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

NCT06196385 | Completed DMC

• 1 other identifier: P.T.REC/012/004910
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Radiculopathy

Keywords

Cervical Traction; Depression; insomnia; Quality of life

Outcome Measures

Primary Outcomes (3)

• Hospital anxiety and depression scale (HADS)

  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.

  before and after 6 WEEKS OF treatment with spinal traction

• Short Form 36 Health Survey (SF-36)

  Qualiveen short version 8 questions from 1 to 4 (worse if high score)

  before and after 6 WEEKS OF treatment with spinal traction

• Insomnia severity index

  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)

  before and after 6 WEEKS OF treatment with spinal traction

Study Arms (2)

intensive Cervical Traction for cervical radiculopathy

EXPERIMENTAL

Using intensive cervical traction through mechanical computerized device

Device: intensive Cervical Traction

intensive Cervical Traction for healthy matched group

ACTIVE COMPARATOR

USING TRACTION FOR HEALTHY MATCHED AGE CONTROL GROUP

Device: intensive Cervical Traction

Interventions

intensive Cervical Traction 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 cervical radiculopathy; intensive Cervical Traction for healthy matched group

Eligibility Criteria

• Age: 30 Years - 45 Years
• Gender Eligibility Details: ISLAMIC ISSUES MORE SPECIFIC FOR HOMOGENITY
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

Related Publications (3)

• 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.

  PMID: 22466247 BACKGROUND

• 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.

  PMID: 22948977 BACKGROUND

• 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.

  PMID: 29805399 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of physical therapy for neurology and neurosurgery

Model Details: post hoc test

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: December 1, 2023
• Primary Completion: February 22, 2024
• Study Completion: March 4, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)