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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01144533
First received: June 8, 2010
Last updated: December 17, 2013
Last verified: December 2013

June 8, 2010
December 17, 2013
June 2010
June 2012   (final data collection date for primary outcome measure)
SPADI Score (Shoulder Pain and Disability Index) [ Time Frame: Postinjection 1month ] [ Designated as safety issue: No ]
Constant Score (Constant score is the total of the scores for each item; pain, activity of daily living, range of motion and power.) [ Time Frame: 6months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01144533 on ClinicalTrials.gov Archive Site
Not Provided
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Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Adhesive Capsulitis
  • 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: 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: 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: 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.
  • Placebo Comparator: Isotonic saline
    Intervention: Procedure: isotonic saline injection into the glenohumeral joint
  • Experimental: Steroid
    Intervention: Procedure: steroid injection into the glenohumeral joint
  • Experimental: Hyaluronate
    Intervention: Procedure: sodium hyaluronate injection into the glenohumeral joint
  • Experimental: Steroid + Hyaluronate
    Intervention: Procedure: steroid and hyaluronate injection into the glenohumeral joint
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01144533
BRM-10-01
No
Hyunchul Jo, Seoul National University Hospital
Seoul National University Hospital
Not Provided
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
Seoul National University Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP