Compare the Effect of Radiofrequency (TECAR) and Ultrasound on Sensation, Hand Dexterity, and Quality of Life in Patients With Carpal Tunnel Syndrome. (TECAR)
27 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
42
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gamasa, Egipto
- Faculty of Physical Therapy Delta University
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Contacto:
- MANAR H Elhadidy, Bachelor's degree in PT
- Número de teléfono: 0201003951547
- Correo electrónico: manar.elhadidy@deltauniv.edu.eg
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Contacto:
- HEND M ELsharkawy, Doctor of Physical Therapy
- Número de teléfono: 0201006111965
- Correo electrónico: Hend.Elsharkawy@deltauniv.edu.eg
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: 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.
Otros nombres:
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Semmes-Weinstein monofilament testing (SWMFs) is used to find mechanical sensory thresholds on the distal palmar pads of hand digits.
Periodo de tiempo: 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)
Periodo de tiempo: 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):
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Boston Carpal Tunnel Questionnaire (BCTQ):
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de agosto de 2026
Finalización primaria (Estimado)
Finalización primaria
31 de diciembre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
28 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2026
Última verificación
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuropatía mediana
- Mononeuropatías
- Síndromes de compresión nerviosa
- Trastornos Traumáticos Acumulativos
- Torceduras y esguinces
- Síndrome del túnel carpiano
- Terapéutica
- Diatermia
- Hipertermia, inducida
- Terapia ultrasónica
Otros números de identificación del estudio
Otros números de identificación del estudio
- F.P.T2607100
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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