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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Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdi Rajabnia
Full name of responsible person - Persian: مهدی رجب نیا
Street address - English: Babol University of Medical Sciences, Ganj Afrooz St
Street address - Persian: خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: BABOL
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: ۴۷۱۷۶۴۷۷۵۴
Phone: +98 11 3225 6285
Fax:
Email: bcrdc90@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahdi Rajabnia
Full name of responsible person - Persian: مهدی رجب نیا
Street address - English: Babol University of Medical Sciences, Ganj Afrooz St
Street address - Persian: خیابان گنج افروز، دانشگاه علوم پزشکی بابل
City - English: BABOL
City - Persian: بابل
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: 4717647754
Phone: +98 11 3225 6285
Fax:
Email: bcrdc90@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mahdi Rajabnia Full name of responsible person - Persian: مهدی رجب نیا Street address - English: Babol University of Medical Sciences, Ganj Afrooz St Street address - Persian: خیابان گنج افروز، دانشگاه علوم پزشکی بابل City - English: BABOL City - Persian: بابل Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: ۴۷۱۷۶۴۷۷۵۴4717647754 Phone: +98 11 3225 6285 Fax: Email: bcrdc90@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Majid Khalilizad
Full name of responsible person - Persian: مجید خلیلی زاد
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol,shahid beheshti hospital
Street address - Persian: بابل، بیمارستان شهید بهشتی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5151524525
Phone: +98 11 3225 7896
Mobile: +98 912 097 8381
Fax:
Email: m.khalilzad@mubabol.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: yasin sharifzadeh
Full name of responsible person - Persian: یاسین شریف زاده
Position - English: Senior Orthopedic Resident
Position - Persian: رزیدنت ارشد ارتوپدی
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Babol,shahid beheshti hospital
Street address - Persian: بابل، بیمارستان شهید بهشتی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 5151524525
Phone: +98 11 3225 7896
Mobile: +98 914 382 2836
Fax:
Email: dryasinsharifzadeh@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Majid Khalilizadyasin sharifzadeh Full name of responsible person - Persian: مجید خلیلی زادیاسین شریف زاده Position - English: Associate professorSenior Orthopedic Resident Position - Persian: استادیاررزیدنت ارشد ارتوپدی Latest degree: specialist Area of specialty/work: 4 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Babol,shahid beheshti hospital Street address - Persian: بابل، بیمارستان شهید بهشتی City - English: Babol City - Persian: بابل Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 5151524525 Phone: +98 11 3225 7896 Mobile: +98 912 097 8381914 382 2836 Fax: Email: m.khalilzaddryasinsharifzadeh@mubabol.ac.irgmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Majid Khalilizad
Full name of responsible person - Persian: مجید خلیلی زاد
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St ,
Street address - Persian: بابل، خیابان شهید سرگرد قاسمی، بیمارستان شهید بهشتی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4716681451
Phone: +98 11 3225 2071
Mobile: +98 912 097 8381
Fax:
Email: m.khalilzad@mubabol.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: yasin sharifzadeh
Full name of responsible person - Persian: یاسین شریف زاده
Position - English: Senior Orthopedic Resident
Position - Persian: رزیدنت ارشد ارتوپدی
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St ,
Street address - Persian: بابل، خیابان شهید سرگرد قاسمی، بیمارستان شهید بهشتی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4716681451
Phone: +98 11 3225 2071
Mobile: +98 914 382 2836
Fax:
Email: dryasinsharifzadeh@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Majid Khalilizadyasin sharifzadeh Full name of responsible person - Persian: مجید خلیلی زادیاسین شریف زاده Position - English: Associate professorSenior Orthopedic Resident Position - Persian: استادیاررزیدنت ارشد ارتوپدی Latest degree: specialist Area of specialty/work: 4 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St , Street address - Persian: بابل، خیابان شهید سرگرد قاسمی، بیمارستان شهید بهشتی City - English: Babol City - Persian: بابل Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4716681451 Phone: +98 11 3225 2071 Mobile: +98 912 097 8381914 382 2836 Fax: Email: m.khalilzaddryasinsharifzadeh@mubabol.ac.irgmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Majid Khalilizad
Full name of responsible person - Persian: مجید خلیلی زاد
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St ,
Street address - Persian: بابل، خیابان شهید سرگرد قاسمی، بیمارستان شهید بهشتی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4716681451
Phone: +98 11 3225 2071
Mobile: +98 912 097 8381
Fax:
Email: m.khalilzad@mubabol.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: yasin sharifzadeh
Full name of responsible person - Persian: یاسین شریف زاده
Position - English: Senior Orthopedic Resident
Position - Persian: رزیدنت ارشد ارتوپدی
Latest degree: specialist
Area of specialty/work: 4
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St ,
Street address - Persian: بابل، خیابان شهید سرگرد قاسمی، بیمارستان شهید بهشتی
City - English: Babol
City - Persian: بابل
Province: Mazandaran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 4716681451
Phone: +98 11 3225 2071
Mobile: +98 914 382 2836
Fax:
Email: dryasinsharifzadeh@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Majid Khalilizadyasin sharifzadeh Full name of responsible person - Persian: مجید خلیلی زادیاسین شریف زاده Position - English: Associate professorSenior Orthopedic Resident Position - Persian: استادیاررزیدنت ارشد ارتوپدی Latest degree: specialist Area of specialty/work: 4 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St , Street address - Persian: بابل، خیابان شهید سرگرد قاسمی، بیمارستان شهید بهشتی City - English: Babol City - Persian: بابل Province: Mazandaran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 4716681451 Phone: +98 11 3225 2071 Mobile: +98 912 097 8381914 382 2836 Fax: Email: m.khalilzaddryasinsharifzadeh@mubabol.ac.irgmail.com Web page address:
Protocol summary
Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
Shoulder function, sleep quality
General information
Reason for update
Acronym
IRCT registration information
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:2
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
majid khalilizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 7896
Email address
m.khalilzad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Investigation of three injection methods under ultrasound guidance inside the shoulder joint in patients with frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Shahid Beheshti Hospital, Shahid Sargerd Ghasemi St , Babol
City
babol
Province
Mazandaran
Postal code
4716681451
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.MUBABOL.REC.1402.232
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis of shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
1) Shoulder function
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
1)Checklist of movement scale (ROM) according to the study of Mardani-Kivi et al
2
Description
2)Pittsburgh Sleep Quality Index
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
3)Pittsburgh Sleep Quality Index
3
Description
4) pain criterion
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group B: intra-articular injection (5 cc lidocaine hydrochloride 2% + 1 cc methylprednisolone 40 mg + 4 cc distilled water)
Category
Treatment - Drugs
3
Description
Intervention group: Intervention group C: Suprascapular nerve block (2 cc lidocaine hydrochloride 2% + 1 cc prednisolone 40 mg + 2 cc distilled water)