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

NCT ID: NCT02203994

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Spinal Cord Injury; Spasticity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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))

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz

Interventions

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

2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Baumberger, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Centre

Locations

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Countries

Switzerland

Other Identifiers

2014-07

Identifier Type: -

Identifier Source: org_study_id