Protocol summary
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Study aim
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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.
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Design
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A randomized, blinded and parallel group trial. Randomization was done with block randomization method, with 50 patient equally enrolled in 2 parallel groups.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-01-01, 1398/10/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2022-03-01, 1400/12/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We used block randomization method.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-11-13, 1397/08/22
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1397.084
Health conditions studied
1
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Description of health condition studied
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Idiopathic Adhesive Capsulitis (Frozen Shoulder)
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ICD-10 code
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M75.00
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ICD-10 code description
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Adhesive capsulitis of unspecified shoulder
Primary outcomes
1
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Description
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Pain
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Timepoint
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At baseline, 4, 12 and 24 weeks after injection
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Method of measurement
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Visual Analog Scale
Secondary outcomes
1
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Description
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Range of Motion
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Timepoint
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At baseline, 4 and 12 weeks after injection
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Method of measurement
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Goniometry
2
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Description
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Inflammation Signs and Symptoms
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Timepoint
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at baseline of injection
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Method of measurement
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Hyperemia, Warmly, Pain, Tendonitis, Tenderness
3
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Description
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Oxford Shoulder Score
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Timepoint
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At baseline, 4 and 12 weeks after injection
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Method of measurement
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Oxford Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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the whole potential data is unpublished after being unidentifiable.
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When the data will become available and for how long
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start the access period 6 month after pricing the result
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To whom data/document is available
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researchers working in academic and industrial institutions.
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Under which criteria data/document could be used
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it can be used to carry out research work.
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From where data/document is obtainable
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Dr Hadi Esmaily, faculty of pharmacy, shahid beheshti university of medical science
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What processes are involved for a request to access data/document
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sending request is available.
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Comments
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