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

NCT07700316 | Not Yet Recruiting

• 1 other identifier: F.P.T2607100
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Semmes-Weinstein monofilament testing (SWMFs) is used to find mechanical sensory thresholds on the distal palmar pads of hand digits.

  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)

  six weeks.

• Handheld dynamometric (HHD)

  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.

  six weeks.

• Nine-Hole Peg Test (NHPT):

  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

  six weeks

Secondary Outcomes (1)

• Boston Carpal Tunnel Questionnaire (BCTQ):

  six weeks.

Study Arms (2)

Group (GI)= 21 will be treated by Radiofrequency TECAR Therapy .

EXPERIMENTAL

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.

Device: Radiofrequency

Group (GII)= 21 will be treated by Ultrasound Therapy.

EXPERIMENTAL

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.

Device: Therapeutic Ultrasound

Interventions

Radiofrequency DEVICE

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.

Also known as: TECAR

Group (GI)= 21 will be treated by Radiofrequency TECAR Therapy .

Therapeutic Ultrasound DEVICE

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

Group (GII)= 21 will be treated by Ultrasound Therapy.

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Physical Therapy Delta University

Gamasa, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)