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Carpal Tunnel Syndrome (CTS)TECARNCT07700316

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

A study testing Radiofrequency and Therapeutic Ultrasound in people with Carpal Tunnel Syndrome (CTS), run by Delta University for Science and Technology at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 35 to 50 years
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Radiofrequency and Therapeutic Ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteEgypt
Study dates
1 Aug 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Faculty of Physical Therapy Delta University

    Gamasa

    MANAR H Elhadidy, Bachelor's degree in PT, 0201003951547, manar.elhadidy@deltauniv.edu.eg

    HEND M ELsharkawy, Doctor of Physical Therapy, 0201006111965, Hend.Elsharkawy@deltauniv.edu.eg

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Radiofrequency, Therapeutic Ultrasound
Keywords
Carpal Tunnel Syndrome (CTS), TECAR, Radiofrequency, Ultrasound, Hand Dexterity, Sensation, Quality of Life
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiofrequencyDevice

    Also called TECAR

    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.

  • Therapeutic UltrasoundDevice

    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

Study groups in NCT07700316
Study groupRoleWhat they receive
Group (GI)= 21 will be treated by Radiofrequency TECAR Therapy .ExperimentalGroup (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.
Receives: Device: Radiofrequency
Group (GII)= 21 will be treated by Ultrasound Therapy.ExperimentalGroup (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.
Receives: Device: Therapeutic Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: six weeks.

  2. 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.

    Measured: six weeks.

  3. 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

    Measured: six weeks

Secondary outcomes (1)
  1. Boston Carpal Tunnel Questionnaire (BCTQ):

    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.

    Measured: six weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700316
Sponsor's protocol ID
F.P.T2607100
Acronym
TECAR
Status last verified
Jun 2026
First submitted
6 Jul 2026
Last updated
28 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency and Therapeutic Ultrasound in people with Carpal Tunnel Syndrome (CTS), run by Delta University for Science and Technology at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semmes-Weinstein monofilament testing (SWMFs) is used to find mechanical sensory thresholds on the distal palmar pads of hand digits. (time frame: six weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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