Determine the therapeutic effect of shockwave therapy. Reducing pain and improving patient performance in patients with shoulder pain after a stroke in 1397.
Design
A clinical trial with a control group, with parallel groups, double blind, randomized
Settings and conduct
This is a RCT randomized clinical trial that was conducted during 1397 in physiotherapy and rehabilitation clinics affiliated to Isfahan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in the study؛ Age group 20-80 years؛ At least 3 months have passed since the stroke occurred؛ Shoulder pain and shoulder paralysis have started after ischemic stroke؛ The severity of the shoulder pain is based on the vas criterion of at least 4 or more for at least 3 months؛ Exclusion criteria: Not being able to express the severity of pain
Surgical history on the shoulder؛ Use of oral hives 3 days before the study
Intraocular infusion or other interventions affecting shoulder in the past month؛ Taking high dose warfarin (INR above 4)؛ Trauma history on shoulders؛ Patients receiving a cardiac pacemaker؛ Moderate to severe depression؛ crps based on patient examination؛ History of shoulder pain before a stroke؛ Based on the examinations, no mechanical causes for pain should be noted.
Intervention groups
Patients are divided into two groups of intervention and control for Shockwave. The number of meetings is 5 sessions, which includes 3 focus sessions with weekly intervals and 5 radial sessions with intervals of two days per week. The protocol of the case and control groups were similar, only in the control group, the Sham method was used, except that they would receive zero energy.
Main outcome variables
Severe shoulder pain؛ Severe shoulder pain؛ The range of shoulder motion؛ Time to start shoulder pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N9
Registration date:2019-05-06, 1398/02/16
Registration timing:prospective
Last update:2019-05-06, 1398/02/16
Update count:0
Registration date
2019-05-06, 1398/02/16
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2020-01-31, 1398/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of shockwave therapy on pain of patient with post stroke hemiplegic shoulder pain
Public title
Evaluation of the effect of shockwave therapy on pain of patient with post stroke hemiplegic shoulder pain
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Age group 20-80 years
At least 3 months have passed since the stroke occurred.
Shoulder pain and shoulder paralysis have started after ischemic stroke.
The severity of the shoulder pain is based on the vas criterion of at least 4 or more for at least 3 months.
Exclusion criteria:
Not being able to express the severity of pain
Surgical history on the shoulder
Use of oral hives 3 days before the study
Intraocular infusion or other interventions affecting shoulder in the past month
Taking high dose warfarin (INR above 4)
Trauma history on shoulders
Patients receiving a cardiac pacemaker
Moderate to severe depression
crps based on patient examination
History of shoulder pain before a stroke
Based on the examinations, no mechanical causes for pain should be noted.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of the two groups by selecting the cards named A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the principal executor is considered to be medical doctors who are fully aware of the goals of the study and the types of treatments. Patients will not be aware of statistical research goals and how to compare treatments. However, they are fully aware of the fact that they are treated with different treatments in one of the two groups and that they receive treatment for their illness and have been studying satisfactorily. Patients will not be aware of shock or vision shock therapy. The counselor for statistics and information analytics, about treatment (shockwave and shock sham) and the name of the patients is not known.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.MUI.MED.REC.1398.035
Health conditions studied
1
Description of health condition studied
Shoulder pain
ICD-10 code
M25.51
ICD-10 code description
Pain in shoulder
Primary outcomes
1
Description
Severe shoulder pain
Timepoint
The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment
Method of measurement
Vas questionnaire
2
Description
Shoulder performance
Timepoint
The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment
Method of measurement
Examination and questionnaire
3
Description
The range of shoulder motion
Timepoint
The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment
Method of measurement
Goniometer
4
Description
Time to start shoulder pain
Timepoint
The beginning of the study, the end of treatment, and weeks 4 and 8 after treatment
Method of measurement
Information Form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Under treatment with shockwave, the number of sessions is 5 sessions, which consists of 3 sessions of focus with intervals and 5 radial sessions with intervals of two days per week. The SHAKEVIEW protocol is in this form. Shockwave focus is expressed as the number of shocks of 1,000 at any point with a J2 / 0-3 / 0 energy of ZH 4 and a radial to 1000 shocks per point with an energy of 1.33 j3 and a frequency of 15Hz.
Category
Treatment - Devices
2
Description
Control group: Sham treatment was used with zero energy
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy and Rehabilitation Clinics of Isfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Street address
Office of Physical Medicine and Rehabilitation, Al-Zahra Educational Center, ,Sofe St., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
haghighatshil@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shila Haghighat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, School of Medicine, Kashani Hospital, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Haghighatshila@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Department of Physical Medicine and Rehabilitation
What processes are involved for a request to access data/document
ِAfter the investigation of researcher request and presentation of required documents will be accessible.