An interventional study of Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland) in Spinal Cord Injury and Spasticity, sponsored by Swiss Paraplegic Research, Nottwil. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-26.
Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Swiss Paraplegic Research, Nottwil is the lead sponsor of 69 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 "T-Top" (Storz Medical AG, Tägerwilen, Switzerland))
Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
severity of spasticity
Ashworth Scale
Time frame: time 0, time 2h
personal goal attainment
Goal Attainment Scale
Time frame: at day 0, 1, 3 and 5
walking speed
10 Meters Walking Test
Time frame: difference between pre- and post-intervention
walking distance
6 Minutes Walking Test
Time frame: difference between pre- and post-intervention
thickness of the treated muscle
thickness measurement of the treated muscle using ultrasound
Time frame: difference between pre- and post-intervention
severity of spasticity
Adductor Tone Rating Scale
Time frame: time 0, time 2h
severity of spasticity
Penn Spasm Frequency Scale
Time frame: time 0, time 2h
severity of spasticity
Clonus Scale
Time frame: time 0, time 2h
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Swiss Paraplegic Research, Nottwil