Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury

May 8, 2026 updated by: Nazife Kapan, Kirsehir Ahi Evran Universitesi

The Effect of Extracorporeal Shock Wave Therapy on Range of Motion, Pain, Dexterity, and Function After Hand Flexor Tendon Injury.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The hand is a fundamental element in daily living activities, occupation, and social independence. Although different studies report varying figures for hand injuries, they constitute approximately 20% of injuries presenting to emergency departments. Soft tissue traumas account for a significant portion of these injuries. Due to the proximity of flexor tendons to the skin, the hand is frequently affected in hand injuries.

One of the agents used to accelerate healing and function in hand tendons after injury or surgery, and to reduce adhesion and contracture formation, is Extracorporeal Shock Wave Therapy (ESWT). ESWT treatment modalities have been tested in experimental animal studies. The idea behind the use of shock waves in the treatment of orthopedic diseases is to stimulate healing in tendons, surrounding tissues, and bones. The importance of shock wave therapy on soft tissues has increased over time.

It has been reported that ESWT significantly reduces deformity in Dupuytren's disease treatment. Brunelli et al. found that radial ESWT (3 bars, 12 Hz, 1400 pulses) applied in 4 sessions to a patient with pain, weakness in the middle and ring fingers, and flexion deformity due to Dupuytren's disease resulted in a significant reduction in hand deformities and improvement in daily living performance. Positive results of the use of ESWT in hand flexor tendon pathologies have been published. In their cadaver study examining the applicability of radial ESWT to the flexor tendon, Lutter et al. stated that ESWT application at different intensities can penetrate soft tissues and is a treatment option in different finger pathologies. Malliaropoulos et al. have found that radial ESWT is effective in reducing pain and improving functional recovery in trigger finger treatment. This study aims to investigate the effect of ESWT on range of motion, pain, grip strength, and dexterity after hand flexor tendon injury. 56 patients who presented with flexor tendon injury and consented to participate will be included in this study and divided into two groups. All patients will be enrolled in a hand rehabilitation program including early passive mobilization according to the Modified Duran Protocol. In addition, the intervention group will receive 2000 pulses of radial ESWT at 2 bar pressure and 10 Hz frequency, applied to the flexor tendon scar tissue in 4 sessions, using a sweeping method with gel applied between the patient's skin and the probe.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • . Volunteering

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

Exclusion Criteria:

  • . Infection

    • • . Open wound

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
In accordance with the Modified Duran Protocol, a hand rehabilitation program, including early passive mobilization, will be implemented for 4 weeks.
Experimental: intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
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
Time Frame: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nine-hole peg test
Time Frame: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
Due to its low cost, ease of application, and speed, it is widely used in assessing dexterity. It consists of a square wooden board with nine holes and nine wooden pegs designed to fit these holes. During the test, the container with the square board and pegs is placed on the side of the extremity being evaluated. Then, the patient is asked to take the pegs one by one and place them in the holes. The order of placement is not important. As soon as the placement is complete, the pegs are removed one by one and returned to the container. The order of removal is not important. The process is timed. The timer starts when the hand first touches a peg at the beginning of placement and ends when the last peg is removed and touches the container.
Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
Duruoz Hand Index
Time Frame: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
The Duruoz Hand Index was first developed in 1996 to assess hand-related activity limitations in patients with Rheumatoid Arthritis. It consists of 18 self-assessed items regarding hand abilities in the kitchen, dressing, personal hygiene, work, and other general movements. Scores range from 0-40 for kitchen tasks, 0-10 for dressing, hygiene, and office tasks, and 0-20 for the "other" category. Individuals rate their abilities on a scale of 0 (no difficulty) to 5 (impossible to perform). The questionnaire results in a total score of 0-90. A higher score represents a greater activity limitation and greater difficulty. The validity and reliability of the Turkish version of the questionnaire have been demonstrated in patients with traumatic hand injuries.
Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
Short Form-36 Questionnaire
Time Frame: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
The Short Form-36 (SF-36) questionnaire is a 36-item scale consisting of subscales of physical function, physical role, emotional role, pain, vitality, general health, and mental health. Each subscale is scored from "0" to "100", indicating the lowest and highest quality of life levels, respectively.
Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kirsehir Ahi Evran Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AYBU-ESWT-MK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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