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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05956171
• Other study ID #: 2023/890
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: March 2024

Study information

• Verified date: October 2023
• Source: Istanbul University
• Contact: Fatmanur Yegin
• Phone: 0905462729955
• Email: fatmanur.yegin[@]istanbul.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder
• Shoulder Capsulitis
• Shoulder Pain

Intervention

Other:
• Intra-articular corticosteroid injection
5 ml blind intra-articular corticosteroid injection
• Ultrasound Guided Hydrodilatation with corticosteroid injection
15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Ultrasound Parameters	Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)	Baseline, 1 month, 3 months
Secondary	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
Secondary	Shoulder Strength	Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation	Baseline, 3 months
Secondary	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
Secondary	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
Secondary	Treatment Satisfaction	Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied	3 months