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EHMTI-0266. Validation of a sham manipulative procedure: a new protocol for conducting placebo-control clinical trials in manual therapy

Background

Few manual therapy studies have attempted to conduct placebo-control clinical trials. Thus, quantification of alleged placebo effects consequently becomes difficult.

Aim

To investigate and validate a new placebo intervention for spinal manipulative therapy clinical trials, i.e. sham manipulation, and investigate the feasibility of a short de-blinding questionnaire.

Method

A single blinded, prospective randomized, placebo-controlled trial with 1 month baseline and 3 months treatment with 12 treatments. 104 participants diagnosed with migraine were equally randomized into 1 of 3 groups: (i) chiropractic spinal manipulative therapy (CSMT), (ii) placebo (sham manipulation), (iii) control group (continued usual management). The participants filled in questionnaire on de-blinding after each treatment session. Primary end-point was the rate of successful blinding through de-blinding questionnaires given after each treatment session.

Results

772 out of 840 individual cases were analyzed, only 8.1 % out of all cases missed their appointment. The unadjusted result shows that both the active and placebo group believed they received active treatment with odds ratio (OR) of ≥88.9 and ≥80.0 respectively. Due to strong cluster effect in our data, logistic regression model was used to adjust for repeated measures which showed a significant OR of >10 in both the active and the placebo group.

Conclusion

This is the first study to successfully demonstrate a manipulative sham procedure over a full length treatment period, assessing the placebo group with de-blinding questionnaire after each session which thus, could be incorporated in future clinical trials.

No conflict of interest.

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Correspondence to A Chaibi.

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Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0), which permits use, duplication, adaptation, distribution, and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

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Chaibi, A., Benth, J.S., Tuchin, P. et al. EHMTI-0266. Validation of a sham manipulative procedure: a new protocol for conducting placebo-control clinical trials in manual therapy. J Headache Pain 15, E7 (2014). https://doi.org/10.1186/1129-2377-15-S1-E7

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Keywords

  • Placebo
  • Migraine
  • Placebo Group
  • Treatment Session
  • Placebo Effect