Effect of Transfer Energy Capacitive and Resistive Therapy on Pain and Range of Motion After Flexor Tendon Repair

NCT ID: NCT07255651

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-02-15

Brief Summary

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The purpose of this study is to evaluate the impact of Transfer Energy Capacitive and Resistive therapy (TECAR) on pain and range of motion (ROM) after hand flexor tendon repair.

Detailed Description

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Lacking satisfactory healing of intrasynovial tendons, such as the flexor tendons of the hand, is particularly challenging due to the formation of fibrous adhesions between the tendon, sheath and surrounding tissues which can further limit mobility.

Transfer Energy Capacitive and Resistive therapy (TECAR) enhances the body's natural ability to repair tissues and reduce pain by improving blood flow and promoting additional benefits, such as cell proliferation. This process, primarily linked to the flow of current, supports cell growth and plays a significant role in the healing process.

There is a lack in quantitative knowledge and information in the published studies about the benefits of TEcar therapy on the improvement of hand function after long flexor tendon repair . So, this study is designed to outline the therapeutic impact of TEcar therapy on pain and ROM after hand flexor tendon repair.

Conditions

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Flexor Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transfer Energy Capacitive and Resistive (TECAR) therapy + Early mobilization protocol

It will receive Transfer Energy Capacitive and Resistive (TECAR) therapy in addition to early mobilization protocol for a month.

Group Type EXPERIMENTAL

Transfer Energy Capacitive and Resistive (TECAR) therapy

Intervention Type DEVICE

Before each session, cables will be checked, the therapist will explain the procedure, the patient will be positioned comfortably, and conductive cream will be applied. The active electrode will be moved in circular motions over the injured tendon while the inactive electrode will be placed under the forearm. Intensity will be set to a comfortable, moderate level based on patient sensation. Radio-frequency (RF) energy will be delivered via capacitive mode for 2 minutes per digit, then resistive mode for 4 minutes per digit (total 6 minutes per digit). Treatment will include 8 sessions, twice weekly.

Early mobilization protocol

Intervention Type OTHER

The dorsal splint/cast will position the wrist at neutral or 15-30° extension with metacarpophalangeal (MCP) joints at 70-90° flexion, featuring low edges for exercise without removal. It will be worn full-time for the first 3 weeks post-surgery, then based on environmental safety (only during sleep and outside home if safe) for weeks 4-6. Patients will begin outpatient physical therapy from week 1 with active mobilization and home exercises every 2 hours. Dressings will be changed every other day. During weeks 1-2, passive/active flexion/extension will follow the Duran protocol (25-50% range of motion) with splint worn during therapy. Weeks 3-4 will progress to 75-100% range of motion, with splint removal at week 4 for active tenodesis exercises. Weeks 5-6 will add tendon gliding, blocking exercises, and light activities while avoiding strenuous lifting or gripping. This progressive protocol will ensure safe healing while gradually restoring function.

Early mobilization protocol

It will receive their early mobilization protocol only for a month.

Group Type ACTIVE_COMPARATOR

Early mobilization protocol

Intervention Type OTHER

The dorsal splint/cast will position the wrist at neutral or 15-30° extension with metacarpophalangeal (MCP) joints at 70-90° flexion, featuring low edges for exercise without removal. It will be worn full-time for the first 3 weeks post-surgery, then based on environmental safety (only during sleep and outside home if safe) for weeks 4-6. Patients will begin outpatient physical therapy from week 1 with active mobilization and home exercises every 2 hours. Dressings will be changed every other day. During weeks 1-2, passive/active flexion/extension will follow the Duran protocol (25-50% range of motion) with splint worn during therapy. Weeks 3-4 will progress to 75-100% range of motion, with splint removal at week 4 for active tenodesis exercises. Weeks 5-6 will add tendon gliding, blocking exercises, and light activities while avoiding strenuous lifting or gripping. This progressive protocol will ensure safe healing while gradually restoring function.

Interventions

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Transfer Energy Capacitive and Resistive (TECAR) therapy

Before each session, cables will be checked, the therapist will explain the procedure, the patient will be positioned comfortably, and conductive cream will be applied. The active electrode will be moved in circular motions over the injured tendon while the inactive electrode will be placed under the forearm. Intensity will be set to a comfortable, moderate level based on patient sensation. Radio-frequency (RF) energy will be delivered via capacitive mode for 2 minutes per digit, then resistive mode for 4 minutes per digit (total 6 minutes per digit). Treatment will include 8 sessions, twice weekly.

Intervention Type DEVICE

Early mobilization protocol

The dorsal splint/cast will position the wrist at neutral or 15-30° extension with metacarpophalangeal (MCP) joints at 70-90° flexion, featuring low edges for exercise without removal. It will be worn full-time for the first 3 weeks post-surgery, then based on environmental safety (only during sleep and outside home if safe) for weeks 4-6. Patients will begin outpatient physical therapy from week 1 with active mobilization and home exercises every 2 hours. Dressings will be changed every other day. During weeks 1-2, passive/active flexion/extension will follow the Duran protocol (25-50% range of motion) with splint worn during therapy. Weeks 3-4 will progress to 75-100% range of motion, with splint removal at week 4 for active tenodesis exercises. Weeks 5-6 will add tendon gliding, blocking exercises, and light activities while avoiding strenuous lifting or gripping. This progressive protocol will ensure safe healing while gradually restoring function.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ages of patients will be ranged from 20 to 35 years.
* All patients underwent flexor tendon primary direct repair
* All patients will be referred by a surgeon before starting the study procedure.

Exclusion Criteria

* Patient with digital nerve repairs.
* Patients with associated vascular injuries requiring arterial repair.
* Patients with associated crush injuries and soft tissue loss.
* Patients with associated bone fractures.
* Patients with associated extensor tendon injuries .
* Patients with preexisting problems limiting joint motion.
* Patients with diminished cognitive capacity.
* Patients with history of previously failed repair.
* Patients with allergic reactions to certain substances in the conductive cream
* Patients with sensation impairment .
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Basma Rajai Amer Amer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hsham Mahran, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Ahmed Mahmoud Ali Gabr Zarraa, PhD

Role: STUDY_DIRECTOR

Lecturer, Cairo university

Amr Abdallah Gomaa, PhD

Role: STUDY_DIRECTOR

Assistant Professor, Suez Canal university

Locations

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Suez Canal University Hospital

Ismailia, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Basma Rajai Amer Amer, B.Sc

Role: CONTACT

+20 101 919 0709

Ahmed Mahmoud Ali Gabr Zarraa, PhD

Role: CONTACT

Facility Contacts

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Basma Rajai Amer Amer, B.Sc

Role: primary

+20 101 919 0709

Ahmed Mahmoud Ali Gabr Zarraa, PhD

Role: backup

Other Identifiers

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P.T.REC/012/006005

Identifier Type: -

Identifier Source: org_study_id

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