此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Measurement of Muscle Strength Using a Manual Muscle Tester in Women With Electrophysiologically Confirmed Carpal Tunnel Syndrome

2026年9月28日 更新者:Bezmialem Vakif University

The aim of this cross-sectional study is to evaluate muscle strength in female patients with carpal tunnel syndrome (CTS) who have only sensory involvement detected on electromyography. Muscle strength will be assessed using the "Lafayette Manual Muscle Tester®".

The main questions of the study are:

  1. Is there a difference in muscle strength between healthy individuals and female patients with carpal tunnel syndrome?
  2. Is there a difference in muscle strength between female patients with carpal tunnel syndrome who have only sensory involvement and those who have both sensory and motor involvement?
  3. Are there differences in the strength of thumb palmar abduction and adduction, radial adduction and abduction, thumb flexion, extension and opposition, and flexion of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints of the fingers between these groups?

The investigators will measure the muscle strength associated with these movements using the "Lafayette Manual Muscle Tester®" in order to objectively evaluate motor involvement in female patients with carpal tunnel syndrome and to compare muscle strength between healthy individuals and patients with different degrees of electrophysiological involvement.

研究概览

地位

尚未招聘

详细说明

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and develops as a result of compression of the median nerve within the carpal tunnel at the level of the wrist. It manifests with pain in the wrist and hand, paresthesia and sensory loss in the dermatome of the median nerve in the hand (paresthesias may sometimes extend to the entire hand and even the arm), as well as weakness in thumb abduction, opposition, and flexion, and flexion of the second and third fingers at the metacarpophalangeal joints. The carpal tunnel is a structure located in the proximal palmar region of the wrist, bounded superiorly by connective tissue and the carpal ligament and inferiorly by the carpal bones, through which the median nerve and flexor tendons pass. The motor fibers of the median nerve passing through the carpal tunnel innervate the thenar muscle group (abductor pollicis brevis, flexor pollicis brevis-superficial head, and opponens pollicis), as well as the first and second lumbrical muscles; its sensory fibers provide innervation to the first three digits and the lateral aspect of the fourth digit

Among the risk factors for this common entrapment neuropathy are female sex, obesity, age, occupations and activities involving repetitive rotational and flexion movements of the hand, trauma, and pregnancy . The diagnosis of CTS is primarily clinical. It is established based on typical signs and symptoms, such as hand and wrist pain, symptoms occurring or worsening at night, relief with shaking of the hand, and positive Tinel and Phalen signs. Electrophysiological studies (nerve conduction studies and needle electromyography) are used both to confirm the diagnosis of CTS and to exclude other conditions included in the differential diagnosis, such as polyneuropathy, hereditary neuropathy with liability to pressure palsies, and C6 radiculopathy. Nerve ultrasonography (US) is also valuable for demonstrating compression of the median nerve within the carpal tunnel and can additionally identify other lesions affecting the nerve at this level, such as a ganglion cyst .

Although patients with CTS may not have overt motor involvement, clumsiness and impairment of fine motor functions are frequently observed. It has been suggested that these findings may result from impaired sensory feedback required for motor coordination or from a central sensory-motor integration disorder

Changes in muscle strength in patients with sensory involvement only on electromyography can be measured precisely using hand-held dynamometers . Hand-held dynamometers have long been used for the objective assessment of muscle strength. In recent years, electronic versions of these devices have been developed. In our study, muscle strength will be objectively assessed using the "Lafayette Manual Muscle Tester®" by measuring the force exerted by the relevant muscle group during isometric contraction against the measurement pad of the device. Quantitative parameters, including peak force, mean force, and time-dependent changes in force, will be obtained.

研究类型

观察性的

注册 (估计的)

42

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Patients who applied to the Bezmialem Vakıf University, Neurology Outpatient Clinic appropriate for eligibility criteria will be enrolled

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Female sex.
  • Unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria.
  • Sensory or motor involvement on electromyography (EMG).
  • Paresthesia, pain, or numbness in the area of the hand innervated by the median nerve for more than 3 months.
  • Presence of Tinel's and Phalen's signs.

Exclusion Criteria:

  • History of hand surgery.
  • Severe cardiovascular disease.
  • Neuromuscular disease affecting muscle strength.
  • Gout.
  • History of hand trauma.
  • History of rheumatoid arthritis or osteoarthritis of the hand or wrist.
  • Pregnancy.
  • Cervical radiculopathy or any upper extremity neuropathy other than carpal tunnel syndrome.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
CTS-affected hand

Participants with unilateral or bilateral carpal tunnel syndrome according to the Boston Carpal Tunnel Syndrome criteria will be admitted to this group.

Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities.

The comparison of the peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be performed.

Needle electromyography will be performed when necessary to exclude radiculopathy.

Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®).

Healthy Control Group

Participants without carpal tunnel syndrome will be included in this group. Muscle strength of thumb palmar abduction, radial abduction, thumb flexion, extension and opposition, and proximal and distal interphalangeal joint flexion of the fingers will be evaluated using a hand-held dynamometer (Lafayette Manual Muscle Tester®).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
大体时间:1 day

A questionnaire consisting of 11 questions assessing symptom severity and 8 questions assessing functional status. Higher scores indicate greater disease severity. The Turkish version of the questionnaire has demonstrated validity and reliability. Numerical Rating Scale (NRS), A scale in which patients rate their pain on a numerical scale from 0 to 10. Higher scores indicate greater pain intensity.

1 day
Phalen Test
大体时间:1 day

The patient is asked to flex both wrists and hold the dorsal surfaces of the hands together for 60 seconds. The test is considered positive if pain or paresthesia occurs in the areas innervated by the median nerve, including the thumb, second and third fingers, the radial half of the fourth finger, or the forearm.

1 day
Durkan Test
大体时间:1 day

The patient's forearm is placed in supination, and pressure is applied over the median nerve between the thenar and hypothenar eminences for 30 seconds. The test is considered positive if paresthesia or pain is experienced.

1 day
Tinel Test
大体时间:1 day

In the symptomatic hand, the distal portion of the palmaris longus tendon near the palmar aspect of the wrist is gently percussed with a neurological reflex hammer. The test is considered positive if paresthesia or pain is experienced.

1 day
Electrophysiological Tests
大体时间:1 day

Median and ulnar sensory and motor nerve conduction studies will be performed in both upper extremities. The peak latency of the median and ulnar sensory responses with fourth-finger stimulation will be compared. Needle electromyography will be performed when necessary to exclude radiculopathy.1

1 day
Thumb Palmar Abduction
大体时间:1 day

The hand will be stabilized with the dorsal surface facing the table. The thumb will be positioned in maximum palmar abduction, perpendicular to the plane of the palm. The measurement pad of the device will be placed on the radial aspect of the proximal phalanx of the thumb. The patient will be instructed to push against the measurement pad with maximum force.Thumb Palmar Abduction Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb Radial Abduction Muscle Strength
大体时间:1 day

The forearm will be positioned in supination with the palm facing upward. The patient will be instructed to move the thumb away from the palm in the radial direction. The measurement pad will be placed against the radial aspect of the proximal phalanx of the thumb, and the patient will be instructed to perform maximal radial abduction against the pad. Radial Abduction Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb Extension Muscle Strength
大体时间:1 day

The hand will be stabilized with the dorsal surface facing the table, and the patient will be asked to lift the thumb upward in the sagittal plane. The measurement pad will be positioned against the radial aspect of the distal phalanx of the thumb, and the patient will be instructed to push against the pad with maximum force. Thumb Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb Opposition Muscle Strength
大体时间:1 day

The measurement device will be placed in the palm, with the measurement pad positioned at the level of the fifth finger. The patient will be instructed to perform thumb opposition and push against the measurement pad with maximum force. Thumb Opposition Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb IP Flexion Muscle Strength
大体时间:1 day

The measurement device will be stabilized on a flat surface while the patient performs flexion of the thumb interphalangeal (IP) joint. The patient will be instructed to press the fingertip against the measurement pad with maximum force. Thumb IP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Thumb MCP Flexion Muscle Strength
大体时间:1 day

The measurement device will be placed in the palm, with the measurement pad positioned over the third metacarpophalangeal (MCP) joint. The patient will be instructed to perform thumb MCP flexion and push against the measurement pad with maximum force.Thumb MCP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Second Finger PIP Flexion
大体时间:1 day

The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the proximal interphalangeal (PIP) joint of the second finger and press the fingertip against the measurement pad with maximum force. Second finger pıp flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Second Finger DIP Flexion Muscle Strength
大体时间:1 day

The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the distal interphalangeal (DIP) joint of the second finger while the metacarpophalangeal (MCP) and distal interphalangeal (DIP) joints are stabilized and press the fingertip against the measurement pad with maximum force. Second Finger DIP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Third Finger PIP Flexion Muscle Strength
大体时间:1 day

The measurement device will be placed on a flat surface. The patient will be instructed to perform flexion of the proximal interphalangeal (PIP) joint of the third finger and press the fingertip against the measurement pad with maximum force. Third Finger PIP Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.

1 day
Third Finger DIP Flexion muscle strength
大体时间:1 day

The third finger will be positioned with the MCP and PIP joints stabilized. The measurement pad will be positioned against the palmar aspect of the distal phalanx. The patient will be instructed to perform maximal flexion of the DIP joint against the pad.

1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年9月9日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅