Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound-Guided Glenohumeral Steroid Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02461368
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

Brief Summary:
The investigators compared the results of the ultrasound-guided anterior and posterior approaches to administer glenohumeral steroid injections to patients with primary adhesive capsulitis of the shoulder joint by a single experienced provider.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis of Shoulder Drug: Glenohumeral triamcinolone injection by anterior approach Drug: Glenohumeral triamcinolone injection by posterior approach Drug: Glenohumeral lidocaine injection by anterior approach Drug: Glenohumeral lidocaine injection by posterior approach Drug: Glenohumeral normal saline injection by anterior approach Drug: Glenohumeral normal saline injection by posterior approach Drug: Glenohumeral Omnipaque injection by anterior approach Drug: Glenohumeral Omnipaque injection by posterior approach Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Anterior and Posterior Approaches for Ultrasound-guided Glenohumeral Steroid Injection: A Randomized Controlled Trial
Study Start Date : December 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: anterior approach
Ultrasound-guided anterior approach of glenohumeral joint injection for primary adhesive capsulitis of shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
Drug: Glenohumeral triamcinolone injection by anterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Drug: Glenohumeral lidocaine injection by anterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Drug: Glenohumeral normal saline injection by anterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Drug: Glenohumeral Omnipaque injection by anterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Active Comparator: posterior approach
Ultrasound-guided anterior approach of glenohumeral joint injection for primary adhesive capsulitis of shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
Drug: Glenohumeral triamcinolone injection by posterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Drug: Glenohumeral lidocaine injection by posterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Drug: Glenohumeral normal saline injection by posterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Drug: Glenohumeral Omnipaque injection by posterior approach
Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).




Primary Outcome Measures :
  1. visual analog scale (VAS) for pain [ Time Frame: Chage from the baseline at 13 weeks ]
  2. range of motion (ROM) [ Time Frame: Chage from the baseline at 13 weeks ]
  3. patient's satisfaction (SAT) [ Time Frame: Chage from the baseline at 13 weeks ]
  4. American Shoulder and Elbow Surgeons (ASES) shoulder score [ Time Frame: Chage from the baseline at 13 weeks ]
  5. Constant score [ Time Frame: Chage from the baseline at 13 weeks ]

Secondary Outcome Measures :
  1. Accuracy of injection using post-injection X-ray [ Time Frame: within 15 minutes after injection ]
    Injection material includes 3cc Omnipaque, therefore, the accuracy of injection can be checked just after the injection. After the injection, anteroposterior, scapular lateral, and axillary x-rays of the shoulder were taken of all patients within 15 min, and leakage was classified into three categories by a musculoskeletal radiologist with 18 years experience: 1) no leakage; 2) leakage; and 3) cannot be determined.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • shoulder pain and limitations of active and passive motion in at least two directions (abduction and forward flexion < 100, external rotation < 30, or internal rotation < L3) on the pre-injection check-up
  • those who underwent MRI or ultrasonography with no secondary cause for adhesive capsulitis, such as a rotator cuff tear, calcific tendinitis, or osteoarthritis

Exclusion Criteria:

  • history of fracture or operation on the affected shoulder
  • loss to follow-up before 13 weeks after the injection
  • receiving another treatment that was different from our protocol within 13 weeks after the injection
  • no functional scores within 13 weeks after the injection

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): NCT02461368


Locations
Layout table for location information
Korea, Republic of
Chuncheon Sacred Heart Hospital
Chuncheon-si, Gangwon-do, Korea, Republic of, 700-204
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jung-Taek Hwang, MD, PhD Chuncheon Sacred Heart Hospital

Layout table for additonal information
Responsible Party: Jung-Taek Hwang, Assistant Professor, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02461368     History of Changes
Other Study ID Numbers: GH injection
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Bursitis
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors