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

NCT04674631 | Completed

• 1 other identifier: 8
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (3)

• Short Form Survey (SF-36)

  The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). The validity and reliability of the Turkish version of SF-36 has been illustrated. SF-36 is a common questionnaire for the evaluation of quality of life, and it includes a total of 36 items in eight separate scales (physical functioning, general health, physical role, bodily pain, vitality, social functioning, mental health and emotional role). Each subscale is scored between 0 and 100, and high scores indicate better quality of life

  through study completion, an average of one and a half months

• Beck Depression Scale (BDS)

  Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Beck Depression Scale, which is a 21-item self report rating inventory, measures characteristic symptoms and attitudes of depression. The scale is scored between 0 and 63. The cut-off point considered is 17. Higher scores reflect more severe depression.

  through study completion, an average of one and a half months

• Pittsburgh Sleep Quality Index (PSQI)

  Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which assesses the individual's self-reported quality of sleep during the last month \[9\]. This 19-item index evaluates seven components of quality of sleep: subjective quality of sleep, sleep duration, sleep latency, sleep disturbances, sleep efficiency, drug use for sleep, and daytime dysfunction. A total PSQI score (range, 0-21) is the total of particular scores from the seven components. A score of ≥6 is considered to indicate poor quality of sleep. The Turkish validation of PSQI was performed.

  through study completion, an average of one and a half months

Study Arms (2)

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.

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.

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

Interventions

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

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

Case group 1; Case group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 98 patients with combat-related extremity injury

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Merve Orucu Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve Orucu Atar, MD

  Gaziler PMR, Training and Research Hospital, Department of PMR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: July 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

TU (1)