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Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Shoulder Stiffness

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ClinicalTrials.gov Identifier: NCT06051370
Recruitment Status : Completed
First Posted : September 22, 2023
Last Update Posted : September 25, 2023
Sponsor:
Information provided by (Responsible Party):
Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

Brief Summary:

A prospective randomized controlled trial enrolled 51 patients diagnosed with shoulder impingement syndrome and mild stiffness.

Patients were randomly assigned to two groups: the glenohumeral injection group (Group GH) or the subacromial injection group (Group SA). After the final follow-up, 48 patients (24 in each group) were included for analysis Using ultrasound guidance, a solution containing 1mL of triamcinolone, 4mL of 1% lidocaine, and 7mL of 0.9% normal saline was injected into either the glenohumeral or the subacromial space. The following assessments were conducted at baseline and during follow-up visits at weeks 3, 7, and 13: ROM measurements for forward elevation, external rotation, and internal rotation; clinical scores including VAS, ASES, and Constant.


Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Adhesive Capsulitis of Shoulder Procedure: Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection Procedure: Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study group underwent ultrasound-guided posterior approach of glenohumeral space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.

Control group underwent ultrasound-guided anterolateral approach of subacromial space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: A final number of 51 patients were enrolled in the trial and randomly assigned to either the glenohumeral ultrasound-guided injection group (Group GH) or the subacromial ultrasound-guided injection group (Group SA). Double-blinded randomization was performed by an independent nurse using a computer-generated random sequence. A musculoskeletal radiologist, blinded to group allocation, performed the diagnostic ultrasound and MRI interpretations. A blinded orthopaedic resident and nurse carried out the physical examination and clinical scoring.
Primary Purpose: Treatment
Official Title: Ultrasound-guided Glenohumeral Versus Subacromial Steroid Injections for Impingement Syndrome With Mild Stiffness: A Randomized Controlled Trial
Actual Study Start Date : January 12, 2013
Actual Primary Completion Date : March 17, 2014
Actual Study Completion Date : June 18, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glenohumeral injection
Ultrasound-guided posterior approach of glenohumeral space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.
Procedure: Ultrasound-guided glenohumeral space triamcinolone, lidocaine and saline injection
Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the glenohumeral space through the posterior approach

Active Comparator: Subacromial injection
Ultrasound-guided anterolateral approach of subacromial space injection for impingement syndrome with mild stiffness of the shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 7 mL normal saline.
Procedure: Ultrasound-guided subacromial space triamcinolone, lidocaine and saline injection
Using a 21-gauge spinal needle, the predefined steroid solution was injected under ultrasound guidance using 5- to 13-MHz linear probe into the subacromial space through the anterolateral approach




Primary Outcome Measures :
  1. Visual analog scale (VAS) for pain [ Time Frame: Change from the baseline at 13 weeks ]
    Patient-reported 0-10 scale of pain, 0: no pain, 10: very severe pain

  2. Range of motion (ROM) [ Time Frame: Change from the baseline at 13 weeks ]
    ROM in degrees, forward elevation (0-150), external rotation (0-90), and internal rotation (0-90)

  3. American Shoulder and Elbow Surgeons (ASES) shoulder score [ Time Frame: Change from the baseline at 13 weeks ]
    Patient-reported shoulder satisfaction score, 0-100, higher scores mean a better outcome.

  4. Constant score [ Time Frame: Change from the baseline at 13 weeks ]
    Patient-reported and healthcare provider-assessed shoulder satisfaction score, 0-100, higher scores mean a better outcome.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with shoulder impingement syndrome with mild stiffness.
  • Impingement syndrome diagnosed based
  • Positive Hawkin's sign and
  • Rotator cuff with intact continuity but tendinosis in MRI or US
  • Possible subacromial enthesophyte
  • Mild stiffness was defined as a degree of stiffness that permits activities of daily activity but still often causes endpoint ROM pain
  • Meeting two or more of the following ROM both active & passive
  • Abduction between 110˚ and 150˚
  • Forward elevation between 120˚ and 140˚
  • External rotation at the side between 30˚ and 50˚
  • Internal rotation at 90˚ of abduction between 30˚ and 50˚.

Exclusion Criteria:

  • Refused to undergo ultrasound-guided injection
  • Diagnosed with a rotator cuff tear, calcific tendinosis, or biceps pathology
  • History of operation, fracture, or nerve injury of the shoulder
  • Received treatment apart from the protocol during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051370


Locations
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Korea, Republic of
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwondo, Korea, Republic of, 700-204
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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Principal Investigator: Jung-Taek Hwang, MD, PhD Chuncheon Sacred Heart Hospital
Publications:
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Responsible Party: Jung-Taek Hwang, Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT06051370    
Other Study ID Numbers: Stiff Impinge - GH vs SA
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 25, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jung-Taek Hwang, Chuncheon Sacred Heart Hospital:
Glenohumeral injection
Subacromial injection
Ultrasound-guided injection
Steroid injection
Additional relevant MeSH terms:
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Bursitis
Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Joint Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids