Hangang sacred heart hodpital
Seoul, 07247, South Korea
Location status: Recruiting
NCT Number: NCT06438224
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Seoul, 07247, South Korea
Location status: Recruiting
Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. 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.
The investigators 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
the sham group was treated using an adapter that had the same shape but did not emit any energy
Time frame: 12 weeks
self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain
Time frame: 12 weeks
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
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
quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger
Time frame: 12 weeks
quantified using ultrasonography (128 BW1 US system, Medison, Korea)
Time frame: 12 weeks
Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels. Higher values indicated darker.
Time frame: 12 weeks
measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation. Higher values indicated skin dryness
Time frame: 12 weeks
Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the severity of erythema. Higher values indicated redder skin.
Contact information is provided by the study sponsor or research team.
Hangang Sacred Heart Hospital
Other
Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns
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