ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

Pain Clinical Trial

Official title:

The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04319679
• Other study ID #: ESWTSCIPain
• Status: Terminated
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: April 13, 2021

Study information

• Verified date: April 2021
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 13, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Myelopathy Cervical
• Pain
• Quadriplegia
• Spastic Tetraplegia
• Spinal Cord Diseases
• Spinal Cord Injuries

Intervention

Device:
• Extracorporeal shockwave therapy
6 times during 2 weeks
• Sham therapy
6 times during 2 weeks

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, CHA Bundang Medical Center,	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Ashworth scale (MAS)	Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)	Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary	Range of motion (ROM)	Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)	Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary	Grasp power	Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)	Up to 4 weeks (baseline, 2 weeks, 4 weeks)