Validation of a novel sham cervical spinal manipulation procedure.

描述（由申请人提供）：已经发表了许多手工治疗慢性颈部疼痛的临床试验。最大数量的试验将脊椎推拿作为主要疗法。没有临床试验脊椎操纵慢性颈部疼痛，无论是单一或多重干预会话，采用假对照组。这让人们对这些研究的结论产生了质疑。在未来的试验中使用安慰剂型组的能力将极大地澄清这种治疗形式的真正治疗效果（“归因”效果）的大小，并有助于将这种效果与其他非特异性效果区分开来。我们打算通过在符合条件的慢性颈部疼痛患者中设计一种安慰剂对照、重复测量的设计来验证一种新颖实用的假颈椎推拿手术，这些患者将被随机分配接受“真实”颈椎或“假”颈椎推拿手术，并确定这种设计是否能使参与者满意地失明（主要结局#1）。我们打算确定这些手术对颈椎旁压痛（主要结局#2）以及主观疼痛评分、颈椎活动范围、颈椎旁肌电图行为和姿势控制（次要结局）的即时和短期影响。我们还打算在这些过程中应用生物力学分析来研究其影响的特异性，通过1]关节空化的存在，以及2]传递给颈椎的力的轮廓来测量。该建议有可能为颈椎推拿的临床试验提供一种新颖、有效、实用的假手术，同时也为未来的试验提供一种新颖、有效的设计。这种临床试验方法的改进将有助于我们的团队（在未来的R01提案中）以及其他研究人员确定这种治疗方式对颈部疼痛患者的真正益处。

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.