## Protocol Section
### Identification Module
**NCT ID:** NCT04319679

**Brief Title:** ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

**Official Title:** The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury

#### Organization Study ID Info
**ID:** ESWTSCIPain
#### Organization
**Class:** OTHER
**Full Name:** Bundang CHA Hospital
### Status Module
#### Completion Date
**Date:** 2021-04-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-04-14

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-13

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2021-04-05

**Type:** ACTUAL

#### Start Date
**Date:** 2020-06-05

**Type:** ACTUAL

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2020-03-24
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-14
**Study First Submit QC Date:** 2020-03-21
**Why Stopped:** Difficulty in recruiting patients
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bundang CHA Hospital

#### Responsible Party

**Investigator Affiliation:** Bundang CHA Hospital

**Investigator Full Name:** MinYoung Kim, MD, PhD

**Investigator Title:** Principal Professor of Rehabilitation Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

**Detailed Description:** 6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/m\^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy

### Conditions Module

**Conditions:**

- Spastic Tetraplegia

- Pain

- Myelopathy Cervical

**Keywords:**

- Extracorporeal shockwave therapy

- Cervical myelopathy

- Spasticity

- Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 4

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 3,000 pulses per time, low energy under 0.3 mJ/mm\^2, tolerable range

**Intervention Names:**

- Device: Extracorporeal shockwave therapy

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Sham therapy

**Intervention Names:**

- Device: Sham therapy

**Label:** Control group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental group

**Description:** 6 times during 2 weeks

**Name:** Extracorporeal shockwave therapy

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 6 times during 2 weeks

**Name:** Sham therapy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Pain intensity (0-10, ordinal scale)

**Measure:** Numerical rating scale (NRS)

**Time Frame:** Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

#### Secondary Outcomes

**Description:** Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)

**Measure:** Modified Ashworth scale (MAS)

**Time Frame:** Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

**Description:** Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)

**Measure:** Range of motion (ROM)

**Time Frame:** Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)

**Description:** Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)

**Measure:** Grasp power

**Time Frame:** Up to 4 weeks (baseline, 2 weeks, 4 weeks)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Spinal cord damage confirmed in the spinal cord image
2. 1 month after spinal cord injury
3. Spasticity of upper extremities
4. Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
5. Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
6. Age: 20 and older
7. Person who has agreed in writing to decide his or her participation and comply with the precautions

Exclusion Criteria:

1. Pain due to trauma
2. Injection treatments two weeks before participating in the study
3. Severe coagulopathy (excluding antiplatelet use)
4. Impaired cognition

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seongnam

**Country:** Korea, Republic of

**Facility:** Department of Rehabilitation Medicine, CHA Bundang Medical Center,

**Zip:** 13496

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

**Name:** Kyunghoon Min, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Information that cannot be identified

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000010243

- Term: Paralysis

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC15

- Name: Blood and Lymph Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12085

- Name: Muscle Spasticity

- Relevance: LOW

- As Found: Unknown

- ID: M15916

- Name: Spinal Cord Injuries

- Relevance: HIGH

- As Found: Spinal Cord Injury

- ID: M5134

- Name: Bone Marrow Diseases

- Relevance: HIGH

- As Found: Myelopathy

- ID: M14632

- Name: Quadriplegia

- Relevance: HIGH

- As Found: Spastic Tetraplegia

- ID: M15915

- Name: Spinal Cord Diseases

- Relevance: HIGH

- As Found: Myelopathy

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013119

- Term: Spinal Cord Injuries

- ID: D000013118

- Term: Spinal Cord Diseases

- ID: D000011782

- Term: Quadriplegia

- ID: D000001855

- Term: Bone Marrow Diseases

### Misc Info Module

- Version Holder: 2024-05-24
