- Meeting abstract
- Open Access
EHMTI-0266. Validation of a sham manipulative procedure: a new protocol for conducting placebo-control clinical trials in manual therapy
The Journal of Headache and Pain volume 15, Article number: E7 (2014)
Few manual therapy studies have attempted to conduct placebo-control clinical trials. Thus, quantification of alleged placebo effects consequently becomes difficult.
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.
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.
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.
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.
About this article
Cite this article
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
- Placebo Group
- Treatment Session
- Placebo Effect