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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Pain; Shoulder Capsulitis; Frozen Shoulder
• Intervention / Treatment: Other: Ultrasound Guided Hydrodilatation with corticosteroid injection; Other: Intra-articular corticosteroid injection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatmanur Yegin; Phone Number: 0905462729955; Email: fatmanur.yegin@istanbul.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Ultrasound Guided Hydrodilatation with corticosteroid injection; 15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance
Active Comparator: 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)	Other: Intra-articular corticosteroid injection; 5 ml blind intra-articular corticosteroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline pain score on Visual Analog Scale(VAS)	Pain scored according to VAS; between 0(no pain) to 10(worst pain)	Baseline, 1 week, 1 month, 3 months
Change in Shoulder Pain and Disability Index(SPADI) scores	Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability	Baseline, 1 month, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Range of Movement(ROM)	Range of shoulder movements assessed with digital inclinometer in sittting and lying positions	Baseline, 1 week, 1 month, 3 months
Ultrasound Parameters	Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)	Baseline, 1 month, 3 months
Proprioception(Active position sense- joint position error)	Shoulder joint is positioned in 30 degree flexion and 15 degree internal and external rotation in lying position, patient is asked to position their joints and errors in degrees noted	Baseline, 3 months
Shoulder Strength	Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation	Baseline, 3 months
Changes in Depression Score	measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression	Baseline, 1 months, 3 months
Changes in Life Quality Score	Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best)	Baseline, 1 month, 3 months
Treatment Satisfaction	Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied	3 months

Collaborators and Investigators

• Sponsor: Istanbul University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; hydrodistension; hydrodilatation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Bursitis
• Other Study ID Numbers: 2023/890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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