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

NCT06001359 | Recruiting

• 1 other identifier: radiculopathy
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy; Elderly

Outcome Measures

Primary Outcomes (5)

• Neck/Arm Pain

  A numeric rating scale will be used to evaluate neck and arm pain severity.

  baseline

• Funcitonal disability

  The Cervical Radiculopathy Impact Scale (CRIS) will used to determine the functional limitation.

  baseline

• Disability

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

  baseline

• life quality

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

  baseline

• Severity of stenosis

  The severity of stenosis will be evaluated with MRI.

  baseline

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

64 patients with spondylotic radiculopathy will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabuk University

Karabük, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J. 2012 Aug;21(8):1459-70. doi: 10.1007/s00586-012-2297-9. Epub 2012 Apr 25.

  PMID: 22531897 BACKGROUND

• Patel EA, Perloff MD. Radicular Pain Syndromes: Cervical, Lumbar, and Spinal Stenosis. Semin Neurol. 2018 Dec;38(6):634-639. doi: 10.1055/s-0038-1673680. Epub 2018 Dec 6.

  PMID: 30522138 BACKGROUND

• Kelly JC, Groarke PJ, Butler JS, Poynton AR, O'Byrne JM. The natural history and clinical syndromes of degenerative cervical spondylosis. Adv Orthop. 2012;2012:393642. doi: 10.1155/2012/393642. Epub 2011 Nov 28.

  PMID: 22162812 BACKGROUND

• Grasso G, Salli M, Torregrossa F. Does Hybrid Surgery Improve Quality of Life in Multilevel Cervical Degenerative Disk Disease? Five-Year Follow-up Study. World Neurosurg. 2020 Aug;140:527-533. doi: 10.1016/j.wneu.2020.03.097.

  PMID: 32797985 RESULT

• Apaydin AS, Gunes M. Relationships between stenosis severity, functional limitation, pain, and quality of life in patients with cervical spondylotic radiculopathy. Turk J Med Sci. 2024 Jun 6;54(4):727-734. doi: 10.55730/1300-0144.5842. eCollection 2024.

  PMID: 39295627 DERIVED

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Aydın Sinan Apaydın, PhD

  Assistant Professor

  STUDY DIRECTOR

Central Study Contacts

Aydın Sinan Aydın Sinan, +905065897613

CONTACT

+905065897613; dr.sinanapaydin@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: December 27, 2023
• Primary Completion: March 15, 2024
• Study Completion: April 30, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)