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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: 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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SPADI Score (Shoulder Pain and Disability Index)	Postinjection 1month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (ESTIMATE): June 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: BRM-10-01