Evaluation of efficacy and safety of US guided Intra-articular injections of Hyaluronic acid versus corticosteroid in patients with frozen shoulder (Adhesive Capsulitis)
Evaluation of efficacy and safety of intra-articular injection of hyaluronic acid and corticosteroid in treatment of frozen shoulder
Design
Randomized control trial with control parallel group, double blind
Settings and conduct
Subjects, interventionist, outcome assessor, statistician and the researcher are all blind to treatment groups allocation; using pre-filled syringes and sealed envelopes.
Subjects will be randomly allocated in 2 groups of 20 (injection of hyaluronic acid with lidocaine or triamcinolone with lidocaine).
The study will take place in Modarres hospital, Tehran.
Participants/Inclusion and exclusion criteria
Subjects with frozen shoulder symptoms;
Exclusion criteria are any history of previous fracture, surgery, bone lesion in the affected shoulder; or physical therapy or intra-articular injections in the past 3 months; allergy to hyaluronic acid or steroids; recurrence of disease in the affected shoulder.
Intervention groups
US guided intra-articular injection of 1 cc hyaluronic acid with 1 cc lidocaine 2%
US guided intra-articular injection of 1 cc triamcinolone 40 mg with 1 cc lidocaine 2%
Main outcome variables
Patient's pain severity and shoulder function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130523013442N28
Registration date:2019-08-01, 1398/05/10
Registration timing:registered_while_recruiting
Last update:2019-08-01, 1398/05/10
Update count:0
Registration date
2019-08-01, 1398/05/10
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and safety of US guided Intra-articular injections of Hyaluronic acid versus corticosteroid in patients with frozen shoulder (Adhesive Capsulitis)
Public title
Evaluation of hyaluronic acid effectiveness in treatment of frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with frozen shoulder
Exclusion criteria:
Recent fracture in the affected shoulder
History of inflammation and joint infections
Any bone lesion in the affected shoulder
Physical therapy or any intra-articular injections in the glenohumeral joint during the past three months
History of surgery on the affected shoulder
History of allergy to steroids and hyaluronic acid
Recurrence of the disease in the affected shoulder
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Subjects with bilateral frozen shoulder will be randomly allocated to treatment groups.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, subjects will be randomly allocated by individual simple randomization method to 2 intervention groups of 20, using computer random number generator, crating numbers between 0&1, and numbers smaller than 0.500 were allocated to group T1 (steroid) and numbers greater than 0.500 were allocated to group T2 (hyaluronic acid).
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects will be blinded by using pre-filled syringes for injections, the interventionist is not in the research team. The researcher and the statistician are also blind to treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committe of Shahid Beheshti University of Medical Sciences
Street address
No. 1983969411, Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.SBMU.MSP.REC.1398.215
Health conditions studied
1
Description of health condition studied
Frozen Shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 1 week and 4 weeks after injection.
Method of measurement
Visual Analogue Scale
2
Description
Active and passive range of motion
Timepoint
Before intervention, 1 week and 4 weeks after injection.
Method of measurement
goniometer
3
Description
Shoulder function
Timepoint
Before intervention, 1 week and 4 weeks after injection.
Method of measurement
Oxford, Shoulder Pain and Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: US guided intra-articular injection of 1 cc hyaluronic acid with 1 cc lidocaine 2%
Category
Treatment - Drugs
2
Description
Control group: US-guided intra-articular injection of 1 cc triamcinolone 40 mg with 1 cc lidocaine 2%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Khadijeh Samadnejad
Street address
No 1998734383, Shahid Modarres hospital , Kaj Square, Sa'adat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
kh.samadnejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Seyed Ahmad Raeissadat
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
a_raeissadat@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
Khadijeh Samadnejad
Position
Resident in Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
kh.samadnejad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
a_raeissadat@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khadijeh Samadnejad
Position
Resident in Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 1998734383, Shahid Modarres Hospital, Kaj square, Saadat abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2236 3244
Email
kh.samadnejad@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available