ESWT for UE Pain in Patients With Cervical Spinal Cord In... | NCT04319679

Studies
ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

NCT04319679

Sponsor

Bundang CHA Hospital

Status

Terminated

Last Update Posted

Apr 14, 2021Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Spastic Tetraplegia
Pain
Myelopathy Cervical

Interventions

Extracorporeal shockwave therapy
Sham therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in recruiting patients

Expanded Access Info

Start Date

Jun 5, 2020Actual

Primary Completion Date

Apr 5, 2021Actual

Completion Date

Apr 13, 2021Actual

First Submitted Date

Mar 14, 2020

First Submission Date that Met QC Criteria

Mar 21, 2020

First Posted Date

Mar 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

MinYoung Kim, MD, PhD, Principal Professor of Rehabilitation Medicine, Bundang CHA HospitalPrincipal Investigator

Lead Sponsor

Bundang CHA HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental	3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range	Device: Extracorporeal shockwave therapy
Control group	Sham Comparator	Sham therapy	Device: Sham therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extracorporeal shockwave therapy	Device	6 times during 2 weeks	Experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numerical rating scale (NRS)	Pain intensity (0-10, ordinal scale)	Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Modified Ashworth scale (MAS)	Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)	Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Range of motion (ROM)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyunghoon Min, MD, PhD	Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rehabilitation Medicine, CHA Bundang Medical Center,		Seongnam		13496	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Information that cannot be identified

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011782	Quadriplegia
D010146	Pain
D009128	Muscle Spasticity

Ancestor Terms

ID	Term
D010243	Paralysis
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074059	Extracorporeal Shockwave Therapy

Ancestor Terms

ID	Term
D014464	Ultrasonic Therapy
D003972	Diathermy
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided