NCT01144533CompletedNot 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 Hospital2 sites in 1 country60 target enrollmentStarted: June 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- SPADI Score (Shoulder Pain and Disability Index)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
SPADI Score (Shoulder Pain and Disability Index)
Time Frame: Postinjection 1month
Secondary Outcomes
No secondary outcomes reported
Investigators
Hyunchul Jo
Assistant Professor, SMG-SNU Boramae Medical Center.
Seoul National University Hospital
Study Sites (2)
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