Clinical trial NCT06255444: Cervical Radiculopathy and Body Mass Index
Official title: Body Mass Index Patients With Cervical Radiculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiculopathy, Cervical
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal, overweight and obese patients with cervical radiculopathy will be included in the study.

Brief summary: Body Mass Index (BMI) is thought to impact radiculopathy symptoms. The pressure exerted by fatty tissue on muscle tissue can also significantly affect the nerves. This condition causes radiculopathy. Therefore, high BMI causes an increase in the incidence of radiculopathy. Consequently, it is thought that pain caused by cervical radiculopathy may be related to BMI and affect functionality. Also, it is believed that with the increase in the load on the cervical region, there will be an increase in degenerative disorders and an increase in the incidence of radiculopathy. This study examines the relationship between BMI and peripheral muscle strength, pain, range of motion, disability, quality of life, and functionality in patients with cervical radiculopathy.

Detailed description: When radiculopathy occurs due to compression of the neck nerve roots due to pathologies in the neck, it is called cervical radiculopathy. It is thought that high and low BMI values have an impact on radiculopathy. The pressure exerted by fatty tissue on muscle tissue can significantly affect the nerves. This causes an increase in radiculopathy symptoms. Therefore, high BMI causes an increase in the incidence of radiculopathy. The relationship between the degree of obesity, visceral fat area, body mass index, abdominal circumference, and lumbar disc herniation and pain is shown. It has been stated in the literature that BMI is related to lumbar radiculopathy and pain level. Still, there appear to be inadequacies in examining its relationship with radiculopathy, which is related to upper extremity functionality. Therefore, it is thought that pain caused by cervical radiculopathy may be associated with BMI and affect functionality more. At the same time, as BMI increases, lumbar lordosis may affect spine biomechanics, leading to deterioration in sagittal balance and an increase in cervical problems. According to an international study It is stated that in obese individuals with high BMI values, vertebral discs undergo degeneration due to the load on the spine.

For this reason, researchers have suggested that pain level increases linearly with BMI value. It is stated that degenerating lumbar vertebrae progress to narrowing over time and that the risk of lumbar spinal stenosis may increase in individuals with high-fat content. Therefore, radiculopathy is thought to be a significant factor when looking at the relationship between pain in the musculoskeletal system and BMI.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Having cervical pathology detected by a neurosurgeon with MRI and having radicular pain symptoms related to this
* BMI \>18.5 kg/m2
* Having symptoms for at least 3 months
* Being able to communicate in Turkish
* Volunteering to participate in the study.

Exclusion Criteria:

* Pregnant patients
* Presence of malignancy in the spine
* Having a serious neurological disease
* Primary or metastatic spinal malignancy, history of spinal fractures
* People with neurological diseases (Hemiplegia, Multiple Sclerosis, Parkinson, etc.).
* Being diagnosed with advanced osteoporosis
* Having undergone a surgical intervention involving the cervical region within the last year
* Lack of cooperation

Primary outcomes:
measure: Pain Severity
timeFrame: First Day
measure: Disability
timeFrame: First Day
measure: Range of Motion
timeFrame: First Day
measure: Peripheral Muscle Strength
timeFrame: First Day
measure: Grip strength
timeFrame: First Day
measure: Qulity of life
timeFrame: The scale is scored between 0-100, and a higher score indicates an increase in quality of life.
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Study officials:
affiliation: Deparment of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Karabuk University
name: Musa Güneş, MsC
role: STUDY_DIRECTOR
References:
citation: Mateos-Valenzuela AG, Gonzalez-Macias ME, Ahumada-Valdez S, Villa-Angulo C, Villa-Angulo R. Risk factors and association of body composition components for lumbar disc herniation in Northwest, Mexico. Sci Rep. 2020 Oct 28;10(1):18479. doi: 10.1038/s41598-020-75540-5.
citation: Stienen MN, Joswig H, Smoll NR, Corniola MV, Schaller K, Hildebrandt G, Gautschi OP. Influence of Body Mass Index on Subjective and Objective Measures of Pain, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disc Disease. World Neurosurg. 2016 Dec;96:570-577.e1. doi: 10.1016/j.wneu.2016.09.070. Epub 2016 Sep 28.
citation: Sheng B, Feng C, Zhang D, Spitler H, Shi L. Associations between Obesity and Spinal Diseases: A Medical Expenditure Panel Study Analysis. Int J Environ Res Public Health. 2017 Feb 13;14(2):183. doi: 10.3390/ijerph14020183.