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

Recruiting

• Conditions: Radiculopathy; Elderly

• Registration Number: NCT06001359
• Lead Sponsor: Karabuk University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Study Start: 2023-12-27
• Status Verified: 2024-03
• Primary Completion: 2024-03-15
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Funcitonal disability	baseline	The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation.
Disability	baseline	Neck Disability Index (NDI) will used to evaluate the effect of neck pain on activities of daily living
Neck/Arm Pain	baseline	A numeric rating scale will be used to evaluate neck and arm pain severity.
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
Severity of stenosis	baseline	The severity of stenosis will be evaluated with MRI.

Trial Locations

Locations (1)

Karabuk University; 🇹🇷 Karabük, Turkey