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临床试验/NCT07281573
NCT07281573已完成不适用

The Effect of Exercises on the Shear Wave Velocity of the Median Nerve and the 3rd FDS in Patients With Carpal Tunnel Syndrome

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2025年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
2
主要终点
Ultrasound shear wave velocity

研究概览

简要总结

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy, and studies suggest exercises can be used for symptom management. Purpose: The study evaluated the impact of exercise protocols on the ultrasound shear wave velocity (SWV) of the median nerve and 3rd flexor digitorum superficialis (3rd FDS) in participants with mild to moderate CTS. Methods: Ninety-one CTS participants (79 females) were divided into control group, nerve and tendon gliding exercise group, and strength exercise group. The participants followed a three-week daily exercise plan. The SWV measurements were conducted using Canon Aplio i800 ultrasound and linear probe (LX18i5). Regions of interest were positioned within the nerve epineurium and hyperechogenic borders of the 3rd FDS tendon. The pre- and post-intervention SWV values were recorded. Results: In preliminary results on a smaller sample, trends indicated reduced SWV in both the median nerve and 3rd FDS in the nerve and tendon gliding group and reduced SWV in the median nerve in the strengthening group. No measurable change was observed in the 3rd FDS in strength group and in the control group. Conclusion: Trends suggest specific exercises may decrease stiffness in the median nerve and 3rd FDS in CTS participants.

详细描述

The aim of the study is to evaluate the impact of exercise protocols on the US SWV of the median nerve and 3rd FDS in the carpal tunnel in participants with mild to moderate CTS. The investigators aim to establish US SWE as a potential method to monitor nerve and tendon SWE changes due to exercise intervention and consequently show the effect of different exercise interventions on mechanical changes within the carpal tunnel.

This study was conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The study protocol adhered to the CONSORT guidelines for reporting randomized trials and received approval from the National Medical Ethics Committee of the Republic of Slovenia (protocol number 0120-25/2023/3). Written informed consent was obtained from all participants prior to enrolment. Participants with suspected CTS were prospectively recruited from April 2025 to October 2025 at a single tertiary referral centre: the Institute of Clinical Neurophysiology, University Medical Centre Ljubljana, Slovenia. The inclusion criteria were as follows: (1) age between 24 and 78 years; (2) affirmative responses to at least two of the following three questions: (a) tingling in at least two of the first four digits; (b) symptoms worsening at night or in the morning; (c) symptom relief with hand flicking (flick sign); and (3) electrodiagnostic (EDx) confirmation of mild to moderate median nerve entrapment neuropathy at the wrist. Exclusion criteria were: (1) previous wrist fracture or surgery; (2) polyneuropathy, motor neuron disease, cervical radiculopathy, or brachial plexopathy; (3) structural abnormalities within the carpal tunnel; and (4) tenosynovitis. The investigators conducted a prospective, randomized, three-arm, parallel-group trial with a 1:1:1 allocation ratio to Gliding, Strength, and Control groups. Outcome measures were assessed before and after the intervention. Randomization of participants into two intervention groups and one control group was performed using the Clinical Trial Randomization Tool developed by the National Cancer Institute. The same tool was applied in participants with bilateral CTS to randomly determine which hand was assessed and included in the study.

The intervention lasted for 3 weeks and was performed once daily. The control group did not participate in any training program and was instructed to continue with their usual daily and work-related activities. Ultrasound SWV measurements were performed by the primary investigator, who was blinded to participants' CTS diagnoses. A second investigator conducted the randomization process and scheduled participants' appointments; consequently, the primary investigator remained unaware of participant details prior to the SWV assessment.

Participants randomized to Gliding or Strength group received written description of exercises supported with images. Nerve and tendon gliding exercises targeted flexion and extension of the index and ring fingers, complemented by wrist flexion and extension movements. These exercises were taken from literature and designed to promote median nerve and tendon gliding through the carpal tunnel, thereby reducing entrapment of the median nerve and the 3rd FDS tendon.

Strengthening exercises involved movement patterns (finger and wrist flexion and extension) similar to the nerve and tendon gliding exercises; however, external resistance was introduced through the use of hand therapy resistance balls or low-weight dumbbells ranging from 0.5 to 2.0 kg depending on the participant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

Ultrasound SWV measurements were performed by the primary investigator, who was blinded to participants' CTS diagnoses. A second investigator conducted the randomization process and scheduled participants' appointments; consequently, the primary investigator remained unaware of participant details prior to the SWV assessment.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 24 and 78 years
  • tingling in at least two of the first four digits;
  • symptoms worsening at night or in the morning;
  • symptom relief with hand flicking (flick sign);
  • electrodiagnostic (EDx) confirmation of mild to moderate median nerve entrapment neuropathy at the wrist.

排除标准

  • previous wrist fracture or surgery;
  • polyneuropathy,
  • motor neuron disease,
  • cervical radiculopathy,
  • brachial plexopathy
  • structural abnormalities within the carpal tunnel
  • tenosynovitis

结局指标

主要结局

Ultrasound shear wave velocity

时间窗: SWV will be measured pre and post intervention in all three groups. There will be 3 weeks between pre and post intervention ultrasound SWV measurement

SWV in m/s will be measured using ultrasound and linear probe i18Lx3. Three consequtive readings will be saved and the median value will be further procesed in statystical analysis

次要结局

未报告次要终点

研究者

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

Jošt Peterca

asst. Jošt Peterca MSc, researcher

University Medical Centre Ljubljana

研究点 (2)

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