NCT06196385

Efficacy Of Intensive Cervical Traction On Depression, Insomnia, Quality of Life In Patients With Cervical Radiculopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Male
• Age: 30 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Radiculopathy

Interventions

Type	Name	Description
DEVICE	intensive 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.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-02-22
• Completion: 2024-03-04
• First posted: 2024-01-09
• Last updated: 2024-03-05

Locations

1 site across 1 country: Egypt