NCT06255444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

February 4, 2024

Last Update Submit

January 13, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Pain Severity

    A visual analog scale will be used to evaluate individuals' neck and arm pain levels during rest and activity.

    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.

    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.

    First Day

  • Peripheral Muscle Strength

    Shoulder abduction and shoulder flexion muscle strength will be measured by using hand-held dynamometer.

    First Day

  • Grip strength

    Hand grip strength will be measured by using Jamar Hand Dynamometer

    First Day

  • Qulity of life

    Short Form-36 will be used to determine the quality of life level.

    The scale is scored between 0-100, and a higher score indicates an increase in quality of life.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal, overweight and obese patients with cervical radiculopathy will be included in the study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University, Physiotherapy and Rehabilitation Application and Research Center

Karabük, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Musa Güneş, MsC

    Deparment of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Karabuk University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director, PT, MsC

Study Record Dates

First Submitted

February 4, 2024

First Posted

February 13, 2024

Study Start

January 1, 2024

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations