NCT05292339 Ketorolac in Upper Extremity Tendinopathy and Arthropathy
| NCT ID | NCT05292339 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Emory University |
| Condition | Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2023-01-31 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the shoulder, elbow, hand, and wrist are common yet disabling diseases. Standard management utilizes conservative measures to minimize pain and improve function. Conservative pharmacological management commonly includes corticosteroid and ketorolac injections which have been well investigated as a modality of pain control and improved function in large joint OA. However, fewer studies yielding mixed results on the duration of symptomatic relief exist for arthropathy and tendinopathy of these joints. The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common shoulder, elbow, wrist, and hand tendinopathy or arthropathy. Participants will be blinded to the treatment received. The duration of an individual participant's participation in this study is 24 weeks. During this time period, patients will be asked to return to the clinic for an in-person follow-up 6 weeks after the injection with either ketorolac or triamcinolone) in order to assess participants' outcomes. All work related to this project will take place at the Emory Sports Medicine Complex, Emory Executive Park, Emory Musculoskeletal Institute, the Emory University Orthopaedic and Spine Hospital, and the Emory Saint Joseph's Hospital. This study will add to existing knowledge by providing further insight into how wrist arthropathy should be most optimally and conservatively managed.
Eligibility Criteria
Inclusion Criteria: * Age 18 or older, * symptomatic tendinopathy or arthropathy of the shoulder, elbow, hand, or wrist who have not undergone prior surgical treatment for their condition. * Diagnoses may include trigger finger, De Quervain's tenosynovitis, radiocarpal osteoarthritis, first carpometacarpal (CMC) joint osteoarthritis, metacarpophalangeal joint osteoarthritis, or proximal interphalangeal joint osteoarthritis. Exclusion Criteria: * Patients under the age of 18, * Patients who have undergone prior triamcinolone or ketorolac injections within the past 6 months, * Patients who have undergone prior surgical treatment for their hand condition, * Patients with allergy or contraindication to triamcinolone or ketorolac injection, * Patients with an active infection at the treatment site \[active infection defined as cellulitis, purulence, fever, chills, or presence of elevated inflammatory markers, ie. white blood cells (WBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)\].
Contact & Investigator
Paul A. Ghareeb, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05292339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05292339 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05292339 currently recruiting?
Yes, NCT05292339 is actively recruiting participants. Contact the research team at paul.ghareeb@emory.edu for enrollment information.
Where is the NCT05292339 trial being conducted?
This trial is being conducted at Atlanta, United States, Atlanta, United States, Atlanta, United States, Atlanta, United States.
Who is sponsoring the NCT05292339 clinical trial?
NCT05292339 is sponsored by Emory University. The principal investigator is Paul A. Ghareeb, MD at Emory University. The trial plans to enroll 160 participants.