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

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Cervical Radiculopathy

Treatments

Device: intensive Cervical Traction

Study type

Interventional

Funder types

Other

Identifiers

NCT06196385
P.T.REC/012/004910

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

Male

Ages

30 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

intensive Cervical Traction for cervical radiculopathy
Experimental group
Description:
Using intensive cervical traction through mechanical computerized device
Treatment:
Device: intensive Cervical Traction
intensive Cervical Traction for healthy matched group
Active Comparator group
Description:
USING TRACTION FOR HEALTHY MATCHED AGE CONTROL GROUP
Treatment:
Device: intensive Cervical Traction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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