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

Seoul National University

Status: Completed

Conditions: Adhesive Capsulitis

Treatments: Procedure: sodium hyaluronate injection into the glenohumeral joint; Procedure: isotonic saline injection into the glenohumeral joint; Procedure: steroid injection into the glenohumeral joint; Procedure: steroid and hyaluronate injection into the glenohumeral joint

Study type: Interventional

Funder types: Other

Identifiers

NCT01144533

BRM-10-01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

Isotonic saline

Placebo Comparator group

Treatment:

Procedure: isotonic saline injection into the glenohumeral joint

Steroid

Experimental group

Treatment:

Procedure: steroid injection into the glenohumeral joint

Hyaluronate

Experimental group

Treatment:

Procedure: sodium hyaluronate injection into the glenohumeral joint

Steroid + Hyaluronate

Experimental group

Treatment:

Procedure: steroid and hyaluronate injection into the glenohumeral joint