Immune-Pineal Axis Function in Chronic Tension-Type Headache
Immune-Pineal Axis Function in Chronic Tension-Type Headache: Noradrenergic Modulation and the Effect of Electroacupuncture
연구 개요
상세 설명
Tension-type headache can be defined as a constant sensation of pressure or heaviness, and is a highly-prevalent condition in the health services. The objective of the present study is to investigate the function of the immuno-pineal axis in chronic tension headache, focussed on the neuro-immune regulatory dysfunction. In addition, the effect of neuro-stimulation (electroacupuncture) on the function of this axis will also be studied.
This is a clinical Trial study, randomised, in parallel, cross-over with a blinded assessor, and with a sham placebo control.
The study will be carried out in the Clinical Research Outpatient Clinic of the Hospital de Clínicas de Porto Alegre (HCPA), with women aged between 18 and 60 years old. The participants will respond to questionnaires at the beginning and end of each therapeutic intervention, with 24-hour urine, blood and saliva collection. The therapeutic intervention will include: 10 electroacupuncture sessions and 10 sham placebo sessions. The measurements taken will be: quality of life, depression, impact of headache on daily life, sleep quality, chronotropic types, immuno-inflammatory mediators, levels of 6-sulfatoxymelatonin, and salivary cortisol.
Through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and sleep, as well as central autonomic regulation. Evidence for these hypotheses will support a minimally-invasive treatment, with few side-effects and a low cost.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90035-003
- Hospital de Clinicas e Porto Alegre (HCPA)
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women,
- Aged between 18 and 60 years old,
- Providing informed consent to participate in the study,
- Literate,
- Clinical diagnosis of Chronic Tension-Type Headache according to the International Headache Society.
Exclusion Criteria:
- Psychiatric or neurologic disorder that unable patient to consent and follow study protocol,
- De-compensated systemic disease,
- Chronic inflammatory disease (e.g. Systemic Lupus Erythematous, Rheumatoid Arthritis),
- HIV.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Electroacupuncture
All patients will receive 10 electroacupuncture sessions.
|
Eletroacupuncture performed using acupuncture needles.
다른 이름들:
|
|
가짜 비교기: Placebo Sham
All patients will receive 10 placebo sham sessions.
|
Placebo Sham is performed using electrodes, without electrical stimulation.
Lights and sounds were identical to active treatment.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Visual Analogue Scale (VAS)
기간: An expected average of 3 months. (At baseline and at the end of each intervention period).
|
The intensity of pain was measured by a 10 cm VAS.
The scores range from no pain (zero) to the worst possible pain (10 cm).
|
An expected average of 3 months. (At baseline and at the end of each intervention period).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Headache Impact Test (HIT-6)
기간: An expected average of 3 months. (At baseline and at the end of each intervention period).
|
This test was developed in 2004, and has equivalent psychometric properties in nine languages, including Portuguese.
It consists of six questions that assess the impact of headache on the ability to work, study, home and in social situations.
|
An expected average of 3 months. (At baseline and at the end of each intervention period).
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Biomarkers (BDNF nd TNF)
기간: An expected average of 3 months. (At baseline and at the end of each intervention period).
|
The BDNF and the TNF will be measured by ELISA.
|
An expected average of 3 months. (At baseline and at the end of each intervention period).
|
공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Wolnei Caumo, MD, PhD, Hospital de Clínicas de Porto Alegre
- 수석 연구원: Mônica Chassot, Federal University of Health Science of Porto Alegre
- 수석 연구원: Francislea C. Sehn, Federal University of Health Science of Porto Alegre
- 수석 연구원: Rafael Vercelino, Federal University of Health Science of Porto Alegre
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .