Validation of a novel sham cervical spinal manipulation procedure.

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DESCRIPTION (provided by applicant): A number of clinical trials of manual therapies for chronic neck pain have been published. The largest number of trials involves spinal manipulation as the primary therapy. No clinical trial of spinal manipulation for chronic neck pain, either of a single or multiple intervention sessions, has employed a sham control group. This calls the conclusions of these studies into question. The ability to employ placebo-type groups in future trials would greatly clarify the magnitude of the true therapeutic effect ("attributable" effect) of this form of treatment and help distinguish this effect from other non-specific effects. We intend to validate a novel practical sham cervical spinal manipulation procedure by designing a placebo-controlled, repeated-measures design in eligible human subjects with chronic neck pain who will be randomized to receive either a "real" cervical or "sham" cervical manipulation procedure and determining if this design results in satisfactory blinding of participants (primary outcome #1). We intend to determine the immediate and short-term effects of these procedures on cervical paraspinal tenderness (primary outcome #2) as well as subjective pain ratings, cervical ranges of motion, cervical paraspinal EMG behaviour and postural control (secondary outcomes). We also intend to apply biomechanical analyses during these procedures to investigate the specificity of their effects, as measured by 1] the presence of joint cavitation, and, 2] the profile of forces imparted to the cervical spine. This proposal has the potential to provide a novel, valid, practical sham procedure for use in clinical trials of cervical spinal manipulation as well as a novel, valid design for such future trials. This improvement in clinical trial methodology will assist our team (in future R01 proposals) as well as other researchers in determining the true benefit of this form of treatment to patients with neck pain. PUBLIC HEALTH RELEVANCE: Neck pain is very common. There is no sham control procedure for clinical trials of spinal manipulation for neck pain. Our study will validate such a procedure and help determine the effect of spinal manipulation on neck pain.