OsteoarthritisNCT00746889
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis
A study testing triamcinolone acetonide and saline in people with Osteoarthritis, run by University of California, San Diego at 2 sites in United States.
Trial summary
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- triamcinolone acetonide and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2004to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- knee pain
- diagnosis of osteoarthritis in affected knee
Who cannot join
- intraarticular corticosteroids in affected knee within past three months
- primary inflammatory connective tissue disease (ie rheumatoid arthritis)
- currently taking oral corticosteroids
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California San Diego Medical Center
La Jolla, California, 92093
San Diego VA Hospital
La Jolla, California, 92161
About this study
Official title: Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.
- Conditions
- Osteoarthritis
- Being tested
- triamcinolone acetonide, saline
- Keywords
- osteoarthritis, knee, corticosteroids, ultrasound
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone acetonideDrug
single intraarticular injection of 40 mg of triamcinolone acetonide
salineDrug
Single intraarticular injection of 1 ml of 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid Injection | Active comparator | 40 mg of intraarticular triamcinolone acetonide Receives: Drug: triamcinolone acetonide |
| Placebo Injection | Placebo comparator | Intraarticular injection of 0.9% saline Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Measured: baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startMar 2004
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Double blind
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Kalunian, MD, Principal investigator, University of California, San DiegoAnna Quan, MD, Study chair, San Diego VA HospitalMichal Kalli Hose, MD, Study director, San Diego VA HospitalJeannie Chao, MD, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746889
- Sponsor's protocol ID
- IRB 051420
- Status last verified
- Sep 2008
- First submitted
- 3 Sep 2008
- Last updated
- 25 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00746889
- Acronym / sponsor ID
- IRB 051420
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, knee, corticosteroids, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Sep 2008 (estimated)
- Results
- Posted 25 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid Injection | Active comparator | Drug: triamcinolone acetonide40 mg of intraarticular triamcinolone acetonide |
| Placebo Injection | Placebo comparator | Drug: salineIntraarticular injection of 0.9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- knee pain
- diagnosis of osteoarthritis in affected knee
Key exclusion criteria (3 listed)
- intraarticular corticosteroids in affected knee within past three months
- primary inflammatory connective tissue disease (ie rheumatoid arthritis)
- currently taking oral corticosteroids
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 |
|---|---|---|
| triamcinolone acetonidesingle intraarticular injection of 40 mg of triamcinolone acetonide | Drug | Corticosteroid Injection |
| salineSingle intraarticular injection of 1 ml of 0.9% saline | Drug | Placebo Injection |
Primary outcome
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale
Time frame: baseline to 4 weeks
WOMAC pain subscale range 0-20 (0=best, 20=worst)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kenneth Kalunian, MD principal investigator
University of California, San Diego
Anna Quan, MD study chair
San Diego VA Hospital
Michal Kalli Hose, MD study director
San Diego VA Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triamcinolone acetonide and saline in people with Osteoarthritis, run by University of California, San Diego at 2 sites in United States.
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 2 inclusion and 3 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 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale (time frame: baseline to 4 weeks). 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 25 Aug 2010.