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Recruiting NCT07320807

Effects of Extracorporeal Shock Wave Therapy After Flexor Tendon Injury

No phase Interventional Tendon Injury - Hand

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ekstracorporeal Shock Wave Therapy.
Who it may be relevant to
Registry conditions: Tendon Injury - Hand. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Visual Analog Scale [Time frame: 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.]
Secondary outcome measures (3)
  • Nine-hole peg test [Time frame: 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.]
  • Short Form-36 Questionnaire [Time frame: Evaluation will be performed before treatment, on the day treatment ends, and one month after treatment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT07320807 · AYBU-ESWT-MK-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗