Evidence Based Rehab

The most savage controversies are those about matters as to which there is no good evidence either way.
- Bertrand Russell

Labels: EBM, Evidence, physical therapy

Ifirst want to apologize for the time between posts. I've been pretty busy at work, and have found it hard to find time to write. However, I get an "Evidence Express" email everyday from the folks over at Evidence in Motion, and today's included a link to an article from the Poughkeepsie Journal out of New York. The article was on craniosacral therapy and how proper rhythm is needed to ensure a healthy living.

Craniosacral Therapy (CST) is not new, but what is disturbing, is we know it's a bunch of hogwash, and journalist are still writing about it. For the fortunate not exposed to this lunacy, here are some of CST practitioners claims (BTW, you'll find PT's, DC's, Osteopaths and Massage therapist all using this):

1. The "founder" and his Upledger Institute states:

   "Using a soft touch generally no greater than 5 grams, or about the weight of a nickel, practitioners release restrictions in the craniosacral system to improve the functioning of the central nervous system."

2. That one can feel the craniosacral rhythms of the cerbrospinal fluid.
3. And that is is effective in treating:
• Migraine Headaches
• Chronic Neck and Back Pain
• Motor-Coordination Impairments
• Colic
• Autism
• Central Nervous System Disorders
• Orthopedic Problems
• Traumatic Brain and Spinal Cord Injuries
• Scoliosis
• Infantile Disorders
• Learning Disabilities
• Chronic Fatigue
• Emotional Difficulties
• Stress and Tension-Related Problems
• Fibromyalgia and other Connective-Tissue Disorders
• Temporomandibular Joint Syndrome (TMJ)
• Neurovascular or Immune Disorders
• Post-Traumatic Stress Disorder
• Post-Surgical Dysfunction

(Emphasis Added)
Wow! Those are some pretty broad claims. In fact, the CST claims have met all 7 of 7 of my "How to Spot Woo" post I made previously. Here are some truths:

1. Some people get better with CST. There is no doubt in this. But some people get better with magnets, with "energy manipulation", with homeopathic water, with...you get the point. The truth, though, is there is no research that shows people can get better BECAUSE of CST.
   
2. 5 grams IS NOT enough force to get movement of a cranial bone. A study by Downey and associates easily showed this.
3. Study after study shows CST providers cannot show reliability of "feeling" the craniosacral rhythm either between different providers or even within the person using repeated measures. To clarify, it's like your doctor diagnosing your heart problem by listening to your heart with a stethoscope, but at worse than chance, 2 doctors can't agree with what they hear, and worse, the same doctor hears something different when he listens a second time. Read studies done by Rogers here, and Wirth-Pattullo here.
   
4. According to a large systematic review of CST related literature, the British Columbia Office of Health Technology Assessment concluded that -
   

The benefit of craniosacral therapy has not been demonstrated using well-designed research. The available studies are of low grade evidence as rated by the Canadian Task Force on Preventive Health Care (20) ranking system, and are of poor quality when judged using standard critical appraisal criteria. Inadequacies in the studies cited above preclude any statement attesting to craniosacral therapy effectiveness.

What does John Upledger counter with? The pathetic argument that many of these snake oil salesman use:

[P]ositive patient outcomes as a result of CranioSacral Therapy should
weigh greater than data from designed research protocols involving
human subjects, as it is not possible to control all of the variables of such
studies.

Classic.

Labels: alternative medicine, cranial sacral therapy, CST, EBM, Evidence, woo

Ihave been meaning to blog on the results of a Lancet article finding neither spinal manipulation or NSAIDs are effective on low back pain. However, Eric from NPAThinktank beat me to it with a post on Evidence in Motion's blog. It is very well done and thought out.

The key point we must all understand, is that the population tested was a heterogeneous group of low back pain sufferers. Despite the mounting evidence, no sub-grouping of patient's was done. Predictably, then, to significant results were found. I don't care how many low back pain studies are done, if no treatment based classification is used, you will not find significant results.

Eric quotes Dr. K. Shepard using a great analogy for this. I post it here for your convenience:

A study that randomly assigns patients with low back pain to various conservative treatment protocols will produce the same results as a study that randomly assigns patients with abdominal pain to undergo appendectomy, cholecystectomy, or exploratory laparotomy. Neither study makes any sense.

Our hope in the rehab world is that the referral sources also have the great evidence of treatment based classification and the dramatic effects of lumbar manipulation on the right sub group of low back pain patients. Please read Eric's great post.

Labels: clinical prediction rules, EBM, Evidence, Low back pain, manipulation, physical therapy

I just finished reading a guest editorial by Robert Wainner, PT, PhD and Julie Whitman, PT, DSc regarding first line interventions for hip pain in the most recent Journal of Orthopaedic & Sports Physical Therapy. Their discussion points to the trend that hip pain, especially OA, is treated in the order of 1. Drugs, 2. Surgery/invasive procedure, 3. Physical Therapy.

Why is PT last? Especially when there are known PT interventions for hip pain that work well. The authors point our that research on exercise for hip pain is not as broad as the knee; but some recent hight quality studies (which include those published by the authors) lend us the ability to form a practice guideline as to treat hip pain. This includes manual physical therapy (mobilization/manipulation) and exercise as the primary exercises.

The general public reading this should also demand (yes, demand, lol) from their primary care doctors that PT is the first line intervention for their hip pain. On our end, we (as PT's) must stay abreast the on current best evidence for treating hip pain - again, mobs and exercise as primary treatment - and APPLY this treatment. We must change and adapt as clinicians.

If you have questions about your hip pain, please as your doctor to refer you to a PT, use the APTA's "Find a PT" tool, or I can try to answer any comments you leave.

Labels: APTA, EBM, Evidence, exercise, Hip, Mobilization, OA, Osteoarthritis, physical therapy

Ihate "health" products being pushed on us simply with anecdotal evidence and testimonials. One of the newest fads is 'Whole Body Vibration'. The claim is that exercising on this vibrating plate significantly increases your strength versus doing the exercises alone. There is very poor, and limited, evidence for this. For a good overview, please read Sal Merinello's excellent synopsis of the evidence over at The Healthy Skeptic. Below is a brand new journal article on this fad in regards to impact on older men over a 1 year period.

: J Gerontol A Biol Sci Med Sci. 2007 Jun;62(6):630-5. Links

Impact of whole-body vibration training versus fitness training on muscle strength and muscle mass in older men: a 1-year randomized controlled trial.

Bogaerts A, Delecluse C, Claessens AL, Coudyzer W, Boonen S, Verschueren SM.

Division of Musculoskeletal Rehabilitation, Katholieke Universiteit Leuven, Tervuursevest 101, Leuven, Belgium.

BACKGROUND: This randomized controlled study investigated the effects of 1-year whole-body vibration (WBV) training on isometric and explosive muscle strength and muscle mass in community-dwelling men older than 60 years. METHODS: Muscle characteristics of the WBV group (n = 31, 67.3 +/- 0.7 years) were compared with those of a fitness (FIT) group (n = 30, 67.4 +/- 0.8 years) and a control (CON) group (n = 36, 68.6 +/- 0.9 years). Isometric strength of the knee extensors was measured using an isokinetic dynamometer, explosive muscle strength was assessed using a counter movement jump, and muscle mass of the upper leg was determined by computed tomography. RESULTS: Isometric muscle strength, explosive muscle strength, and muscle mass increased significantly in the WBV group (9.8%, 10.9%, and 3.4%, respectively) and in the FIT group (13.1%, 9.8%, and 3.8%, respectively) with the training effects not significantly different between the groups. No significant changes in any parameter were found in the CON group. CONCLUSION: WBV training is as efficient as a fitness program to increase isometric and explosive knee extension strength and muscle mass of the upper leg in community-dwelling older men. These findings suggest that WBV training has potential to prevent or reverse the age-related loss in skeletal muscle mass, referred to as sarcopenia

The results show NO DIFFERENCE between groups; but, the authors make the conclusion that

"WBV training has potential to prevent or reverse the age-related loss in skeletal muscle mass..."

Huh? I guess that is true if general exercise does (which is true). But it doesn't do it any better and at a greater cost and inconvenience. Look for the manufacturers to post this on their websites as "evidence" that WBV training prevents muscle mass loss!

I say: Buyer beware!

Labels: alternative medicine, EBM, Evidence, exercise, fitness, outcomes

Stumbled across this article from Yahoo News on a chiropractor boasting the use of "Cold Laser Therapy" or as it is often referred to as - "Low Level Laser Therapy". The article itself was what you'd expect. Mostly self promotion of the DC's practice. That's ok. Good for him in getting the article done. I had a few questions regarding some claims and comments made. Here are some examples:

For carpal tunnel syndrome especially, the treatment helps to alleviate pain associated with repetitive motion in hands and wrists.

and..

Cold laser therapy speeds up the healing process after injury to the wrists and hands.

Hmm, I thought. Is this his opinion, or is there good research to back this up. I've researched LLLT in the past and found that most studies were negative in it's use. But this was for musculoskeletal pain and balance improvement only. I don't know about carpal tunnel specifically. So I looked and here is what I found:

Archives of Physical Medicine and Rehabilitation: July 2002 83(7)

OBJECTIVE: To investigate whether real or sham low-level laser therapy (LLLT) plus microamperes transcutaneous electric nerve stimulation (TENS) applied to acupuncture points significantly reduces pain in carpal tunnel syndrome (CTS). DESIGN: Randomized, double-blind, placebo-control, crossover trial. Patients and staff administered outcome measures blinded. SETTING: Outpatient, university-affiliated Department of Veterans Affairs medical center. PARTICIPANTS: Eleven mild to moderate CTS cases (nerve conduction study, clinical examination) who failed standard medical or surgical treatment for 3 to 30 months. INTERVENTION: Patients received real and sham treatment series (each for 3-4wk), in a randomized order. Real treatments used red-beam laser (continuous wave, 15mW, 632.8nm) on shallow acupuncture points on the affected hand, infrared laser (pulsed, 9.4W, 904nm) on deeper points on upper extremity and cervical paraspinal areas, and microamps TENS on the affected wrist. Devices were painless, noninvasive, and produced no sensation whether they were real or sham. The hand was treated behind a hanging black curtain without the patient knowing if devices were on (real) or off (sham). MAIN OUTCOME MEASURES: McGill Pain Questionnaire (MPQ) score, sensory and motor latencies, and Phalen and Tinel signs. RESULTS: Significant decreases in MPQ score, median nerve sensory latency, and Phalen and Tinel signs after the real treatment series but not after the sham treatment series. Patients could perform their previous work (computer typist, handyman) and were stable for 1 to 3 years. CONCLUSIONS: This new, conservative treatment was effective in treating CTS pain; larger studies are recommended. Copyright 2002 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation

Photomedicine and Laser Surgery: April 2006 Volume 24(2)

In this review, seven studies using photoradiation to treat carpal tunnel syndrome (CTS) are discussed: two controlled studies that observed real laser to have a better effect than sham laser, to treat CTS; three openprotocol studies that observed real laser to have a beneficial effect to treat CTS; and two studies that did not observe real laser to have a better effect than a control condition, to treat CTS. In the five studies that observed beneficial effect from real laser, higher laser dosages (9 Joules, 12-30 Joules, 32 J/cm(2), 225 J/cm(2)) were used at the primary treatment sites (median nerve at the wrist, or cervical neck area), than dosages in the two studies where real laser was not observed to have a better effect than a control condition (1.8 Joules or 6 J/cm(2)). The average success rate across the first five studies was 84% (SD, 8.9; total hands = 171). The average pain duration prior to successful photoradiation was 2 years. Photoradiation is a promising new, conservative treatment for mild/moderate CTS cases (motor latency <>

Photomedicine and Laser Surgery: February 2007 Volume 25(1)

OBJECTIVE: This prospective, randomized, placebo-controlled trial aimed to investigate the efficacy of laser therapy in the treatment of carpal tunnel syndrome (CTS). BACKGROUND DATA: Low-level laser therapy (LLLT) has been found to have positive effects in the treatment of CTS and various musculoskeletal conditions. METHODS:A total of 81 patients were included in this study. Diagnosis of CTS was based on both clinical examination and electromyographic (EMG) study. Patients were randomly assigned into two groups. Group 1 (n = 41) underwent laser therapy (7 joules/2 min) over the carpal tunnel area. Group 2 (n = 40) received placebo laser therapy. All patients received therapy five times per week, for a total of 10 sessions. Patients also used a wrist splint each night. Patients were assessed according to pain, hand-pinch grip strength, and functional capacity. Pain was evaluated by Visual Analog Scale (VAS; day-night). Hand grip was measured by Jamar dynometer, and pinch grip was measured by pinchmeter. Functional capacity was assessed by a self-administered questionnaire for severity of symptoms. RESULTS: The mean age of the patients (70 women, 11 Men) was 49.3 +/- 11.0 (range, 26-78). After therapy there were statistically significant improvements in VAS, pinch grip, and functional capacity measurement in both groups CONCLUSION: In using LLLT, (1) there was no difference relative to pain relief and functional capacity during the follow-up in CTS patients; (2) there were positive effects on hand and pinch grip strengths.

Australian Journal of Physiotherapy: 2004;50(3)

This study was designed to compare the efficacy of ultrasound and laser treatment for mild to moderate idiopathic carpal tunnel syndrome. Ninety hands in 50 consecutive patients with carpal tunnel syndrome confirmed by electromyography were allocated randomly in two experimental groups. One group received ultrasound therapy and the other group received low level laser therapy. Ultrasound treatment (1 MHz, 1.0 W/cm(2), pulse 1:4, 15 min/session) and low level laser therapy (9 joules, 830 nm infrared laser at five points) were applied to the carpal tunnel for 15 daily treatment sessions (5 sessions/week). Measurements were performed before and after treatment and at follow up four weeks later, and included pain assessment by visual analogue scale; electroneurographic measurement (motor and sensory latency, motor and sensory action potential amplitude); and pinch and grip strength. Improvement was significantly more pronounced in the ultrasound group than in low level laser therapy group for motor latency (mean difference 0.8 m/s, 95% CI 0.6 to 1.0), motor action potential amplitude (2.0 mV, 95% CI 0.9 to 3.1), finger pinch strength (6.7 N, 95% CI 5.0 to 8.2), and pain relief (3.1 points on a 10-point scale, 95% CI 2.5 to 3.7). Effects were sustained in the follow-up period. Ultrasound treatment was more effective than laser therapy for treatment of carpal tunnel syndrome. Further study is needed to investigate the combination therapy effects of these treatments in carpal tunnel syndrome patients.

Muscle and Nerve: August 2004 Volume 30(2)

Several studies have suggested that low-level laser therapy (LLLT) is effective in patients with carpal tunnel syndrome (CTS). In a double-blind randomized controlled trial of LLLT, 15 CTS patients, 34 to 67 years of age, were randomly assigned to either the control group (n = 8) or treatment group (n =7). Both groups were treated three times per week for 5 weeks. Those in the treatment group received 860 nm galium/aluminum/arsenide laser at a dosage of 6 J/cm2 over the carpal tunnel, whereas those in the control group were treated with sham laser. The primary outcome measure was the Levine Carpal Tunnel Syndrome Questionnaire, and the secondary outcome measures were electrophysiological data and the Purdue pegboard test. All patients completed the study without adverse effects. There was a significant symptomatic improvement in both the control (P = 0.034) and treatment (P =0.043) groups. However, there was no significant difference in any of the outcome measures between the two groups. Thus, LLLT is no more effective in the reduction of symptoms of CTS than is sham treatment.

Cochrane Database of Systematic Reviews: 2003(1)

BACKGROUND: Non-surgical treatment for carpal tunnel syndrome is frequently offered to those with mild to moderate symptoms. The effectiveness and duration of benefit from non-surgical treatment for carpal tunnel syndrome remain unknown. OBJECTIVES: To evaluate the effectiveness of non-surgical treatment (other than steroid injection) for carpal tunnel syndrome versus a placebo or other non-surgical, control interventions in improving clinical outcome. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group specialised register (searched March 2002), MEDLINE (searched January 1966 to February 7 2001), EMBASE (searched January 1980 to March 2002), CINAHL (searched January 1983 to December 2001), AMED (searched 1984 to January 2002), Current Contents (January 1993 to March 2002), PEDro and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised studies in any language of participants with the diagnosis of carpal tunnel syndrome who had not previously undergone surgical release. We considered all non-surgical treatments apart from local steroid injection. The primary outcome measure was improvement in clinical symptoms after at least three months following the end of treatment. DATA COLLECTION AND ANALYSIS: Three reviewers independently selected the trials to be included. Two reviewers independently extracted data. Studies were rated for their overall quality. Relative risks and weighted mean differences with 95% confidence intervals were calculated for the primary and secondary outcomes in each trial. Results of clinically and statistically homogeneous trials were pooled to provide estimates of the efficacy of non-surgical treatments. MAIN RESULTS: Twenty-one trials involving 884 people were included. A hand brace significantly improved symptoms after four weeks (weighted mean difference (WMD) -1.07; 95% confidence interval (CI) -1.29 to -0.85) and function (WMD -0.55; 95% CI -0.82 to -0.28). In an analysis of pooled data from two trials (63 participants) ultrasound treatment for two weeks was not significantly beneficial. However one trial showed significant symptom improvement after seven weeks of ultrasound (WMD -0.99; 95% CI -1.77 to - 0.21) which was maintained at six months (WMD -1.86; 95% CI -2.67 to -1.05). Four trials involving 193 people examined various oral medications (steroids, diuretics, nonsteroidal anti-inflammatory drugs) versus placebo. Compared to placebo, pooled data for two-week oral steroid treatment demonstrated a significant improvement in symptoms (WMD -7.23; 95% CI -10.31 to -4.14). One trial also showed improvement after four weeks (WMD -10.8; 95% CI -15.26 to -6.34). Compared to placebo, diuretics or nonsteroidal anti-inflammatory drugs did not demonstrate significant benefit. In two trials involving 50 people, vitamin B6 did not significantly improve overall symptoms. In one trial involving 51 people yoga significantly reduced pain after eight weeks (WMD -1.40; 95% CI -2.73 to -0.07) compared with wrist splinting. In one trial involving 21 people carpal bone mobilisation significantly improved symptoms after three weeks (WMD -1.43; 95% CI -2.19 to -0.67) compared to no treatment. In one trial involving 50 people with diabetes, steroid and insulin injections significantly improved symptoms over eight weeks compared with steroid and placebo injections. Two trials involving 105 people compared ergonomic keyboards versus control and demonstrated equivocal results for pain and function. Trials of magnet therapy, laser acupuncture, exercise or chiropractic care did not demonstrate symptom benefit when compared to placebo or control. REVIEWER'S CONCLUSIONS: Current evidence shows significant short-term benefit from oral steroids, splinting, ultrasound, yoga and carpal bone mobilisation. Other non-surgical treatments do not produce significant benefit. More trials are needed to compare treatments and ascertain the duration of benefit.

Journal of Neurology: March 2002 Volume 249(3)

Carpal tunnel syndrome (CTS) is a common disorder, for which various conservative treatment options are available. The objective of this study is to determine the efficacy of the various conservative treatment options for relieving the symptoms of CTS. Computer-aided searches of MEDLINE (1/1966 to 3/2000), EMBASE (1/1988 to 2/2000) and the Cochrane Controlled Trials Register (2000, issue 1) were conducted, together with reference checking. Included were randomised controlled trials evaluating the efficacy of conservative treatment options in a study population of CTS patients, with a full report published in English, German, French or Dutch. Two reviewers independently selected the studies. Fourteen randomised controlled trials were included in the review. Assessment of methodological quality and data-extraction was independently performed by two reviewers. A rating system, based on the number of studies and their methodological quality and findings, was used to determine the strength of the available evidence for the efficacy of the treatment. Diuretics, pyridoxine, non-steroidal anti-inflammatory drugs, yoga and laser-acupuncture seem to be ineffective in providing short-term symptom relief (varying levels of evidence) and steroid injections seem to be effective (limited evidence). There is conflicting evidence for the efficacy of ultrasound and oral steroids. For providing long-term relief from symptoms there is limited evidence that ultrasound is effective, and that splinting is less effective than surgery. In conclusion, there is still little known about the efficacy of most conservative treatment options for CTS. To establish stronger evidence more high quality trials are needed.

I was able to find these 6 peer reviewed articles on CTS and treatment with LLLT. Out of the 6, only 2 had positive results toward using LLLT. One (Arch Phys Med) included Microcurrent with the LLLT treatment. Therefore unable to tell if it was LLLT, Micro, or the interaction of the two that was beneficial. The second was a review that does not have the articles reviewed listed, making it very difficult for an individual to read the studies they feel support the use of LLLT for CTS.

My conclusion from the best literature available is that there is no evidence that LLLT is effective in treating CTS at this time. I think the DC's own statement in the Yahoo article sums up where it is being used for CTS despite evidence it doesn't help:

Cold laser therapy was accepted by the Food and Drug Administration (FDA) in 2002 and is used by athletic trainers, chiropractors and practitioners of alternative medicine.

Surprise, surprise. Although, it is easy to find many PT's making similar claims. We all love the next gadgets that can cure people without the patient or clinician having to put any effort into it.

Anyone have more compelling literature that I may have missed or not know about? Let me know. Use good peer reviewed studies to show me that my conclusion is wrong or that I am spot on.

Labels: Chiropractic, EBM, Evidence, Low Level laser therapy

Reading one of my favorite medical blogs - Respectful Insolence - Orac posted on a Homeopath in Arizona that had a patient die after performing liposuction on her. To make this even more interesting, the assisting physician had already had 2 patients die after lipo and his lisence had been put on probation.

This got me thinking, do people really know what homeopathy is? Or do they just blindly believe what these pseudo doctors are telling them?

Here is a great video of James Randi explaining Homeopathy and the "4 rules of homeopathy":



My favorite line when referring to a homeopathic medicine:

Has no side effects. That's true. My question is 'does it have any other effects'?

Absurdity, this is. I believe people should be able to choose how to treat their ailments. However, homeopathy is duping the desperate, fearful, and needy. Educate those who ask about the quackery that homeopathy medical treatment is.

Labels: EBM, education, Evidence, Fraud

Evidence Based Medicine is dependent on us keeping up to date with current evidence. But how many of us actually have time to search our, read, and incorporate this evidence?

That is why it is very important to find ways to get preprocessed literature, that is relevant to your practice, sent to you. There are resources for this, and I'll take the time to list the one's I know. Please leave comments with other sources you use.

• Evidence in Motion - Great site for discussion, current literature, and Con. Ed.
• Rehab Edge - A discussion forum with views and treatment ideas from all over the world.
• Cochrane - Literature reviews of specific pathologies
• InfoPoems - POEMS are Patient Oriented Evidence that Matters.
• Hooked On Evidence - Our own association has this great tool for us summarizing benefits of select treatments.
  

Labels: EBM, Evidence, physical therapy