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Compare the Effect of Radiofrequency (TECAR) and Ultrasound on Sensation, Hand Dexterity, and Quality of Life in Patients With Carpal Tunnel Syndrome.

Radiofrequency Versus Ultrasound on Sensation, Hand Dexterity and Quality of Life in Patients With Carpal Tunnel Syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07700316
Acronym
TECAR
Enrollment
42
Registered
2026-07-14
Start date
2026-08-01
Completion date
2026-12-31
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome (CTS), TECAR, Radiofrequency, Ultrasound, Hand Dexterity, Sensation, Quality of Life

Brief summary

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.

Detailed description

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.

Interventions

DEVICERadiofrequency

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.

DEVICETherapeutic Ultrasound

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

Sponsors

Delta University for Science and Technology
Lead SponsorOTHER
Cairo University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

This study will include forty-two patients, ages 35 to 50, of both sexes who suffer from moderate CTS. The patients will be randomly divided into two groups. * Patients must have had typical CTS symptoms for at least one month. * Cut-off values of VAS are defined between 35 mm and 64 mm. * Patients diagnosed with unilateral moderate idiopathic CTS confirmed by electrophysiological testing (NCS), which confirms moderate CTS by reduced sensory conduction velocity with delayed distal motor latency with a normal CMAP amplitude in the APB muscle, and clinically by positive Tinel's sign and a positive Phalen's test * Body mass index is between 18.5 and 24. 9. Therapeutic Equipment and Tools: TECAR (Transfer Electrical Capacitive and Resistive) therapy and ultrasound therapy are advanced non-invasive therapeutic modalities used in physiotherapy to accelerate tissue healing and pain relief. TECAR therapy uses radiofrequency energy to generate deep endogenous heat, which enhances blood flow.

Eligibility

Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Semmes-Weinstein monofilament testing (SWMFs) is used to find mechanical sensory thresholds on the distal palmar pads of hand digits.six weeks.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)
Handheld dynamometric (HHD)six weeks.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.
Nine-Hole Peg Test (NHPT):six weeksThe 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

Secondary

MeasureTime frameDescription
Boston Carpal Tunnel Questionnaire (BCTQ):six weeks.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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026