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Clinical Trials/NCT02203994
NCT02203994
Completed
N/A

The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury

Swiss Paraplegic Research, Nottwil1 site in 1 country20 target enrollmentJuly 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
Swiss Paraplegic Research, Nottwil
Enrollment
20
Locations
1
Primary Endpoint
severity of spasticity
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Swiss Paraplegic Research, Nottwil
Responsible Party
Sponsor

Eligibility Criteria

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)
  • severity of spasticity(time 0, time 2h)
  • 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)

Study Sites (1)

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