Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury

NCT07320807 | Not Yet Recruiting

• 1 other identifier: AYBU-ESWT-MK-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

In this study aims to investigate the effects of extracorporeal shock wave therapy, applied to the intervention group in addition to the rehabilitation program applied to the control and intervention groups, on range of motion, pain, grip strength, and dexterity after hand flexor tendon injury.

Conditions

Tendon Injury - Hand

Keywords

rehabilitation; ekstrakorporeal shock wave therapy

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  For VAS assessment, patients are informed about the meaning of the numbers placed on a 10 cm line from 0 to 10. It is explained that no pain is worth 0 points, moderate pain is worth 5 points, and the most severe pain felt is worth 10 points. Based on these explanations, the patient is asked to mark the pain on the 10 cm line. The distance between the marked point and the starting point is measured with a ruler to determine the pain intensity.

  Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.

• Range of Motion

  Range of motion (ROM) is one of the most frequently used outcome variables after tendon injuries in the hand. ROM measurement in the hand is performed using a finger goniometer. In active ROM assessment for the fingers, the patient is asked to make a fist for flexion and extend the finger straight; that is, the measurement is performed in a compound manner. In this study, the Modified Strickland calculation will be used for fingers 2-5. Active distal interphalangeal (DIF) and proximal interphalangeal (PIF) joint flexion are added together, and the active extension loss is subtracted. 175° is considered ideal and compared to 175°. The results are; 75°-100° is considered excellent, 50°-74° good, 25°-49° average, and 0°-24° poor.

  Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.

Secondary Outcomes (3)

• Nine-hole peg test

  Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.

• Duruoz Hand Index

  Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.

• Short Form-36 Questionnaire

  Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.

Study Arms (2)

control

NO INTERVENTION

In accordance with the Modified Duran Protocol, a hand rehabilitation program, including early passive mobilization, will be implemented for 4 weeks.

intervention

EXPERIMENTAL

In addition to a hand rehabilitation program that includes early passive mobilization in accordance with the Modified Duran Protocol, ESWT will be applied.

Device: Ekstracorporeal Shock Wave Therapy

Interventions

Ekstracorporeal Shock Wave Therapy DEVICE

Radial ESWT with 2 bar pressure, 10 Hz frequency, and 2000 pulses will be applied to the flexor tendon scar tissue in a total of 4 sessions, once a week, using a sweeping method with gel applied between the patient's skin and the probe.

intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• . Volunteering
• Being 8-12 weeks post-operatively after flexor tendon repair
• Having undergone flexor tendon zone II-IV surgical repair

You may not qualify if:

• Infection
• . Open wound
• Pregnancy
• History of finger or wrist fracture
• Inflammatory rheumatic disease
• Malignant tumor mass

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Central Study Contacts

Merve KAPAN, PhD

CONTACT

+905057603658; fzt.kapan@gmail.com

Nazife KAPAN TUNÇER, Asst. Prof.

CONTACT

+905555839701; nazifekapan@gmail.com

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: Asist.Prof.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: January 15, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)