- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04674631
The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury
21. november 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
98
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Cankaya
-
Ankara, Cankaya, Kalkun, 06100
- Merve Orucu Atar
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2020
Primær færdiggørelse (Faktiske)
1. november 2021
Studieafslutning (Faktiske)
1. november 2021
Datoer for studieregistrering
Først indsendt
14. december 2020
Først indsendt, der opfyldte QC-kriterier
14. december 2020
Først opslået (Faktiske)
19. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 8
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Neuropatisk smerte
-
Quiropraxia y EquilibrioUniversidad Nacional Andres BelloAfsluttetMyofascial Trigger Point Pain (MTrP)Chile
-
East Carolina UniversityTrukket tilbage
-
Quiropraxia y EquilibrioIkke rekrutterer endnuMyofascial Trigger Point Pain (MTrP)Chile
-
Wake Forest University Health SciencesRekruttering
-
Rijnstate HospitalSaluda Medical Pty LtdTilmelding efter invitationPolyneuropatier | Kronisk smertesyndrom | Multi Focal Pain | Mislykket nakkekirurgi syndromHolland
-
University of California, San DiegoJohns Hopkins University; United States Department of Defense; The Cleveland... og andre samarbejdspartnereTilmelding efter invitationKirurgisk amputation af nedre ekstremiteter | Post-amputation Phantom Limb PainForenede Stater
-
Oslo University HospitalUniversity of Oslo; Fysiofondet; Oslo Metropolitan UniversityRekrutteringGluteal tendinopati | Trochanterisk bursitis | Lateral hoftesmerter | GTPS - Greater Trochanteric Pain SyndromeNorge
-
Brugmann University HospitalTrukket tilbagePhantom Limb Pain (PLP) | Primær/sekundær arhyperalgesiBelgien
-
Pôle Saint HélierRekruttering
-
Guna S.p.aAfsluttetStørre trochanterisk smertesyndrom | Pertrokantær fraktur | Gluteal tendinitis | GTPS - Greater Trochanteric Pain Syndrome | Senelidelse | Gluteal musklerItalien
Kliniske forsøg med The effect of neuropathic pain on quality of life, depression and sleep quality
-
Assiut UniversityAfsluttet
-
Hacettepe UniversityAnkara City Hospital BilkentAfsluttetKolorektal cancerKalkun
-
Bogomolets National Medical UniversityAfsluttetKronisk smerteUkraine
-
Memorial Sloan Kettering Cancer CenterRekrutteringCushings syndrom | Cushings sygdom | Cushings sygdomForenede Stater