Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- Patient-rated pain (0-10 scale, 11 box)
研究概览
简要总结
The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.
详细描述
Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly.
The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity.
Primary Aims
• To determine the relative clinical effectiveness of 1) chiropractic manual treatment and home exercise, 2) supervised rehabilitative exercise and home exercise, and 3) home exercise alone in both the short-term (after 12 weeks) and long-term (after 52 weeks), using patient-rated neck pain as the main outcome measure.
Secondary Aims
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic neck pain (Defined as current episode more than 12 weeks duration.)
- •Quebec Task Force classifications 1, 2, 3 and
- •This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.
- •65 years of age and older
- •Independent ambulation
- •Community dwelling (residency outside nursing home)
- •Score of 20 or more on Folstein Mini-Mental State Examination
- •Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)
排除标准
- •Referred neck pain from local joint lesions of the upper extremities or from visceral diseases
- •Significant infectious disease
- •Ongoing treatment for neck pain by other health care providers
- •Mean neck pain score of less than 20 percentage points
- •Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease)
- •Contraindications to spinal manipulation (i.e. Progressive neurological deficits, blood clotting disorders, severe osteoporosis, infectious and non-infectious inflammatory or destructive tissue changes of the spine)
结局指标
主要结局
Patient-rated pain (0-10 scale, 11 box)
时间窗: short term = 12 weeks; long term = 52 weeks
次要结局
- General Health(short term = 12 weeks; long term = 52 weeks)
- Disability(short term = 12 weeks; long term = 52 weeks)
- Improvement(short term = 12 weeks; long term = 52 weeks)
- Satisfaction(short term = 12 weeks; long term = 52 weeks)
- Medication use(short term = 12 weeks; long term = 52 weeks)
- Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior(short term = 12 weeks)