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ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

B

Bundang CHA Hospital

Status

Terminated

Conditions

Spastic Tetraplegia
Myelopathy Cervical
Pain

Treatments

Device: Sham therapy
Device: Extracorporeal shockwave therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04319679
ESWTSCIPain

Details and patient eligibility

About

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.

Full 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

Enrollment

4 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Spinal cord damage confirmed in the spinal cord image
  2. 1 month after spinal cord injury
  3. Spasticity of upper extremities
  4. Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
  5. Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
  6. Age: 20 and older
  7. Person who has agreed in writing to decide his or her participation and comply with the precautions

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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