compared to the 2 single-blinded trials: 34–46% vs. 0 and 4%. The nonspecific or placebo effect is so large that single-blind trials cannot be considered reliable for assessing this technology. Moreover, it was difficult to compare results among the double-blind trials using the composite measure reported in the HealthTronics trial, so the component measures were analyzed separately.

As in the HealthTronics trial, the Dornier trial (n=150) used high-energy shock waves delivered in a single session. The study population had plantar fasciitis for a median duration of 15 months. In contrast, the Buchbinder trial (n=166) used low-energy shock waves delivered in several sessions in a population with median duration of plantar fasciitis of 8.8 months.

It has been suggested that the Buchbinder trial is flawed because it used low-dose shock wave therapy and that its inclusion in the present Assessment is not consistent. However, the proposition that low-dose therapy is ineffective is a hypothesis. There are no controlled clinical trials that test the relative efficacy of various techniques for shock wave dosage and delivery. A second objection is that the Buchbinder trial was not adequately blinded because anesthetic was not used during the procedure. However, inadequate blinding would favor the ESWT group, as is shown by the single-blind trials. In any event, the researchers evaluated the quality of blinding and showed that it was adequate. A third objection is that the trial did not select a population with chronic plantar fasciitis, as the minimum duration for entry was 6 weeks. However, the patients actually enrolled in a trial had a median duration of 8.8 months. Whether this trial represents a
different population from that in HealthTronics or Dornier is a hypothesis that has not been tested in a controlled trial.

Finally, the 2 single-blinded trials also used low-dose, multi-session therapy and have a population with a similar median duration of plantar fasciitis as in the Buchbinder trial. In the 2001 Assessment, these trials were viewed as substantiating the pain and functional outcomes reported in the largest trial. Thus, the 2001 and 2003 TEC Assessments are consistent in utilizing data on both high-energy and low-energy ESWT.

In summary, the available evidence consists largely of good quality studies; there are 3 doubleblind, randomized controlled trials that included over 600 patients. Overall, the results of the trials are inconclusive. If ESWT provided a clinically significant improvement in plantar fasciitis, one would expect consistent improvement across multiple ways of measuring pain and function (e.g., morning pain, use of pain medications, ability to walk without pain). However, the results of various measures within studies and across studies do not give a consistent picture concerning the effect of ESWT on health outcomes for plantar fasciitis.

Other Indications

Tendinitis of the Shoulder. There is not sufficient evidence to permit conclusions on whether ESWT improves outcomes for patients with tendinitis of the shoulder. The highest quality evidence, 2 randomized, placebo-controlled (n=114 total) trials including one that was doubleblinded found no significant differences between treatment and control groups. Outcomes measured were shoulder pain and disability index, Constant and Murley score for functional assessment of the shoulder, pain at rest and pain with activity.

Two other studies (n=159 total) were nonrandomized and uncontrolled, including one that compared ESWT with surgery. These studies reported significant results favoring ESWT, but represent a poor quality of trial design.

Tendinitis of the Elbow. There are 2 trials that evaluated ESWT for tendinitis of the elbow. Both were randomized, double-blind, placebo-controlled trials. The first (n=114) reported statistically significant improvement in pain on resisted extension and the upper extremity function score. The second (n=75) reported no group differences on elbow pain during the day or at night. This study appeared to have some group differences at baseline, although none was reported as statistically significant. Thus, the existing evidence from randomized, controlled trials does not permit conclusions on the effect of ESWT for tendinitis of the elbow.

3. The technology must improve the net health outcome.

The evidence is not sufficient to permit conclusions on the health outcome effects of ESWT for any of the musculoskeletal indications evaluated; therefore it is not possible to conclude whether overall health outcomes are improved.

4. The technology must be as beneficial as any established alternatives.

The evidence is not sufficient to permit conclusions on the health outcome effects of ESWT for any of the musculoskeletal indications evaluated; therefore, it is not possible to conclude whether the technology is as beneficial as alternatives.

5. The improvement must be attainable outside the investigational settings.

Whether extracorporeal shock wave treatment for musculoskeletal indications improves health outcomes has not been demonstrated in the investigational setting.

Therefore, based on the above, extracorporeal shock wave treatment for musculoskeletal
indications does not meet the TEC criteria.

1. As this Assessment went to press, an additional randomized, double-blind trial was published; however, this publication does not affect the Assessment conclusions.

Full Study

Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Indications

Full studies are in PDF format. You

Re: Cure/no cure????

Dr. Z on 9/12/03 at 13:54 (129720)

I like using the R/M scoring because it is the patients opinion as to how much pain was reduced and how it improved the PATIENTS life style. The bottom line in a medical treatment is quality of life and this scoring measures quality of life as reviewed by the patient and not the doctor.