The Relationship Between Obesity and Chronic Headache

October 10, 2024 updated by: HATİCE TOPRAK, Karaman Training and Research Hospital

Investigation of the Effectiveness of Obesity in the Development of Chronic Headache After Traumatic Brain Injury

The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Merkez
      • Karaman, Merkez, Turkey, 70200
        • Recruiting
        • Karaman Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

individuals over the age of 18 who suffered a head injury

Description

Inclusion Criteria:

  • Individuals over the age of 18 who suffered a head injury

Exclusion Criteria:

  • People with severe head trauma
  • Those who do not speak Turkish
  • Those with a history of chronic opioid user
  • Those with alcohol and drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between Bady Mass Index (BMI) and the development of chronic headache
Time Frame: Postoperative 3 month.
BMI is calculated by dividing weight in kilograms by the square of height in metres.
Postoperative 3 month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between the nature of trauma and the development of chronic headache
Time Frame: Postoperative 3 month.
Head traumas that occur due to different reasons will be examined
Postoperative 3 month.
The relationship between patients' education levels and chronic headache
Time Frame: Postoperative 3 month
Education levels will be defined as primary school, secondary school and university graduate.
Postoperative 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karaman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-2024/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing will be evaluated in cases where the responsible researcher is contacted.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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