跳至主要内容
临床试验/NCT05915611
NCT05915611招募中不适用

Evaluating the Effectiveness of a Combined Physical and Psychological Intervention in Carpal Tunnel Syndrome Patients With Nociplastic Pain: A Randomized Controlled Trial

Ahram Canadian University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
Pain intensity using the Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

To assess the effectiveness of a combined physical and psychological intervention in reducing pain and improving function in carpal tunnel syndrome patients with nociplastic pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 25-65 years
  • •Both sexes
  • •Diagnosis of carpal tunnel syndrome based on clinical examination and nerve conduction studies
  • •Presence of nociplastic pain as determined by the Central Sensitization Inventory (CSI) with a score ≥40
  • •Positive tinel and phalen sign.

排除标准

  • •Previous carpal tunnel release surgery
  • •Other musculoskeletal or neurological disorders affecting the upper extremity

研究组 & 干预措施

Intervention group

Experimental

Participants will receive a twelve-week combined physical and psychological intervention.

干预措施: Combined physical and psychological intervention (Other)

Control group

Active Comparator

Participants will receive a twelve-week of standard care of splinting, tendon and nerve gliding exercises.

干预措施: Standard care (Other)

结局指标

主要结局

Pain intensity using the Numeric Pain Rating Scale (NPRS)

时间窗: Changes in pain intensity at baseline, 6 weeks, 12 weeks.

Median nerve sensory distal latency

时间窗: Changes in Median nerve sensory distal latency at baseline, 6 weeks, 12 weeks.

Functional ability using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire

时间窗: Changes in Functional ability at baseline, 6 weeks, 12 weeks.

Median nerve motor distal latency

时间窗: Changes in Median nerve motor distal latency at baseline, 6 weeks, 12 weeks.

次要结局

  • Pain catastrophizing using the Pain Catastrophizing Scale (PCS)(Changes in Pain Catastrophizing Scale (PCS) at baseline, 6 weeks, 12 weeks.)
  • Fear of movement using the Tampa Scale for Kinesiophobia (TSK)(Changes in Tampa Scale for Kinesiophobia (TSK) at baseline, 6 weeks, 12 weeks.)
  • Grip strength measured using a hand dynamometer(Changes in Grip strength at baseline, 6 weeks, 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

研究点 (1)

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