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

Istanbul University

Status: Not yet enrolling

Conditions: Shoulder Pain; Shoulder Capsulitis; Frozen Shoulder

Treatments: Other: Ultrasound Guided Hydrodilatation with corticosteroid injection; Other: Intra-articular corticosteroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05956171

2023/890

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Ultrasound Guided Hydrodilatation with corticosteroid injection

Experimental group

Description:

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)

Treatment:

Other: Ultrasound Guided Hydrodilatation with corticosteroid injection

Blind intra-articular corticosteroid injection

Active Comparator group

Description:

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)

Treatment:

Other: Intra-articular corticosteroid injection