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

Official title

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

Overview

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

• Device Radiofrequency
  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 hi
• Device Therapeutic 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 f

Primary outcome measures

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

Secondary outcome measures (1)

• Boston Carpal Tunnel Questionnaire (BCTQ): [Time frame: six weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical Therapy Delta University — Gamasa

Identifiers

NCT: NCT07700316 · F.P.T2607100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗