Clinical trial NCT06196385: Efficacy Of Intensive Cervical Traction On Depression, Insomnia, Quality of Life In Patients With Cervical Radiculopathy
Official title: Efficacy Of Intensive Cervical Traction On Depression, Insomnia, Quality of Life In Patients With Cervical Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical Traction
Depression
insomnia
Quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: post hoc test
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital anxiety and depression scale (HADS)
timeFrame: before and after 6 WEEKS OF treatment with spinal traction
measure: Short Form 36 Health Survey (SF-36)
timeFrame: before and after 6 WEEKS OF treatment with spinal traction
measure: Insomnia severity index
timeFrame: before and after 6 WEEKS OF treatment with spinal traction
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
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