The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns

NCT04340271 | Completed DMC

• 1 other identifier: HangangSHH-10
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group.

Conditions

Burn Scar

Keywords

burn scar; extracorporeal shock wave therapy; skin characteristics

Outcome Measures

Primary Outcomes (1)

• scar thickness

  The thickness was measured with a ultrasonic wave equipment

  4 weeks

Secondary Outcomes (5)

• skin darkness

  4 weeks

• skin reddness

  4 weeks

• skin dryness

  4 weeks

• sebum level

  4 weeks

• Elasticity

  4 weeks

Study Arms (2)

Extracorporeal shock wave therapy group

EXPERIMENTAL

Patients in the ESWT group were explained to select the most hypertrophic and retracting area for the treatment on dominant hand. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.

Other: Extracorporeal shock wave therapy; Other: conventional occupational therapy

sham stimulation group

SHAM COMPARATOR

The same shock wave equipment used in the experimental group was used with a sham adapter that had the same shape but emitted no energy

Other: conventional occupational therapy

Interventions

Extracorporeal shock wave therapy OTHER

ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.

Extracorporeal shock wave therapy group

conventional occupational therapy OTHER

Standard accupational therapy consist of range of motion exercise, strengthening exercises, and activities of daily living exercises

Extracorporeal shock wave therapy group; sham stimulation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥18 years
• deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn
• less than 6 months since the onset of the burn injury

You may not qualify if:

• history of cancer
• fourth-degree burns (involving muscles, tendons, and bone injuries)
• musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases)
• pregnancy
• if there was potential for additional damage to the skin due to the use of ESWT and conventional occupational therapy

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

Location

Related Publications (2)

• 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.

  PMID: 29301325 RESULT

• Saggini R, Saggini A, Spagnoli AM, Dodaj I, Cigna E, Maruccia M, Soda G, Bellomo RG, Scuderi N. Extracorporeal Shock Wave Therapy: An Emerging Treatment Modality for Retracting Scars of the Hands. Ultrasound Med Biol. 2016 Jan;42(1):185-95. doi: 10.1016/j.ultrasmedbio.2015.07.028. Epub 2015 Oct 9.

  PMID: 26454624 RESULT

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 1. The patients didnot know whether it is included in the experimental group and control group 2. Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: The patients' burn scars had re-epithelialized after split-thickness skin graft (STSG). We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their upper extremities, having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury.

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 9, 2020
• Study Start: April 15, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

KR (1)