The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

NCT04138355 | Completed DMC

• 1 other identifier: HangangSHH-7
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands, the investigators compare the results of ESWT combined with manual therapy group to the results of matched conventional(CON) rehabilitation combined with manual therapy group.

Conditions

Hand Burn

Outcome Measures

Primary Outcomes (5)

• thickness

  scar thickness(cm)

  4 weeks

• melanin and erythema

  measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)

  4 weeks

• transepithelial water loss

  the degree of water evaporation

  4 weeks

• sebum

  the severity of greese, the higher values indicating a more greese(mg/cm2)

  4 weeks

• elasticity

  The numeric values (mm) of the skin's distortion is presented as the elasticity.

  4 weeks

Secondary Outcomes (2)

• grip strength

  4 weeks

• Jebsen-Taylor hand function test

  4 weeks

Study Arms (2)

Extracorporeal shock wave therapy group

EXPERIMENTAL

. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen,Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave. 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

conventional manual therapy

NO INTERVENTION

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.

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. 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

Eligibility Criteria

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

You may qualify if:

• a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands
• less than 6 months since the onset of the burn injury

You may not qualify if:

• fourth-degree burns(involving muscles, tendons, and bone injuries)\\
• musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hands
• neurological diseases(such as peripheral nerve disorders)
• preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention)
• severe pain impeding hand rehabilitation

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead
• Hallym University: collaborator

Study Sites (1)

Hangang Sacred Heart Hospital

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

Location

Related Publications (3)

• van der Veer WM, Bloemen MC, Ulrich MM, Molema G, van Zuijlen PP, Middelkoop E, Niessen FB. Potential cellular and molecular causes of hypertrophic scar formation. Burns. 2009 Feb;35(1):15-29. doi: 10.1016/j.burns.2008.06.020. Epub 2008 Oct 25.

  PMID: 18952381 RESULT

• 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

• Cho YS, Joo SY, Cui H, Cho SR, Yim H, Seo CH. Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study. Medicine (Baltimore). 2016 Aug;95(32):e4575. doi: 10.1097/MD.0000000000004575.

  PMID: 27512886 RESULT

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

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

Study Officials

• Study Design Participants Intervention Outcome measures Seo, M.D

  Hangang Scared Heart Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients' burn scars had re-epithelialized after aseptic care or skin graft. We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands, with joint contracture(hand and wrist), having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury. Selected patients had a history of hand surgery resulting in painful, retracting scarring on hands.

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 24, 2019
• Study Start: November 2, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 20, 2020
• Last Updated: April 24, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)