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

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ClinicalTrials.gov Identifier: NCT02203994
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Tracking Information
First Submitted Date  ICMJE July 28, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date January 26, 2017
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
severity of spasticity [ Time Frame: time 0, time 2h ]
Ashworth Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • personal goal attainment [ Time Frame: at day 0, 1, 3 and 5 ]
    Goal Attainment Scale
  • walking speed [ Time Frame: difference between pre- and post-intervention ]
    10 Meters Walking Test
  • walking distance [ Time Frame: difference between pre- and post-intervention ]
    6 Minutes Walking Test
  • thickness of the treated muscle [ Time Frame: difference between pre- and post-intervention ]
    thickness measurement of the treated muscle using ultrasound
  • severity of spasticity [ Time Frame: time 0, time 2h ]
    Adductor Tone Rating Scale
  • severity of spasticity [ Time Frame: time 0, time 2h ]
    Penn Spasm Frequency Scale
  • severity of spasticity [ Time Frame: time 0, time 2h ]
    Clonus Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
Official Title  ICMJE The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injury
  • Spasticity
Intervention  ICMJE Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
Study Arms  ICMJE 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))
Intervention: Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203994
Other Study ID Numbers  ICMJE 2014-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Paraplegic Centre Nottwil
Study Sponsor  ICMJE Swiss Paraplegic Centre Nottwil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Baumberger, Dr. med. Swiss Paraplegic Centre
PRS Account Swiss Paraplegic Centre Nottwil
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP