Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury

Kirsehir Ahi Evran Universitesi

Status: Not yet enrolling

Conditions: Tendon Injury - Hand

Treatments: Device: Ekstracorporeal Shock Wave Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07320807

AYBU-ESWT-MK-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

control

No Intervention group

Description:

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

intervention

Experimental group

Description:

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

Treatment:

Device: Ekstracorporeal Shock Wave Therapy