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

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.

Studieoversikt

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

98

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Cankaya
      • Ankara, Cankaya, Tyrkia, 06100
        • Merve Orucu Atar

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

A total of 98 patients with combat-related extremity injury

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Short Form Survey (SF-36)
Tidsramme: through study completion, an average of one and a half months
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)
Tidsramme: 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.
through study completion, an average of one and a half months
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: through study completion, an average of one and a half months
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2020

Primær fullføring (Faktiske)

1. november 2021

Studiet fullført (Faktiske)

1. november 2021

Datoer for studieregistrering

Først innsendt

14. desember 2020

Først innsendt som oppfylte QC-kriteriene

14. desember 2020

Først lagt ut (Faktiske)

19. desember 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. desember 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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