Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorKirsehir Ahi Evran Universitesi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• . Volunteering

. Being 8-12 weeks post-operatively after flexor tendon repair

. Having undergone flexor tendon zone II-IV surgical repair

Disqualifiers

. Infection

• . Open wound

. Pregnancy

. History of finger or wrist fracture

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: controlNo intervention 0 interventions
Group B: interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
2

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.

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

Secondary outcomes

1

Nine-hole peg test

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.

Time frame
Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
2

Duruoz Hand Index

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.

Time frame
Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.
3

Short Form-36 Questionnaire

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.

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

Other outcomes

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