Adhesive CapsulitisNCT01144533
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis
A study testing isotonic saline injection into the glenohumeral joint, steroid injection into the glenohumeral joint and sodium hyaluronate injection into the glenohumeral joint in people with Adhesive Capsulitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- isotonic saline injection into the glenohumeral joint, steroid injection into the glenohumeral joint and sodium hyaluronate injection into the glenohumeral joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, 156-707
About this study
Official title: Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial
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.
- Conditions
- Adhesive Capsulitis
- Being tested
- 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
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotonic saline injection into the glenohumeral jointProcedure or surgery
- 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 jointProcedure or surgery
- 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 jointProcedure or surgery
- 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 jointProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Isotonic saline | Placebo comparator | Not described Receives: Procedure: isotonic saline injection into the glenohumeral joint |
| Steroid | Experimental | Not described Receives: Procedure: steroid injection into the glenohumeral joint |
| Hyaluronate | Experimental | Not described Receives: Procedure: sodium hyaluronate injection into the glenohumeral joint |
| Steroid + Hyaluronate | Experimental | Not described Receives: Procedure: steroid and hyaluronate injection into the glenohumeral joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPADI Score (Shoulder Pain and Disability Index)
Measured: Postinjection 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Jo, Seoul National University Hospital
- Investigators
- Chris H. Jo, M.D., Ph.D, Principal investigator, Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144533
- Sponsor's protocol ID
- BRM-10-01
- Status last verified
- Dec 2013
- First submitted
- 8 Jun 2010
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01144533
- Acronym / sponsor ID
- BRM-10-01
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Isotonic saline | Placebo comparator | Procedure: isotonic saline injection into the glenohumeral joint |
| Steroid | Experimental | Procedure: steroid injection into the glenohumeral joint |
| Hyaluronate | Experimental | Procedure: sodium hyaluronate injection into the glenohumeral joint |
| Steroid + Hyaluronate | Experimental | Procedure: steroid and hyaluronate injection into the glenohumeral joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical diagnosis : Adhesive Capsulitis of the Shoulder
- defining of adhesive capsulitis
- duration : symptomatic for < 1 year
Key exclusion criteria (19 listed)
- bilateral symptoms
- uncontrolled diabetes mellitus
- overt hypothyroidism or hyperthyroidism
- previous shoulder surgery
- previous glenohumeral joint injection within recent 6months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Isotonic saline |
| 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. | Procedure or surgery | Steroid |
| 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. | Procedure or surgery | 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. | Procedure or surgery | Steroid + Hyaluronate |
Primary outcome
SPADI Score (Shoulder Pain and Disability Index)
Time frame: Postinjection 1month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris H. Jo, M.D., Ph.D principal investigator
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isotonic saline injection into the glenohumeral joint, steroid injection into the glenohumeral joint and sodium hyaluronate injection into the glenohumeral joint in people with Adhesive Capsulitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPADI Score (Shoulder Pain and Disability Index) (time frame: Postinjection 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.