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
  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

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:


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 ]

Enrollment: 60
Study Start Date: June 2010
Study Completion Date: December 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.
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.
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.
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.

  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
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, see Learn About Clinical Studies.

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: December 17, 2013
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
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on July 31, 2014