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

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
isotonic saline injection into the glenohumeral joint
steroid injection into the glenohumeral joint
sodium hyaluronate injection into the glenohumeral joint
steroid and hyaluronate injection into the glenohumeral joint
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Isotonic saline

Steroid

Hyaluronate

Steroid + Hyaluronate

Arm Description

Outcomes

Primary Outcome Measures

SPADI Score (Shoulder Pain and Disability Index)

Secondary Outcome Measures

Full Information

First Posted
June 8, 2010
Last Updated
December 17, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01144533
Brief Title
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis
Official Title
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotonic saline
Arm Type
Placebo Comparator
Arm Title
Steroid
Arm Type
Experimental
Arm Title
Hyaluronate
Arm Type
Experimental
Arm Title
Steroid + Hyaluronate
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
isotonic saline injection into the glenohumeral joint
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
steroid injection into the glenohumeral joint
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sodium hyaluronate injection into the glenohumeral joint
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
steroid and hyaluronate injection into the glenohumeral joint
Intervention Description
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 Outcome Measure Information:
Title
SPADI Score (Shoulder Pain and Disability Index)
Time Frame
Postinjection 1month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris H. Jo, M.D., Ph.D
Organizational Affiliation
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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