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临床试验/NCT06550284
NCT06550284招募中不适用

Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
Quantitative Sensory Testing (QST)

研究概览

简要总结

The diagnosis of carpal tunnel syndrome (CTS) is typically based on clinical findings and confirmatory electrodiagnostic testing. However, electrodiagnostic testing can only assess large A-alpha and A-beta nerve fibers. Quantitative sensory testing (QST) is a series of tests used to assess small nerve fiber changes in the A-delta, c-fibers, and A-beta nerve fibers as well. Previous studies have used QST to assess small nerve fiber changes related to carpal tunnel syndrome and found changes compared to controls. This study will utilize a course of standard physical therapy care and assess for any changes to small nerve fiber activity and how those changes may or may not relate to patient outcomes.

详细描述

Purpose: To assess changes in A-beta, A-deta, and C-fiber function after standard physical therapy interventions in individuals with CTS.

Specific Aim 1 (primary aim): Determine if A-beta, A-deta, and C-fiber functions change following a course of Physical Therapy (PT) in individuals with CTS.

Specific Aim 2 (secondary aim): Describe the relationship between changes in QST and changes in a patient-reported outcome measure after a course of PT in individuals with a clinical diagnosis of CTS.

Specific Aim 3 (secondary aim): Determine if there are differences in A-beta, A-deta, and C-fiber function between the affected and unaffected wrists in individuals with a clinical diagnosis of CTS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • DEERS eligible Age 18-65 Pain and paresthesia in the median nerve distribution A positive Phalen test A positive Tinel test over the carpal tunnel Willing to attend physical therapy

排除标准

  • Nerve root signs consistent with a radiculopathy Suspected radial and ulnar nerve involvement based on monofilament testing Bilateral CTS Previous hand surgery Injections in the upper quarter in the last 6 months Cervical, shoulder, or UE trauma in the last 6 months Currently pregnant or postpartum within the last 6 months No more than minimal care (evaluation and patient education, 1 visit) for the current episode

结局指标

主要结局

Quantitative Sensory Testing (QST)

时间窗: From enrollment until the end of the study at 12 weeks

QST is a test method that measures sensory thresholds for temperature sensations, touch, vibration, and pain and is described in section 10.1. All thermal testing (CDT, WDT, CPT, and HPT) will be performed via the TSA 2 Thermosensory Stimulator.

次要结局

  • Boston Carpal Tunnel Questionnaire (BCTQ)(From enrollment until the end of the study at 12 weeks)
  • Numeric Pain Rating Scale (NPRS)(From enrollment until the end of the study at 12 weeks)

研究者

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

Cortney Shewmaker

Orthopedic Manual Physical Therapy Fellow

Brooke Army Medical Center

研究点 (2)

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