Clinical trial NCT06001359: Functional Limitation, Pain and Quality of Life in Patients With Cervical Spondylotic Radiculopathy
Official title: Functional Limitation, Pain, Disability and Quality of Life in Patients With Cervical Spondylotic Radiculopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Radiculopathy
Elderly
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 64 patients with spondylotic radiculopathy will be included.

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.


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

Primary outcomes:
measure: Neck/Arm Pain
timeFrame: baseline
measure: Funcitonal disability
timeFrame: baseline
measure: Disability
timeFrame: baseline
measure: life quality
timeFrame: baseline
measure: Severity of stenosis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University
Study officials:
affiliation: Assistant Professor
name: Aydın Sinan Apaydın, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.