Protocol summary
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Study aim
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Determining and comparing the effectiveness of three methods: 1) suprascapular block injection with 2) methylprednisolone injection with 3) hydrodistension injection, in reducing pain and improving shoulder function and sleep quality of patients.
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Design
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Our study is a clinical trial without a control group, which is randomized in 3 parallel groups, three blind, and phase 3 is a clinical trial that is conducted on 102 patients. For randomization, block random division produced by Random Allocation Software was used in blocks of six into three groups with a ratio of 1:1:1.
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Settings and conduct
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Patients after randomization, in room number 9 of the operating room by an anesthesiologist under ultrasound guidance and with a gray spine needle injection of the shoulder in one of three types: 1) suprascapular nerve block and 2) methylprednisolone and 3) hydrodistension of the shoulder joint based on the internal group The envelope is done. In this study, both the patients, the outcome assessor, and the data analyst are blinded. In order to hide the random allocation, the codes created by the software will be placed in non-transparent and sealed envelopes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age between 18-60 years
Definitive diagnosis of frozen shoulder
Failure to respond to non-invasive treatments
exclusion criteria:
History of recent trauma or surgery
Acromioclavicular joint osteoarthritis
radiculopathy
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Intervention groups
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1) Intra-articular injection of the shoulder under ultrasound guidance
2) Suprascapular notch injection under ultrasound guidance
3) Intra-articular hydrodeposition injection under ultrasound guidance
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Main outcome variables
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Shoulder function, sleep quality
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230316057742N2
Registration date:
2024-04-30, 1403/02/11
Registration timing:
prospective
Last update:
2025-01-25, 1403/11/06
Update count:
1
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Registration date
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2024-04-30, 1403/02/11
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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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2024-05-21, 1403/03/01
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Expected recruitment end date
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2025-05-22, 1404/03/01
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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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Comparison of the effectiveness of three methods of injection under ultrasound guidance inside the shoulder joint and hydrodistension of the shoulder joint and suprascapular nerve block on shoulder function in patients with frozen shoulder.
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Public title
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Investigation of three injection methods under ultrasound guidance inside the shoulder joint in patients with frozen shoulder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Definitive diagnosis of ice shoulder by an orthopedic doctor
Failure to respond to non-invasive treatments such as physiotherapy and drug therapy
Active and passive reduction of rom movements
Age between 18-60 years
Exclusion criteria:
known systemic diseases such as rheumatoid arthritis
History of recent trauma or surgery or known chronic disease (such as rotator cuff lesions) Pivacaine, any known systemic disease
Midclavicular joint, cervical radiculopathy
Brachial plexopathy, neoplasm
pregnancy
Addiction to opioids
diabetes
Osteoarthritis
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
102
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, the data analyst and the result evaluator and the participant are blinded.
Due to the same treatment method (injection) and the same color of injectable drugs and the same injection site in all three groups, the possibility of blinding at the participant level is also possible.
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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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2024-03-06, 1402/12/16
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Ethics committee reference number
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IR.MUBABOL.REC.1402.232
Health conditions studied
1
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Description of health condition studied
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Adhesive capsulitis of shoulder
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ICD-10 code
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M75.0
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ICD-10 code description
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Adhesive capsulitis of shoulder
Primary outcomes
1
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Description
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1) Shoulder function
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Timepoint
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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Method of measurement
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1)Checklist of movement scale (ROM) according to the study of Mardani-Kivi et al
2
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Description
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2)Pittsburgh Sleep Quality Index
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Timepoint
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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Method of measurement
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3)Pittsburgh Sleep Quality Index
3
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Description
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4) pain criterion
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Timepoint
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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Method of measurement
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Visual Analog Scale
Intervention groups
1
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Description
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After the diagnosis of frozen shoulder by the orthopedist in the clinic, the patients refer to the operating room for injection and are randomly divided into three groups. For injection, a gray spine needle number 27 is used. The exact location of the injection is determined using an ultrasound guide, and the desired drugs are 2% lidocaine ampoule from Caspin Tamin Company, 40 mg methylprednisolone acetate ampoule from Elixir Company, and distilled water from Shahid Ghazi Company. Only one injection is given to the patients and then they undergo follow-up for 24 weeks, which will include 5 examinations. Once upon entering the clinic, then 2 weeks after the injection, 6 weeks after the injection, 12 weeks after the injection, and 24 weeks after the injection, the patients are examined. Group A, in which the injection under ultrasound guidance inside the shoulder joint in the form of hydrodistention, which includes (5 cc of distilled water, 5 cc of 2% lidocaine hydrochloride) will be injected into the patient's shoulder.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Intervention group B: intra-articular injection (5 cc lidocaine hydrochloride 2% + 1 cc methylprednisolone 40 mg + 4 cc distilled water)
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Intervention group C: Suprascapular nerve block (2 cc lidocaine hydrochloride 2% + 1 cc prednisolone 40 mg + 2 cc distilled water)
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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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Babol 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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Public
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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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data is potentially shareable after de-identifying individuals
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When the data will become available and for how long
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The time of data release is one year after the results are published
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To whom data/document is available
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The data will be available only to researchers working in academic and scientific institutions and orthopedic specialist colleagues
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Under which criteria data/document could be used
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Other than the above conditions, there is no specific limitation in the data
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From where data/document is obtainable
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To Dr. Khalilzad, knee specialist, faculty of Babol University of Medical Sciences
09143822836
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What processes are involved for a request to access data/document
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majidkhalizad@yahoo.com
Dr. Khalilzad, orthopedic specialist
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Comments
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