The evaluation of Pentoxifylline efficacy on Adhesive Capsulitis
Design
Two arm parallel group double blind randomized controlled trial, single center.
Settings and conduct
the study is double bind( both patient and clinician) and is performed in rheumatologic clinic. blindness is done by a third person who is pharmacist with computerized randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
diagnosis of adhesive capsulitis is made by a Rheumatologist;
informed contest is obtained;
Non Inclusion criteria:
patient dissatisfaction;
adhesive capsulitis due to malignancy;
history of cardiac arhythmia;
history of NSAID use;
pregnancy or lactation
Intervention groups
Intervention group:
prescription of pentoxifylline, BID, for 3 months.
Control group:
prescription of placebo, BID, for 3 months.
Main outcome variables
affected shoulder range of motion; serum TNF-alpha level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181103041531N1
Registration date:2019-02-28, 1397/12/09
Registration timing:registered_while_recruiting
Last update:2019-02-28, 1397/12/09
Update count:0
Registration date
2019-02-28, 1397/12/09
Registrant information
Name
Leila Mahmoudieh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2360 2188
Email address
l.mahmoudieh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
2022-01-21, 1400/11/01
Scientific title
Evaluation the efficacy of Pentoxifylline and placebo on Adhesive Capsulitis
Public title
The evaluation of Pentoxifylline efficacy on Adhesive Capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of adhesive capsulitis is made by a Rheumatologist
informed contest is obtained
Exclusion criteria:
patient dissatisfaction
adhesive capsulitis secondary to malignancy
history of cardiac arhythmia
history of NSAID use
pregnancy or lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
72
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Those patients who are diagnosed as adhesive capsulitis by rheumatologist are randomly assigned to case or control groups. Randomization will be done using random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
randomization is done by a third person and participants and doctor are both blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Shahid Beheshti university of medical science
Street address
Labbafinejad Hospital, 9th Boostan, Pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.SBMU.MSP.REC.1396.515
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
affected shoulder range of motion
Timepoint
before intervention and after intervention, weekly up to 3 months
Method of measurement
physical examination
2
Description
level of TNF-alpha in blood
Timepoint
before intervention and at the end of study
Method of measurement
blood measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group pentoxifylline, oral tablet 400mg which is produced by Amin pharmaceutical company is prescribed twice daily for 3 months
Category
Treatment - Drugs
2
Description
Control group: In this group placebo, oral tablet 400mg, which is produced by Amin pharmaceutical company is prescribed twice daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad hospital
Full name of responsible person
Leila Mahmoudieh
Street address
9th Bosstan, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2188
Email
l.mahmoudieh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zargh
Street address
Next to Taleghani hospital, Shahid Arabi ave., Yaman street, Chamran boulevard
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Leila Mahmoudieh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Labbafinejad hospital, 9th Boostan, Pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2188
Email
l.mahmoudieh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Leila Mahmoudieh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
LAbbafinejad hospital, 9th Boostan, Pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2188
Email
l.mahmoudieh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Leila Mahmoudieh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Labbafinejad hospital, 9th Boostan, Pasdaran ave.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2188
Email
l.mahmoudieh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no plan to share data with other researches or organizations yet
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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not 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
all collected data will be deidentified before sharing.
When the data will become available and for how long
data will be available 6 months after publication.
To whom data/document is available
Data is available for academic people and organizations.
Under which criteria data/document could be used
there is no limitation on how to use data
From where data/document is obtainable
l.mahmoudieh@sbmu.ac.ir
What processes are involved for a request to access data/document
Request should be sent by email and after identitiy obtaining, data will be sent by email