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

NCT ID: NCT04931511

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-09-01

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.

Conditions

Frozen Shoulder; Shoulder Pain; Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Gluteal muscle injection plus physical therapy group

Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy

Group Type: EXPERIMENTAL

Compound betamethasone Injection(Gluteal muscle injection)

Intervention Type: DRUG

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

Physical therapy

Intervention Type: BEHAVIORAL

paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home

Subacromial Ultrasound Guided injection plus physical therapy group

Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy

Group Type: EXPERIMENTAL

Compound betamethasone Injection(Subacromial Ultrasound Guided injection)

Intervention Type: DRUG

Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)

Physical therapy

Intervention Type: BEHAVIORAL

paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home

Interventions

Compound betamethasone Injection(Gluteal muscle injection)

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

Intervention Type: DRUG

Compound betamethasone Injection(Subacromial Ultrasound Guided injection)

Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)

Intervention Type: DRUG

Physical therapy

paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home

Intervention Type: BEHAVIORAL

Other Intervention Names

corticosteroid; corticosteroid

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

huang pintong

Director of the department of ultrasound

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pintong Huang

Role: PRINCIPAL_INVESTIGATOR

Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Study 2020-1064

Identifier Type: -

Identifier Source: org_study_id