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

Purpose

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.

Condition	Intervention
Adhesive Capsulitis	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
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:

Drug Information available for: Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

SPADI Score (Shoulder Pain and Disability Index) [ Time Frame: Postinjection 1month ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2013
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144533

Locations

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

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:

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

More Information

No publications provided

Responsible Party:	Hyunchul Jo, Assistant Professor, SMG-SNU Boramae Medical Center., Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01144533 History of Changes
Other Study ID Numbers:	BRM-10-01
Study First Received:	June 8, 2010
Last Updated:	March 11, 2013
Health Authority:	Korea: Institutional Review Board

Additional relevant MeSH terms:

Bursitis
Periarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis

Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013