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Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03134053
Enrollment
22
Registered
2017-04-28
Start date
2017-10-01
Completion date
2019-06-01
Last updated
2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophy; Scar

Keywords

hypertrophy scar, burn

Brief summary

Assess the effect of extracorporeal shock waves on hypertrophy scar

Detailed description

Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars. Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.

Interventions

DEVICEextracorporeal shock-wave

to treat painful and retracting scars

OTHERmassage

to treat painful and retracting scars

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. aged between 18 \ 65 years old; 2. at least 4 weeks since onset of onset of wound; 3. healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks 4. the most important of all, read and signed the inform concern of this study.

Exclusion criteria

1. patients with open wound; 2. oxygen dependent 3. having evidence of cognitive deficit; 4. having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT; 5. patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.

Design outcomes

Primary

MeasureTime frameDescription
change from baseline thick of scarimmediately post intervention, 1 month after, and 3 monthssonography for thick of scar

Secondary

MeasureTime frameDescription
change from baseline Modified Vancouver Scar Scaleimmediately post intervention, 1 month after, and 3 monthsquestionnaires of Modified Vancouver Scar Scale for scar measure
change from baseline Visual analogue scores (VAS)immediately post intervention, 1 month after, and 3 monthsVisual analogue scores (VAS) for pain
change from baseline skin colorimmediately post intervention, 1 month after, and 3 monthsDermaLab Combo series for skin color
change from baseline Patient Scar Assessment Scale (POSAS)immediately post intervention, 1 month after, and 3 monthsquestionnaires of Patient Scar Assessment Scale (POSAS) for scar measure

Countries

Taiwan

Contacts

Primary ContactLi-Ru Chen, MD
gracealex168@gmail.com886-2-2543-3535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026