Quantitative Sensory Testing to Predict Progression to Nociplastic Pain in Carpal Tunnel Syndrome: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression to Nociplastic Pain
研究概览
简要总结
This study aims to investigate the predictive value of quantitative sensory testing (QST) in identifying patients with carpal tunnel syndrome (CTS) who are at risk of developing nociplastic pain.
详细描述
The study will recruit 120 adults diagnosed with CTS and conduct baseline QST measures. The progression to nociplastic pain will be assessed over a one-year follow-up period to determine the predictive value of QST measures.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-60
- •Clinical diagnosis of CTS based on presence of parasthesias and/or pain in median nerve distribution, positive Phalen's test and/or Tinel's sign, and nocturnal symptoms
- •Electrodiagnostic evidence of median neuropathy at the wrist:
- •Prolonged median motor distal latency >4.2 ms
- •Prolonged median sensory latency >3.4 ms
- •Symptom duration between 6 months and 2 years (to exclude very early or very late stages)
- •Pain severity of ≥5 on 0-10 numerical rating scale
- •No evidence of thenar muscle atrophy on physical exam
- •No prior surgery or fracture of the affected wrist
- •No evidence of comorbid diabetes mellitus, cervical radiculopathy, polyneuropathy, or other neuromuscular disorders
排除标准
- •Diabetes mellitus, as a common cause of polyneuropathy, which can confound QST measures.
- •Cervical radiculopathy or other upper limb neuropathies, which can cause overlapping sensory symptoms and signs.
- •History of wrist fracture or surgery, which may cause structural abnormalities affecting nerve function.
- •Pregnancy, due to physiological changes that can affect nerve function.
- •Patients with severe thenar muscle atrophy, indicating long-standing severe median neuropathy.
- •Patients unable to provide informed consent or comply with study procedures.
结局指标
主要结局
Progression to Nociplastic Pain
时间窗: 1 year from the start of the study
Development of nociplastic pain in patients with carpal tunnel syndrome, as identified by a Kosek, by clinical criteria suggest by E., Clauw, D., Nijs, J., Baron, R., Gilron, I., Harris, R. E., ... \& Sterling, M. (2021). Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain, 162(11), 2629-2634.
次要结局
- Change in Quantitative Sensory Testing (QST) Measures(Changes in QST at baseline and 1 year)
研究者
Mohamed Magdy ElMeligie
Lecturer of Physical Therapy and Director of Electromyography Lab
Ahram Canadian University