- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07700316
Compare the Effect of Radiofrequency (TECAR) and Ultrasound on Sensation, Hand Dexterity, and Quality of Life in Patients With Carpal Tunnel Syndrome. (TECAR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gamasa, Egypt
- Faculty of Physical Therapy Delta University
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Contact:
- MANAR H Elhadidy, Bachelor's degree in PT
- Phone Number: 0201003951547
- Email: manar.elhadidy@deltauniv.edu.eg
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Contact:
- HEND M ELsharkawy, Doctor of Physical Therapy
- Phone Number: 0201006111965
- Email: Hend.Elsharkawy@deltauniv.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 tobetween 18.5 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 previous 3 months.
- Use of wrist splints or other CTS treatments in the last 3 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
Other Names:
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Semmes-Weinstein monofilament testing (SWMFs) is used to find mechanical sensory thresholds on the distal palmar pads of hand digits.
Time Frame: 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)
Time Frame: 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):
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Boston Carpal Tunnel Questionnaire (BCTQ):
Time Frame: 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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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F.P.T260800
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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