## Protocol Section
### Identification Module
**NCT ID:** NCT06438224

**Brief Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

**Official Title:** Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

#### Organization Study ID Info
**ID:** HangangSHH-18
#### Organization
**Class:** OTHER
**Full Name:** Hangang Sacred Heart Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-15

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hangang Sacred Heart Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

**Detailed Description:** Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns.

Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. We planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

### Conditions Module

**Conditions:**

- Hand Injuries

- Extracorporeal Shock Wave Therapy

- Burns

**Keywords:**

- Extracorporeal shock wave therapy

- hypertrophic scar

- burns

- hand function

- nerve injury

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. As in previous studies, the sham group was treated using an adapter that had the same shape but did not emit any energy

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.

**Intervention Names:**

- Other: Extracorporeal shock wave therapy (ESWT)

**Label:** Extracorporeal shock wave therapy (ESWT)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy

**Intervention Names:**

- Other: sham stimulation

**Label:** sham group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Extracorporeal shock wave therapy (ESWT)

**Description:** Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.

**Name:** Extracorporeal shock wave therapy (ESWT)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- sham group

**Description:** the sham group was treated using an adapter that had the same shape but did not emit any energy

**Name:** sham stimulation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain

**Measure:** 10-point visual analog scale (VAS)

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** range of motion measurement

**Measure:** the total active motion (TAM) scoring system

**Time Frame:** 12 weeks

**Description:** The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function

**Measure:** Jebsen-Taylor hand function test (JTT)

**Time Frame:** 12 weeks

**Description:** quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger

**Measure:** Grip and pinch strengths

**Time Frame:** 12 weeks

**Description:** quantified using ultrasonography (128 BW1 US system, Medison, Korea)

**Measure:** Scar thickness

**Time Frame:** 12 weeks

**Description:** Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels and the severity of erythema. Higher values indicated darker and redder skin.

**Measure:** erythema and pigementation

**Time Frame:** 12 weeks

**Description:** measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation.

**Measure:** Trans-epidermal water loss (TEWL)

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ≥ 18 years old
* had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury
* nerve injury to the hand was confirmed by electromyography
* \< 6 months prior to the enrollment

Exclusion Criteria:

* musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands
* acute infection
* malignant tumors
* coagulopathy
* pregnancy
* potential for additional skin damage if exposed to ESWT and conventional occupational therapy.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sung6652@hallym.or.kr

**Name:** Sung Rakyum

**Phone:** 82-2-2639-5900

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** sung6652@hallym.or.kr

- **Name:** Ragyem Sung

- **Phone:** 82-10-5939-2541

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Hangang sacred heart hodpital

**Status:** RECRUITING

**Zip:** 07247

#### Overall Officials

**Official 1:**

**Affiliation:** handgang sacred heart hospital

**Name:** SO YOUNG JOO

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Thiele S, Thiele R, Gerdesmeyer L. Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy. Int J Surg. 2015 Dec;24(Pt B):165-70. doi: 10.1016/j.ijsu.2015.09.034. Epub 2015 Oct 9.

**PMID:** 26455532

**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.

**PMID:** 29301325

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000002921

- Term: Cicatrix

- ID: D000005355

- Term: Fibrosis

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: HIGH

- As Found: Shock

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophic

- ID: M19708

- Name: Cicatrix, Hypertrophic

- Relevance: HIGH

- As Found: Hypertrophic Scar

- ID: M5326

- Name: Burns

- Relevance: HIGH

- As Found: Burn

- ID: M9322

- Name: Hand Injuries

- Relevance: HIGH

- As Found: Hand Injuries

- ID: M6160

- Name: Cicatrix

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Injury

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012769

- Term: Shock

- ID: D000006984

- Term: Hypertrophy

- ID: D000017439

- Term: Cicatrix, Hypertrophic

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000002056

- Term: Burns

- ID: D000006230

- Term: Hand Injuries

### Misc Info Module

- Version Holder: 2024-05-31
