ESWT for Shoulder Pain in Patients With Brain Damage

November 2, 2020 updated by: MinYoung Kim, MD, PhD, Bundang CHA Hospital

The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range) on subscapularis and lesser and greater tuberlces of humerus to reduce pain in patients with brain damage

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MinYoung Kim, MD, PhD
  • Phone Number: 82-30-780-6281
  • Email: kmin@cha.ac.kr

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 13496
        • Recruiting
        • Department of Rehabilitation Medicine, CHA Bundang Medical Center
        • Contact:
          • MinYoung Kim, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Brain damaged patient confirmed in the brain image
  • 1 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
Device: Extracorporeal shockwave therapy
Extracorporeal shockwave therapy 6 times during 2 weeks
Sham Comparator: Control group
Sham therapy
Device: Extracorporeal shockwave therapy
Extracorporeal shockwave therapy 6 times during 2 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)
Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst)
Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bundang CHA Hospital

Investigators

  • Principal Investigator: MinYoung Kim, MD, PhD, Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

February 5, 2021

Study Registration Dates

First Submitted

March 21, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESWTbraindamage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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