- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Hannover, Tyskland, 30625
- Hannover Medical School
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Chronic pain
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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No trauma
Patients suffering from chronic pain without traumatic life events
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Accidental trauma
Patients suffering from chronic pain who have experienced at least one accidental trauma
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Interpersonal trauma
Patients suffering from chronic pain who have experienced at least one interpersonal trauma
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PTSD
Patients suffering from chronic pain and diagnosed with PTSD
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in pain area
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Pain area derived from electronic pain drawings (SymptomMapper).
The score ranges from 0 to 100% body area.
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
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Difference in pain widespreadness
Tidsramme: 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).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Difference in current pain
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no pain") to 100 ("maximal imaginable pain").
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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
Tidsramme: 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
|
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Difference in maximal pain in the last four weeks
Tidsramme: 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").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
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Difference in acceptable pain
Tidsramme: 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").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
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Difference in sleep impairment
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Visual analogue scale from 0 ("no impairment") to 100 ("maximal imaginable impairment").
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in pain-related disability
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Pain-related disability assessed via the Pain Disability Index (PDI).
The score ranges from 0 (no pain-related disability) to 70 (maximal disability).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
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Difference in depression
Tidsramme: 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).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in somatic symptoms
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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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).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
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Difference in anxiety
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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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).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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Difference in stress
Tidsramme: First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
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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).
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First visit of each patient at the Pain outpatient department of Hannover Medical School between 2019-02-28 and 2020-07-07
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jorge Manuel Sánchez, Hannover Medical School
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 9681 (Anden identifikator: CTEP)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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