OsteoarthritisPhase 4NCT05292339
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
A Phase 4 study testing Triamcinolone injection to the shoulder, elbow, wrist, or hand and Ketorolac injection to the shoulder, elbow, wrist, or hand in people with Osteoarthritis and Tendinopathy, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Tendinopathy, Arthropathy
- What is being tested?
- Triamcinolone injection to the shoulder, elbow, wrist, or hand and Ketorolac injection to the shoulder, elbow, wrist, or hand
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Jan 2023to Jul 2027
- Phase
- Phase 4
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)].
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
Paul A. Ghareeb, MD, (404) 778-3350, paul.ghareeb@emory.edu
- Recruiting
Emory University Orthopaedic and Spine Center
Atlanta, Georgia, 30324
Amanda L Demsey, MD, (404) 778-6381, amanda.l.dempsey@emory.edu
- Recruiting
12 Executive Park Drive
Atlanta, Georgia, 30329
Paul A. Ghareeb, MD, (404) 778-3350, paul.ghareeb@emory.edu
- Recruiting
Emory University Orthopaedic and Spine Hospital
Atlanta, Georgia, 30329
Paul A. Ghareeb, MD, 404-778-3350, paul.ghareeb@emory.edu
About this study
Official title: Single Blind RCT to Evaluate the Effect of Ketorolac in Upper Extremity Tendinopathy and Arthropathy
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.
Read the 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
- Being tested
- Triamcinolone injection to the shoulder, elbow, wrist, or hand, Ketorolac injection to the shoulder, elbow, wrist, or hand
- Keywords
- First Carpometacarpal Joint, Ketoralac, metacarpophalangeal joint osteoarthritis, trigger finger, De Quervain's tenosynovitis, radiocarpal osteoarthritis, Triamcinolone, Upper extremity
- Medical subject headings
- Osteoarthritis, Tendinopathy, Joint Diseases, Trigger Finger Disorder, De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone injection to the shoulder, elbow, wrist, or handDrug
Also called Triamcinolone
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 handDrug
Also called Ketoralac
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ketorolac injection to the shoulder, elbow, wrist, or hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 6 weeks, 24 weeks
Secondary outcomes (5)
Changes in the patient-Reported Outcomes Measurement Information System (PROMIS)
The Upper Extremity Patient-Reported Outcomes Measurement Information System (PROMIS) is a patient outcomes questionnaire that will be completed by the study participant at every visit. Questions pertaining to pain interference subjective score (series of questions pertaining to different aspects of daily living: e.g. How much did the pain interfere with your day-to-day activities? Rated from "Not at all" to "Very much".
Measured: Baseline, 6 weeks, 24 weeks
Changes in Hand subjectivity value
Participants will provide ratings of their subjective hand function from 0 to 100
Measured: Baseline, 6 weeks, 24 weeks
Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment
The Quick DASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. It is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high-performance sport/music or work modules (four items, scored 1-5).
Measured: Baseline, 6 weeks, 24 weeks
Changes in Grip Strength
All strength measures will be evaluated using a handgrip and key pinch dynamometer. Patients will be instructed to position the upper arm vertically with the elbow flexed at 90 degrees and the forearm and wrist in a neutral position. For grip strength, the patient will be instructed to squeeze the handle of the dynamometer as hard as possible and the force will be measured and recorded.
Measured: Baseline, 6 weeks, 24 weeks
Changes in Key Pinch
All strength measures will be evaluated using a handgrip and key pinch dynamometer. Patients will be instructed to position the upper arm vertically with the elbow flexed at 90 degrees and the forearm and wrist in a neutral position. For assessment of key pinch strength, the patient will be instructed to squeeze the thumb digit pad against the lateral aspect of the proximal interphalangeal joint of the index finger.
Measured: Baseline, 6 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start31 Jan 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for Hand Surgery: AAHS
- Responsible party
- Principal investigator, Paul A Ghareeb, MD, Emory University
- Investigators
- Paul A. Ghareeb, MD, Principal investigator, Emory UniversityAmanda L Dempsey, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292339
- Sponsor's protocol ID
- STUDY00003892
- Other IDs
- 2025P013471
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No