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Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01144533
First received: June 8, 2010
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.


Condition Intervention
Adhesive Capsulitis
 Procedure: isotonic saline injection into the glenohumeral joint
Procedure: steroid injection into the glenohumeral joint
Procedure: sodium hyaluronate injection into the glenohumeral joint
Procedure: steroid and hyaluronate injection into the glenohumeral joint
Procedure: intra-articular injection of the glenohumeral joint

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • SPADI Score (Shoulder Pain and Disability Index) [ Time Frame: Postinjection 1month ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Isotonic saline Procedure: isotonic saline injection into the glenohumeral joint
  • Total volume of injection drugs: 8ml
  • isotonic saline 4ml + telebrix(contrast media) 4ml
  • The number of injections : only once during the study period
  • Injection site : glenohumeral joint
  • Material : 22-gauze spinal needle
  • Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
Procedure: intra-articular injection of the glenohumeral joint

List of drugs that will be administered in the interventions

  • Placebo Comparator: sodium chloride 0.9% 4ml + telebrix meglumin 4ml
  • Experimental (Steroid): triamcinolone acetonide(40mg/ml) 1ml + sodium chloride 0.9% 3ml + telebrix meglumin 4ml
  • Experimental (Hyaluronate): High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 2ml + telebrix meglumin 4ml
  • Experimental (Steroid + Hyaluronate): triamcinolone acetonide(40mg/ml) 1ml + High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 1ml + telebrix meglumin 4ml
Experimental: Steroid Procedure: steroid injection into the glenohumeral joint
  • Total volume of injection drugs: 8ml
  • triamcinolone(40mg)1ml + isotonic saline 3ml + telebrix(contrast media)4ml
  • The number of injections : only once during the study period
  • Injection Site : glenohumeral joint
  • Material : 22-gauze spinal needle
  • Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
Procedure: intra-articular injection of the glenohumeral joint

List of drugs that will be administered in the interventions

  • Placebo Comparator: sodium chloride 0.9% 4ml + telebrix meglumin 4ml
  • Experimental (Steroid): triamcinolone acetonide(40mg/ml) 1ml + sodium chloride 0.9% 3ml + telebrix meglumin 4ml
  • Experimental (Hyaluronate): High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 2ml + telebrix meglumin 4ml
  • Experimental (Steroid + Hyaluronate): triamcinolone acetonide(40mg/ml) 1ml + High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 1ml + telebrix meglumin 4ml
Experimental: Hyaluronate Procedure: sodium hyaluronate injection into the glenohumeral joint
  • Total volume of injection drugs: 8ml
  • sodium hyaluronate 2ml + isotonic saline 2ml + telebrix(contrast media)4ml
  • The number of injections : only once during the study period
  • Injection Site : glenohumeral joint
  • Material : 22-gauze spinal needle
  • Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
Procedure: intra-articular injection of the glenohumeral joint

List of drugs that will be administered in the interventions

  • Placebo Comparator: sodium chloride 0.9% 4ml + telebrix meglumin 4ml
  • Experimental (Steroid): triamcinolone acetonide(40mg/ml) 1ml + sodium chloride 0.9% 3ml + telebrix meglumin 4ml
  • Experimental (Hyaluronate): High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 2ml + telebrix meglumin 4ml
  • Experimental (Steroid + Hyaluronate): triamcinolone acetonide(40mg/ml) 1ml + High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 1ml + telebrix meglumin 4ml
Experimental: Steroid + Hyaluronate Procedure: steroid and hyaluronate injection into the glenohumeral joint
  • Total volume of injection drugs: 8ml
  • triamcinolone(40mg)1ml + sodium hyaluronate 2ml + isotonic saline 1ml + telebrix(contrast media)4ml
  • The number of injections : only once during the study period
  • Injection Site : glenohumeral joint
  • Material : 22-gauze spinal needle
  • Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection.
Procedure: intra-articular injection of the glenohumeral joint

List of drugs that will be administered in the interventions

  • Placebo Comparator: sodium chloride 0.9% 4ml + telebrix meglumin 4ml
  • Experimental (Steroid): triamcinolone acetonide(40mg/ml) 1ml + sodium chloride 0.9% 3ml + telebrix meglumin 4ml
  • Experimental (Hyaluronate): High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 2ml + telebrix meglumin 4ml
  • Experimental (Steroid + Hyaluronate): triamcinolone acetonide(40mg/ml) 1ml + High Molecular Weight sodium hyaluronate(20mg/2ml) 2ml + sodium chloride 0.9% 1ml + telebrix meglumin 4ml

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis : Adhesive Capsulitis of the Shoulder

  • defining of adhesive capsulitis

    • the presence of shoulder pain
    • limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder
  • duration : symptomatic for < 1 year

Exclusion Criteria:

  • bilateral symptoms
  • uncontrolled diabetes mellitus
  • overt hypothyroidism or hyperthyroidism
  • previous shoulder surgery
  • previous glenohumeral joint injection within recent 6months
  • trauma to the shoulder the last six months that required hospital care
  • neurological symptoms
  • allergy to injection material
  • secondary adhesive capsulitis
  • systemic inflammatory ds including rheumatoid arthritis
  • degenerative arthritis of shoulder joint
  • infectious arthritis of shoulder joint
  • dislocation of shoulder joint
  • blood coagulation disease
  • rotator cuff tear
  • serious mental illness
  • pregnancy
  • fracture in shoulder lesion
  • CVA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144533

Locations
Korea, Republic of
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chris H. Jo, M.D., Ph.D Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
  More Information

No publications provided

Responsible Party: Hyunchul Jo, Assistant Professor, SMG-SNU Boramae Medical Center., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01144533     History of Changes
Other Study ID Numbers: BRM-10-01
Study First Received: June 8, 2010
Last Updated: October 11, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012