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The study will be the first three-armed manual therapy randomised clinical trial (RCT) assessing the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continue usual pharmacological management without receiving manual intervention) for migraineurs.
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).
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.
To develop a sham manipulation procedure for the cervical spine for use in randomized clinical trials of cervical disorders.
After a baseline observation period, Group 2 received manipulation (toggle recoil) to the cervical spine, whereas Group 1 received sham manipulation.
This was followed by the final trial phase, in which Group 2 received sham manipulation and Group 1 received no treatment.
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No clinical trial of spinal manipulation for chronic neck pain (NP), for either single or multiple intervention session(s), has used an effective manual sham-manipulation control group.
An ancillary purpose of this study was to determine if a suitable sham for osteopathic manipulation could be devised.
Using a cross-over treatment design, with a one-week washout period and, in contrast to a sham procedure, the authentic manipulation produced significant alterations in both heart rate and measures of heart-rate variability calculated from power spectrum analysis.
Relative respiratory disease transmission risk for infants is further elevated by the fact that they frequently engage in sham biting and oral manipulation of objects [28].
In sham animals, no further manipulation was performed before closure of the abdominal wall with sutures.
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