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Evaluation of the therapeutic effect of shock wave therapy on pain and function of patients with osteoarthritis of the knee compared to placebo

Protocol summary

Study aim
Evaluation of therapeutic effect of shock wave therapy on pain and function of patients with osteoarthritis of the knee compared to placebo
Design
In this study 50 patients with osteoarthritis of the knee are divided in to intervention and control groups. The intervention group is treated with shock wave therapy ( 3 sessions), local anti pain and hot pack. The control group is treated with sham shock wave (3 sessions), local anti pain and hot pack. The severity of knee pain, knee injury and patient's dysfunction is assessed and compared before intervention and 1, 3 and 10 weeks after intervention by standard questionnaires.
Settings and conduct
This study is done in Alzahra, Ayatollah Kashani and Eisabn Maryam hospitals in Isfahan University of Medical Science. Patients with osteoarthritis of the knee who referred to physical medicine and rehabilitation clinics are selected to participate in this study.The intervention group is treated with shock wave therapy ( 3 sessions), local anti pain and hot pack. The control group is treated with sham shock wave (3 sessions), local anti pain and hot pack. The severity of knee pain, knee injury and patient's dysfunction is assessed and compared before intervention and 1, 3 and 10 weeks after intervention by standard questionnaires.
Participants/Inclusion and exclusion criteria
1) Having Osteoarthritis of the knee based on based on American college of Rheumatology, 2)Knee pain, crepitation and joint dryness, 3)Level 2 or 3 in Kellgren Lawrence scale and 4)Patient's willingness to participate in this study
Intervention groups
Intervention group: Patients in intervention group are treated with shock wave therapy, local anti pain and hot pack. Control group: Patients in control group are treated with sham shock wave, local anti pain and hot pack.
Main outcome variables
Severity of knee pain, knee injury and patient's dysfunction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120729010439N3
Registration date: 2019-08-14, 1398/05/23
Registration timing: retrospective

Last update: 2019-08-14, 1398/05/23
Update count: 0
Registration date
2019-08-14, 1398/05/23
Registrant information
Name
Babak Vahdatpour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 5555
Email address
vahdatpour@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-06-20, 1398/03/30
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Evaluation of the therapeutic effect of shock wave therapy on pain and function of patients with osteoarthritis of the knee compared to placebo
Public title
Shock wave and osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoarthritis of the knee based on based on American college of Rheumatology Knee pain, crepitation and joint dryness Level 2 or 3 in Kellgren Lawrence scale Patient's willingness to participate in this study
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were divided in to two groups (Intervention and Control) based on random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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 Science
Street address
Isfahan University of Medical Science, Hezarjrib Street, Azadi Square, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2019-02-14, 1397/11/25
Ethics committee reference number
IR.MUI.REC.1397.234

Health conditions studied

1

Description of health condition studied
Osteoarthritis of the knee
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site

Primary outcomes

1

Description
The severity of knee pain
Timepoint
Before intervention, 1, 3 and 10 weeks after intervention
Method of measurement
The Visual Analogue Scale

2

Description
The severity of knee injury
Timepoint
Before intervention, 1, 3 and 10 weeks after intervention
Method of measurement
Knee Injury and Osteoarthritis outcome Score Questionnaire

3

Description
Patient's dysfunction
Timepoint
Before intervention, 1, 3 and 10 weeks after intervention
Method of measurement
The Lequense questionnnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in intervention group is treated with shock wave therapy (3 sessions weekly, 1000 shocks with frequency of 406 Hz), local anti pain (anti pain gel 2 times a day) and hot pack (3 times a day).
Category
Treatment - Devices

2

Description
Control group: Patients in control group is treated with sham shock wave therapy (3 sessions weekly), local anti pain (anti pain gel 2 times a day) and hot pack (3 times a day).
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Babak Vahdatpour
Street address
Alzahra hospital, Shohadaye Sofeh Sreet, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
vahdatpour@med.mui.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Babak Vahdatpour
Street address
Ayatollah Kashani hospital, Kashani street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3323 3091
Email
vahdatpour@med.mui.ac.ir

3

Recruitment center
Name of recruitment center
Eisabne Maryam hospital
Full name of responsible person
Babak Vahdatpour
Street address
Eisabne Maryam hospital, Shamsabadi street, Isfahan city
City
Isfahan
Province
Isfehan
Postal code
8134735845
Phone
+98 31 3323 2065
Email
vahdatpour@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fariba Farajzadegan
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
dean@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
Faezeh Mortazavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan University of Medical Science, Hezargrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
f_9268@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 1668 7898
Email
vahdatpour@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Rehabilitation Medicine, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 1668 7898
Email
vahdatpour@med.mui.ac.ir

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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