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

• Sponsor: Istanbul University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05956171
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frozen Shoulder; Shoulder Capsulitis; Shoulder Pain	Other: Intra-articular corticosteroid injection; Other: Ultrasound Guided Hydrodilatation with corticosteroid injection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline pain score on Visual Analog Scale(VAS) [Baseline, 1 week, 1 month, 3 months]

   Pain scored according to VAS; between 0(no pain) to 10(worst pain)

2. Change in Shoulder Pain and Disability Index(SPADI) scores [Baseline, 1 month, 3 months]

   Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability

Secondary Outcome Measures

1. Change in Range of Movement(ROM) [Baseline, 1 week, 1 month, 3 months]

   Range of shoulder movements assessed with digital inclinometer in sittting and lying positions

2. Ultrasound Parameters [Baseline, 1 month, 3 months]

   Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)

3. Proprioception(Active position sense- joint position error) [Baseline, 3 months]

   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

4. Shoulder Strength [Baseline, 3 months]

   Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation

5. Changes in Depression Score [Baseline, 1 months, 3 months]

   measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression

6. Changes in Life Quality Score [Baseline, 1 month, 3 months]

   Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best)

7. Treatment Satisfaction [3 months]

   Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatmanur Yegin, Research Assistant Doctor, Istanbul University
• ClinicalTrials.gov Identifier: NCT05956171
• Other Study ID Numbers: 2023/890
• First Posted: Jul 21, 2023
• Last Update Posted: Jul 21, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fatmanur Yegin, Research Assistant Doctor, Istanbul University: hydrodilatation; hydrodistension; ultrasound
• Additional relevant MeSH terms: Shoulder Pain; Bursitis

Study Results

No Results Posted as of Jul 21, 2023