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

NCT05956171 | Unknown

• 1 other identifier: 2023/890
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

hydrodilatation; hydrodistension; ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Range of Movement(ROM)

  Baseline, 1 week, 1 month, 3 months

• Ultrasound Parameters

  Baseline, 1 month, 3 months

• Proprioception(Active position sense- joint position error)

  Baseline, 3 months

• Shoulder Strength

  Baseline, 3 months

• Changes in Depression Score

  Baseline, 1 months, 3 months

Study Arms (2)

Ultrasound Guided Hydrodilatation with corticosteroid injection

EXPERIMENTAL

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

Blind intra-articular corticosteroid injection

ACTIVE COMPARATOR

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

Interventions

Intra-articular corticosteroid injection OTHER

5 ml blind intra-articular corticosteroid injection

Blind intra-articular corticosteroid injection

Ultrasound Guided Hydrodilatation with corticosteroid injection OTHER

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

Ultrasound Guided Hydrodilatation with corticosteroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Fatmanur Yegin

CONTACT

0905462729955; fatmanur.yegin@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Model Details: Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 21, 2023
• Study Start: October 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share