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

NCT01144533 | Completed

• 1 other identifier: BRM-10-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Outcome Measures

Primary Outcomes (1)

• SPADI Score (Shoulder Pain and Disability Index)

  Postinjection 1month

Study Arms (4)

Isotonic saline

PLACEBO COMPARATOR

Procedure: isotonic saline injection into the glenohumeral joint

Steroid

EXPERIMENTAL

Procedure: steroid injection into the glenohumeral joint

Hyaluronate

EXPERIMENTAL

Procedure: sodium hyaluronate injection into the glenohumeral joint

Steroid + Hyaluronate

EXPERIMENTAL

Procedure: steroid and hyaluronate injection into the glenohumeral joint

Interventions

isotonic saline injection into the glenohumeral joint PROCEDURE

* 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.

Isotonic saline

steroid injection into the glenohumeral joint PROCEDURE

* 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.

Steroid

sodium hyaluronate injection into the glenohumeral joint PROCEDURE

* 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.

Hyaluronate

steroid and hyaluronate injection into the glenohumeral joint PROCEDURE

* 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.

Steroid + Hyaluronate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, 156-707, South Korea

Location

MeSH Terms

Conditions

Bursitis

Interventions

Steroids

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, SMG-SNU Boramae Medical Center.

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 15, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

KR (1)