Hand BurnNCT04138355
The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns
A study testing Extracorporeal shock wave therapy in people with Hand Burn, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hand Burn
- What is being tested?
- Extracorporeal shock wave therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2019to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hangang Sacred Heart Hospital
Seoul, Yeong-deungpo-Dong, 150-719
About this study
Official title: The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study
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.
Read the 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.
- Conditions
- Hand Burn
- Being tested
- Extracorporeal shock wave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
thickness
scar thickness(cm)
Measured: 4 weeks
melanin and erythema
measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)
Measured: 4 weeks
transepithelial water loss
the degree of water evaporation
Measured: 4 weeks
sebum
the severity of greese, the higher values indicating a more greese(mg/cm2)
Measured: 4 weeks
elasticity
The numeric values (mm) of the skin's distortion is presented as the elasticity.
Measured: 4 weeks
Secondary outcomes (2)
grip strength
measure grip strength, the higher values indicating a more strength
Measured: 4 weeks
Jebsen-Taylor hand function test
The JTT measure the performance speed of standardized tasks. The JTT involves a series of 7 subtests. We used a scoring system (each subtest score ranged from 0 to 15, and the total score ranged from 0 to 105).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start2 Nov 2019
- Primary completion1 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hand BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University
- Responsible party
- Sponsor
- Investigators
- Study Design Participants Intervention Outcome measures Seo, M.D, Study director, Hangang Scared Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138355
- Sponsor's protocol ID
- HangangSHH-7
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18952381Cui 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.
PubMed 29301325Cho 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.
PubMed 27512886
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04138355
- Acronym / sponsor ID
- HangangSHH-7
- Conditions
- Hand Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Hallym University
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy group | Experimental | Other: Extracorporeal shock wave therapy. 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapyESWT 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 group |
Primary outcome
thickness
Time frame: 4 weeks
scar thickness(cm)
melanin and erythema
Time frame: 4 weeks
measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)
transepithelial water loss
Time frame: 4 weeks
the degree of water evaporation
sebum
Time frame: 4 weeks
the severity of greese, the higher values indicating a more greese(mg/cm2)
elasticity
Time frame: 4 weeks
The numeric values (mm) of the skin's distortion is presented as the elasticity.
2 secondary outcomes
grip strength
Time frame: 4 weeks
Jebsen-Taylor hand function test
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Results publication: PubMed 18952381van 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.
- Results publication: PubMed 29301325Cui 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.
- Results publication: PubMed 27512886Cho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Design Participants Intervention Outcome measures Seo, M.D study director
Hangang Scared Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy in people with Hand Burn, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04138355, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.