- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04488146
Pain in Patients With Crohn Disease (PAINCD) (PAINCD)
Epidemiology and Characterization of Pain in Patients With Crohn Disease
Abdominal pain is a common symptom in patients with Crohn disease (CD). Pain is multifactorial, may result from inflammation but persists in many patients during remission.
The aim of our study is to determine the epidemiology of pain in CD patients and define the characteristics of pain : localisation, temporal and sensorial characteristics, neuropathic component, impact on quality of life and mood.
연구 개요
상세 설명
Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD) that alters quality of life and can lead to increased healthcare utilization. In addition to abdominal pain, pain can result from extra-intestinal manifestation of IBD. 40% of IBD patients suffer from extra-intestinal manifestations. Although abdominal pain has been traditionally attributed to inflammation, functional abdominal pain exists in patients with IBD, associated with a variety of potential causes. About 20-40% of patients in complete clinical and endoscopic remission continue to experience chronic pain. Thus, when examining an IBD patient with abdominal pain, in addition to IBD-related complications (e.g., inflammation, stricture), it is important to screen for other contributors, including peripheral factors (visceral hypersensitivity, bacterial overgrowth, and bowel dysmotility) and centrally mediated neurobiological and psychosocial underpinnings. These central factors include psychological symptoms, sleep disturbance, and stress. Opioid-induced hyperalgesia (e.g., narcotic bowel syndrome) is also growing in recognition as a potential central source of abdominal pain.
Pronounced severe pain impacts health related quality of life (QoL). Longstanding pain leads to decreased QoL, increase in pain medication intake, and co-morbidities including depression, anxiety and even addiction. Furthermore, pain attacks severely interfere with social and professional life.
Knowledge of these potential aetiologies should be used to individualize treatment of abdominal pain in patients with IBD. Accurate assessment of the source of pain can help guide appropriate diagnosis workup and use of modifying therapy.
The aim of the study is to determine the epidemiology of pain in patients with Crohn disease (CD) and to characterize their pain (localisation, temporal characteristics, acute vs. chronic, sensorial characteristics, existence of neuropathic component, existence of hyperalgesia), and their impact of QoL, depression and anxiety
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- any patient with Crohn disease in remission or relapse period age ≥ 18 yo.
Exclusion Criteria:
- No exclusion criteria beside no informed consent and inadequate French language skills
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain intensity in patients with Crohn Disease (CD)
기간: During the last 30 days
|
Pain intensity measured using a 100 mm visual analog scale (0 = no pain; 100 the worst imaginable pain)
|
During the last 30 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Presence of hyperalgesia
기간: During the last 30 days
|
Using Von Frey hairs (size 2.83 for dectection of allodynia; size 6.65 for temporal somation)
|
During the last 30 days
|
|
Search for a neuropathic component of pain
기간: During the last 30 days
|
Using DN-4 questionnaires : a score ≥ 3 = neuropathic component
|
During the last 30 days
|
|
Investigation of the impact of pain on depression and anxietey
기간: During the last 30 days
|
Using the HAD (Hospital anxiety depression) scale : as score > 11 = true symptomatology
|
During the last 30 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-François Brichant, M.D., CHU Liege, Domaine du Sart Tilman, Liege, Belgium
간행물 및 유용한 링크
일반 간행물
- Srinath A, Young E, Szigethy E. Pain management in patients with inflammatory bowel disease: translational approaches from bench to bedside. Inflamm Bowel Dis. 2014 Dec;20(12):2433-49. doi: 10.1097/MIB.0000000000000170.
- Morrison G, Van Langenberg DR, Gibson SJ, Gibson PR. Chronic pain in inflammatory bowel disease: characteristics and associations of a hospital-based cohort. Inflamm Bowel Dis. 2013 May;19(6):1210-7. doi: 10.1097/MIB.0b013e318280e729.
- Zeitz J, Ak M, Muller-Mottet S, Scharl S, Biedermann L, Fournier N, Frei P, Pittet V, Scharl M, Fried M, Rogler G, Vavricka S; Swiss IBD Cohort Study Group. Pain in IBD Patients: Very Frequent and Frequently Insufficiently Taken into Account. PLoS One. 2016 Jun 22;11(6):e0156666. doi: 10.1371/journal.pone.0156666. eCollection 2016.
- Hardy PY, Fikri J, Libbrecht D, Louis E, Joris J. Pain Characteristics in Patients with Inflammatory Bowel Disease: A Monocentric Cross-Sectional Study. J Crohns Colitis. 2022 Sep 8;16(9):1363-1371. doi: 10.1093/ecco-jcc/jjac051.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
-
Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
-
Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)