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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06445595
Other study ID # 05-2024/19
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date October 1, 2025

Study information

Verified date May 2024
Source Karaman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date October 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
patients with traumatic brain injury
Patients will be contacted by phone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Karaman Training and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The relationship between Bady Mass Index (BMI) and the development of chronic headache BMI is calculated by dividing weight in kilograms by the square of height in metres. Postoperative 3 month.
Secondary The relationship between the nature of trauma and the development of chronic headache Head traumas that occur due to different reasons will be examined Postoperative 3 month.
Secondary The relationship between patients' education levels and chronic headache Education levels will be defined as primary school, secondary school and university graduate. Postoperative 3 month
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