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

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001359
• Other study ID #: radiculopathy
• Status: Recruiting
• Start date: December 27, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: Karabuk University
• Contact: Aydin Sinan Aydin Sinan, +905065897613
• Phone: +905065897613
• Email: dr.sinanapaydin[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 30, 2024
• Est. primary completion date: March 15, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Radiculopathy

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Karabuk University	Karabük

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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