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

NCT ID: NCT06196385

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-03-04

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.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intensive Cervical Traction for cervical radiculopathy

Using intensive cervical traction through mechanical computerized device

Group Type: EXPERIMENTAL

intensive Cervical Traction

Intervention Type: DEVICE

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.

intensive Cervical Traction for healthy matched group

USING TRACTION FOR HEALTHY MATCHED AGE CONTROL GROUP

Group Type: ACTIVE_COMPARATOR

intensive Cervical Traction

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moataz Mohamed Talaat El Semary

Assistant Professor of physical therapy for neurology and neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of physical therapy

Cairo, , Egypt

Countries

Egypt

References

Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

Reference Type: BACKGROUND

PMID: 22466247 (View on PubMed)

Van't Veer A, Yano JM, Carroll FI, Cohen BM, Carlezon WA Jr. Corticotropin-releasing factor (CRF)-induced disruption of attention in rats is blocked by the kappa-opioid receptor antagonist JDTic. Neuropsychopharmacology. 2012 Dec;37(13):2809-16. doi: 10.1038/npp.2012.151. Epub 2012 Sep 5.

Reference Type: BACKGROUND

PMID: 22948977 (View on PubMed)

Oktay EA, Ersahan S, Gokyay S. Effect of intracanal medicaments used in endodontic regeneration on the push-out bond strength of a calcium-phosphate-silicate-based cement to dentin. Pak J Med Sci. 2018 Mar-Apr;34(2):310-315. doi: 10.12669/pjms.342.14630.

Reference Type: BACKGROUND

PMID: 29805399 (View on PubMed)

Other Identifiers

P.T.REC/012/004910

Identifier Type: -

Identifier Source: org_study_id