ESWT for UE Pain in Patients With Cervical Spinal Cord Injury

N/ATerminatedNCT04319679

Bundang CHA Hospital4 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spastic Tetraplegia Pain Myelopathy Cervical

Interventions

Extracorporeal shockwave therapyDEVICE

6 times during 2 weeks

Sham therapyDEVICE

6 times during 2 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Rehabilitation Medicine, CHA Bundang Medical Center,

Seongnam, South Korea

Outcomes

Primary Outcomes

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

Modified Ashworth scale (MAS)

Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)

Time frame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)

Range of motion (ROM)

Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)

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

Grasp power

Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)

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

Data from ClinicalTrials.gov

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