The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder

NCT ID: NCT05956171

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-03-31

Brief Summary

The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are:

• Is hydrodilatation better than intraarticular corticosteroid injection?
• Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments?

Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.

Conditions

Frozen Shoulder; Shoulder Capsulitis; Shoulder Pain

Study Design

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

Study Groups

Ultrasound Guided Hydrodilatation with corticosteroid injection

15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance

Drugs:

• betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml)
• prilocaine hydrochloride %2 (4 ml)
• Sodium chloride %0,9 (10 ml)

Group Type: EXPERIMENTAL

Ultrasound Guided Hydrodilatation with corticosteroid injection

Intervention Type: OTHER

15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance

Blind intra-articular corticosteroid injection

5 ml intra-articular blind injection to shoulder via posterior approach

Drugs:

• betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml)
• prilocaine hydrochloride %2 (4 ml)

Group Type: ACTIVE_COMPARATOR

Intra-articular corticosteroid injection

Intervention Type: OTHER

5 ml blind intra-articular corticosteroid injection

Interventions

Intra-articular corticosteroid injection

5 ml blind intra-articular corticosteroid injection

Intervention Type: OTHER

Ultrasound Guided Hydrodilatation with corticosteroid injection

15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who fulfill the diagnostic criteria for frozen shoulder
• Agree to participate in the study
• Having the opportunity to follow up for at least 3 months

Exclusion Criteria

• Refusing to participate in the study
• History of shoulder injection in the last 3 months
• Having diabetes mellitus
• Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis
• Known history of allergy or anaphylaxis to drugs used in treatment

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

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Fatmanur Yegin

Research Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatmanur Yegin

Role: CONTACT

fatmanur.yegin@istanbul.edu.tr

0905462729955

Other Identifiers

2023/890

Identifier Type: -

Identifier Source: org_study_id