To assess the effectiveness of methotrexate on adhesive capsulitis of the shoulder, in comparison to oral naproxen
Design
Pragmatic, Two-arm parallel randomized trial
Settings and conduct
The study is conducted as a randomized clinical trial. Random allocation is done using a random number table generated by Microsoft Excel. Intervention arms are oral naproxen vs. intramuscular methotrexate injection. Due to the difference in intervention, blinding is not applicable. Sampling will be done using the convenience method.
Participants/Inclusion and exclusion criteria
All patients diagnosed with primary adhesive capsulitis of the shoulder, older than 18 years old, without a history of trauma, or any secondary cause. Pregnant women, as well as patients with renal or hepatic insufficiency, are excluded.
Range of motion (ROM);
Visual Analog Scale (VAS);
Shoulder Pain and Disability Index Questionnaire (SPADI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181101041523N1
Registration date:2022-12-20, 1401/09/29
Registration timing:retrospective
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Sina Owlia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 8410
Email address
sinowlia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-02-01, 1397/11/12
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-03-05, 1398/12/15
Scientific title
Therapeutic efficacy of intramuscular methotrexate versus oral naproxen in adhesive capsulitis of the shoulder: a randomized controlled trial
Public title
Intramuscular methotrexate on adhesive capsulitis of the shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients diagnosed with adhesive capusilits older than 18 years old
Exclusion criteria:
History of trauma
Evidence of degenerative processes
Active gastric ulcer
History of GI bleeding
History of hepatitis
Patients with renal insufficiency
Pregnant women
Age
From 18 days old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization would be done by allowing the included patients to choose among sealed and opaque envelopes containing the allocation to either of the treatment groups. As diabetes condition is strongly correlated with the disease (presumably 70% of patients with adhesive capsulitis), this parameter has been selected as the factor for stratified randomization. Patients with diabetes condition would choose from 'Diabetes strata' while patients without diabetes condition would choose an envelope from 'Non-Diabetes' strata.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Ethics Committee
Street address
School of Medicine, Alem sq., Safaiyeh, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۳
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.111
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis of the shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Passive range of motion of the involved shoulder (flexion, abduction, internal rotation, external rotation)
Timepoint
Before intervention, and at 2, 4, and 8 weeks after intervention
Method of measurement
Analog Goniometer
2
Description
Perceived pain
Timepoint
Before intervention, and at 2, 4, and 8 weeks after intervention
Method of measurement
Visual Analog Scale
3
Description
Functional and disability outcomes
Timepoint
Before intervention, and at 2, 4, and 8 weeks after intervention
Method of measurement
Shoulder pain and disability index (SPADI) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intramuscular methotrexate (12.5 mg every 10 days for 40 days)
Category
Treatment - Drugs
2
Description
Intervention group: Oral Naproxen (500 mg Daily for 40 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaeipour Day Clinic
Full name of responsible person
Sina Owlia
Street address
Baghaeipour day clinic, Ibn Sina blvd., Safaiyeh, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 9105
Email
baghaeipourclinic@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Prof. Owlia private office
Full name of responsible person
Sina Owlia
Street address
#33, Kamelia Ave., Abouzar sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916884566
Phone
+98 35 3825 5550
Email
sinowlia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Masoud Mirzaei
Street address
Shahid Sadoughi Blvd., Bahonar sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3725 8474
Email
ethic@ssu.ac.ir
Web page address
http://www.ssu.ac.ir/cms/index.php?id=16257
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Sina Owlia
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Rheumatology
Street address
Central Administration, Bahonar Sq., Yazd 8916978477 I.R. Iran
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3725 8410
Fax
+98 35 3725 4750
Email
sinowlia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohammad Bagher Owlia
Position
Professor of Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Rheumatology Division, Shahid Sadoughi Hospital, Ibn Sina blvd., Safaiyeh, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
bagherowlia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Sina Owlia
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
Rheumatology
Street address
Central Administration, Bahonar Sq., Yazd 8916978477 I.R. Iran
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3725 8410
Fax
+98 35 3725 4750
Email
sinowlia@gmail.com
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
َAll patient data are handled with their informed consent. No personal data, disclosing patient identities would be shared. IPD collected for the primary outcome measure only
When the data will become available and for how long
Three months after publication
To whom data/document is available
We try to publish it in an open-access journal for maximum visibility and accessibility.
Under which criteria data/document could be used
Only for academic purposes, and comparing with other studies, unidentified data would be accessible.
From where data/document is obtainable
Send an email via sinowlia@gmail.com
What processes are involved for a request to access data/document