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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury; Spasticity
• Intervention / Treatment: Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of spasticity	Ashworth Scale	time 0, time 2h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
personal goal attainment	Goal Attainment Scale	at day 0, 1, 3 and 5
walking speed	10 Meters Walking Test	difference between pre- and post-intervention
walking distance	6 Minutes Walking Test	difference between pre- and post-intervention
thickness of the treated muscle	thickness measurement of the treated muscle using ultrasound	difference between pre- and post-intervention
severity of spasticity	Adductor Tone Rating Scale	time 0, time 2h
severity of spasticity	Penn Spasm Frequency Scale	time 0, time 2h
severity of spasticity	Clonus Scale	time 0, time 2h

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Investigators: Principal Investigator: Michael Baumberger, Dr. med., Swiss Paraplegic Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: spasticity; spinal cord injury; extracorporal shock wave therapy (ESWT)
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Muscle Hypertonia; Wounds and Injuries; Spinal Cord Injuries; Muscle Spasticity
• Other Study ID Numbers: 2014-07