Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 70
- 主要终点
- Boston Carpal Tunnel Syndrome Symptom Severity Score
研究概览
简要总结
70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptoms of CTS for more than 3 months
- •classic or probable CTS according to Katz' hand diagram (2, 27)
- •clinical signs of unilateral CTS with a positive Tinel's and Phalen's test
- •age between 18 and 70 years
- •nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side
- •no contraindications for MR examinations.
排除标准
- •bilateral symptoms
- •having been operated for CTS previously
- •prior wrist or carpal fracture
- •thyroid disease
- •rheumatoid arthritis
- •neurological disease
- •drug abuse
- •complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.
研究组 & 干预措施
EMLA®
adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity
干预措施: EMLA® adjuvant (Other)
EMLA®
adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity
干预措施: Sensory training (Behavioral)
Skin cream
skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training
干预措施: Sensory training (Behavioral)
结局指标
主要结局
Boston Carpal Tunnel Syndrome Symptom Severity Score
时间窗: 8 weeks
score between 1 and 5, with higher scores indicating worse symptoms or function
functional MRI activation affected vs healthy side (more activation voxels means more active brain area)
时间窗: 8 weeks
The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)
次要结局
- quick-DASH upper extremity symptom score(8 weeks)
- 2 Point Discrimination (2PD)(8 weeks)
- Sensory conduction velocity(8 weeks)
- Sensory conduction amplitude(8 weeks)
- functional MRI dig 1+2(8 weeks)
- functional MRI dig 5(8 weeks)