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Validation of a novel sham cervical spinal manipulation procedure.

验证新型假颈椎操作程序。

基本信息

批准号：
7528882
负责人：
Howard Terry Vernon
金额：
$ 15.6万
依托单位：
CANADIAN MEMORIAL CHIROPRACTIC COLLEGE
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-09-30 至 2011-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7528882
关键词：
Accounting Address Agreement Articular Range of Motion Behavior Biological Markers Biomechanics Cervical Cervical Manipulation Cervical spine Characteristics Chronic neck pain Clinical Trials Clinical Trials Design Complex Consent Control Groups Controlled Clinical Trials Cues Effectiveness Electromyography Elements Enrollment Frequencies Future General Population Head and neck structure Intervention Joints Left Low Back Pain Manuals Masks Measures Mechanics Methodology Modification Motion Musculoskeletal Musculoskeletal Equilibrium Nature Neck Neck Pain Numbers Outcome Pain Pain Threshold Participant Patient Self-Report Patients Physiological Placebo Control Placebos Procedures Public Health Publishing Randomized Range of motion exercise Rate Reporting Research Personnel Sample Size Sampling Skeletal muscle structure of neck Skin Specificity Spinal Manipulation Standards of Weights and Measures Stimulus Tactile Testing Therapeutic Therapeutic Effect Tissues Uncertainty Validation Work design human subject novel pressure response soft tissue sound treatment effect

项目摘要

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.

描述(申请人提供)：已经发表了一些手动治疗慢性颈部疼痛的临床试验。涉及脊柱手法作为主要治疗方法的试验数量最多。没有一项脊柱手法治疗慢性颈痛的临床试验，无论是单一干预还是多重干预，都没有采用假对照组。这让这些研究的结论受到了质疑。在未来的试验中使用安慰剂组的能力将极大地阐明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痛受试者中设计一种安慰剂控制的重复测量设计来验证一种新的实用的假颈椎推拿手术，这些受试者将被随机分为“真正的”颈椎推拿手术和“假”颈椎推拿手术，并确定该设计是否导致参与者满意的失明(主要结果#1)。我们打算确定这些手术对颈椎旁压痛的即时和短期影响(主要结果2)以及主观疼痛等级、颈椎活动范围、颈椎旁肌电行为和体位控制(次要结果)。我们还打算在这些手术中应用生物力学分析来研究其影响的特异性，如1)关节空洞的存在，以及2)施加到颈椎的力的分布。这一建议有可能为颈椎手法的临床试验提供一种新的、有效的、实用的假手术方法，并为未来的此类试验提供一种新的、有效的设计。临床试验方法学的这一改进将帮助我们的团队(在未来的R01建议中)以及其他研究人员确定这种形式的治疗对颈部疼痛患者的真正好处。公共卫生相关性：颈部疼痛是非常常见的。脊椎手法治疗颈部疼痛的临床试验没有假的对照程序。我们的研究将验证这一过程，并有助于确定脊柱手法对颈部疼痛的效果。