Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438224
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-27
Brief Title:
Clinical Utility of ESWT in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns
Sponsor:
Hangang Sacred Heart Hospital
Organization:
Hangang Sacred Heart Hospital
Study Overview
Official Title:
Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 005-030 mJmm2 frequency 4 Hz 1000 to 2000 impulses per treatment and 12 treatments oneweek 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
Detailed Description:
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 005-030 mJmm2 frequency 4 Hz 1000 to 2000 impulses per treatment and 12 treatments oneweek 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
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 005-030 mJmm2 frequency 4 Hz 1000 to 2000 impulses per treatment and 12 treatments oneweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None