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

Primary Purpose

Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intra-articular corticosteroid injection
Ultrasound Guided Hydrodilatation with corticosteroid injection
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring hydrodilatation, hydrodistension, ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ultrasound Guided Hydrodilatation with corticosteroid injection

    Blind intra-articular corticosteroid injection

    Arm 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)

    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)

    Outcomes

    Primary Outcome Measures

    Change from baseline pain score on Visual Analog Scale(VAS)
    Pain scored according to VAS; between 0(no pain) to 10(worst pain)
    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

    Secondary Outcome Measures

    Change in Range of Movement(ROM)
    Range of shoulder movements assessed with digital inclinometer in sittting and lying positions
    Ultrasound Parameters
    Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)
    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
    Shoulder Strength
    Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation
    Changes in Depression Score
    measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression
    Changes in Life Quality Score
    Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best)
    Treatment Satisfaction
    Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    October 9, 2023
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05956171
    Brief Title
    The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
    Official Title
    The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain
    Keywords
    hydrodilatation, hydrodistension, ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound Guided Hydrodilatation with corticosteroid injection
    Arm Type
    Experimental
    Arm 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)
    Arm Title
    Blind intra-articular corticosteroid injection
    Arm Type
    Active Comparator
    Arm 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)
    Intervention Type
    Other
    Intervention Name(s)
    Intra-articular corticosteroid injection
    Intervention Description
    5 ml blind intra-articular corticosteroid injection
    Intervention Type
    Other
    Intervention Name(s)
    Ultrasound Guided Hydrodilatation with corticosteroid injection
    Intervention Description
    15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance
    Primary Outcome Measure Information:
    Title
    Change from baseline pain score on Visual Analog Scale(VAS)
    Description
    Pain scored according to VAS; between 0(no pain) to 10(worst pain)
    Time Frame
    Baseline, 1 week, 1 month, 3 months
    Title
    Change in Shoulder Pain and Disability Index(SPADI) scores
    Description
    Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability
    Time Frame
    Baseline, 1 month, 3 months
    Secondary Outcome Measure Information:
    Title
    Change in Range of Movement(ROM)
    Description
    Range of shoulder movements assessed with digital inclinometer in sittting and lying positions
    Time Frame
    Baseline, 1 week, 1 month, 3 months
    Title
    Ultrasound Parameters
    Description
    Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)
    Time Frame
    Baseline, 1 month, 3 months
    Title
    Proprioception(Active position sense- joint position error)
    Description
    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
    Time Frame
    Baseline, 3 months
    Title
    Shoulder Strength
    Description
    Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation
    Time Frame
    Baseline, 3 months
    Title
    Changes in Depression Score
    Description
    measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression
    Time Frame
    Baseline, 1 months, 3 months
    Title
    Changes in Life Quality Score
    Description
    Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best)
    Time Frame
    Baseline, 1 month, 3 months
    Title
    Treatment Satisfaction
    Description
    Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatmanur Yegin
    Phone
    0905462729955
    Email
    fatmanur.yegin@istanbul.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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