Pain Phenotyping of Rheumatic Diseases - An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).
研究概览
简要总结
Study Description:
Pain is one of the most common presenting complaints across all rheumatic diseases. Pain is often complex, and can be debilitating with symptoms resulting from a combination of underlying mechanisms, such as nociceptive pain, neuropathic pain, and nociplastic pain. A better characterization of pain in rheumatic diseases is needed to improve pain management. With this study we aim to better phenotype pain in rheumatic diseases by using patient reported outcomes and bedside quantitative sensory testing.
Objectives:
Primary Objective:
To gain a deeper understanding of the distinct pain mechanisms in rheumatic diseases to ultimately improve pain management and treatment outcomes for individuals with these conditions. To compare these measures with age- and sex-matched healthy controls.
Secondary Objectives:
- Explore associations between pain phenotypes and disease activity/progression.
- Investigate the impact of pain phenotypes on patient-reported outcomes (PROs) and quality of life (QOL) in comparison with the age and sex matched healthy volunteers
Endpoints:
Primary Endpoint:
Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST). Establish age- and sex-adjusted norms derived from healthy volunteers.
Secondary Endpoints:
- Explore associations between pain phenotypes and disease activity/progression. Investigate the impact of pain phenotypes on patient-reported outcomes (PROs) and quality of life (QOL).
- Establish an age- and sex-matched baseline for QOL. Patient demographics and standard measures of disease activity and damage are to be collected at the time of performing QST.
详细描述
Study Description:
Pain is one of the most common presenting complaints across all rheumatic diseases. Pain is often complex, and can be debilitating with symptoms resulting from a combination of underlying mechanisms, such as nociceptive pain, neuropathic pain, and nociplastic pain. A better characterization of pain in rheumatic diseases is needed to improve pain management. With this study we aim to better phenotype pain in rheumatic diseases by using patient reported outcomes and bedside quantitative sensory testing.
Objectives:
Primary Objective:
To gain a deeper understanding of the distinct pain mechanisms in rheumatic diseases to ultimately improve pain management and treatment outcomes for individuals with these conditions. To compare these measures with age- and sex-matched healthy controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA
- •Inclusion Criteria for Subjects Suspected or Diagnosed with Rheumatic Diseases
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged 9-85 years
- •Diagnosed or suspected of having a rheumatic disease.
- •Ability of the subject to understand and the willingness to sign a written informed consent document or assent.
- •Must be enrolled in one of the NIAMS protocols (01-AR-0227, 94-AR-0066, 11-AR-0223)
- •To be able to answer PRO questionnaires in either English and/or Spanish languages.
- •Inclusion Criteria Healthy Volunteers
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged 9-85 years
- •No known history of a rheumatic disease or any other chronic medical illness.
- •Ability of the subject to understand and the willingness to sign a written informed consent document or assent.
- •To be enrolled in either of the ongoing NIAMS protocols 01-AR-0227, 94-AR-0066, or 11-AR-
- •To be able to answer PRO questionnaires in either English and/or Spanish languages.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Treatment with investigational drug or other investigational intervention while enrolled in this study.
- •Any physical exam finding that precludes bedside QST.
- •Developmental delay or cognitive impairment that interfere with following or understanding the test instructions.
- •Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded.
- •Any chronic medical condition that may hinder participation in the study as determined by the study PI.
研究组 & 干预措施
Adult patients
Who are suspected or diagnosed with rheumatic diseases
干预措施: Bedside quantitative sensory testing (Device)
Healthy adult volunteer
Who do not have or are not suspected to have rheumatic diseases
干预措施: Bedside quantitative sensory testing (Device)
Minor patients aged 9 and above
Who are suspected or diagnosed with rheumatic diseases
干预措施: Bedside quantitative sensory testing (Device)
Minor healthy volunteer aged 9 and above
Who do not have or are not suspected to have rheumatic diseases
干预措施: Bedside quantitative sensory testing (Device)
结局指标
主要结局
Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST).
时间窗: Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional)
Ratings of stimulus intensity and pain will be captured using a 0 (no sensation/no pain) to 10 (most intense sensation/pain imaginable) numerical rating scale.
次要结局
- Quality of life(Enrollment/baseline visit6 month visit (optional) 12 month visit 18 month visit (optional) 24 month visit Unscheduled visit (optional))