Placebos for Knee Osteoarthritis: Reaffirmation of “Needle Is Better Than Pill”

Discussion in 'Pain Medicine' started by 101N, Aug 3, 2015.

  1. 101N

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  2. drusso

    Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    Nothing new. Moo-shu pork practitioners, charlatans, and quacks have known this forever. Now, it's the law of the land...

    http://jaoa.org/article.aspx?articleid=2093333

    J Am Osteopath Assoc. 2006 Aug;106(8):457-63.
    Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment.
    Licciardone JC1, Russo DP.
    Author information

    Abstract
    CONTEXT:
    In testing an experimental new drug or therapy, the gold standard in biomedical research for determining treatment efficacy is the randomized controlled trial (RCT). In pharmaceutical trials, inert placebos are an easily administered control that facilitates blinded comparisons. In clinical trials that study the effects of manual interventions, researchers must carefully consider their use of treatment control models. Choosing credible controls that will minimize bias in osteopathic manipulative treatment (OMT) clinical trials poses unique challenges to researchers because of heterogeneous OMT methods and practice.

    OBJECTIVE:
    To compare the treatment credibility of sham manipulative treatment and untreated controls to active OMT.

    METHODS:
    Subjects recruited for an OMT clinical trial for chronic low back pain completed a treatment-credibility rating scale comparing two written descriptions of the study interventions offered. The scale was administered to subjects before trial entry and at 6-month follow-up. Scale scores were used to compute credibility ratios for both intervention protocols (ie, OMT vs sham manipulative treatment). Repeated measures analysis of variance was used to assess changes in the credibility ratio over time, including the measurement of study group and time main effects, as well as study group x time interaction effects.

    RESULTS:
    Subjects (N=91) perceived OMT as a more credible therapeutic option than sham manipulative treatment both at trial entry and at 6-month follow-up (P<.05). Among subjects completing the study protocol (n=66), there were no changes in perceived credibility of the study interventions over time. There were no significant differences in the credibility ratio among study groups (P=.64) or over time (P=.79). In addition, there were no significant study group x time interactions (P=.59).

    CONCLUSIONS:
    In clinical trials, OMT may be perceived by subjects as a more credible treatment alternative than many control procedures. Treatment credibility can interact with subject expectations and study design in complex ways. When analyzing the treatment effects of OMT, investigators must consider the effects of these two subjective elements when competing interventions are offered and subjects are asked to self-report data. Study design should be optimized to equalize these effects among interventions.
     
  3. Ducttape

    Ducttape SDN Lifetime Donor
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    you know, while i do disagree with some of your opinions, i do respect them....

    with the exception of your use of moo-shu. Moo-shu is a tasty and venerable dish with a long history. yes, the americanized version is full of junk fillers like cabbage.

    but i for one like (occasionally) my moo shu!!
     
  4. lobelsteve

    lobelsteve SDN Lifetime Donor
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    Mu-shu is only good because of the hoison.
     
  5. drusso

    Physician Moderator Emeritus Lifetime Donor Classifieds Approved 10+ Year Member

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    There cannot be two standards of "evidence."

    Something is either science-based or magical. Sometimes it might be wise to pay for things that don't work (regardless if it's science-based or magic), but we shouldn't pretend that it is an evidence-based intervention when it is not. We shouldn't promote it as such and we shouldn't delude ourselves into thinking that science and magic are the same. Increasingly, I'm seeing science-based interventions in our specialty passed over for magical interventions because there is no data to favor one over the other. Policymakers are too stupid to know the difference because they lack content expertise in the matter. Sometimes they've been purposely mislead by promoters of magic or naysayers of science. Most policymakers enjoy a degree of magical thinking themselves and think it would be "good" for patients.

    Any science-based pain physician who advocates for magic over science because it's less harmful, less expensive, or simply the least of two evils is undermining the foundation of the doctor-patient relationship (first do no harm) and debasing the ethical practice of medicine (patients deserve to know the LIMITS of what evidence exists for any intervention). Our field should promote science-based alternatives not metaphysical moo-shu pain pork...
     
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  6. ampaphb

    ampaphb Interventional Spine
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    BFD. We know that placebos provide significant relief ~35% of the time. Appropriate interventions, when performed on well selected patients, should achieve statistically significance, and greater than minimally important clinical difference, without overlapping confidence intervals. Duh.
     
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  7. 101N

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    "Any science-based pain physician who advocates for magic over science because it's less harmful, less expensive, or simply the least of two evils is undermining the foundation of the doctor-patient relationship (first do no harm) and debasing the ethical practice of medicine (patients deserve to know the LIMITS of what evidence exists for any intervention). Our field should promote science-based alternatives not metaphysical moo-shu pain pork..."

    Translation: "I don't want to lose control of this large referral base - chronic, non-radiating, low back pain, working-aged adults - so I'm going to pretend that I have something to offer them that's better
    than: PT, CBT/ACT, chiro, massage, acuputure."
     
  8. Ducttape

    Ducttape SDN Lifetime Donor
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    just one quick question...

    what EBM is available that we can use, to show that IPM has long term benefit?

    there is some EBM that shows that PT, exercise, CBT, SCS, RFA has moderate-strong evidence for long term benefit. is there evidence, better than "weak", for FJI, SIJ, ESI, TF, etc.? evidence for PRP, stem cell?
     
  9. 101N

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    For CLBP in working-aged adults (WAA): PT, exercise, CBT yes.
    Most would argue SCS is reserved for tx of leg pain. When it is, it appears to lose effectiveness @ 2yrs. What references are you using for RFA?

    N Engl J Med. 2000 Aug 31;343(9):618-24.
    Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy.
    Kemler MA1, Barendse GA, van Kleef M, de Vet HC, Rijks CP, Furnée CA, van den Wildenberg FA.
    Author information

    Abstract
    BACKGROUND:
    Chronic reflex sympathetic dystrophy (also called the complex regional pain syndrome) is a painful, disabling disorder for which there is no proven treatment. In observational studies, spinal cord stimulation has reduced the pain associated with the disorder.

    METHODS:
    We performed a randomized trial involving patients who had had reflex sympathetic dystrophy for at least six months. Thirty-six patients were assigned to receive treatment with spinal cord stimulation plus physical therapy, and 18 were assigned to receive physical therapy alone. The spinal cord stimulator was implanted only if a test stimulation was successful. We assessed the intensity of pain (on a visual-analogue scale from 0 cm [no pain] to 10 cm [very severe pain]), the global perceived effect (on a scale from 1 [worst ever] to 7 [best ever]), functional status, and the health-related quality of life.

    RESULTS:
    The test stimulation of the spinal cord was successful in 24 patients; the other 12 patients did not receive implanted stimulators. In an intention-to-treat analysis, the group assigned to receive spinal cord stimulation plus physical therapy had a mean reduction of 2.4 cm in the intensity of pain at six months, as compared with an increase of 0.2 cm in the group assigned to receive physical therapy alone (P<0.001 for the comparison between the two groups). In addition, the proportion of patients with a score of 6 ("much improved") for the global perceived effect was much higher in the spinal cord stimulation group than in the control group (39 percent vs. 6 percent, P=0.01). There was no clinically important improvement in functional status. The health-related quality of life improved only in the 24 patients who actually underwent implantation of a spinal cord stimulator. Six of the 24 patients had complications that required additional procedures, including removal of the device in 1 patient.

    CONCLUSIONS:
    In carefully selected patients with chronic reflex sympathetic dystrophy, electrical stimulation of the spinal cord can reduce pain and improve the health-related quality of life.

    N Engl J Med. 2006 Jun 1;354(22):2394-6.
    Spinal cord stimulation for chronic reflex sympathetic dystrophy--five-year follow-up.
    Kemler MA, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M.

    J Neurosurg. 2008 Feb;108(2):292-8. doi: 10.3171/JNS/2008/108/2/0292.
    Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial.
    Kemler MA1, de Vet HC, Barendse GA, van den Wildenberg FA, van Kleef M.
    Author information

    Abstract
    OBJECT:
    Chronic complex regional pain syndrome-Type I (CRPS-I) is a painful, disabling disorder for which no treatment with proven effect is available. In the present randomized controlled trial, the authors assessed the effectiveness of spinal cord stimulation (SCS) in reducing pain due to CRPS-I at the 5-year follow-up.

    METHODS:
    The authors performed a randomized trial in a 2:1 ratio in which 36 patients with CRPS-I were allocated to receive SCS and physical therapy (PT) and 18 patients to receive PT alone. Twenty-four patients who received SCS+PT also underwent placement of a permanent spinal cord stimulator after successful test stimulation; the remaining 12 patients did not receive a permanent stimulator. The authors assessed pain intensity, global perceived effect, treatment satisfaction, and health-related quality of life. Patients were examined before randomization, before implantation, and every year until 5 years thereafter. Ten patients were excluded from the final analysis.

    RESULTS:
    At 5 years posttreatment, SCS+PT produced results similar to those following PT for pain relief and all other measured variables. In a subgroup analysis, the results with regard to global perceived effect (p=0.02) and pain relief (p=0.06) in 20 patients with an implant exceeded those in 13 patients who received PT.

    CONCLUSIONS:
    Despite the diminishing effectiveness of SCS over time, 95% of patients with an implant would repeat the treatment for the same result.
     
  10. emd123

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    People that get better with these, don't even need us to begin with. You know damn well these treatments only work on those who are going to get better on their own anyways.
     

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