A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
To evaluate the effectiveness of treatment in subjects with cervical radicular pain with Vista Therapy Collar, using a Visual Analog Scale, a Neck Disability Index and the SF-36 quality of life survey.
详细描述
To evaluate the effective of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to a 'wait and see' approach.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:
- •Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
- •Muscle weakness in one or more adjacent myotomes.
- •Neck Disability Index (NDI) score >= 10 points
- •VAS for neck pain >= 40
- •Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted
- •Subject is willing and able to attend visits as scheduled and to comply with the study protocol
排除标准
- •Serious somatic or psychiatric disorder
- •Previous Neck Surgery
- •Whiplash as the primary incident
- •History of spinal tumor or infection
- •Cervical Instability per opinion of PI
- •Morbid Obesity (BMI>40)
- •Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
- •Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
- •Subject is involved in Worker's Compensation litigation
- •Non-English speaking
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 90 days
Scale used to measure pain. The subject will mark their pain on a scale with a length of 100mm. The scale is scored by measuring (mm) from the left end of the scale to the subject's marking. The VAS is scored from 0-100, higher scores signify a greater amount of pain.
Neck Disability Index (NDI)
时间窗: 90 days
Questionnaire used to measure how neck pain affects activities of daily living. Each of the 10 items are scored from 0-5, the maximum score is 50. Higher scores signify greater disability. A score over 34 signifies complete disability.
SF-36 Quality of Life Survey
时间窗: 90 days
Questionnaire used to measure quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The total score is calculated as a percentage of the total points possible. A higher total percent signifies better outcomes.
次要结局
未报告次要终点
研究者
Alexios Carayannopoulos
Medical Director, Comprehensive Spine Center; Chief of Physical Medicine and Rehabilitation Medicine, Chief of Lifespan Physican Group, Rhode Island Hospital, Newport Hospital
Rhode Island Hospital