Functional Limitation, Pain and Quality of Life in Patients With Cervical Spondylotic Radiculopathy

Sponsor
Karabuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06001359
Collaborator
(none)
64
1
7
9.1

Study Details

Study Description

Brief Summary

Radiculopathy is a neurological condition in which transmission along a spinal nerve and its roots is limited or inhibited. It is most caused by spondylotic changes such as cervical disc herniation leading to nerve root compression, inflammatory changes, and the formation of bony prominences in this region [1]. Pain is the initial symptom and cervical radiculopathy should be suspected when pain radiates from the neck to the shoulder and arm, accompanied by sensory complaints and motor weakness. It is most commonly caused by spondylotic changes, such as cervical disc herniation and bony prominences in this area, leading to nerve root compression and inflammatory changes. Stenotic changes in the spine, which are often observed with aging, can cause nerve damage and compression in individuals, causing radicular pain. However, there is insufficient study in which the relationship between pain caused by cervical spondylotic radiculopathy caused by stenosis and functional disability, disability and quality of life due to radiculopathy in patients is insufficient. In addition, the lack of a comprehensive outcome scale that evaluates the functional limitation caused by radicular pain has also led to a deficiency in the evaluation of functional limitation. In this context, CRES is a newly developed scale used to evaluate functional limitation associated with radicular pain. In this context, in this study, it was aimed to examine the relationship between pain, functional disability, disability and quality of life in patients with cervical spondylotic radiculopathy.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
64 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Functional Limitation, Pain, Disability and Quality of Life in Patients With Cervical Spondylotic Radiculopathy
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Neck Pain [baseline]

    The Numeric Rating Scale measures the severity of pain. Scores range from 0 (no pain/numbness) to 10 (worst possible pain/numbness).

  2. Funcitonal disability [baseline]

    The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation. This scale includes 21 questions consisting of 3 sub-headings.

  3. Disability [baseline]

    Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living

  4. life quality [baseline]

    The EuroQol Five-Dimensions - 3-Level (EQ-5D-3L) General Quality of Life Scale will used to evaluate the quality of life of individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • over 18 years of age

  • with lateral-foraminal spinal stenosis in the cervical region

  • with or without neck pain consistent with the diagnosis obtained from magnetic resonance imaging

  • with unilateral root symptoms such as pain, numbness, weakness in the affected limb, and diagnosis based on MRI and computerized tomography

Exclusion Criteria:
  • signs of increased ventral pressure, such as ventral osteophytes, disc calcification, and ligament hypertrophy

  • severe neurological deficits, pregnant women, spinal malignancies,

  • those who had undergone cervical surgery in the last 12 months

  • and those who could not cooperate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karabuk University Karabük Turkey

Sponsors and Collaborators

  • Karabuk University

Investigators

  • Study Director: Aydın Sinan Apaydın, PhD, Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Aydın Sinan Apaydin, Doctor, Karabuk University
ClinicalTrials.gov Identifier:
NCT06001359
Other Study ID Numbers:
  • radiculopathy
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023