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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal shock wave therapy (ESWT) | Experimental | 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 group | Sham Comparator | the sham group was treated using an adapter that had the same shape but did not emit any energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock wave therapy (ESWT) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-point visual analog scale (VAS) | self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Jebsen-Taylor hand function test (JTT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung Rakyum | Contact | 82-2-2639-5900 | sung6652@hallym.or.kr |
| Name | Affiliation | Role |
|---|---|---|
| SO YOUNG JOO | handgang sacred heart hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangang sacred heart hodpital | Recruiting | Seoul | 07247 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26455532 | Result | Thiele S, Thiele R, Gerdesmeyer L. Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy. Int J Surg. 2015 Dec;24(Pt B):165-70. doi: 10.1016/j.ijsu.2015.09.034. Epub 2015 Oct 9. | |
| 29301325 | Result | Cui HS, Hong AR, Kim JB, Yu JH, Cho YS, Joo SY, Seo CH. Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar. Int J Mol Sci. 2018 Jan 2;19(1):124. doi: 10.3390/ijms19010124. |
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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. As in previous studies, the sham group was treated using an adapter that had the same shape but did not emit any energy
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The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
|
| sham stimulation | Other | the sham group was treated using an adapter that had the same shape but did not emit any energy |
|
The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function |
| 12 weeks |
| Grip and pinch strengths | quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger | 12 weeks |
| Scar thickness | quantified using ultrasonography (128 BW1 US system, Medison, Korea) | 12 weeks |
| erythema | Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels. Higher values indicated darker. | 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 | 12 weeks |
| pigmentation | Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the severity of erythema. Higher values indicated redder skin. | 12 weeks |
| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| D002056 | Burns |
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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