NCT07255651

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

December 1, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Active range of motion (ROM) of the proximal interphalangeal (PIP) joint

    Active ROM of the PIP joint will be assessed, at the 2nd, 4th, and 6th postoperative weeks using a finger goniometer, with the patient sitting, forearm mid-position and supported on a plinth. The therapist will stabilize the metacarpophalangeal (MCP) joint in 90° flexion at the injured phalanx. The goniometer's axis will be placed over the upper surface of the PIP joint, with the stationary arm aligned to the proximal phalanx's longitudinal axis and the movable arm aligned to the middle phalanx's longitudinal axis. The patient will be instructed to actively flex and then extend the PIP joint through its full range (normally 0°-100°), and the measured ROM will be recorded.

    one month

  • Active range of motion (ROM) of the distal interphalangeal (DIP) joint

    Active ROM of the DIP joint will be assessed with the patient seated, forearm in mid-position and supported on the plinth. From a neutral wrist position, the therapist will stabilize the metacarpophalangeal (MCP) joint in 90° flexion and the middle phalanx in extension. The goniometer axis will be placed over the upper surface of the DIP joint, with the stationary arm aligned to the middle phalanx's longitudinal axis and the movable arm aligned to the distal phalanx. The patient will actively flex and extend the DIP joint through its full range (0°-90°), and the ROM will be recorded.

    one month

Study Arms (2)

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

EXPERIMENTAL

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

Device: Transfer Energy Capacitive and Resistive (TECAR) therapyOther: Early mobilization protocol

Early mobilization protocol

ACTIVE COMPARATOR

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

Other: Early mobilization protocol

Interventions

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.

Transfer Energy Capacitive and Resistive (TECAR) therapy + 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.

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

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University Hospital

Ismailia, Egypt

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Hsham Mahran, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Ahmed Mahmoud Ali Gabr Zarraa, PhD

    Lecturer, Cairo university

    STUDY DIRECTOR
  • Amr Abdallah Gomaa, PhD

    Assistant Professor, Suez Canal university

    STUDY DIRECTOR

Central Study Contacts

Basma Rajai Amer Amer, B.Sc

CONTACT

Ahmed Mahmoud Ali Gabr Zarraa, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

December 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 15, 2026

Last Updated

December 1, 2025

Record last verified: 2025-11

Locations