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Influence of Trauma on Pain Area and Widespreadness in Chronic Pain Patients

2022년 1월 12일 업데이트: 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).

연구 개요

상태

완전한

연구 유형

관찰

등록 (실제)

914

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Hannover, 독일, 30625
        • Hannover Medical School

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients with chronic pain visiting the pain outpatient department at Hannover Medical School.

설명

Inclusion Criteria:

  • Chronic pain

Exclusion Criteria:

  • None

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Difference in pain area
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Difference in current pain
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Jorge Manuel Sánchez, Hannover Medical School

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 2월 28일

기본 완료 (실제)

2020년 7월 7일

연구 완료 (실제)

2020년 7월 7일

연구 등록 날짜

최초 제출

2021년 12월 10일

QC 기준을 충족하는 최초 제출

2022년 1월 12일

처음 게시됨 (실제)

2022년 1월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 1월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 1월 12일

마지막으로 확인됨

2022년 1월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 9681 (기타 식별자: CTEP)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

만성 통증에 대한 임상 시험

3
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