Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients
12 gennaio 2022 aggiornato da: Manuel Sanchez, Jorge, Hannover Medical School
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).
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
914
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Hannover, Germania, 30625
- Hannover Medical School
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients with chronic pain visiting the pain outpatient department at Hannover Medical School.
Descrizione
Inclusion Criteria:
- Chronic pain
Exclusion Criteria:
- None
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Difference in pain area
Lasso di tempo: 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
Lasso di tempo: 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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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Difference in current pain
Lasso di tempo: 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
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Difference in mean pain in the last four weeks
Lasso di tempo: 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
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Difference in maximal pain in the last four weeks
Lasso di tempo: 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
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Difference in acceptable pain
Lasso di tempo: 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
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Difference in sleep impairment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Jorge Manuel Sánchez, Hannover Medical School
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
28 febbraio 2019
Completamento primario (Effettivo)
7 luglio 2020
Completamento dello studio (Effettivo)
7 luglio 2020
Date di iscrizione allo studio
Primo inviato
10 dicembre 2021
Primo inviato che soddisfa i criteri di controllo qualità
12 gennaio 2022
Primo Inserito (Effettivo)
13 gennaio 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 gennaio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 gennaio 2022
Ultimo verificato
1 gennaio 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 9681 (Altro identificatore: CTEP)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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