- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02240303
Pain, Brain and Mobility Study (PBAM)
2016년 2월 16일 업데이트: University of Florida
Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults
The aim of this project will be to document the central and peripheral mechanisms, which may predict clinical pain characteristics and associated physical performance in older adults.
Although chronic pain is common among older adults, there is limited understanding on the processing of pain and the mechanisms by which it affects physical function in these individuals.
The first aim of this study will be to examine predictors of clinical pain in older adults.
These will include a comprehensive somatosensory assessment battery including mechanical and thermal detection and pain thresholds in older adults with and without chronic pain.
The investigators will also assess basal cognitive and physical function to determine their associations with chronic pain.
Finally, brain structure and function will be assessed in these older adults with and without pain.
연구 개요
상태
빼는
상세 설명
The purpose of this research study is to learn more about how pain in older individuals changes the brain and impacts a person's mobility and function.
Pain is influenced by biology (like hormones), psychology (thoughts and feelings), and habits (like sleep or exercise) that may make older adults more likely to have higher or lower levels of pain.
연구 유형
관찰
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
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Older adults
설명
Inclusion Criteria:
- Age 65 years and older
- Willingness to participate in all study procedures
- Cognitively intact as defined by 3MS score > 80
Exclusion Criteria:
- Failure to provide informed consent;
- Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
- Active treatment for cancer or history of cancer in the past year
- Severe cardiac disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;
- Previous stroke with upper and/or lower extremities involvement within the last 6 months
- History of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
- Renal disease requiring dialysis
- Lung disease requiring steroids
- Inability to reliably rate pain intensity
- Current use of tobacco products
- Uncontrolled hypertension (BP of greater than 150/99 mm Hg)
- Serious systemic disease that restrict normal daily activities
- Neurological problems with significant changes in somatosensory and pain perception at the intended stimulation sites,
- Uncontrolled psychiatric condition (e.g., experiencing symptoms of schizophrenia, bipolar disorder, etc.) or hospitalization within the preceding year for psychiatric illness
- Daily use of narcotic medication
- Lower extremity amputation
- Uncontrolled diabetes (self-reported medication use and/or HA1C value)
- A known diagnosis of dementia
- Inability to communicate because of severe hearing loss or speech disorder;
- Severe visual impairment, which would preclude completion of the assessments and/or intervention.
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 |
개입 / 치료 |
|---|---|
|
Chronic Pain Group
Participants that experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done.
In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
|
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
|
|
No Chronic Pain Group
Participants that do not experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done.
In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
|
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Brain magnetic resonance imaging (MRI)
기간: Baseline and 12 months later
|
Differences in the MRI on the brain scans of participants with greater pain severity
|
Baseline and 12 months later
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Inflammatory markers in blood samples
기간: Baseline
|
To test the markers of pro-inflammatory (IL-1b, tumor necrosis factor (TNF-a)) and anti-inflammatory (IL-4, IL-10) with participants more sensitive to pain than the ones less sensitive to pain.
|
Baseline
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mobility (gait speed)
기간: Baseline and 12 months
|
Inverse dynamics will be used to calculate gait speed.
|
Baseline and 12 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Yenisel Cruz-Almeida, MSPH, PhD, University of Florida
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
2015년 4월 1일
기본 완료 (실제)
2015년 4월 1일
연구 완료 (실제)
2015년 4월 1일
연구 등록 날짜
최초 제출
2014년 9월 2일
QC 기준을 충족하는 최초 제출
2014년 9월 11일
처음 게시됨 (추정)
2014년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 2월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 2월 16일
마지막으로 확인됨
2016년 2월 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. .
Clinical Pain에 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)