Cervical Radiculopathy
Conditions
Keywords
Cervical Traction, Depression, insomnia, Quality of life
Brief summary
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).
Detailed description
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.
Interventions
DEVICEintensive Cervical Traction
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. We evaluate at prior to the treatment and, at the end of the protocol, for depression, insomnia, and quality of life.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
double blinded
Intervention model description
post hoc test
Eligibility
Sex/Gender
MALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital anxiety and depression scale (HADS) | 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. |
| Short Form 36 Health Survey (SF-36) | 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 | 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) |
Countries
Egypt
Outcome results
None listed