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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extracorporeal shock wave therapy (ESWT) | Experimental | 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)) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland) | Device | 2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz |
|
| Measure | Description | Time Frame |
|---|---|---|
| severity of spasticity | Ashworth Scale | time 0, time 2h |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Baumberger, Dr. med. | Swiss Paraplegic Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |