Clinical Utility of ESWT in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangang Sacred Heart Hospital

About this trial

Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. The investigators planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old

had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury

nerve injury to the hand was confirmed by electromyography

< 6 months prior to the enrollment

Disqualifiers

musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands

acute infection

malignant tumors

coagulopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extracorporeal shock wave therapy (ESWT)

    Other intervention

    Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.

  • sham stimulation

    Other intervention

    the sham group was treated using an adapter that had the same shape but did not emit any energy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Extracorporeal shock wave therapy (ESWT)Experimental treatment 1 intervention
Group B: sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

10-point visual analog scale (VAS)

self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain

Time frame
12 weeks

Secondary outcomes

1

the total active motion (TAM) scoring system

range of motion measurement, higher scores indicating better range of motion. For each finger, the maximum angle is 260 degrees and the minimum angle is 260 degrees.

Time frame
12 weeks
2

Jebsen-Taylor hand function test (JTT)

The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function

Time frame
12 weeks
3

Grip and pinch strengths

quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger

Time frame
12 weeks
4

Scar thickness

quantified using ultrasonography (128 BW1 US system, Medison, Korea)

Time frame
12 weeks

Other outcomes

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