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

Spinal Cord Injury Clinical Trial

— ESWT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203994
• Other study ID #: 2014-07
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: January 25, 2017
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)
2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

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