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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

Study Description
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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) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : July 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. severity of spasticity [ Time Frame: time 0, time 2h ]
    Ashworth Scale


Secondary Outcome Measures :
  1. personal goal attainment [ Time Frame: at day 0, 1, 3 and 5 ]
    Goal Attainment Scale

  2. walking speed [ Time Frame: difference between pre- and post-intervention ]
    10 Meters Walking Test

  3. walking distance [ Time Frame: difference between pre- and post-intervention ]
    6 Minutes Walking Test

  4. thickness of the treated muscle [ Time Frame: difference between pre- and post-intervention ]
    thickness measurement of the treated muscle using ultrasound

  5. severity of spasticity [ Time Frame: time 0, time 2h ]
    Adductor Tone Rating Scale

  6. severity of spasticity [ Time Frame: time 0, time 2h ]
    Penn Spasm Frequency Scale

  7. severity of spasticity [ Time Frame: time 0, time 2h ]
    Clonus Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203994


Locations
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Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
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Principal Investigator: Michael Baumberger, Dr. med. Swiss Paraplegic Centre
More Information
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT02203994    
Other Study ID Numbers: 2014-07
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Keywords provided by Swiss Paraplegic Centre Nottwil:
extracorporal shock wave therapy (ESWT)
spasticity
spinal cord injury
Additional relevant MeSH terms:
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Muscle Spasticity
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations