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

NCT ID: NCT06001359

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2024-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karabuk University

OTHER

Sponsor Role: lead

Responsible Party

Aydın Sinan Apaydin

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aydın Sinan Apaydın, PhD

Role: STUDY_DIRECTOR

Assistant Professor

Locations

Karabuk University

Karabük, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Aydın Sinan Aydın Sinan, +905065897613

Role: CONTACT

dr.sinanapaydin@yahoo.com

+905065897613

Facility Contacts

Aydın Sinan Apaydın, PhD

Role: primary

dr.sinanapaydin@yahoo.com

+905065897613

References

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.

Reference Type: BACKGROUND

PMID: 22531897 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30522138 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22162812 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32797985 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39295627 (View on PubMed)

Other Identifiers

radiculopathy

Identifier Type: -

Identifier Source: org_study_id