- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05190367
Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients
It is well known that patients suffering from chronic pain report higher levels of pain, anxiety, and depression if they have experienced a traumatic event. However, little is know about pain area and widespreadness.
In this retrospective study, we want to investigate whether pain area and widespreadness differs in chronic pain patients with and without traumatic events. To test this hypothesis we will retrospectively analyse pain drawings collected at the pain outpatient department from Hannover Medical School. Participants will be divided into four groups depending on the severity of their traumatic events: no trauma; accidental trauma; interpersonal trauma; post-traumatic stress disorder (PTSD).
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Hannover, Duitsland, 30625
- Hannover Medical School
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Chronic pain
Exclusion Criteria:
- None
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
---|
No trauma
Patients suffering from chronic pain without traumatic life events
|
Accidental trauma
Patients suffering from chronic pain who have experienced at least one accidental trauma
|
Interpersonal trauma
Patients suffering from chronic pain who have experienced at least one interpersonal trauma
|
PTSD
Patients suffering from chronic pain and diagnosed with PTSD
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Difference in pain area
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Pain area derived from electronic pain drawings (SymptomMapper).
The score ranges from 0 to 100% body area.
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in pain widespreadness
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Widespread pain index (WPI) derived from electronic pain drawings (SymptomMapper).
The score ranges from 0 (no pain) to 19 (pain affects all possible regions).
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Difference in current pain
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in mean pain in the last four weeks
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in maximal pain in the last four weeks
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in acceptable pain
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in sleep impairment
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Visual analogue scale from 0 ("no impairment") to 100 ("maximal imaginable impairment").
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in pain-related disability
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Pain-related disability assessed via the Pain Disability Index (PDI).
The score ranges from 0 (no pain-related disability) to 70 (maximal disability).
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in depression
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Depression assessed via the 9-item depression scale (PHQ-9) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no depression) to 27 (maximal depression).
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in somatic symptoms
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Somatic symptoms assessed via the 15-item somatic scale (PHQ-15) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no somatic symptom burden) to 30 (maximal somatic symptom burden).
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in anxiety
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Anxiety assessed via the 7-item anxiety scale (GAD-7) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no anxiety) to 21 (maximal anxiety).
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Difference in stress
Tijdsspanne: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Stress assessed via the 10-item stress scale (PHQ-Stress) from the German version of the Patient Health Questionnaire (PHQ-D).
The score ranges from 0 (no stress) to 20 (maximal stress).
|
First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jorge Manuel Sánchez, Hannover Medical School
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 9681 (Andere identificatie: CTEP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .