Effect of Extracorporeal Shock Waves on Hypertrophy Scar

Not Applicable

• Conditions: Hypertrophy; Scar
• Interventions: Other: massage; Device: extracorporeal shock-wave

• Registration Number: NCT03134053
• Lead Sponsor: Mackay Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Study Start: 2017-10-01
• Primary Completion: 2017-12-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
massage	massage	-
extracorporeal shock-wave	extracorporeal shock-wave	-

Primary Outcome Measures

Name	Time	Method
change from baseline thick of scar	immediately post intervention, 1 month after, and 3 months	sonography for thick of scar

Secondary Outcome Measures

Name	Time	Method
change from baseline Modified Vancouver Scar Scale	immediately post intervention, 1 month after, and 3 months	questionnaires of Modified Vancouver Scar Scale for scar measure
change from baseline Visual analogue scores (VAS)	immediately post intervention, 1 month after, and 3 months	Visual analogue scores (VAS) for pain
change from baseline skin color	immediately post intervention, 1 month after, and 3 months	DermaLab Combo series for skin color
change from baseline Patient Scar Assessment Scale (POSAS)	immediately post intervention, 1 month after, and 3 months	questionnaires of Patient Scar Assessment Scale (POSAS) for scar measure

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan