Combined Chiropractic Care and Tai Chi for Chronic Non-Specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
This feasibility project aims to evaluate the effectiveness of chiropractic care combined with Tai Chi (TC) training to reduce pain and disability in adults with chronic non-specific neck pain (CNNP).
详细描述
This is a three-armed, mixed-methods pilot study. 48 adults with CNNP will be randomized to receive either 1) 10 chiropractic treatments (delivered over 16 weeks) with concurrent TC training (16 weeks of group training) plus enhanced usual care (EUC) with CNNP educational materials); 2) chiropractic care plus EUC; or 3) EUC alone. Individuals will be followed for 8 weeks after the end of their intervention period to assess longer-term outcomes. Our primary outcomes will be focused on the feasibility of recruiting, retaining and monitoring the safety of adults with CNNP into our trial. Secondary clinical outcomes include following patients centered-outcomes: pain, disability, health-related quality of life, self-efficacy, cognitive and affective outcomes (postural awareness, pain catastrophizing, fear of movement, interoceptive awareness).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic nonspecific neck pain at least 5 days a week for at least 3 consecutive months
- •Neck pain averaged over past week of 3 or more on numerical rating scale ranging from 0 to 10, with 10 described as 'worst neck pain imaginable'
- •Neck Disability Index score of 5 or greater
- •Agreeable to participate in all study procedures and be randomized to all intervention groups
- •Fluent in English
排除标准
- •Currently, or having received chiropractic care in past 12 months
- •Regular practice (on average, weekly) of Yoga, Tai Chi or Qigong in the past 6 months
- •Any major systemic illness or unstable medical condition (e.g. Parkinson's disease, cancer) or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol
- •Any disability precluding exercise practice
- •History of stroke, carotid artery dissection, or vertebral artery dissection
- •Signs of myelopathy or carotid bruits or evidence of pathological hypermobility (e.g. Ehlers Danlos Syndrome) during the clinical exam
- •Neck pain caused by congenital deformity of the spine that contraindicate treatment, neck pain related to neoplasm, inflammatory rheumatic disease, neurological disorder, active oncologic disease, severe affective disorder, addiction, or psychosis
- •Neck pain associated with unstable radicular pain or radiculopathy
- •Pregnancy
- •Recent spinal injections (in the past 4 weeks)
- •Neck pain with litigation
- •Any prior cervical surgery/spinal surgery within previous year
- •Persons currently involved in a disability/accident claim
结局指标
主要结局
Recruitment rate
时间窗: Through study completion (an average of 18 months)
Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
Retention rate
时间窗: Through study completion (an average of 18 months)
Retention rate will be quantified by the proportion of subjects who remain in the study to complete the 24-week visit.
Intervention adherence
时间窗: Through study completion (an average of 18 months)
Intervention adherence will be measured by collection of chiropractic visit attendance and Tai Chi class attendance data.
次要结局
- Pain intensity(Baseline, 16-weeks, and 24-weeks)
- Pain on movement (POM)(Baseline, 16-weeks, and 24-weeks)
- Disability(Baseline, 16-weeks, and 24-weeks)
- Self-efficacy(Baseline, 16-weeks, and 24-weeks)
- Postural awareness(Baseline, 16-weeks, and 24-weeks)
- Fear of Movement(Baseline, 16-weeks, and 24-weeks)
- Interoceptive Awareness(Baseline, 16-weeks, and 24-weeks)
- Perceptions of treatments(Baseline and 16-weeks)
- Bothersomeness of pain(Baseline, 16-weeks, and 24-weeks)
- Health-related quality of life(Baseline, 16-weeks, and 24-weeks)
- Pain Catastrophizing Scale(Baseline, 16-weeks, and 24-weeks)
研究者
Peter Wayne
Principal Investigator
Harvard University Faculty of Medicine