ClinicalTrials.gg
RecruitingNCT05292339Updated Sep 3, 2026

Ketorolac in Upper Extremity Tendinopathy and Arthropathy

A Phase 4 interventional study of Triamcinolone injection to the shoulder, elbow, wrist, or hand and Ketorolac injection to the shoulder, elbow, wrist, or hand in Osteoarthritis, Tendinopathy and Arthropathy, sponsored by Emory University. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Emory University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Osteoarthritis
  • Tendinopathy
  • Arthropathy

Keywords

  • First Carpometacarpal Joint
  • Ketoralac
  • metacarpophalangeal joint osteoarthritis
  • trigger finger
  • De Quervain's tenosynovitis
  • radiocarpal osteoarthritis
  • Triamcinolone
  • Upper extremity
03

In context

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.

This study's planned enrollment of 160 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.

Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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)].
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
160 participants (estimated)

Study 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.

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

  • 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.

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

Interventions

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

    Also known as: Triamcinolone

  • DrugKetorolac 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.

    Also known as: Ketoralac

06

What researchers measure

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).

    Time frame: Baseline, 6 weeks, 24 weeks

Secondary outcomes

  1. 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".

    Time frame: Baseline, 6 weeks, 24 weeks

  2. Changes in Hand subjectivity value

    Participants will provide ratings of their subjective hand function from 0 to 100

    Time frame: Baseline, 6 weeks, 24 weeks

  3. 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).

    Time frame: Baseline, 6 weeks, 24 weeks

  4. 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.

    Time frame: Baseline, 6 weeks, 24 weeks

  5. 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.

    Time frame: Baseline, 6 weeks, 24 weeks

07

Study locations

4 of 4 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05292339
Lead sponsor
Emory University
Collaborators
American Association for Hand Surgery: AAHS
Responsible party
Paul A Ghareeb, MD (Assistant Professor, Emory University) — Principal investigator
First posted
Mar 23, 2022
Start date
Jan 31, 2023
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Paul A. Ghareeb, MD
Contact
paul.ghareeb@emory.edu
404-778-3350
Paul A. Ghareeb, MD
principal investigator · Emory University
Amanda L Dempsey
principal investigator · Emory University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Triamcinolone

Start the discussion