The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns

Hangang Sacred Heart Hospital

Status: Completed

Conditions: Burn Scar

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04340271

HangangSHH-10

Details and patient eligibility

About

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.

Full description

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. Each intervention was applied to the hypertrophic scars of upper extremities after autologous split-thickness skin grafting (STSG) using Materiderm for 4 weeks once per week. The ESWT group (n=18) received shock waves with low-energy flux density (0.05-0.30 mJ/mm2). The interval between treatments is a 1-week. The ESWT group also received standard treatment. The control group (n=18) received sham stimulation with standard treatment. The investigators compared the skin quality of the ESWT and control groups. Participants were made comfortable and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. TEWL was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in mg/cm2. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Extracorporeal shock wave therapy group

Experimental group

Description:

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.

Treatment:

Other: Extracorporeal shock wave therapy

Other: conventional occupational therapy

sham stimulation group

Sham Comparator group

Description:

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

Treatment:

Other: conventional occupational therapy