Radiculopathy, CervicalNCT06255444
Cervical Radiculopathy and Body Mass Index
An observational study of Radiculopathy, Cervical, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy, Cervical
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Normal, overweight and obese patients with cervical radiculopathy will be included in the study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University, Physiotherapy and Rehabilitation Application and Research Center
Karabük
About this study
Official title: Body Mass Index Patients With Cervical Radiculopathy
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.
Read the 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.
- Conditions
- Radiculopathy, Cervical
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overweight/Obese BMI | This group consists of overweight and obese patients diagnosed with cervical radiculopathy by a neurosurgeon. | |
| Normal BMI | This group consists of patients with normal BMI who were diagnosed with cervical radiculopathy by a neurosurgeon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
A visual analog scale will be used to evaluate individuals' neck and arm pain levels during rest and activity.
Measured: First Day
Disability
"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.
Measured: First Day
Range of Motion
A universal goniometer will be used to evaluate the flexion and extension cervical region joint range of motion of the patients.
Measured: First Day
Peripheral Muscle Strength
Shoulder abduction and shoulder flexion muscle strength will be measured by using hand-held dynamometer.
Measured: First Day
Grip strength
Hand grip strength will be measured by using Jamar Hand Dynamometer
Measured: First Day
Qulity of life
Short Form-36 will be used to determine the quality of life level.
Measured: The scale is scored between 0-100, and a higher score indicates an increase in quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jan 2024
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
- Investigators
- Musa Güneş, MsC, Study director, Deparment of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255444
- Sponsor's protocol ID
- Karabuk University-06
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33116248Stienen 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.
PubMed 27686509Sheng 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.
PubMed 28208824Gunes M, Ucuzova EG, Apaydin AS, Ozmen T. Relationship between body mass index and pain, peripheral muscle strength, disability and quality of life in patients with cervical radiculopathy. J Bodyw Mov Ther. 2025 Dec;45:864-869. doi: 10.1016/j.jbmt.2025.10.006. Epub 2025 Oct 20.
PubMed 41316662
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Mass Index Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT06255444
- Acronym / sponsor ID
- Karabuk University-06
- Conditions
- Radiculopathy, Cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight/Obese BMI | – | –This group consists of overweight and obese patients diagnosed with cervical radiculopathy by a neurosurgeon. |
| Normal BMI | – | –This group consists of patients with normal BMI who were diagnosed with cervical radiculopathy by a neurosurgeon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Normal, overweight and obese patients with cervical radiculopathy will be included in the study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Severity
Time frame: First Day
A visual analog scale will be used to evaluate individuals' neck and arm pain levels during rest and activity.
Disability
Time frame: First Day
"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.
Range of Motion
Time frame: First Day
A universal goniometer will be used to evaluate the flexion and extension cervical region joint range of motion of the patients.
Peripheral Muscle Strength
Time frame: First Day
Shoulder abduction and shoulder flexion muscle strength will be measured by using hand-held dynamometer.
Grip strength
Time frame: First Day
Hand grip strength will be measured by using Jamar Hand Dynamometer
Qulity of life
Time frame: The scale is scored between 0-100, and a higher score indicates an increase in quality of life.
Short Form-36 will be used to determine the quality of life level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Results publication: PubMed 33116248Mateos-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.
- Results publication: PubMed 27686509Stienen 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.
- Results publication: PubMed 28208824Sheng 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.
- Derived from this study: PubMed 41316662Gunes M, Ucuzova EG, Apaydin AS, Ozmen T. Relationship between body mass index and pain, peripheral muscle strength, disability and quality of life in patients with cervical radiculopathy. J Bodyw Mov Ther. 2025 Dec;45:864-869. doi: 10.1016/j.jbmt.2025.10.006. Epub 2025 Oct 20.
- Individual participant dataSharing planned: No
Related trials for Radiculopathy, Cervical
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Musa Güneş, MsC study director
Deparment of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiculopathy, Cervical, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: First Day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06255444, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.