Clinical trial NCT02203994: Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
Official title: The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Spasticity
Keywords: extracorporal shock wave therapy (ESWT)
spasticity
spinal cord injury
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2014-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: severity of spasticity
timeFrame: time 0, time 2h
Secondary outcomes:
measure: personal goal attainment
timeFrame: at day 0, 1, 3 and 5
measure: walking speed
timeFrame: difference between pre- and post-intervention
measure: walking distance
timeFrame: difference between pre- and post-intervention
measure: thickness of the treated muscle
timeFrame: difference between pre- and post-intervention
measure: severity of spasticity
timeFrame: time 0, time 2h
measure: severity of spasticity
timeFrame: time 0, time 2h
measure: severity of spasticity
timeFrame: time 0, time 2h
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Centre
name: Michael Baumberger, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: