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

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

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Pain; Bursitis; Frozen Shoulder
• Intervention / Treatment: Drug: Compound betamethasone Injection(Gluteal muscle injection); Behavioral: Physical therapy; Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gluteal muscle injection plus physical therapy group; Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy	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); Other Names: corticosteroid; Behavioral: Physical therapy; paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home
Experimental: 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	Behavioral: Physical therapy; paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home; 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); Other Names: corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Anterior flexion of shoulder joint (0-180°)	Passive activity of the shoulder joint	0,1,2,4,8,12 weeks
shoulder joint abduction (0-180°)	Passive activity of the shoulder joint	0,1,2,4,8,12 weeks
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
shoulder external rotator (0-180°)	Passive activity of the shoulder joint	0,1,2,4,8,12 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Pintong Huang, Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Bursitis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
• Other Study ID Numbers: Study 2020-1064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No