Ketorolac in Upper Extremity Tendinopathy and Arthropathy

NCT ID: NCT05292339

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2027-07-31

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.

Detailed Description

Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the upper extremity are common yet disabling diseases. These pathologic processes are progressive and painful leading to significant impairments in quality of life. Diagnosed patients experience a profound reduction of strength and dexterity hindering all activities of daily living. For a majority of the aforementioned shoulder, elbow, and hand/wrist arthropathies and tendinopathies, no curative treatments exist. Standard management utilizes conservative measures to minimize pain and improve function. These non-surgical treatments include physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs), orthosis, occupational protective equipment, and intra-articular injections.

Corticosteroid injections have been well investigated as a modality of pain control and improved function in large joint OA, however, fewer studies with mixed results on the duration of symptomatic relief exist for OA or tendinopathy of the smaller structures of the upper extremities. Furthermore, intra-articular corticosteroid injections are not without side effects. Adverse effects such as intra-articular infection, intra-articular calcification, skin atrophy, hypopigmentation, and tendinopathy have been reported.

NSAIDs, such as ketorolac, are widely used in OA to provide analgesia and reduce the underlying inflammatory process. The literature demonstrates that intra-articular NSAID injections are effective in reducing pain and functional disability in patients with knee and hip OA, however, randomized controlled trials involving the upper extremity are lacking. The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common shoulder, elbow, hand, and wrist tendinopathy or arthropathy.

Conditions

Osteoarthritis; Tendinopathy; Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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

Triamcinolone is a corticosteroid that decreases the inflammatory process by inhibiting the release of arachidonic acid from phospholipids.

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

Other Intervention Names

Triamcinolone; Ketoralac

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)].

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Association for Hand Surgery: AAHS

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Paul A Ghareeb, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul A. Ghareeb, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Amanda L Dempsey

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Orthopaedic and Spine Center

Atlanta, Georgia, United States

Site Status: RECRUITING

12 Executive Park Drive

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University Orthopaedic and Spine Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul A. Ghareeb, MD

Role: CONTACT

paul.ghareeb@emory.edu

404-778-3350

Facility Contacts

Paul A. Ghareeb, MD

Role: primary

paul.ghareeb@emory.edu

(404) 778-3350

Amanda L Demsey, MD

Role: primary

amanda.l.dempsey@emory.edu

(404) 778-6381

Paul A. Ghareeb, MD

Role: primary

paul.ghareeb@emory.edu

(404) 778-3350

Paul A. Ghareeb, MD

Role: primary

paul.ghareeb@emory.edu

404-778-3350

Other Identifiers

STUDY00003892

Identifier Type: -

Identifier Source: org_study_id