- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06255444
Cervical Radiculopathy and Body Mass Index
Body Mass Index Patients With Cervical Radiculopathy
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Karabük, Turkey
- Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Overweight/Obese BMI
This group consists of overweight and obese patients diagnosed with cervical radiculopathy by a neurosurgeon.
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Normal BMI
This group consists of patients with normal BMI who were diagnosed with cervical radiculopathy by a neurosurgeon.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pain Severity
Time Frame: First Day
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A visual analog scale will be used to evaluate individuals' neck and arm pain levels during rest and activity.
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First Day
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Disability
Time Frame: First Day
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"Neck Disability Index" (NDI) will be used to evaluate the effects of neck pain on daily living activities.
The scale is scored between 0 and 100, and a higher score indicates higher disability.
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First Day
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Range of Motion
Time Frame: First Day
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A universal goniometer will be used to evaluate the flexion and extension cervical region joint range of motion of the patients.
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First Day
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Peripheral Muscle Strength
Time Frame: First Day
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Shoulder abduction and shoulder flexion muscle strength will be measured by using hand-held dynamometer.
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First Day
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Grip strength
Time Frame: First Day
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Hand grip strength will be measured by using Jamar Hand Dynamometer
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First Day
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Qulity of life
Time Frame: The scale is scored between 0-100, and a higher score indicates an increase in quality of life.
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Short Form-36 will be used to determine the quality of life level.
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The scale is scored between 0-100, and a higher score indicates an increase in quality of life.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Musa Güneş, MsC, Deparment of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Karabuk University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk University-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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