Clinical trial NCT04138355: The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns
Official title: The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Burn
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University
First posted: 2019-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible and responsible functional and cosmetic impairments.

This randomized, controlled trial involved 40 patients with burns and dominant right-hand function impairment. Patients were randomized into a ESWT or a CON group. Each intervention was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: thickness
timeFrame: 4 weeks
measure: melanin and erythema
timeFrame: 4 weeks
measure: transepithelial water loss
timeFrame: 4 weeks
measure: sebum
timeFrame: 4 weeks
measure: elasticity
timeFrame: 4 weeks
Secondary outcomes:
measure: grip strength
timeFrame: 4 weeks
measure: Jebsen-Taylor hand function test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
state: Yeong-deungpo-Dong
Study officials:
affiliation: Hangang Scared Heart Hospital
name: Study Design Participants Intervention Outcome measures Seo, M.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.