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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144533
• Other study ID #: BRM-10-01
• Status: Completed
• Phase: N/A
• First received: June 8, 2010
• Last updated: December 17, 2013
• Start date: June 2010
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPADI Score (Shoulder Pain and Disability Index)		Postinjection 1month	No