An interventional study of Extracorporeal shock wave therapy (ESWT) and sham stimulation in Hand Injuries, Extracorporeal Shock Wave Therapy and Burns, sponsored by Hangang Sacred Heart Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Hangang Sacred Heart Hospital · Not applicable, Interventional, and Treatment
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.
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.
122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.
This study's planned enrollment of 120 is above the median of 55 across 97 interventional studies indexed under Hand Injuries.
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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.
Other: Extracorporeal shock wave therapy (ESWT)
the sham group was treated using an adapter that had the same shape but did not emit any energy
Other: sham stimulation
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
10-point visual analog scale (VAS)
self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain
Time frame: 12 weeks
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
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
Grip and pinch strengths
quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger
Time frame: 12 weeks
Scar thickness
quantified using ultrasonography (128 BW1 US system, Medison, Korea)
Time frame: 12 weeks
erythema
Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels. Higher values indicated darker.
Time frame: 12 weeks
Trans-epidermal water loss (TEWL)
measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation. Higher values indicated skin dryness
Time frame: 12 weeks
pigmentation
Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the severity of erythema. Higher values indicated redder skin.
Time frame: 12 weeks
Plan to share: No
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