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The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury

NCT ID: NCT04674631

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-11-01

Brief Summary

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It has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. To date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with psychological comorbidity and quality of life.Combat related extremity injury significantly influences the patients' quality of life and psychological state. In this context, the purpose of this study is to illustrate to what extent neuropathic pain influences the quality of life, depression level and sleep quality of patients with combat-related extremity injury.

Detailed Description

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A total of 120 patients with combat-related extremity injury and 60 age and BMI-matched healthy controls will be participated in this cross-sectional study. The presence of neuropathic pain will be evaluated using Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire. The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI).

Conditions

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Neuropathic Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case group 1

52 patients with score of 12 or more on Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire will be included in the neuropathic pain group.

The effect of neuropathic pain on quality of life, depression and sleep quality

Intervention Type OTHER

The effect of neuropathic pain on quality of life, depression and sleep quality

Case group 2

46 patients with scores less than 12 on LANSS will be included in the group without neuropathic pain.

The effect of neuropathic pain on quality of life, depression and sleep quality

Intervention Type OTHER

The effect of neuropathic pain on quality of life, depression and sleep quality

Interventions

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The effect of neuropathic pain on quality of life, depression and sleep quality

The effect of neuropathic pain on quality of life, depression and sleep quality

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 18-65 years who had previous history of combat-related extremity injury

Exclusion Criteria

* Previous history of the cervical or lumbosacral radiculopathy, any known rheumatic disease or neurologic or endocrine disorders, excessive alcohol consumption and vitamin B12 deficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Demir

Physical Medicine and Rehabilitation Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Orucu Atar, MD

Role: PRINCIPAL_INVESTIGATOR

Gaziler PMR, Training and Research Hospital, Department of PMR

Locations

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Merve Orucu Atar

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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8

Identifier Type: -

Identifier Source: org_study_id