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Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome

Primary Purpose

Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Impingement

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corticosteroid injection
Dry Needling
Sponsored by
Uskudar State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients aged 18-65 years old Diagnosis of subacromial impingement syndrome, confirmed by clinical examination and imaging (such as X-ray or MRI) Moderate to severe shoulder pain, with a score of at least 4 on a 0-10 visual analog scale (VAS) for pain Willingness to comply with the study protocol and attend all study visits and assessments Ability to provide informed consent to participate in the study. Exclusion Criteria: Contraindications to corticosteroid injection or dry needling, such as local infection, bleeding disorders, or allergy to the injectate or needle Previous shoulder surgery on the affected shoulder Other active shoulder conditions, such as rotator cuff tear or adhesive capsulitis, that may confound the study results Systemic conditions, such as rheumatoid arthritis or osteoarthritis, that may affect the shoulder joint and its function History of shoulder dislocation or instability Pregnancy or breastfeeding Current use of systemic corticosteroids or immunosuppressive drugs Injection to shoulder area in the past six months. Inability to complete the study assessments or follow the study protocol, such as due to cognitive impairment or language barrier.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    The corticosteroid (Triamcinolone Acetonide) injection group

    Tendon dry needling group

    Arm Description

    Participants in this group will receive a single subacromial injection of 40mg triamcinolone acetonide.

    Participants in this group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons.

    Outcomes

    Primary Outcome Measures

    Change in Visual Analog Scale for Pain
    A Visual Analog Scale (VAS) for pain is a commonly used tool to measure the intensity of pain experienced by a patient. It typically consists of a horizontal or vertical line, typically 10 centimeters long, with endpoints labeled as "no pain" and "worst possible pain." The patient is asked to mark on the line the point that best represents the intensity of their pain, with the distance from the "no pain" end of the line to the patient's mark representing the pain score.
    Change in The Shoulder Pain and Disability Index (SPADI)
    The Shoulder Pain and Disability Index (SPADI) is a validated patient-reported outcome measure that is commonly used to assess pain and functional disability related to shoulder disorders. The SPADI consists of 13 items that assess pain and disability in two domains: 1) pain and 2) disability. The pain domain consists of five items that assess the intensity and frequency of shoulder pain, while the disability domain consists of eight items that assess the impact of shoulder pain on daily activities such as sleeping, dressing, and carrying objects.
    Change in Range Of Motion (ROM) Measurements
    ROM of the shoulder joint is typically assessed using a goniometer, a device that measures joint angles. The goniometer is used to measure the degree of movement in different directions, including flexion, extension, abduction, adduction, internal rotation, and external rotation. The measurements obtained from the goniometer can then be used to determine the improvement or deterioration in ROM over time, which can be an indicator of treatment efficacy.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 7, 2023
    Last Updated
    May 20, 2023
    Sponsor
    Uskudar State Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05882786
    Brief Title
    Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome
    Official Title
    Comparing the Efficacy of Corticosteroid Injection and Tendon Dry Needling for Subacromial Impingement Syndrome: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Uskudar State Hospital

    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
    This randomized clinical trial aims to compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.
    Detailed Description
    This randomized clinical trial will compare the efficacy of corticosteroid injection and tendon dry needling for the treatment of subacromial impingement syndrome.Participants will be randomized to receive either a corticosteroid injection or tendon dry needling treatment. The corticosteroid injection group will receive a single subacromial injection of 40mg triamcinolone acetonide under ultrasound guidance. The tendon dry needling group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons. Patients will be assessed before treatment, after treatment, after three weeks and after three months with visual analog scale, Shoulder Pain and Disability Index (SPADI) and shoulder range of motion measurements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Impingement, Subacromial Impingement Syndrome, Subacromial Impingement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    Outcomes Assessor
    Masking Description
    The outcomes assessor will be blinded.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The corticosteroid (Triamcinolone Acetonide) injection group
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive a single subacromial injection of 40mg triamcinolone acetonide.
    Arm Title
    Tendon dry needling group
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive a total of 3 sessions of dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscle tendons.
    Intervention Type
    Procedure
    Intervention Name(s)
    Corticosteroid injection
    Intervention Description
    Subacromial injection of 40mg triamcinolone acetonide.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dry Needling
    Intervention Description
    Dry needling treatment to the supraspinatus, infraspinatus, and subscapularis muscles tendons.
    Primary Outcome Measure Information:
    Title
    Change in Visual Analog Scale for Pain
    Description
    A Visual Analog Scale (VAS) for pain is a commonly used tool to measure the intensity of pain experienced by a patient. It typically consists of a horizontal or vertical line, typically 10 centimeters long, with endpoints labeled as "no pain" and "worst possible pain." The patient is asked to mark on the line the point that best represents the intensity of their pain, with the distance from the "no pain" end of the line to the patient's mark representing the pain score.
    Time Frame
    First day, after three weeks, after three months
    Title
    Change in The Shoulder Pain and Disability Index (SPADI)
    Description
    The Shoulder Pain and Disability Index (SPADI) is a validated patient-reported outcome measure that is commonly used to assess pain and functional disability related to shoulder disorders. The SPADI consists of 13 items that assess pain and disability in two domains: 1) pain and 2) disability. The pain domain consists of five items that assess the intensity and frequency of shoulder pain, while the disability domain consists of eight items that assess the impact of shoulder pain on daily activities such as sleeping, dressing, and carrying objects.
    Time Frame
    First day, after three weeks, after three months
    Title
    Change in Range Of Motion (ROM) Measurements
    Description
    ROM of the shoulder joint is typically assessed using a goniometer, a device that measures joint angles. The goniometer is used to measure the degree of movement in different directions, including flexion, extension, abduction, adduction, internal rotation, and external rotation. The measurements obtained from the goniometer can then be used to determine the improvement or deterioration in ROM over time, which can be an indicator of treatment efficacy.
    Time Frame
    First day, after three weeks, after three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients aged 18-65 years old Diagnosis of subacromial impingement syndrome, confirmed by clinical examination and imaging (such as X-ray or MRI) Moderate to severe shoulder pain, with a score of at least 4 on a 0-10 visual analog scale (VAS) for pain Willingness to comply with the study protocol and attend all study visits and assessments Ability to provide informed consent to participate in the study. Exclusion Criteria: Contraindications to corticosteroid injection or dry needling, such as local infection, bleeding disorders, or allergy to the injectate or needle Previous shoulder surgery on the affected shoulder Other active shoulder conditions, such as rotator cuff tear or adhesive capsulitis, that may confound the study results Systemic conditions, such as rheumatoid arthritis or osteoarthritis, that may affect the shoulder joint and its function History of shoulder dislocation or instability Pregnancy or breastfeeding Current use of systemic corticosteroids or immunosuppressive drugs Injection to shoulder area in the past six months. Inability to complete the study assessments or follow the study protocol, such as due to cognitive impairment or language barrier.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mustafa H Temel, M.D.
    Phone
    +905342714872
    Email
    mhuseyintemel@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatih Bağcıer, M.D.
    Phone
    05442429042
    Email
    bagcier_42@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mustafa H Temel, M.D.
    Organizational Affiliation
    Uskudar State Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data will be shared upon reasonable request by the corresponding author.
    IPD Sharing Time Frame
    1 month.
    IPD Sharing Access Criteria
    Individual participant data will be shared upon reasonable request by the corresponding author.

    Learn more about this trial

    Corticosteroid Injection Versus Tendon Dry Needling for Subacromial Impingement Syndrome

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