Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis
NCT ID: NCT01144533
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-06-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Isotonic saline
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.
Steroid
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.
Hyaluronate
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.
Steroid + Hyaluronate
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.
Interventions
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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.
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.
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.
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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Hyunchul Jo
Assistant Professor, SMG-SNU Boramae Medical Center.
Principal Investigators
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Chris H. Jo, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Locations
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Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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BRM-10-01
Identifier Type: -
Identifier Source: org_study_id