ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

Not Applicable

Terminated

• Conditions: Spastic Tetraplegia; Pain; Myelopathy Cervical
• Interventions: Device: Sham therapy; Device: Extracorporeal shockwave therapy

• Registration Number: NCT04319679
• Lead Sponsor: Bundang CHA Hospital

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Study Start: 2020-06-05
• Status Verified: 2021-04
• Primary Completion: 2021-04-05
• Study Completion: 2021-04-13
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)	Pain intensity (0-10, ordinal scale)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center,; 🇰🇷 Seongnam, Korea, Republic of