Knee ArthritisPhase 3NCT03616340
Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
A Phase 3 study testing Shoulder injection and knee injection in people with Knee Arthritis and Shoulder Arthritis, run by OSF Healthcare System.
Trial summary
The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Arthritis, Shoulder Arthritis, Shoulder Impingement
- What is being tested?
- Shoulder injection and knee injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Aug 2020
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee and shoulder arthritis
- shoulder impingement
- rotator cuff tear
Who cannot join
- chronic pain management
- allergy to NSAIDs or steroids
- prior surgery
- kidney disease that would preclude NSAID administration
Trial locations and contacts
No sites are listed yet.
About this study
The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder
Read the detailed description
This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections
- Conditions
- Knee Arthritis, Shoulder Arthritis, Shoulder Impingement, Meniscus Lesion, Rotator Cuff Tear, Rotator Cuff Tear Arthropathy
- Being tested
- Shoulder injection, knee injection
- Medical subject headings
- Shoulder Impingement Syndrome, Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder injectionDrug
intra articular or subacromial shoulder injection
knee injectionDrug
intra-articular knee injection
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | Not described Receives: Drug: Shoulder injection; Drug: knee injection |
| Kenalog | Experimental | Not described Receives: Drug: Shoulder injection; Drug: knee injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level: VAS score
VAS score
Measured: 0-6 months
length pain relief
length of time patient reports pain relief
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Ramirez, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616340
- Sponsor's protocol ID
- 1209087-1
- Status last verified
- Jul 2018
- First submitted
- 31 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
- ClinicalTrials.gov ID
- NCT03616340
- Acronym / sponsor ID
- 1209087-1
- Conditions
- Knee Arthritis, Shoulder Arthritis, Shoulder Impingement, Meniscus Lesion, Rotator Cuff Tear, Rotator Cuff Tear Arthropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- 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 proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder
Detailed description
This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: Shoulder injection, Drug: knee injection |
| Kenalog | Experimental | Drug: Shoulder injection, Drug: knee injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- knee and shoulder arthritis
- shoulder impingement
- rotator cuff tear
Key exclusion criteria (4 listed)
- chronic pain management
- allergy to NSAIDs or steroids
- prior surgery
- kidney disease that would preclude NSAID administration
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 |
|---|---|---|
| Shoulder injectionintra articular or subacromial shoulder injection | Drug | Kenalog, Ketorolac |
| knee injectionintra-articular knee injection | Drug | Kenalog, Ketorolac |
Primary outcome
Pain level: VAS score
Time frame: 0-6 months
VAS score
length pain relief
Time frame: 0-6 months
length of time patient reports pain relief
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shoulder injection and knee injection in people with Knee Arthritis and Shoulder Arthritis, run by OSF Healthcare System.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel ramirez, MD (17857661273, maramirez09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level: VAS score (time frame: 0-6 months). The study lists 2 primary outcomes in all. 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 6 Aug 2018.