Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Triamcinolone injection to the shoulder, elbow, wrist, or hand
DrugTriamcinolone 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
DrugKetorolac is a non-steroidal anti-inflammatory drug (NSAID) that reduces inflammation by inhibiting Cyclo-oxygenase (COX)-2 dependent prostaglandin release via the cyclooxygenase pathway.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Triamcinolone injection to the shoulder, elbow, wrist, or handActive comparator 1 intervention
Group B: Ketorolac injection to the shoulder, elbow, wrist, or handActive comparator 1 intervention
Trial outcomes
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 weeksSecondary 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 weeks2
Changes in Hand subjectivity value
Participants will provide ratings of their subjective hand function from 0 to 100
Time frame
Baseline, 6 weeks, 24 weeks3
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 weeks4
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
American Association for Hand Surgery: AAHS
Collaborator
Source ClinicalTrials.gov