Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injury; Spasticity
• Interventions: Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)

• Registration Number: NCT02203994
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
extracorporeal shock wave therapy (ESWT)	Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)	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))

Primary Outcome Measures

Name	Time	Method
severity of spasticity	time 0, time 2h	Ashworth Scale

Secondary Outcome Measures

Name	Time	Method
personal goal attainment	at day 0, 1, 3 and 5	Goal Attainment Scale
severity of spasticity	time 0, time 2h	Clonus Scale
walking speed	difference between pre- and post-intervention	10 Meters Walking Test
walking distance	difference between pre- and post-intervention	6 Minutes Walking Test
thickness of the treated muscle	difference between pre- and post-intervention	thickness measurement of the treated muscle using ultrasound

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland