search
Back to results

Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome

Primary Purpose

Shoulder Impingement, Ultrasound Guided Injection

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bupivacaine and methylprednisolone
bupivacaine and methylprednisolone
bupivacaine and methylprednisolone
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement

Eligibility Criteria

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

Inclusion Criteria:

  • patients aged 18-65,
  • who were suffering from shoulder pain for more than three months and
  • who were diagnosed with IS.
  • All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging.

Exclusion Criteria:

  • the presence of cervical radiculopathy;
  • undergoing shoulder operation before;
  • the presence of central nervous system or
  • the presence of rheumatological disease, and polyneuropathy;
  • receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and
  • receiving any injection therapy in the past.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    subacromial injection

    acromioclavicular joint and subacromial injection

    suprascapular nerve block

    Arm Description

    ultrasound (US)-guided subacromial injection

    ultrasound (US)-guided acromioclavicular joint and subacromial injection

    ultrasound (US)-guided suprascapular nerve block

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS)
    for pain. 0: no pain at all, 10: worst pain imaginable

    Secondary Outcome Measures

    Shoulder pain and disability index (SPADI)
    This scale was developed to measure pain and disability associated with shoulder pain. It consists of two parts evaluating pain and disability.
    Short-Form 12 (SF-12)
    The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale

    Full Information

    First Posted
    August 18, 2021
    Last Updated
    August 19, 2021
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05015322
    Brief Title
    Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome
    Official Title
    Comparison of the Effectiveness of the Ultrasound Guided Subacromial, Acromioclavicular With Subacromial Injection and Suprascapular Nerve Block in Patients With Shoulder Impingement Syndrome ; A Randomized Controlled, Single Blind, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    January 1, 2021 (Actual)
    Study Completion Date
    January 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Shoulder pain, which is the third most common cause of musculoskeletal pain, has different etiologies. Muscle, bone structures and connective tissue pathologies can cause shoulder pain. Impingement syndrome (IS), which can cover many terms such as rotator cuff disorders, tendinitis and tears, is one of the most common pathologies of shoulder pain.
    Detailed Description
    The hypothesis of this study was that injection types including ACJ would increase treatment efficacy.Therefore, this study investigated the six-month follow-up results of patients undergoing SA injection and SSNB and those receiving SA and ACJ injection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Impingement, Ultrasound Guided Injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective,randomized controlled, single blind
    Masking
    Outcomes Assessor
    Masking Description
    The patients were followed up and questioned by the evaluator, who was blind to the type of injection administered to the patient.
    Allocation
    Randomized
    Enrollment
    88 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    subacromial injection
    Arm Type
    Active Comparator
    Arm Description
    ultrasound (US)-guided subacromial injection
    Arm Title
    acromioclavicular joint and subacromial injection
    Arm Type
    Active Comparator
    Arm Description
    ultrasound (US)-guided acromioclavicular joint and subacromial injection
    Arm Title
    suprascapular nerve block
    Arm Type
    Active Comparator
    Arm Description
    ultrasound (US)-guided suprascapular nerve block
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine and methylprednisolone
    Intervention Description
    5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine and methylprednisolone
    Intervention Description
    5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine and methylprednisolone
    Other Intervention Name(s)
    suprascapular nerve block
    Intervention Description
    suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS)
    Description
    for pain. 0: no pain at all, 10: worst pain imaginable
    Time Frame
    six month
    Secondary Outcome Measure Information:
    Title
    Shoulder pain and disability index (SPADI)
    Description
    This scale was developed to measure pain and disability associated with shoulder pain. It consists of two parts evaluating pain and disability.
    Time Frame
    six month
    Title
    Short-Form 12 (SF-12)
    Description
    The SF-12 has a physical (SF12-PCS) and mental (SF12-MCS) state assessment scale
    Time Frame
    six month

    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: patients aged 18-65, who were suffering from shoulder pain for more than three months and who were diagnosed with IS. All patients included in the study were diagnosed with IS using Shoulder Magnetic Resonance imaging. Exclusion Criteria: the presence of cervical radiculopathy; undergoing shoulder operation before; the presence of central nervous system or the presence of rheumatological disease, and polyneuropathy; receiving physical therapy in the shoulder area with a diagnosis of IS within the last six months; and receiving any injection therapy in the past.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Burcu Metin Ökmen, Assoc. Prof
    Organizational Affiliation
    University of Health Sciences, Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Korgün M Ökmen, Assoc. Prof
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of the Effectiveness of the Ultrasound Guided Injections in Patients With Shoulder Impingement Syndrome

    We'll reach out to this number within 24 hrs