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

Primary Purpose

Spinal Cord Injury, Spasticity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring extracorporal shock wave therapy (ESWT), spasticity, spinal cord injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

  • Swiss Paraplegic Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

extracorporeal shock wave therapy (ESWT)

Arm Description

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))

Outcomes

Primary Outcome Measures

severity of spasticity
Ashworth Scale

Secondary Outcome Measures

personal goal attainment
Goal Attainment Scale
walking speed
10 Meters Walking Test
walking distance
6 Minutes Walking Test
thickness of the treated muscle
thickness measurement of the treated muscle using ultrasound
severity of spasticity
Adductor Tone Rating Scale
severity of spasticity
Penn Spasm Frequency Scale
severity of spasticity
Clonus Scale

Full Information

First Posted
July 28, 2014
Last Updated
January 25, 2017
Sponsor
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT02203994
Brief Title
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
Acronym
ESWT
Official Title
The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Spasticity
Keywords
extracorporal shock wave therapy (ESWT), spasticity, spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extracorporeal shock wave therapy (ESWT)
Arm Type
Experimental
Arm Description
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))
Intervention Type
Device
Intervention Name(s)
Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
Intervention Description
2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
Primary Outcome Measure Information:
Title
severity of spasticity
Description
Ashworth Scale
Time Frame
time 0, time 2h
Secondary Outcome Measure Information:
Title
personal goal attainment
Description
Goal Attainment Scale
Time Frame
at day 0, 1, 3 and 5
Title
walking speed
Description
10 Meters Walking Test
Time Frame
difference between pre- and post-intervention
Title
walking distance
Description
6 Minutes Walking Test
Time Frame
difference between pre- and post-intervention
Title
thickness of the treated muscle
Description
thickness measurement of the treated muscle using ultrasound
Time Frame
difference between pre- and post-intervention
Title
severity of spasticity
Description
Adductor Tone Rating Scale
Time Frame
time 0, time 2h
Title
severity of spasticity
Description
Penn Spasm Frequency Scale
Time Frame
time 0, time 2h
Title
severity of spasticity
Description
Clonus Scale
Time Frame
time 0, time 2h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Baumberger, Dr. med.
Organizational Affiliation
Swiss Paraplegic Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic Centre
City
Nottwil
State/Province
LU
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

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

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