Myelopathy Cervical, Pain, Spastic Tetraplegia
Conditions
Keywords
Extracorporeal shockwave therapy, Cervical myelopathy, Spasticity, Pain
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
Interventions
DEVICEExtracorporeal shockwave therapy
6 times during 2 weeks
DEVICESham therapy
6 times during 2 weeks
Sponsors
Bundang CHA Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
South Korea
Outcome results
None listed