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 volunteersQualifiers
≥ 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
Parallel
Treatments tested in this trial
Extracorporeal shock wave therapy (ESWT)
Other interventionThose 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 interventionthe sham group was treated using an adapter that had the same shape but did not emit any energy
Treatment groups
Trial outcomes
Primary outcomes
10-point visual analog scale (VAS)
self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain
Secondary outcomes
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.
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
Grip and pinch strengths
quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger
Scar thickness
quantified using ultrasonography (128 BW1 US system, Medison, Korea)
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