The Effect of Extracorporeal Shock Wave Therapy in the Treatment of Post Burn Scars

Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04558944

Enrollment

Registered

2020-09-22

Start date

2017-01-01

Completion date

2019-02-15

Last updated

2020-10-01

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

Conditions

Cicatrix, Hypertrophic

Brief summary

A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks. The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.

Interventions

DEVICEExtracorporal Shock Wave Therapy

Acoustic high amplitude waves with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Two randomized groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group (ESWT) received the standard treatment and treatment of postburn scars with ESWT 512 impulses of o.15mJ/mm 2 in each session, twice per week for 4 weeks.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with hypertrophic post burn scars of approximately 64 cm2 surface area.

Exclusion criteria

* Patients younger than 18 year. * Pregnant women. * Having a known skin condition (e.g. psoriasis, skin cancer etc.). * Immunosuppression. * Hemophilia . * Matured scars. * Scars located above the lungs, the bowels, the gonads or electronic implants.

Design outcomes

Primary

Measure	Time frame	Description
Scar appearance	6 months from inclusion	Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.

Secondary

Measure	Time frame	Description
Scar pruritus	6 months from inclusion	Pruritus measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.
Scar pain	6 months from inclusion	Pain measured by Visual Analogue Scale. Minimum value 0. Maximum value 10. Higher scores mean a worse outcome.

Countries

Spain

Outcome results

None listed

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