None listed
Conditions
Brief summary
Post-stroke spasticity is still a significant medical problem and challenge for the medicine specialist as well as physiotherapist. In two thirds of patients, the spasticity impairs the limb function, mostly affecting the upper limbs. A total of 12 million people worldwide suffer from spasticity. There are wide range of physical modalities reducing spasticity but without any doubts the ESW is a novel and promising method. Biological mechanism of the shock wave has not been fully known and explained. Well designed clinical studies confirmed efficiency and safety of ESW therapy in musculoskeletal disorders especially. Recent reports have suggested strong analgesic properties and favourable changes at the microcirculation level. The ESW effect causing the reduction of muscle hypertonia associated with neurological disorders is insufficiently studied, both in Poland and around the world. Recent data suggest that focused ESW could be valuable supportive therapy in post-stroke patients but clinical investigations are still in the initial stages.
Interventions
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
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.
Sponsors
University of Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Exclusion criteria
1. ischemic stroke episode less than 9 months previously; 2. different than ischemic stoke aetiology of spasticity (hemorrhagic stroke, craniocerebral trauma, multiple sclerosis, cerebral palsy); 3. post-stroke upper limb spasticity measured at 0 on the Modified Ashworth Scale; 4. spasticity reducing surgery in the past (rhizotomy, neurectomy, cordectomy, myotomy); 5. spasticity reducing pharmacotherapy at present (Diazepam, Baclofen, Dantrolene, Tizanidine, Botuline); 6. spasticity reducing physiotherapy at present (physical medicine, exercises, massages, neurophysiological methods); 7. the presence of contraindications to ESW stimulation (pregnancy, cancer, local tumors, coagulation disorders, acute and recurrent inflammatory states, pacemakers and other electronic implants); 8. lack of informed consent of the patients.
Outcome results
None listed