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

Sponsor

Swiss Paraplegic Centre Nottwil (Other)

Overall Status

Completed

CT.gov ID

NCT02203994

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury Spasticity	Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: extracorporeal shock wave therapy (ESWT) 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

Arm

Intervention/Treatment

Experimental: extracorporeal shock wave therapy (ESWT)

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

Outcome Measures

Primary Outcome Measures

severity of spasticity [time 0, time 2h]
Ashworth Scale

Secondary Outcome Measures

personal goal attainment [at day 0, 1, 3 and 5]
Goal Attainment 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
severity of spasticity [time 0, time 2h]
Adductor Tone Rating Scale
severity of spasticity [time 0, time 2h]
Penn Spasm Frequency Scale
severity of spasticity [time 0, time 2h]
Clonus Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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