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Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome

Primary Purpose

Subacromial Impingement, Pain, Shoulder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyaluronic acid
Corticosteroids Triamcinolone Acetonide
Electrotherapy
Sponsored by
Şeyhmus KAPLAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The diagnosis of subacromial impingement syndrome

Exclusion Criteria:

  • Patients aged <20 or >50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Electrotherapy

    corticosteroid

    hyaluronic acid

    Arm Description

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale
    Higher scores represent higher level of shoulder pain.
    range of motion
    Higher scores represent lower level of shoulder function.
    Shoulder Disability Questionnaire
    Higher scores represent higher level of shoulder pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 2, 2021
    Last Updated
    April 5, 2021
    Sponsor
    Şeyhmus KAPLAN
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04833738
    Brief Title
    Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
    Official Title
    Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 11, 2013 (Actual)
    Primary Completion Date
    December 10, 2013 (Actual)
    Study Completion Date
    May 28, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Şeyhmus KAPLAN

    4. Oversight

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

    5. Study Description

    Brief Summary
    Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome. Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Electrotherapy
    Arm Type
    Active Comparator
    Arm Title
    corticosteroid
    Arm Type
    Active Comparator
    Arm Title
    hyaluronic acid
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic acid
    Intervention Type
    Drug
    Intervention Name(s)
    Corticosteroids Triamcinolone Acetonide
    Intervention Description
    triamcinolone acetonide, 40 mg/ml, single dose
    Intervention Type
    Other
    Intervention Name(s)
    Electrotherapy
    Intervention Description
    electrotherapy
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale
    Description
    Higher scores represent higher level of shoulder pain.
    Time Frame
    1 min.
    Title
    range of motion
    Description
    Higher scores represent lower level of shoulder function.
    Time Frame
    5 min.
    Title
    Shoulder Disability Questionnaire
    Description
    Higher scores represent higher level of shoulder pain.
    Time Frame
    15 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The diagnosis of subacromial impingement syndrome Exclusion Criteria: Patients aged <20 or >50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome

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