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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injury, Spasticity

Intervention / Treatment
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* Device: Duolith® SD 1 T-Top (Storz Medical AG, Switzerland)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: extracorporeal shock wave therapy (ESWT)<br>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)<br>* 2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, extracorporal shock wave therapy (ESWT), spasticity