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NCT Number: NCT01144533

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

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.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. SPADI Score (Shoulder Pain and Disability Index)

    Time frame: Postinjection 1month

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 15, 2010
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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