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

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

Tracking Information

• First Submitted Date: July 28, 2014
• First Posted Date: July 30, 2014
• Last Update Posted Date: January 26, 2017
• Actual Study Start Date: July 2014
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2014)

severity of spasticity [ Time Frame: time 0, time 2h ]

Ashworth Scale

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Spinal Cord Injury
• Spasticity

Intervention

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

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2014): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02203994
• Other Study ID Numbers: 2014-07
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Swiss Paraplegic Centre Nottwil
• Study Sponsor: Swiss Paraplegic Centre Nottwil
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Baumberger, Dr. med.; Swiss Paraplegic Centre

• PRS Account: Swiss Paraplegic Centre Nottwil
• Verification Date: January 2017