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CompletedNCT04320108Updated Jun 19, 2025

ESWT for Shoulder Pain in Patients With Brain Damage

An interventional study of Extracorporeal shockwave therapy in Brain Damage, Hypoxic, Stroke and Brain Tumor, sponsored by Bundang CHA Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Bundang CHA Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Brain Damage, Hypoxic
  • Stroke
  • Brain Tumor
  • ICH

Keywords

  • Extracorporeal shockwave therapy
  • Brain damage
  • Pain
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pain due to trauma
  • Injection treatments two weeks before participating in the study
  • Severe coagulopathy (excluding antiplatelet use)
  • Impaired cognition
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Experimental group

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

    Device: Extracorporeal shockwave therapy

  • Sham comparator
    Control group

    Sham therapy

    Device: Extracorporeal shockwave therapy

Interventions

  • DeviceExtracorporeal shockwave therapy

    Extracorporeal shockwave therapy 6 times during 2 weeks

05

What researchers measure

Primary outcomes

  1. Numerical rating scale (NRS)

    Pain intensity (0-10, ordinal scale)

    Time frame: 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)

    Scoring scale consist of 5 pain scale and 8 disability scale, in %, 0 (best) to 100 (worst)

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

06

Study locations

1 site
  • Department of Rehabilitation Medicine, CHA Bundang Medical Center
    Seongnam, South Korea 13496, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04320108
Lead sponsor
Bundang CHA Hospital
Responsible party
MinYoung Kim, MD, PhD (Principal professor of Rehabilitation Medicine, Bundang CHA Hospital) — Principal investigator
First posted
Mar 24, 2020
Start date
May 29, 2020
Primary completion
Oct 31, 2021
Completion
Dec 11, 2023
Last update
Jun 19, 2025

Study contacts

MinYoung Kim, MD, PhD
principal investigator · Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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