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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General information
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To examine the amount of shoulder movement and ROM, we had defined it with only one variable in the protocol, but during the examination with the goniometer, each movement had to be measured separately and entered into the questionnaire. We separated the 4 basic movements of the shoulder, which include abduction and flexion, sternal rotation and internal rotation, and included each as a separate variable in the protocol. We also added another variable called recovery time, which examines the time the patient reached recovery in the 3 groups so that a better comparison can be made between the groups, which is based on the criteria of pain and ROM.
To examine the amount of shoulder movement and ROM, we had defined it with only one variable in the protocol, but during the examination with the goniometer, each movement had to be measured separately and entered into the questionnaire. We separated the 4 basic movements of the shoulder, which include abduction and flexion, sternal rotation and internal rotation, and included each as a separate variable in the protocol. We also added another variable called recovery time, which examines the time the patient reached recovery in the 3 groups so that a better comparison can be made between the groups, which is based on the criteria of pain and ROM.
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برای بررسی میزان حرکت و ROM شانه ما آن را فقط با یک متغیر تعریف کرده بودیم در پروتوکل ولی در حین بررسی و معاینه با دستگاه گونیومتر باید هر حرکت را جداگانه سنجید و وارد پرسشنامه کرد ، که ما 4 حرکت اصلی شانه را که شامل ابداکشن و فلکشن و اکسترنال روتیشن و اینترنال روتیشن است را بصورت جدا جدا و هر کدام را بعنوان یک متغییر وارد پروتوکل کردیم.
یک متغیردیگر هم با اسم زمان بهبودی اضافه کردیم که زمان رسیدن بیمار به بهبودی را در 3 گروه بررسی میکند که بتوان بین گروه ها مقایسه بهتری انجام داد که بر اساس معیار درد و ROM بدست می آید.
برای بررسی میزان حرکت و ROM شانه ما آن را فقط با یک متغیر تعریف کرده بودیم در پروتوکل ولی در حین بررسی و معاینه با دستگاه گونیومتر باید هر حرکت را جداگانه سنجید و وارد پرسشنامه کرد ، که ما 4 حرکت اصلی شانه را که شامل ابداکشن و فلکشن و اکسترنال روتیشن و اینترنال روتیشن است را بصورت جدا جدا و هر کدام را بعنوان یک متغییر وارد پروتوکل کردیم. یک متغیردیگر هم با اسم زمان بهبودی اضافه کردیم که زمان رسیدن بیمار به بهبودی را در 3 گروه بررسی میکند که بتوان بین گروه ها مقایسه بهتری انجام داد که بر اساس معیار درد و ROM بدست می آید.
Primary outcomes
#1
1) Shoulder function
Score obtained on the Shoulder Pain and Disability Index
1)Score obtained on the Shoulder functionPain and Disability Index
1) عملکرد شانه
امتیاز کسب شده در شاخص درد و ناتوانی شانه
1) عملکردامتیاز کسب شده در شاخص درد و ناتوانی شانه
1)Checklist of movement scale (ROM) according to the study of Mardani-Kivi et al
Shoulder Pain and Disability Index
1)Checklist of movement scale (ROM) according to the study of Mardani-Kivi et alShoulder Pain and Disability Index
1)چک لیست مقیاس حرکتي شانه
مقیاس شاخص درد و ناتوانی شانه
1)چک لیست مقیاس حرکتيشاخص درد و ناتوانی شانه
#2
2)Pittsburgh Sleep Quality Index
Score obtained on the Pittsburgh Sleep Quality Questionnaire
2)PittsburghScore obtained on the Pittsburgh Sleep Quality IndexQuestionnaire
2) کیفیت خواب
امتیاز کسب شده در پرسشنامه کیفیت خواب پیتزبورگ
2)امتیاز کسب شده در پرسشنامه کیفیت خواب پیتزبورگ
3)Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index
3)PittsburghPittsburgh Sleep Quality Index
3) پرسشنامه کیفیت خواب پیتزبورگ
شاخص کیفیت خواب پیتسبورگ
3) پرسشنامهشاخص کیفیت خواب پیتزبورگپیتسبورگ
#3
4) pain criterion
Visual Analogue Pain Scale
4) pain criterionVisual Analogue Pain Scale
4) معیار درد
امتیاز کسب شده در مقیاس آنالوگ ظاهری
4) معیار دردامتیاز کسب شده در مقیاس آنالوگ ظاهری
Visual Analog Scale
Score obtained on the visual analog scale
Visual Analog ScaleScore obtained on the visual analog scale
مقیاس آنالوگ ظاهری
مقیاس آنالوگ بصری درد
مقیاس آنالوگ ظاهریبصری درد
#4
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Shoulder Internal Rotation Movement Scale score
Shoulder Internal Rotation Movement Scale score
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نمره در مقياس حرکات اینترنال روتیشن شانه
نمره در مقياس حرکات اینترنال روتیشن شانه
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
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Score obtained based on the goniometer device
Score obtained based on the goniometer device
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امتیاز کسب شده بر اساس دستگاه گونیومتر
امتیاز کسب شده بر اساس دستگاه گونیومتر
#5
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Shoulder external rotation movement scale score
Shoulder external rotation movement scale score
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نمره در مقياس حرکات اکسترنال روتیشن شانه
نمره در مقياس حرکات اکسترنال روتیشن شانه
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
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Score obtained based on the goniometer device
Score obtained based on the goniometer device
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امتیاز کسب شده بر اساس دستگاه گونیومتر
امتیاز کسب شده بر اساس دستگاه گونیومتر
#6
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Shoulder abduction range of motion score
Shoulder abduction range of motion score
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نمره در مقياس حرکات ابداکشن شانه
نمره در مقياس حرکات ابداکشن شانه
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
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Score obtained based on the goniometer device
Score obtained based on the goniometer device
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امتیاز کسب شده بر اساس دستگاه گونیومتر
امتیاز کسب شده بر اساس دستگاه گونیومتر
#7
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Shoulder flexion movement scale
Shoulder flexion movement scale
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نمره در مقياس حرکات فلکشن شانه
نمره در مقياس حرکات فلکشن شانه
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Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
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قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
قبل از تزريق و در زمانهای پیگیری ۲-۶-۱۲-۲۴هفته بعد از مداخله
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Score obtained based on the goniometer device
Score obtained based on the goniometer device
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امتیاز کسب شده بر اساس دستگاه گونیومتر
امتیاز کسب شده بر اساس دستگاه گونیومتر
#8
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Time to recovery
Time to recovery
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زمان رسیدن به بهبودی
زمان رسیدن به بهبودی
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At follow-up times every week after the intervention
At follow-up times every week after the intervention
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در زمانهای پیگیری هر هفته بعد از مداخله
در زمانهای پیگیری هر هفته بعد از مداخله
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Recovery of maximum shoulder ROM based on goniometry and absence of pain based on visual analog scale (VAS)
Recovery of maximum shoulder ROM based on goniometry and absence of pain based on visual analog scale (VAS)
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بازیابی حداکثر ROM شانه بر اساس گونیومتر و نبود درد بر اساس مقیاس آنالوگ ظاهریVAS
بازیابی حداکثر ROM شانه بر اساس گونیومتر و نبود درد بر اساس مقیاس آنالوگ ظاهریVAS
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
To examine the amount of shoulder movement and ROM, we had defined it with only one variable in the protocol, but during the examination with the goniometer, each movement had to be measured separately and entered into the questionnaire. We separated the 4 basic movements of the shoulder, which include abduction and flexion, sternal rotation and internal rotation, and included each as a separate variable in the protocol. We also added another variable called recovery time, which examines the time the patient reached recovery in the 3 groups so that a better comparison can be made between the groups, which is based on the criteria of pain and ROM.
Acronym
IRCT registration information
IRCT registration number:IRCT20230316057742N2
Registration date:2024-04-30, 1403/02/11
Registration timing:prospective
Last update:2025-07-25, 1404/05/03
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
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Actual recruitment end date
empty
Trial completion date
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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
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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
Score obtained on the Shoulder Pain and Disability Index
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Shoulder Pain and Disability Index
2
Description
Score obtained on the Pittsburgh Sleep Quality Questionnaire
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
3
Description
Visual Analogue Pain Scale
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Score obtained on the visual analog scale
4
Description
Shoulder Internal Rotation Movement Scale score
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Score obtained based on the goniometer device
5
Description
Shoulder external rotation movement scale score
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Score obtained based on the goniometer device
6
Description
Shoulder abduction range of motion score
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Score obtained based on the goniometer device
7
Description
Shoulder flexion movement scale
Timepoint
Before the injection and during the follow-up times 2-6-12-24 weeks after the intervention
Method of measurement
Score obtained based on the goniometer device
8
Description
Time to recovery
Timepoint
At follow-up times every week after the intervention
Method of measurement
Recovery of maximum shoulder ROM based on goniometry and absence of pain based on visual analog scale (VAS)
Secondary outcomes
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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)