Pain Mechanisms in Patients With Bronchiectasis
2019년 1월 29일 업데이트: Víctor Doménech, Universidad San Jorge
Characteristics of Underlying Pain Mechanisms in Patients With Bronchiectasis: a Cross-sectional Study
Pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet.
The aim of the research is to assess the presence of central pain mechanisms in patients with bronchiectasis using the Quantitative Sensory Testing (QST) assumptions.
연구 개요
상세 설명
Background and objective:
Recent findings suggest that pain can play an important role in terms of physical activity limitation in respiratory patients. Nevertheless, pain mechanisms and their clinical impact in patients with bronchiectasis have not been investigated yet. The objective of the observational study is to determine the somatosensorial profile in order to assess the presence of central pain mechanisms in patients with bronchiectasis.
Methodology:
Repeated-measures prospective cross-sectional study. A sample of patients diagnosed with bronchiectasis will be recruited and matched by age and sex with healthy controls. Pressure pain thresholds (PPTs), conditioned pain modulation (CPM) and referral pain will be assessed before and after the Incremental Shuttle Walking test (ISW). Levels of physical activity will be assessed using accelerometry during a 7-days period. Sleep quality (Pittsburgh sleep quality test), level of catastrophizing (Pain Catastrophizing Scale), level of sensitization (Central Sensitization Inventory) and level of anxiety and depression (Hospital Anxiety and Depression) will be assessed. The assessments will be done twice: 1) at baseline; and 2) at 6 months follow-up period.
연구 유형
관찰
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Zaragoza
-
Villanueva de Gállego, Zaragoza, 스페인, 50830
- Universidad San Jorge
-
-
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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Adult patients diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase.
설명
Bronchiectasis Group
Inclusion Criteria:
- Diagnosis of bronchiectasis by high-resolution computed tomography.
- Ability to understand and perform all the clinical procedure.
- Acquisition of informed consent.
Exclusion Criteria:
- Diagnosis or clinical suspicion of cystic fibrosis by genetic test or sweat electrolytes test.
- Diagnosis of rheumatic disease.
- Being on a waiting list for lung transplantation.
- Thoraco-abdominal surgery in the last 6 months.
- Chronic use of pain medication.
Control Group
Inclusion Criteria:
- Healthy subjects matched by age and sex with Bronchiectasis Group's subjects
Exclusion Criteria:
- Be taking pain medication.
- Presence of pain condition or pathology.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Adult subjets
Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase, matched by by sex and age with healthy subjects.
|
개입 없음
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Referred pain area
기간: Baseline
|
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
|
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of body areas affected by referred pain
기간: Baseline
|
Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS
|
Baseline
|
|
Pain intensity after supra threshold pain stimulus (STPS)
기간: Baseline
|
Level of pain in a visual analogue scale from 0 to 10 after STPS
|
Baseline
|
|
Pressure pain thresholds (PPTs)
기간: Baseline
|
Level of pressure tolerated by the patient just before feel pain.
The pressure is done with an algometer (SB-MEDIC Electronics, Solna, Sweden).
PPTS will be assessed bilaterally in infraspinatus, supraspinatus and medial gastrocnemius muscles.
|
Baseline
|
|
PPTs with a Conditioned Pain Modulation (CPM) pressure stimulus
기간: Baseline
|
Level of pressure tolerated by patient just before feel pain.
The conditionated pressure stimulus is preform by a blood pressure cuff.
CPM will be assessed bilaterally in infraspinatus, supraspinatus and medial gastrocnemius muscles.
|
Baseline
|
|
Total physical activity time
기간: 7 days period
|
Total time spent per day in physical activities at different intensities equal or superior to 100 counts per minute (≥100 cpm), obtained by accelerometry (Actigraph gt3x+).
|
7 days period
|
|
Sedentary behaviour time
기간: 7 days period
|
Total time spent per day in physical activities at different intensities inferior to 100 cpm (<100 cpm).
|
7 days period
|
|
Light physical activity time
기간: 7 days period
|
Total time spent per day in physical activities at intensities between 100 and 1951 cpm (100-1951 cpm).
|
7 days period
|
|
Moderate-Vigorous physical activity time
기간: 7 days period
|
Total time spent per day in physical activities at intensities equal or superior to 1952 cpm (≥1952 cpm).
|
7 days period
|
|
Level of catastrophizing
기간: Baseline
|
Punctuation obtained in Pain Catastrophizing Scale (PCS).
It comprises 13 items which focus on thoughts and feelings encountered while experiencing pain.
Each item is scored from 0 (not at all) to 4 (all the time) with a total PCS score range from 0-52 points, where higher scores indicating higher levels of pain catastrophizing.
|
Baseline
|
|
Level of sensitization
기간: Baseline
|
Punctuation obtained in Central Sensitization Inventory (CSI).
CSI assesses 25 health-related symptoms common to Central Sensitivity Syndromes.
Responses are recorded about the frequency of each symptom, with a Likert scale from 0 (never) to 4 (always), resulting in a total possible score of 100.
Higher scores are associated with a higher degree of self-reported symptomology.
|
Baseline
|
|
Level of anxiety and depression
기간: Baseline
|
Punctuation obtained in Hospital Anxiety and Depression (HAD).
The HAD is a 14-item self-report scale measuring the presence of symptoms of both anxiety (seven items) and depression (seven items) during the past week.
Each item is scored from 0 to 3, so the final score for each subscale is between 0 and 21.
The majority of the studies use the cutoffs of 7/8 for possible and 10/11 for probable anxiety or depression.
|
Baseline
|
|
Quality of sleep
기간: Baseline
|
Punctuation obtained in Pittsburgh Sleep Quality Index (PSQI).
The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.
Each sleep component yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction.
Sleep component scores were summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
|
Baseline
|
|
Level of resilience
기간: Baseline
|
Punctuation obtained in Brief Resilience Scale (BRS).
This is a 6-item self-report scale with a 5-point response scale ranging from 1 (strongly disagree) to 5 (strongly agree).
A higher score indicates a higher degree of resilience.
|
Baseline
|
|
Distance in ISW test
기간: Baseline
|
Meters reached in the ISW test.
|
Baseline
|
|
Changes in referred pain area
기간: Baseline and after 6 months follow-up
|
Amount of pixels painted in an electronic body chart (Navigate Pain, Aalborg, Denmark) after supra threshold pain stimulus (STPS) in infraspinatus muscle.
|
Baseline and after 6 months follow-up
|
|
Changes in number of body areas affected by referred pain
기간: Baseline and after 6 months follow-up
|
Body chart is divided in 15 regions and the frequency of pain in each one is registered after STPS
|
Baseline and after 6 months follow-up
|
|
Changes in pain intensity after supra threshold pain stimulus (STPS)
기간: Baseline and after 6 months follow-up
|
Level of pain in a visual analogue scale from 0 to 10 after STPS.
|
Baseline and after 6 months follow-up
|
|
Changes in pressure pain thresholds (PPTs)
기간: Baseline and after 6 months follow-up
|
Level of pressure tolerated by the patient just before feel pain.
The pressure is done with an algometer (SB-MEDIC Electronics, Solna, Sweden)
|
Baseline and after 6 months follow-up
|
|
Changes in Pressure Pain Thresholds (PPTs) with a Conditioned Pain Modulation (CPM) pressure stimulus
기간: Baseline and after 6 months follow-up
|
Level of pressure tolerated by patient just before feel pain.
The conditionated pressure stimulus is preform by a blood pressure cuff
|
Baseline and after 6 months follow-up
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2017년 9월 29일
기본 완료 (예상)
2019년 10월 31일
연구 완료 (예상)
2019년 11월 30일
연구 등록 날짜
최초 제출
2017년 10월 19일
QC 기준을 충족하는 최초 제출
2017년 12월 15일
처음 게시됨 (실제)
2017년 12월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 1월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 1월 29일
마지막으로 확인됨
2019년 1월 1일
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. .
개입 없음에 대한 임상 시험
-
Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
-
Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로
-
Guangzhou Women and Children's Medical Center아직 모집하지 않음NEC - 괴사성 장염
-
Monash UniversityThe Alfred; Melbourne Sexual Health Centre모병매독중국, 호주, 남아프리카, 영국
-
IRCCS San Raffaele모집하지 않고 적극적으로