Efficacy Of Intensive Cervical Traction On Depression, Insomnia, Quality of Life In Patients With Cervical Radiculopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Short Form 36 Health Survey (SF-36)
研究概览
简要总结
Cervical radiculopathy is a common and disabling condition involving local pain in the neck region and pain that radiates into the upper limb. Recent data suggest that cervical traction may effectively reduce disability and pain, with a dose-response relationship. The main aim of this study was therefore to evaluate the effect of an intensive cervical traction protocol for patients with cervical radiculopathy on depression, insomnia, and quality of life (1).
详细描述
The investigators will conduct a prospective open observational study of thirty-six patients referred by their neurosurgeons for symptoms suggestive of cervical radiculopathy. All patients undergo the same treatment: a 30-minute cervical traction protocol, twice a day, for five consecutive days per week for 6 weeks. The main objective will be the evaluation of depression, insomnia, and quality of life. The investigators will evaluate at prior to the treatment and, at the end of the protocol, for depression, insomnia, and quality of life. The primary outcomes will be hospital anxiety and depression scale (HADS) and Short Form 36 Health Survey (SF-36) before and after treatment with spinal traction. Thirty-five healthy controls, matched with patients for age and sex, completed the same questionnaires. Traction was added to patients' medications which were not enough to control patients' symptoms and did not change during traction.
Depressive and anxiety symptoms were assessed by an Arabic version of Hospital Anxiety and Depression scale. Health-related quality of life was assessed by applying the Arabic version of the Short-Form 36 Health Survey (SF-36) [ Insomnia severity index will be used to evaluate insomnia.
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)
盲法说明
double blinded
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with prolapsed cervical disc were diagnosed based on clinical examination and MRI cervical spine
- •Patients showed only some improvement on medical treatment, NSAI drugs, muscle relaxants, and drugs for neuropathic pain, which will continue and will not change during spinal traction
排除标准
- •In addition to non-consenting patients, patients with the following conditions will be excluded from the present study: ligamentous instability, osteomyelitis, diskitis, primary or metastatic spinal cord tumor, severe osteoporosis, myelopathy, fibromyalgia, or untreated hypertension.
- •Patients currently treated for psychiatric disorders, or those who had past history of psychiatric disorders, will also excluded
结局指标
主要结局
Short Form 36 Health Survey (SF-36)
时间窗: before and after 6 WEEKS OF treatment with spinal traction
Qualiveen short version 8 questions from 1 to 4 (worse if high score)
Insomnia severity index
时间窗: before and after 6 WEEKS OF treatment with spinal traction
Though developers point out that their chosen cutoff scores have not been validated, they offer a few guidelines for interpreting scale results: a total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe)
Hospital anxiety and depression scale (HADS)
时间窗: before and after 6 WEEKS OF treatment with spinal traction
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that has been found to be a reliable instrument for detecting states of anxiety and depression in the setting of hospital outpatient clinic. The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
次要结局
未报告次要终点
研究者
Moataz Mohamed Talaat El Semary
Assistant Professor of physical therapy for neurology and neurosurgery
Cairo University