Overview

This trial is active, not recruiting.

Conditions spinal cord injury, spasticity
Treatment duolith® sd 1 "t-top" (storz medical ag, switzerland)
Sponsor Swiss Paraplegic Centre Nottwil
Start date July 2014
End date October 2016
Trial size 20 participants
Trial identifier NCT02203994, 2014-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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))
duolith® sd 1 "t-top" (storz medical ag, switzerland)
2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz

Primary Outcomes

Measure
severity of spasticity
time frame: time 0, time 2h

Secondary Outcomes

Measure
personal goal attainment
time frame: at day 0, 1, 3 and 5
walking speed
time frame: difference between pre- and post-intervention
walking distance
time frame: difference between pre- and post-intervention
thickness of the treated muscle
time frame: difference between pre- and post-intervention
severity of spasticity
time frame: time 0, time 2h
severity of spasticity
time frame: time 0, time 2h
severity of spasticity
time frame: time 0, time 2h

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
Principal investigator Michael Baumberger, Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Swiss Paraplegic Centre Nottwil.