Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Group registration
研究概览
简要总结
Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions.
H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview.
H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure.
H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures.
A total of 372 subjects will be recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •21 to 60 years of age
- •Chronic neck pain
- •Neck pain duration greater than 6 weeks
- •Numeric Rating Scale greater than 30, less than 65
- •Pain distribution between nuchal ridge and spine of the scapula
- •Pain aggravated by local provocation maneuvers at single motion segment
- •Antero-posterior glide
- •Paraspinal tenderness
- •Negative provocative maneuvers at adjacent segment
- •Able to tolerate neck movement to 50 percent normal in all directions
排除标准
- •Worker's compensation or other medico-legal claim
- •Cervical spine surgery or fracture or dislocation
- •Uncontrolled hypertension (Blood Pressure over 140 over 90)
- •Stroke or Transient Ischemic Attack
- •Upper respiratory infection within 4 weeks
- •Severe degenerative disease of the cervical spine
- •New or significantly altered pattern of headache complaint
- •Connective tissue disease
- •Primary fibromyalgia
- •Metabolic or metaplastic bone disease
- •Whiplash injury within 12 months
- •High cholesterol levels not well-managed medically
- •Cardiovascular surgery in the past 6 months or planned
- •Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants
- •Angina pectoris
- •Dizziness
- •Blurred vision, vertigo, undiagnosed sensory and motor disturbances
- •Radicular symptoms and signs
- •Current use of anticoagulant therapy
- •Upper respiratory infection
- •Neck pain on provocation greater than 7 out of 10
- •Provocation of radicular pain or sensory disturbance
- •Hypermobility of multiple peripheral joints,
- •Physical or mental impairment precluding following instructions or participating -in supine recumbent postures
研究组 & 干预措施
Spinal manipulation
Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days.
干预措施: Spinal manipulation (Procedure)
Control manipulation
Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.
干预措施: Spinal manipulation (Procedure)
结局指标
主要结局
Group registration
时间窗: At exit assessment following the third intervention session
Participants will be asked to identify which of the two interventions they feel they received.
次要结局
- Pain severity(1. at baseline, and 2. At exit assessment following the third intervention session)
- Improvement(At exit assessment following the third intervention session)
- Disability(1. at baseline, and 2. At exit assessment following the third intervention session)
- Tenderness(1. at baseline, and 2. At exit assessment following the third intervention session)