- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04674631
The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury
21 november 2021 uppdaterad av: Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
The Effect of Neuropathic Pain on Quality of Life, Depression and Sleep in Patients With Combat-related Extremity Injury
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
98
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Cankaya
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Ankara, Cankaya, Kalkon, 06100
- Merve Orucu Atar
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Testmetod
Sannolikhetsprov
Studera befolkning
A total of 98 patients with combat-related extremity injury
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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.
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The effect of neuropathic pain on quality of life, depression and sleep quality
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Case group 2
46 patients with scores less than 12 on LANSS will be included in the group without neuropathic pain.
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The effect of neuropathic pain on quality of life, depression and sleep quality
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Short Form Survey (SF-36)
Tidsram: through study completion, an average of one and a half months
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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
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through study completion, an average of one and a half months
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Beck Depression Scale (BDS)
Tidsram: through study completion, an average of one and a half months
|
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.
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through study completion, an average of one and a half months
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Pittsburgh Sleep Quality Index (PSQI)
Tidsram: through study completion, an average of one and a half months
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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.
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through study completion, an average of one and a half months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2020
Primärt slutförande (Faktisk)
1 november 2021
Avslutad studie (Faktisk)
1 november 2021
Studieregistreringsdatum
Först inskickad
14 december 2020
Först inskickad som uppfyllde QC-kriterierna
14 december 2020
Första postat (Faktisk)
19 december 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 december 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 november 2021
Senast verifierad
1 november 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 8
Läkemedels- och apparatinformation, studiedokument
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