to assess the efficacy of extracorporeal shockwave therapy in the treatment of patients with de Quervain’s tenosynovitis in the present study
Design
controlled, randomized, clinical trial study
Settings and conduct
patients with de Quervain’s Tenosynovitis who referred to Physical medicine and rehabilitation centers of Isfahan University of Medical Sciences during 2015-2018:
Intervention group: shock wave therapy
control group: Placebo
Participants/Inclusion and exclusion criteria
The inclusion criteria were patients with de Quervain’s
Tenosynovitis, with age over 18 years, no history using of physiotherapy modalities or corticosterone injections for disease during a recent month and written informed consent for participation in the study. De Quervain’s Tenosynovitis was diagnosed based on standard criteria including pain and tenderness in the lateral wrist and positive result of the Finkelstein test.
However, in case of other neurological disorders and rheumatologic diseases causing wrist pain, pregnancy, history of fracture or surgery in the hand or severe trauma and coagulation disorders, were excluded from the study. Also, the patients who had chosen to withdraw the study during treatment or had a severe or acute complication after intervention or need to change the treatment were excluded from the study
Intervention groups
the patients were randomly divided into two parallel groups as extracorporeal shock wave therapy and placebo based on Random Allocation Software
Main outcome variables
Average duration of disease; evaluation of wrist pain; evaluation of disability in arm, shoulder and hand
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120729010439N2
Registration date:2019-06-17, 1398/03/27
Registration timing:retrospective
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
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
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-05-22, 1397/03/01
Scientific title
Efficacy assessment of ESWT in treatment of de Quervain’s Tenosynovitis for patients
Public title
Effect of extracorporeal shockwave therapy in the patients with de Quervain tenosynovitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with de Quervain’s Tenosynovitis . De Quervain’s Tenosynovitis was diagnosed based on standard criteria including pain and tenderness in the lateral wrist and positive result of the Finkelstein test
no history using of physiotherapy modalities or corticosterone injections for disease during a recent month
written informed consent for participation in the 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:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
After filling written informed consent, patients randomly divided into placebo or treatment group by randomizer 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 Sciences
Street address
Soffeh street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.Mui.Rec.1395.3.805
Health conditions studied
1
Description of health condition studied
Quervain’s Tenosynovitis
ICD-10 code
M65.4
ICD-10 code description
Radial styloid tenosynovitis [de Quervain]
Primary outcomes
1
Description
DISABILITIES OF THE ARM, SHOULDER AND HAND )DASH
Timepoint
in the beginning and the weeks 3 and 6 after onset treatment
Method of measurement
questioner
Secondary outcomes
1
Description
evaluation of wrist pain
Timepoint
in the beginning and the weeks 3 and 6 after onset of treatment
Method of measurement
VAS
Intervention groups
1
Description
Intervention group: shock wave therapy
Category
Treatment - Other
2
Description
Control group: therapy with turned on machine without shock induction
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
kashani educational medical center
Full name of responsible person
Elham Ataei
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 5555
Email
Dreliataei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5149
Email
research@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
Babak Vahdatpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
vahdatpour@med.mui.ac.ir
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
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
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
Hezar jarib
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5555
Email
Vahdatpour@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
After making sure that the participants personal data is not possible to track, all the data and outcomes can be shared
When the data will become available and for how long
5 years after publishing the data
To whom data/document is available
Verified university research centers
Under which criteria data/document could be used
research and therapeutic purposes
From where data/document is obtainable
sending e-mail to the corresponding person
What processes are involved for a request to access data/document
receiving e-mail and checking the inquiry with the related university. After confirmation they will be introduced to our center to receive the data.