Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder
Primary Purpose
Frozen Shoulder, Shoulder Pain, Bursitis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Compound betamethasone Injection(Gluteal muscle injection)
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder
Eligibility Criteria
Inclusion Criteria:
- 1. Primary frozen shoulder
- 2. Older than 18 years of age and less than 75 years of age
- 3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
- 4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
- 5. corticosteroid injections were not given within 3 months of visit
Exclusion Criteria:
- 1. A history of trauma, osteoarthritis, tumors, etc.
- 2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
- 3. There is a history of corticosteroid injections within 3 months of visit
- 4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
- 5. Both side shoulder joints become ill at the same time
- 6. The patient has not signed an informed consent form
Sites / Locations
- The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Gluteal muscle injection plus physical therapy group
Subacromial Ultrasound Guided injection plus physical therapy group
Arm Description
Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy
Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy
Outcomes
Primary Outcome Measures
The Change of Shoulder Pain and Disability Index (SPADI)
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Secondary Outcome Measures
The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line. Similar to the pain VAS, the NRS is anchored by terms describing pain severity extremes
Anterior flexion of shoulder joint (0-180°)
Passive activity of the shoulder joint
shoulder joint abduction (0-180°)
Passive activity of the shoulder joint
shoulder internal rotator (1-18 score)
The thumb tip reaches the highest point of the back cone:Score1-12: T1-T12; Score13-17:L1-L5;18: below the sacrum;
shoulder external rotator (0-180°)
Passive activity of the shoulder joint
Full Information
NCT ID
NCT04931511
First Posted
April 8, 2021
Last Updated
November 23, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04931511
Brief Title
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder
Official Title
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.
Detailed Description
In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Shoulder Pain, Bursitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gluteal muscle injection plus physical therapy group
Arm Type
Experimental
Arm Description
Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy
Arm Title
Subacromial Ultrasound Guided injection plus physical therapy group
Arm Type
Experimental
Arm Description
Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy
Intervention Type
Drug
Intervention Name(s)
Compound betamethasone Injection(Gluteal muscle injection)
Other Intervention Name(s)
corticosteroid
Intervention Description
Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)
Intervention Type
Drug
Intervention Name(s)
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
Other Intervention Name(s)
corticosteroid
Intervention Description
Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy
Intervention Description
paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home
Primary Outcome Measure Information:
Title
The Change of Shoulder Pain and Disability Index (SPADI)
Description
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Time Frame
0,1,2,4,8,12 weeks
Secondary Outcome Measure Information:
Title
The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)
Description
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line. Similar to the pain VAS, the NRS is anchored by terms describing pain severity extremes
Time Frame
0,1,2,4,8,12 weeks
Title
Anterior flexion of shoulder joint (0-180°)
Description
Passive activity of the shoulder joint
Time Frame
0,1,2,4,8,12 weeks
Title
shoulder joint abduction (0-180°)
Description
Passive activity of the shoulder joint
Time Frame
0,1,2,4,8,12 weeks
Title
shoulder internal rotator (1-18 score)
Description
The thumb tip reaches the highest point of the back cone:Score1-12: T1-T12; Score13-17:L1-L5;18: below the sacrum;
Time Frame
0,1,2,4,8,12 weeks
Title
shoulder external rotator (0-180°)
Description
Passive activity of the shoulder joint
Time Frame
0,1,2,4,8,12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Primary frozen shoulder
2. Older than 18 years of age and less than 75 years of age
3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
5. corticosteroid injections were not given within 3 months of visit
Exclusion Criteria:
1. A history of trauma, osteoarthritis, tumors, etc.
2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
3. There is a history of corticosteroid injections within 3 months of visit
4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
5. Both side shoulder joints become ill at the same time
6. The patient has not signed an informed consent form
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pintong Huang
Phone
18857168333
Email
huangpintong@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Han
Phone
13735402700
Email
icydoctor2@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pintong Huang
Organizational Affiliation
Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pintong huang
Phone
18857168333
Email
huangpintong@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Bin Han
Phone
13735402700
Email
icydoctor2@163.com
First Name & Middle Initial & Last Name & Degree
Pintong huang
First Name & Middle Initial & Last Name & Degree
Bin Han
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
I'd like to share the IPD with the other researchers after the paper is published.
IPD Sharing Time Frame
I'd like to share the IPD with the other researchers after the paper is published.
Learn more about this trial
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder
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