Somatosensory Profiles in Individuals With Persistent Musculoskeletal Pain and Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Conditioned pain modulation (CPM)
研究概览
简要总结
This study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (IBD) and experiences of ongoing musculoskeletal (MSK) pain. Previous results and current literature suggest that MSK pain in IBD may be influenced by hypersensitivity of the central nervous system, termed central sensitization. However, specific mechanisms contributing to pain experiences are unknown. Therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and IBD features to sensory profiles. This study hypothesizes that IBD patients with MSK pain will demonstrate altered sensory function, and IBD/psychosocial features will be associated with altered sensory functioning and worse pain experiences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18 years of age or older)
- •Clinical diagnosis of IBD or healthy control
排除标准
- •Participants with IBD (with and without MSK pain) will be excluded if they report any of the following:
- •pregnancy
- •current history of drug or alcohol abuse
- •any condition resulting in altered sensation such as: nerve injuries, neurological conditions (e.g. stroke, multiple sclerosis, and Parkinson's disease)
- •surgery within the last 3 months
结局指标
主要结局
Conditioned pain modulation (CPM)
时间窗: Baseline
CPM in the present study includes: PPT of tibialis anterior (test stimulus) and cold pressor test (CPT) to the contralateral hand (conditioning stimulus). PPT will be performed and recorded as descried above prior to and immediately following CPT. CPT: Hand will be submerged in an ice bath with the temperature maintained below 3°C for a maximum of 2 minutes. Participants will withdraw their hand when the pain perceived becomes intolerable or 2 minute maximum is reached. Participants will give a numeric pain rating (0-100) at the time of hand removal. Total immersion time (minutes:seconds) and pain rating will be recorded for CPT. CPM (primary outcome) will be defined as the absolute numerical difference of PPT after minus before the CPT, with positive values indicating successful pain modulation.
Pain pressure threshold (PPT)
时间窗: Baseline
PPT will be assessed using an electronic handheld algometer (Wagner Force One™ FDIX) in: 1) low back (local), and 2) contralateral tibialis anterior. Individuals in "IBD with MSK pain" group will undergo an additional PPT assessment related to the region identified as their "main" area of MSK pain. PPT will be assessed by a series of 3 ascending stimulus intensities given as a slowly increasing ramp (50 kilopascal (kPa/s)) from 0 to a maximum pressure of 1000 kPa. Pressure corresponding to the moment when participants identify that the sensation of pressure alone changing to one of pressure and pain, will be recorded for each trial. PPT for each region will be described as the mean of three trials in kPa. Decreased values indicates hypersensitivity of the nervous system.
Temporal summation (TS)
时间窗: Baseline
Mechanical TS in the present study will be assessed by a wind-up-ratio (WUR) of the volar aspect of the non-dominant arm using a Semmes-Weinstein monofilament (no. 6.45). The perceived intensity of a single stimulus will be compared with that of a series of 10 repetitive stimuli of the same physical intensity. Participants will be asked to give a pain rating for the single stimulus and a pain rating for the series of 10 stimuli as a whole, using a '0-100' numerical rating scale. This procedure will be repeated for three trials, with 1 minute between trials, and performed at different areas of the volar forearm for each trial. The mean pain rating of the 10 series divided by the mean pain rating of the single stimuli will be calculated as WUR. Higher scores indicate greater mechanical TS, indicating an increase in central sensitivity or facilitation.
次要结局
- Health-related quality of life (HRQOL) - EQ-5D(Baseline)
- Central sensitization inventory (CSI)(Baseline)
- Positive and Negative Affective Schedule (PANAS)(Baseline)
- MSK pain intensity - numeric rating scale(Baseline)
- Abdominal pain: Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a short form(Baseline)
- Abdominal pain intensity: numeric rating scale(Baseline)
- Situational Catastrophizing Questionnaire (SCQ)(Baseline)
- 10-item Perceived Stress Scale (PSS-10)(Baseline)
- Hospital Anxiety and Depression Scale (HADS)(Baseline)
- MSK pain location(Baseline)
- MSK pain - PROMIS Pain Interference 4a(Baseline)
- Health-related quality of life (EQ-5D)(Baseline)
- IBD type(Baseline)
- Total comorbidity score(Baseline)
- IBD duration(Baseline)
研究者
Corey Siegel
Section Chief, Gastroenterology and Hepatology
Dartmouth-Hitchcock Medical Center