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Evaluating the Efficacy and Safety of adding Intra- Articular High Molecular Weight Hyaluronic Acid (Viscor® MW>2000 KD) Injections in Comparison of Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-800 KD) and lidocaine In Idiopathic Adhesive Capsulitis

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History
# Registration date Revision Id
2 2022-10-01, 1401/07/09 241872
1 2020-01-01, 1398/10/11 116256
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  • General information

    51
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    2019-09-01, 1398/06/10
    2022-03-01, 1400/12/10
    2018-11-22, 1397/09/01
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    2019-10-13, 1398/07/21
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    2020-01-20, 1398/10/30
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    The results of the study at the end of the 12-week follow-up period showed that the two groups did not have a significant difference in terms of study outcomes, considering that the duration of effect of the injections of two molecular weights of hyaluronic acid could have been different in a longer period, the research team of the study was decided to continue the study for 24 weeks follow-up, due to the lack of complete referral of the patients included in the study in the 24-week follow-up, patient recruitment was continued again until the study reached the desired sample size.
    empty
    نتایج مطالعه در انتهای زمان فالوآپ 12 هفته ای نشان داد، دو گروه از نظر اوت کام های مطالعه، تفاوت معنی داری ندارند، با توجه به اینکه طول اثر تزریق دو وزن مولکولی هیالورونیک اسید می توانست در مدت طولانی تر متفاوت باشد، تیم تحقیقاتی مطالعه تصمیم گرفت مطالعه را به مدت 24 هفته ادامه دهد، به دلیل عدم مراجعه کامل بیماران وارد شده به مطالعه در فالوآپ 24 هفته ای، بیمارگیری مجدداً ادامه یافت تا مطالعه به حجم نمونه مورد نظر دست یابد.

  • Primary outcomes

    #1
    At baseline, 4 and 12 weeks after injection
    At baseline, 4, 12 and 24 weeks after injection
    در زمان تزریق، ۱ ماه، ۳ ماه بعد از تزریق
    در زمان تزریق، 4 هفته، 12 هفته و 24 هفته بعد از تزریق

  • Secondary outcomes

    #1
    goniometry
    Goniometry

  • Intervention groups

    #1
    گروه مداخله: تزریق داخل مفصلی هیالورونیک اسید با وزن مولکولی بالا (ویسکور >۲۰۰۰ کبلودالتون) در شانه به همراه فیزیکال تراپی
    گروه مداخله: تزریق داخل مفصلی هیالورونیک اسید با وزن مولکولی بالا (ویسکور >۲۰۰۰ کیلودالتون) در شانه به همراه فیزیکال تراپی

Protocol summary

Study aim
The aim of this study is to investigate the add on effectiveness and safety of intra-articular injection of two types of hyaluronic acid differ on the molecular weight and with physical therapy of adult patients with adhesive capsulitis.
Design
A randomized, blinded and parallel group trial. Randomization was done with block randomization method, with 50 patient equally enrolled in 2 parallel groups.
Settings and conduct
The recruitment of patients will be done in Shahid Modarres Hospital, Tehran, Iran. All Participants, Investigators, Outcome assessors, Data analyst and quality controller are blinded
Participants/Inclusion and exclusion criteria
Adult Patients (16-65 years) who were diagnosed as adhesive capsulitis in the last month were included in this study, whom who had a history of traumatic injury to shoulder, active tendonitis and history of rotator cuff tears were and who have used systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in last week and systemic corticosteroids in last month were excluded from this study.
Intervention groups
One group received intra-articular injection of high molecular weight hyaluronic acid (Viscor® >2000 KD) and second group revived intra-articular injection of low molecular weight hyaluronic acid (Hyalgan® 500-800 KD), physical therapy will be learned to both groups.
Main outcome variables
The primary outcome is visual analog score difference, The secondary outcomes will be active, passive, internal, external range of motion, oxford score and patient satisfaction.

General information

Reason for update
The results of the study at the end of the 12-week follow-up period showed that the two groups did not have a significant difference in terms of study outcomes, considering that the duration of effect of the injections of two molecular weights of hyaluronic acid could have been different in a longer period, the research team of the study was decided to continue the study for 24 weeks follow-up, due to the lack of complete referral of the patients included in the study in the 24-week follow-up, patient recruitment was continued again until the study reached the desired sample size.
Acronym
IRCT registration information
IRCT registration number: IRCT20170608034390N4
Registration date: 2020-01-01, 1398/10/11
Registration timing: registered_while_recruiting

Last update: 2022-10-03, 1401/07/11
Update count: 1
Registration date
2020-01-01, 1398/10/11
Registrant information
Name
Hadi Esmaily
Name of organization / entity
SBMU
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
esmaily_hadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy and Safety of adding Intra- Articular High Molecular Weight Hyaluronic Acid (Viscor® MW>2000 KD) Injections in Comparison of Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-800 KD) and lidocaine In Idiopathic Adhesive Capsulitis
Public title
Comparing the Add on Effectiveness of Intra-Articular Injections of High Molecular Weight Hyaluronic Acid (Viscor®>2000 KD) with Low Molecular Weight Hyaluronic Acid (Hyalgan® MW= 500-800 KD) and Lidocaine In Frozen Shoulder Conventional Physical Therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults (>18 years) Less than 65 years old It takes less than three month from the onset of the disorder
Exclusion criteria:
History of Traumatic Injury to the shoulder Active Tendonitis History of rotator cuff tear History of NSAIDs use during the last week History of systemic corticosteroid use during the last 1 month
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
We used block randomization method.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All Participants, Investigators, Outcome assessors, Data analyst and quality controller are blinded. Sequentially numbered opaque sealed envelopes containing treatment allocations were prepared and were opened in sequence by an independent administrator who was not involved in eligibility, treatment, or outcome measurement.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Central Department of Ministerial of Health and Medical Education, Sima Iran St, between South Falamak and Zarafshan St, Shark Gharb
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.084

Health conditions studied

1

Description of health condition studied
Idiopathic Adhesive Capsulitis (Frozen Shoulder)
ICD-10 code
M75.00
ICD-10 code description
Adhesive capsulitis of unspecified shoulder

Primary outcomes

1

Description
Pain
Timepoint
At baseline, 4, 12 and 24 weeks after injection
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Range of Motion
Timepoint
At baseline, 4 and 12 weeks after injection
Method of measurement
Goniometry

2

Description
Inflammation Signs and Symptoms
Timepoint
at baseline of injection
Method of measurement
Hyperemia, Warmly, Pain, Tendonitis, Tenderness

3

Description
Oxford Shoulder Score
Timepoint
At baseline, 4 and 12 weeks after injection
Method of measurement
Oxford Questionnaire

Intervention groups

1

Description
Intervention group: One arm revived intra-articular injection of High Molecular Weight hyaluronic acid (Viscor® >2000 KD) in shoulder joint adding to the conventional physical therapy.
Category
Treatment - Drugs

2

Description
Intervention group: Second arm revived intra articular injection of Low Molecular Weight hyaluronic acid (Hyalgan® 500-800 KD) in shoulder joint adding to the conventional physical therapy.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeis Sadat
Street address
Saadat Abad St. Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
a_raeissadat@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti university of medical sciences, taleghani hospital, shahid arabi st, yemen ave, shahid chairman highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
zarghi@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
Private
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
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 211579064
Email
Esmaily_hadi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hadi Esmaily
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
esmaily_hadi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshad Mir
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Beheshti Pharmaceutical Faculty, Vali Ars AVe
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
m_mir@sbmu.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
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
Yes - There is 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
the whole potential data is unpublished after being unidentifiable.
When the data will become available and for how long
start the access period 6 month after pricing the result
To whom data/document is available
researchers working in academic and industrial institutions.
Under which criteria data/document could be used
it can be used to carry out research work.
From where data/document is obtainable
Dr Hadi Esmaily, faculty of pharmacy, shahid beheshti university of medical science
What processes are involved for a request to access data/document
sending request is available.
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