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Placebo for heel pain

Discussion in 'General Issues and Discussion Forum' started by PodAc doc, Jan 28, 2019.

  1. PodAc doc

    PodAc doc Active Member


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    For your interest ...

    Ludger Gerdesmeyer, et al. Pain Physician 2017; 20:387-396
    Randomized Placebo-Controlled Placebo Trial to Determine the Placebo Effect Size

    Abstract:
    Background: It is the gold standard to use a placebo treatment as the control group in
    prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal
    an effect of an active treatment, the pure effect of a placebo treatment alone has never been
    presented or evaluated. No evidence-based, placebo-therapeutic options are currently available,
    and no placebo-controlled trials have been performed to elucidate the pure placebo effect.
    Objectives: To analyze the pure placebo effect on clinical, chronic pain through a blinded RCT.
    Study Design: A prospective, randomized, placebo-controlled trial.
    Setting: Medical University centers.
    Methods: One-hundred eighty-two patients suffering from chronic plantar heel pain for over
    6 months,who failed to respond to conservative treatments, were screened and 106 of these
    patients were enrolled into this study. The patients were randomly assigned to receive either a
    blinded placebo shockwave treatment or an unblinded placebo shockwave treatment. The primary
    outcome measure was the differences in percentage change of visual analogue scale (VAS) scores
    6 weeks after the intervention. The secondary outcome measure was the differences in Roles and
    Maudsley pain score (RMS) 6 weeks after intervention. As an exploratory outcome, 2-sided group
    comparisons for baseline characteristics between active treatment and controls were done using
    the Mann-Whitney-U tests for group comparisons; treatment efficiency was calculated by the
    effect size coefficient and benchmarks for the Mann-Whitney estimator according to the t-test
    of 2 independent samples for quantitative data, as well as the Fisher’s exact test for binary data.
    Results: Patients from both groups did not differ with respect to heel pain ratings at baseline,
    for both the VAS (P = .476) and RMS (P = .810) scores. After 6 weeks, patients receiving the
    blinded placebo treatment reported less heel pain on both scales (VAS: P = .031; RMS: P = .004).
    Change scores of pain ratings were significantly higher in the blinded placebo group than in the
    un-blinded placebo group (VAS: P = .002; RMS: P = .002).
    Limitations: As the study represents the first to use an inverse placebo RCT (IPRCT), further
    conceptual and methodological issues need to be addressed to describe detailed, underlying
    mechanisms. Specific contextual, intrapersonal, and interpersonal factors modulating the placebo
    effects should be addressed in future IPRCTs.
    Conclusion: The present study indicated that true placebo effect sizes can be analyzed through
    a proper IPRCT design. Instead of treating high numbers of patients with placebos in a RCT, which
    increases the risk for subjects not receiving the active treatment, the IPRCT technique seems to
    be much more appropriate to analyze the effect sizes of any active treatment,
     

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