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Completed

NCT Number: NCT04320108

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.

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Key information

Conditions

Brain Damage, Hypoxic Brain Diseases Brain Injuries Brain Neoplasms Brain Tumor Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Craniocerebral Trauma Hypoxia Hypoxia, Brain ICH Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, CHA Bundang Medical Center

Seongnam, South Korea, 13496

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal shockwave therapy

Device

Extracorporeal shockwave therapy 6 times during 2 weeks

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Bundang CHA Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Mar 24, 2020
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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