Ketorolac in Upper Extremity Tendinopathy and Arthropathy

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05292339
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Triamcinolone injection to the shoulder, elbow, wrist, or hand — DRUG
    Triamcinolone is a corticosteroid that decreases the inflammatory process by inhibiting the release of arachidonic acid from phospholipids.
  • Ketorolac injection to the shoulder, elbow, wrist, or hand — DRUG
    Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that reduces inflammation by inhibiting Cyclo-oxygenase (COX)-2 dependent prostaglandin release via the cyclooxygenase pathway.

Study Details

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.

Key Dates

Start date
Jan 31, 2023
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Triamcinolone injection to the shoulder, elbow, wrist, or hand
    Participants will receive the triamcinolone injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.
  • Active Comparator: Ketorolac injection to the shoulder, elbow, wrist, or hand
    Participants will receive the Ketoralac injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Primary Outcome Measure

Changes in Visual Analog Scale (VAS) pain score [ Time Frame: Baseline, 6 weeks, 24 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
12 Executive Park DriveAtlantaGeorgia30329
Paul A. Ghareeb, MD
[email protected]
(404) 778-3350
Emory Saint Joseph's HospitalAtlantaGeorgia30308
Paul A. Ghareeb, MD
[email protected]
(404) 778-3350
Emory University Orthopaedic and Spine CenterAtlantaGeorgia30324
Amanda L Demsey, MD
[email protected]
(404) 778-6381
Emory University Orthopaedic and Spine HospitalAtlantaGeorgia30329
Paul A. Ghareeb, MD
[email protected]
404-778-3350

Find similar trials in Atlanta, GA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
12 Executive Park Drive· Atlanta, GAEmory Saint Joseph's Hospital· Atlanta, GAEmory University Orthopaedic and Spine Center· Atlanta, GAEmory University Orthopaedic and Spine Hospital· Atlanta, GA

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