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

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Spasticity; Spinal Cord Injury

Treatments: Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02203994

2014-07

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

extracorporeal shock wave therapy (ESWT)

Experimental group

Description:

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))

Treatment:

Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)