Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001233718
Ethics application status
Approved
Date submitted
5/11/2013
Date registered
11/11/2013
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Shock wave therapy on upper limb spasticity after stroke.
Scientific title
Electrophysiological and thermal changes after extracorporeal shock wave stimulation on upper limb spasticity after ischemic stroke: a randomized single blind controlled study.
Secondary ID [1] 283512 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-stroke upper limb spasticity 290430 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290821 290821 0 0
Physiotherapy
Stroke 290822 290822 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288217 0
Treatment: Devices
Intervention code [2] 288232 0
Rehabilitation
Comparator / control treatment
patients in control group recives a single placebo ESW stimulation
Control group
Placebo

Outcomes
Primary outcome [1] 290817 0
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)
Timepoint [1] 290817 0
baseline, immediately after, and at 1 and 24 hours after intervention
Primary outcome [2] 290830 0
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)
Timepoint [2] 290830 0
baseline, immediately after, and at 1 and 24 hours after intervention
Secondary outcome [1] 305385 0
nil
Timepoint [1] 305385 0
nil

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by appropriate website http://www.random.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis and evaluation of the results will be based on the comparison of intra- and intergroup results. Statistical analysis of these results will be performed by means of the Statistica 10 software, manufactured by StatSoft (licence of Medical University in Wroclaw).

All analysed intergroup qualitative variables will be checked with respect to their similarity (chi2 NW). For measurable variables (quantitative), arithmetic mean, standard deviations, medians and range of variability (extreme values) will be calculated and the normal distribution will be used by Shapiro – Wilk test. For qualitative variables, the frequency of occurrence (percentage) will be calculated. Comparison of intergroup results (for the independent variables) in order to determine the significance of the achieved differences, will be performed by means of parametric (Student's t-test) or non-parametric (Mann-Whitney's test) tests, depending on meeting criteria for the specific test. The parameters before and after the study will be compared in the groups (for dependent variables) by parametric (t-test) or non-parametric (Wilcoxon's test), depending on meeting criteria for the specific test. For all analysis a critical significance level a = 0.05 will be considered statistically significant.

According to statistical estimation the population over 30-35 is needed for further analysis of normal distribution, the scientific team had to include at least 80 participants in two groups to this study and use the parametric tests. To achieve study objectives the minimal number of participants is 40 in each group. Smaller number of patients is not enough from both statistical and clinical point of view.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2013
Actual
22/10/2013
Date of last participant enrolment
Anticipated
Actual
25/02/2015
Date of last data collection
Anticipated
Actual
27/02/2015
Sample size
Target
100
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 5569 0
Poland
State/province [1] 5569 0
Lower Silesia

Funding & Sponsors
Funding source category [1] 288215 0
Government body
Name [1] 288215 0
National Science Centre
Country [1] 288215 0
Poland
Primary sponsor type
University
Name
University of Medicine
Address
Pasteura Street 1, 50-367 Wroclaw
Country
Poland
Secondary sponsor category [1] 286939 0
None
Name [1] 286939 0
Address [1] 286939 0
Country [1] 286939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290125 0
Commission of Bioethics at Wroclaw Medical University
Ethics committee address [1] 290125 0
Ethics committee country [1] 290125 0
Poland
Date submitted for ethics approval [1] 290125 0
02/07/2012
Approval date [1] 290125 0
11/07/2012
Ethics approval number [1] 290125 0
KB-610/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44074 0
Dr Robert Dymarek
Address 44074 0
Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw
Country 44074 0
Poland
Phone 44074 0
+48 723 895 770
Fax 44074 0
Email 44074 0
[email protected]
Contact person for public queries
Name 44075 0
Robert Dymarek
Address 44075 0
Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw
Country 44075 0
Poland
Phone 44075 0
+48 723 895 770
Fax 44075 0
Email 44075 0
[email protected]
Contact person for scientific queries
Name 44076 0
Robert Dymarek
Address 44076 0
Department of Nervous System Diseases, University of Medicine in Wroclaw, Bartla Street 5, 51-618 Wroclaw
Country 44076 0
Poland
Phone 44076 0
+48 723 895 770
Fax 44076 0
Email 44076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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