Ketorolac in Upper Extremity Tendinopathy and Arthropathy

NCT05292339 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00003892
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis; Tendinopathy; Arthropathy

Keywords

First Carpometacarpal Joint; Ketoralac; metacarpophalangeal joint osteoarthritis; trigger finger; De Quervain's tenosynovitis; radiocarpal osteoarthritis; Triamcinolone; Upper extremity

Outcome Measures

Primary Outcomes (1)

• Changes in Visual Analog Scale (VAS) pain score

  Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The visual analog scale or visual analog scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain).

  Baseline, 6 weeks, 24 weeks

Secondary Outcomes (5)

• Changes in the patient-Reported Outcomes Measurement Information System (PROMIS)

  Baseline, 6 weeks, 24 weeks

• Changes in Hand subjectivity value

  Baseline, 6 weeks, 24 weeks

• Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment

  Baseline, 6 weeks, 24 weeks

• Changes in Grip Strength

  Baseline, 6 weeks, 24 weeks

• Changes in Key Pinch

  Baseline, 6 weeks, 24 weeks

Study Arms (2)

Triamcinolone injection to the shoulder, elbow, wrist, or hand

ACTIVE COMPARATOR

Participants will receive the triamcinolone injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Drug: Triamcinolone injection to the shoulder, elbow, wrist, or hand

Ketorolac injection to the shoulder, elbow, wrist, or hand

ACTIVE COMPARATOR

Participants will receive the Ketoralac injection solutions in a standard fashion. Injections will be performed using the treating physician's standard technique.

Drug: Ketorolac injection to the shoulder, elbow, wrist, or hand

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.

Also known as: Triamcinolone

Triamcinolone injection to the shoulder, elbow, wrist, or hand

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.

Also known as: Ketoralac

Ketorolac injection to the shoulder, elbow, wrist, or hand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[active infection defined as cellulitis, purulence, fever, chills, or presence of elevated inflammatory markers, ie. white blood cells (WBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)\].

Sponsors & Collaborators

• Emory University: lead
• American Association for Hand Surgery: AAHS: collaborator

Study Sites (4)

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Orthopaedic and Spine Center

Atlanta, Georgia, 30324, United States

RECRUITING

12 Executive Park Drive

Atlanta, Georgia, 30329, United States

RECRUITING

Emory University Orthopaedic and Spine Hospital

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Tendinopathy; Joint Diseases; Trigger Finger Disorder; De Quervain Disease

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries; Tendon Entrapment

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Paul A. Ghareeb, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Amanda L Dempsey

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul A. Ghareeb, MD

CONTACT

404-778-3350; paul.ghareeb@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 23, 2022
• Study Start: January 31, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)