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

NCT04931511 | Terminated Phase 4 DMC

• 1 other identifier: Study 2020-1064
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Frozen Shoulder; Shoulder Pain; Bursitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)

  0,1,2,4,8,12 weeks

• Anterior flexion of shoulder joint (0-180°)

  0,1,2,4,8,12 weeks

• shoulder joint abduction (0-180°)

  0,1,2,4,8,12 weeks

• shoulder internal rotator (1-18 score)

  0,1,2,4,8,12 weeks

• shoulder external rotator (0-180°)

  0,1,2,4,8,12 weeks

Study Arms (2)

Gluteal muscle injection plus physical therapy group

EXPERIMENTAL

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

Drug: Compound betamethasone Injection(Gluteal muscle injection); Behavioral: Physical therapy

Subacromial Ultrasound Guided injection plus physical therapy group

EXPERIMENTAL

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

Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection); Behavioral: Physical therapy

Interventions

Compound betamethasone Injection(Gluteal muscle injection) DRUG

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

Also known as: corticosteroid

Gluteal muscle injection plus physical therapy group

Compound betamethasone Injection(Subacromial Ultrasound Guided injection) DRUG

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

Also known as: corticosteroid

Subacromial Ultrasound Guided injection plus physical therapy group

Physical therapy BEHAVIORAL

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

Gluteal muscle injection plus physical therapy group; Subacromial Ultrasound Guided injection plus physical therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Primary frozen shoulder
• \. Older than 18 years of age and less than 75 years of age
• \. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
• \. 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
• \. corticosteroid injections were not given within 3 months of visit

You may not qualify if:

• \. A history of trauma, osteoarthritis, tumors, etc.
• \. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
• \. There is a history of corticosteroid injections within 3 months of visit
• \. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
• \. Both side shoulder joints become ill at the same time
• \. The patient has not signed an informed consent form

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Adrenal Cortex Hormones; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics; Rehabilitation

Study Officials

• Pintong Huang

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of ultrasound

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: June 18, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: I'd like to share the IPD with the other researchers after the paper is published.

Locations

CN (1)