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Clinical Trials/NCT01144533
NCT01144533
Completed
Not Applicable

Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial

Seoul National University Hospital1 site in 1 country60 target enrollmentJune 2010
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ConditionsAdhesive Capsulitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adhesive Capsulitis
Sponsor
Seoul National University Hospital
Enrollment
60
Locations
1
Primary Endpoint
SPADI Score (Shoulder Pain and Disability Index)
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyunchul Jo

Assistant Professor, SMG-SNU Boramae Medical Center.

Seoul National University Hospital

Eligibility 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

Outcomes

Primary Outcomes

SPADI Score (Shoulder Pain and Disability Index)

Time Frame: Postinjection 1month

Study Sites (1)

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