Shock wave therapy on upper limb spasticity after stroke.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: The aim of the study is to assess electrophysiological and thermal changes after single extracorporeal shock wave stimulation on upper limb spasticity in patients after ischemic stroke. Intervention: All patients will be randomized and randomly assigned into two comparative groups. Group A will be the study group, where active shock wave stimulation (ESW) will be used. Group B will be a placebo group where the participants will be received a quasi‐ESW without biological effect. A single active ESW or placebo ESW stimulation will be performed in all patients, depending on the random assignment to a particular group. Physical energy will be applied directly to the spastic carpal flexors muscle bellies in patients with post‐stroke hemiparesis. To carry out the stimulation, a device BTL‐5000 ESW Power (BTL, Poland) emitting radial shock wave will be used. ESW parameters in the study group will involve safe and painless dose with no local anaesthesia. Pressure will be at 1.5 bar (0.1 mJ/mm2), frequency at 5 pulses per second (5 Hz) and total 1500 number of pulses. ESW is administered once only over a period of approximately 5 minutes. In the placebo group, a passive quasi‐ESW lacking biologically active component will be applied. The special polyethylene cap filled with sponge to ensure an absorption of the ESW shocks in placebo‐controlled group will cover an applicator head over. CONDITION: post‐stroke upper limb spasticity PRIMARY OUTCOME: to decrease the resting muscle bioelectrical activity of the carpal flexors muscles; surface electromyography: Noraxon MyoSystem 1400A (Noraxon, USA) will be used to assess the resting muscle bioelectrical activity of the flexors carpal muscles (µV) to increase the mean temperature of the flexors forearm region; infra‐red thermal imaging: MobIR M8 (Test‐Therm, Poland) will be used to register thermal changes at the microcirculation level in examined forearm muscles, as well as to visualize changes in local temperature distribution of stimulated tissues (°C) SECONDARY OUTCOME: nil INCLUSION CRITERIA: 1. ischemic stroke episode for at least 9 months previously; 2. post‐stroke upper limb spasticity measured for at least 1 at the Modified Ashworth Scale; 3. lack of contraindications to ESW stimulation; 4. lack of surgical interventions reducing spasticity in the past; 5. lack of pharmacological medications reducing spasticity at present; 6. lack of physiotherapy reducing spasticity at present; 7. good compliance and willingness to sign the written consent form.
Epistemonikos ID: bedbdaccf1fb6294e87ac6f26ed256db7cf6f8b2
First added on: Aug 22, 2024