Assessing Central Nervous System Contributions to Accelerate Musculoskeletal Pain Diagnosis and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Central Aspects of Pain Questionnaire
研究概览
简要总结
BACKGROUND: Chronic pain continues for more than 12 weeks despite medication or treatment. Chronic pain is the main symptom of muscle and joint problems, rarely explained by damage to the muscle and joints alone. Activity in the central nervous system (CNS; nerves, spinal cord, and brain) pathways governs our ability to describe pain intensity and our emotional response to pain. Musculoskeletal conditions (e.g., inflammatory arthritis, osteoarthritis, low back pain, fibromyalgia) share altered CNS pathways, acknowledged by recent classifications of 'primary' and 'nociplastic' pain. Clinically useful tools to diagnose and measure activity and reveal abnormalities in these CNS pathways are needed to improve clinical decisions and accelerate new treatment development. Laboratory pain sensitivity testing and brain imaging confirm the CNS as a primary contributor to pain. These assessments are less acceptable or unfeasible for clinical practice. Simpler clinical pain sensitivity assessments are being developed. The investigators simple Central Aspects of Pain (CAP) questionnaire detects some people with pain sensitivity and knee, rheumatoid arthritis or low back pain. Combining the CAP questionnaire reflecting emotional processing and simpler pain sensitivity assessment, combining two different dimensions should be better than either approach alone.
PURPOSE: To optimise diagnosis and measurement of CNS as the primary contribution to chronic musculoskeletal pain by using the CAP questionnaire and simpler pain sensitivity assessments to ensure timely, effective diagnosis and treatment.
OBJECTIVES: 1. Assess the ease, ability and performance of the combined CAP questionnaire and simpler pain sensitivity assessments to identify CNS as the primary contributor to chronic pain across musculoskeletal conditions.
2. Use the CAP questionnaire alone or with substitute measures of activity in CNS pathways, demographic, and clinical variables to indicate pain levels at six and twelve weeks.
3. Understand the relationship between CAP and simpler pain sensitivity assessment with laboratory pain sensitivity assessments as a tool to inform the current CNS activity contributing to pain.
4. Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or over.
- •One for more of the following self-reported diagnoses: fibromyalgia, inflammatory MSK condition (e.g., rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis), low back pain, osteoarthritis.
- •MSK diagnosis and pain onset more than 3 months prior to baseline
- •Self-reported pain levels ≥ 3 on a 0 to 10 numerical rating scale where 0 = 'no pain' and 10 = 'worst pain imaginable' on most days in the 3 months before baseline.
- •Ability to give informed consent.
排除标准
- •Terminal/uncontrolled medical or mental health condition that would prevent participants from completing assessments or pose a significant risk to participants or staff.
- •Insufficient understanding of spoken or written English to comply with the requirements of the study protocol.
- •Inability to adhere to the study protocol.
结局指标
主要结局
Central Aspects of Pain Questionnaire
时间窗: Baseline, 6 and 12 weeks
Zero indicates low levels of central aspects of pain, 16 indicated high central aspects of pain
Simpler pain sensitivity measures
时间窗: Baseline
Simpler pain sensitivity will be assessed as a combination of the point at pressure changes from a feeling of pressure to a feeling of pain or discomfort (kg), temporal summation is measured at the difference between one stimuli and ten consecutive stimuli scores from 0-10 of a Visual Analog Scale (0 = no pain or sharpness, 10 = worse pain or sharpness). Conditioned pain modulation will assess the point at which pressure changes to pain or discomfort (kg) when a conditioned stimuli is applied to the contralateral arm. The number of tender sites will be assessed by palpating 18 body sites and scored based on the number of tender sites reported. Conditioned pain modulation will also be assessed based on the number of tender sites reported with and without a conditioned stimuli to the forearm. Low scores indicate low pain sensitivity, high scores indicate high pain sensitivity.
次要结局
- Sleep efficiency(Baseline)
- Central Sensitization Index (CSI)(Baseline, 6 and 12 weeks)
- Fibromyalgia classification criteria(Baseline, 6 and 12 weeks)
- McGill pain(Baseline, 6 and 12 weeks)
- Cognitive Failures Questionnaire (CFQ)(Baseline, 6 and 12 weeks)
- Pittsburgh Sleep Quality (PSQI)(Baseline, 6 and 12 weeks)
- Hospital Anxiety and Depression Scale (HADs)(Baseline, 6 and 12 weeks)
- Self-reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)(Baseline, 6 and 12 weeks)
- Laboratory pain sensitivity(Baseline)
- Health Assessment Questionnaire (HAQ)(Baseline, 6 and 12 weeks)
- Fatigue Impact Scale (FIS)(Baseline, 6 and 12 weeks)
- 36-Item Short Form Survey (SF-36)(Baseline, 6 and 12 weeks)