The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- severity of spasticity
Study Overview
Brief Summary
Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury.
The purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Traumatic or non traumatic spinal cord injury
- •Minimum age: 18 years
- •Minimum time since spinal cord injury: two years
- •Lesion: C3-Th10
- •American Association of Spinal Cord Injury Impairment Score C and D
- •Focal spasticity in the adductor muscles and/ or triceps surae
- •Ability to walk 14 meters
- •Spasticity/clonus/spasms disturbing the activities of daily living or participation
Exclusion Criteria
- •Changes in spasticity medication during the last 3 months
- •Treatment with botulinum toxin during the last 6 months
- •Anticoagulant medication
- •Thrombosis
- •Malignant tumors
- •Pregnancy
- •Inflammations or skin lesions in the treated area
- •Acute urinary tract infection
- •Intended change in spasticity medication within 5 days after intervention
Outcomes
Primary Outcomes
severity of spasticity
Time Frame: time 0, time 2h
Ashworth Scale
Secondary Outcomes
- personal goal attainment(at day 0, 1, 3 and 5)
- walking speed(difference between pre- and post-intervention)
- walking distance(difference between pre- and post-intervention)
- thickness of the treated muscle(difference between pre- and post-intervention)
- severity of spasticity(time 0, time 2h)