NCT04320108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 29, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

March 21, 2020

Last Update Submit

June 17, 2025

Conditions

Brain Damage, HypoxicStrokeBrain TumorICH

Keywords

Extracorporeal shockwave therapyBrain damagePain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Shoulder Pain and Disability Index (SPADI)

    Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)

Study Arms (2)

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: Extracorporeal shockwave therapy

Interventions

Extracorporeal shockwave therapyDEVICE

Extracorporeal shockwave therapy 6 times during 2 weeks

Control groupExperimental group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Brain damaged patient confirmed in the brain image
  • month after brain damage
  • Pain in hemiplegic shoulder areas 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, South Korea, 13496, South Korea

Location

MeSH Terms

Conditions

Hypoxia, BrainStrokeBrain NeoplasmsBrain InjuriesPain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • MinYoung Kim, MD, PhD

    Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal professor of Rehabilitation Medicine

Study Record Dates

First Submitted

March 21, 2020

First Posted

March 24, 2020

Study Start

May 29, 2020

Primary Completion

October 31, 2021

Study Completion

December 11, 2023

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

KR(1)