Compare the Effect of Radiofrequency (TECAR) and Ultrasound on Sensation, Hand Dexterity, and Quality of Life in Patients With Carpal Tunnel Syndrome. (TECAR)
2026年7月27日 更新者：Delta University for Science and Technology
Radiofrequency Versus Ultrasound on Sensation, Hand Dexterity and Quality of Life in Patients With Carpal Tunnel Syndrome
The purpose of the current study is to:
Compare the effect of radiofrequency (TECAR) therapy and ultrasound on sensation, manual dexterity, and quality of life in individuals diagnosed with carpal tunnel syndrome (CTS). The study also correlates sensation, hand dexterity, and quality of life in patients with carpal tunnel syndrome.
研究概览
详细说明
Carpal tunnel syndrome (CTS) is a prevalent compressive peripheral neuropathy caused by the median nerve's entrapment in the wrist's carpal tunnel, primarily affecting the dominant hand due to frequent use and anatomical factors.
Typically occurring between ages 30 and 65, with a mean onset age of 40.42 years, CTS accounts for about 90% of upper-limb entrapment neuropathies and affects 1-6% of the general population.
Patients often experience significant challenges in hand dexterity that hinder their ability to perform various tasks, particularly those requiring fine motor control; up to 50% report dropping objects, attributed to challenges in grip strength and sensing.
Therapeutic approaches such as TECAR therapy and therapeutic ultrasound deliver deep heat and mechanical effects to affected tissues, aiming to alleviate pain, reduce pain intensity, improve joint range of motion, stimulate and accelerate tissue healing, and enhance both functional outcomes and quality of life.
These modalities have demonstrated efficacy in promoting tissue healing and facilitating functional recovery across various musculoskeletal conditions.
Although current research on the application of TECAR therapy to neuropathic conditions is limited, emerging evidence suggests that it may improve nerve conduction and reduce neuropathy symptoms, particularly in cases such as diabetic peripheral neuropathy.
Further studies should establish the potential of TECAR therapy for managing peripheral entrapment neuropathies and neuropathic pain.
Assessment instruments including the Semmes-Weinstein monofilament test (SWMFs), Nine-Hole Peg Test (NHPT), Handheld Dynamometry (HHD), and the Arabic version of the Boston Carpal Tunnel Questionnaire (BCTQ) are utilized to ascertain mechanical sensory thresholds, evaluate manual dexterity, and assess the coordinated functions of intrinsic and extrinsic hand muscles via grip strength measurements.
The questionnaire is utilized to evaluate symptoms of carpal tunnel syndrome (CTS) and associated functional impairments, thereby offering a thorough assessment of sensory and motor hand functions concurrently.
研究类型
介入性
注册 (估计的)
42
阶段
- 不适用
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。
学习地点
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Gamasa、埃及
- Faculty of Physical Therapy Delta University
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接触：
- MANAR H Elhadidy, Bachelor's degree in PT
- 电话号码：0201003951547
- 邮箱：manar.elhadidy@deltauniv.edu.eg
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接触：
- HEND M ELsharkawy, Doctor of Physical Therapy
- 电话号码：0201006111965
- 邮箱：Hend.Elsharkawy@deltauniv.edu.eg
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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
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
The patients will be selected according to the following criteria:
- Adults aged 35 to 50 years.
- Presence of typical CTS symptoms for at least one month.
- Cutoff values of VAS are defined between 35 mm and 64 mm.
- Patients were diagnosed with moderate carpal tunnel syndrome clinically by physical examination (positive Phalen's test and Tinel's sign) and confirmed by an electrodiagnostic study (EDX) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less and with sensory distal latency more than 3.6 ms and less than 4 ms and a normal CMAP amplitude in the APB muscle.
- Body mass index from 18.5 to 24.9. and ability and willingness to provide informed consent and comply with the study protocol.
Exclusion Criteria:
- Participants will be excluded if they meet any of the following criteria:
- Severe carpal tunnel syndrome requires surgical intervention.
- Presence of systemic diseases associated with CTS, such as diabetes mellitus, rheumatoid arthritis, hypothyroidism, or other inflammatory disorders.
- Pregnancy.
- History of fractures, trauma, or surgery in the wrist or hand region.
- Corticosteroid injection in the carpal tunnel within the last three months.
- Use of wrist splints or other CTS treatments in the past three months.
- Presence of peripheral neuropathy or other neurological disorders affecting the upper limb.
- Burns or skin lesions in the hand or forearm area.
- Presence of pacemakers, metal implants, prostheses, or intrauterine devices (IUDs) that may interfere with electrotherapy modalities.
- Peripheral vascular diseases affect the upper limb.
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Group (GI)= 21 will be treated by Radiofrequency TECAR Therapy .
Group (GI): 21 patients who will receive radiofrequency for 15 minutes in addition to the selected physical therapy program (exercise for 45 min) for three sessions weekly for six weeks.
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Radiofrequency (TECAR) therapy is a non-invasive, non-ablative treatment that uses electromagnetic energy to generate endogenous heat, promoting increased blood flow and tissue healing in both superficial and deep tissues.
With a long wavelength and low frequency (300 KHz to 1 MHz), it can penetrate deeply into muscles, tendons, and bones, making it suitable even in acute conditions.
TECAR operates in two modes: capacitive (targeting soft tissues rich in electrolytes) and resistive (targeting high-resistance tissues like bones and tendons).
Transfer energy capacitive and resistive therapy promotes natural body repair by reducing motor recovery time.
It uses diathermia with electromagnetic energy to raise tissue temperature, causing ion flow and micro-hyperemia.
This process releases pain-relieving substances, enhances blood flow, boosts immune defenses, and stimulates tissue regeneration.
其他名称：
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实验性的：Group (GII)= 21 will be treated by Ultrasound Therapy.
Group (II): 21 patients who will receive US for 15 minutes in addition to the selected physical therapy program (exercise for 45 min) for three sessions weekly for six weeks.
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The ultrasonic waves enhance healing by augmenting local vascularity and improving several features, including energy absorption capacity.
maximum tensile rupture resistance, enhanced collagen synthesis, fibroblast proliferation, release of growth factors induced by mast cell degranulation, and better platelet and macrophage responsiveness, anticipating the proliferative and remodeling phases.
Continuous ultrasound at 1 MHz, possessing a half-value depth of roughly 2.3 cm, is commonly employed for the treatment of deep tissues situated between 2.3 and 5 cm in depth
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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 |
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Semmes-Weinstein monofilament testing (SWMFs) is used to find mechanical sensory thresholds on the distal palmar pads of hand digits.
大体时间：six weeks.
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Semmes-Weinstein Monofilament tests (SMWs): The SWM test will be evaluated as a valid and reliable instrument for determining mechanical sensory thresholds.
(Touch Test Complete Hand Kit) is used to assess tactile sensory thresholds on the distal palmar pads of hand digits.
Each digit and the palm are tested three times, applying sufficient force for 1.5 seconds.
The monofilament kit will contain five monofilaments, each representing a specific sensory threshold: 2.83 (normal), 3.61 (diminished light touch), 4.31 (diminished protective sensation), 4.56 (loss of protective sensation), and 6.65 (loss of deep pressure sensation).
The numeric value will represent the logarithm of 10 times the force in milligrams required to bend the monofilament.
Testing occurs with wrists in a neutral position and again after a 5-minute wrist flexion (Phalen's maneuver)
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six weeks.
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Handheld dynamometric (HHD)
大体时间：six weeks.
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Handheld dynamometric (HHD) is a reliable and valid instrument for hand grip strength, providing a more accurate quantification of strength loss and recovery compared to traditional manual muscle testing (MMT).
They assess the synergistic functions of intrinsic and extrinsic hand muscles through hand grip measurements.
During the evaluation, the patient exerts maximum effort while squeezing the dynamometer, and the resultant force is measured in kilograms or pounds.
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six weeks.
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Nine-Hole Peg Test (NHPT):
大体时间：six weeks
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The Nine-Hole Peg Test The gold standard and most used tool for assessing manual dexterity across various clinical and research settings is a well-established measure of manual dexterity using a square platform with nine holes and corresponding cylinders.
The holes measure 0.71 cm in diameter, while the cylinders have a diameter of 0.64 cm and a length of 3.2 cm.
Patients are instructed to get the 9 cylinders quickly from the storage box, insert them into the designated holes, and thereafter return them to the storage box.
Time is recorded in seconds, and the test is recognized as an effective method for evaluating clinical and functional aspects of CTS
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six weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Boston Carpal Tunnel Questionnaire (BCTQ):
大体时间：six weeks.
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It is a gold standard self-questionnaire for evaluating CTS.
It consists of two independent subscales that evaluate different aspects of the impact of carpal tunnel syndrome.
The Symptom Severity Scale (SSS) involves 11 items, assessing the intensity of pain experienced by the patient both during the day and at night, along with the frequency of painful episodes, numbness, weakness, tingling in the hand, and challenges in grasping and manipulating small things.
And the Functional Status Scale (FSS) assesses functionality across eight categories, including activities such as writing and dressing, using a 5-point scale from 1 (minimal symptoms) to 5 (severe symptoms or inability).
Scores are calculated by averaging responses and are rounded to two decimal places, with higher scores indicating greater handicap.
(Higher scores illustrate a greater degree of disability.)
The Arabic BCTQ has been recommended for both clinical and research applications in Arab populations with CTS.
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six weeks.
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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。
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8月1日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月11日
首次发布 (实际的)
2026年7月14日
研究记录更新
最后更新发布 (实际的)
2026年7月28日
上次提交的符合 QC 标准的更新
2026年7月27日
最后验证
2026年6月1日
更多信息
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.