Validation of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Neck Disability Index
研究概览
简要总结
The purpose of this study is to see if a recently developed clinical prediction rule (CPR) will successfully identify which patients with neck pain will respond rapidly and favorably to manipulation of their cervical spine.
详细描述
Consenting patients with a primary complaint of neck pain will be screened for contraindications to cervical spine manipulation and if eligible to participate in the study, will undergo a detailed subjective (history) and objective (physical) examination. At the completion of the examination, they will be assigned to one of two treatment arms - cervical manipulation and exercise or exercise only. They will receive up to 5 treatment sessions and be followed at 1 month, 3 months and 6 months after initial visit.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary complaint of mechanical neck pain with or without unilateral upper extremity symptoms (mechanical neck pain is defined as neck pain/ symptoms that are altered/ affected by activity, movement and posture)
- •NDI score at least 10 points out of 50.
排除标准
- •Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
- •History of whiplash injury within the past six weeks
- •Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
- •Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
- •Two or more positive neurologic signs consistent with nerve root compression, including any two of the following: a. Muscle weakness involving a major muscle group of the upper extremity b. Diminished upper extremity muscle stretch reflex (biceps brachii, Brachioradialis, or triceps reflex) c. Diminished or absent sensation to pinprick in any upper extremity dermatome
- •Prior surgery to the neck or thoracic spine
- •Pending legal action regarding their neck pain
- •Insufficient English language skills to complete all questionnaires
- •Inability to comply with treatment and follow-up schedule
研究组 & 干预措施
Manipulation
Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises
干预措施: Manipulation (Procedure)
Manipulation
Patients will receive cervical manipulation on 2 visits and then a further 3 visits of therapeutic exercises
干预措施: Exercise (Procedure)
Exercise
Patients will receive 5 visits of therapeutic exercises
干预措施: Exercise (Procedure)
结局指标
主要结局
Neck Disability Index
时间窗: 6 months
10-item patient self-report measure of perceived disability
次要结局
- Medication Use(6 months)
- Global Rating of Change Scale(6 months)
- Numeric Pain Rating Scale(6 months)
研究者
Emilio J Puentedura, PT, DPT, PhD
Associate Professor
University of Nevada, Las Vegas