Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder

Shoulder Pain Clinical Trial

Official title:

Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04931511
• Other study ID #: Study 2020-1064
• Status: Terminated
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder
• Shoulder Pain

Intervention

Drug:
• Compound betamethasone Injection(Gluteal muscle injection)
Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)
• Compound betamethasone Injection(Subacromial Ultrasound Guided injection)
Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)

Behavioral:
• Physical therapy
paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hanzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0,1,2,4,8,12 weeks
Secondary	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	0,1,2,4,8,12 weeks
Secondary	Anterior flexion of shoulder joint (0-180°)	Passive activity of the shoulder joint	0,1,2,4,8,12 weeks
Secondary	shoulder joint abduction (0-180°)	Passive activity of the shoulder joint	0,1,2,4,8,12 weeks
Secondary	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;	0,1,2,4,8,12 weeks
Secondary	shoulder external rotator (0-180°)	Passive activity of the shoulder joint	0,1,2,4,8,12 weeks