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Ketorolac in Hand and Wrist Tendinopathy and Arthropathy

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ClinicalTrials.gov Identifier: NCT05292339
Recruitment Status : Not yet recruiting
First Posted : March 23, 2022
Last Update Posted : December 1, 2022
Sponsor:
Collaborator:
American Association for Hand Surgery
Information provided by (Responsible Party):
Paul Ghareeb, Emory University

Brief Summary:

Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the 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 the hand and wrist.

The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common hand and wrist 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 in-person follow-up in regular intervals (4 weeks, 12 weeks, and 24 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 conservatively managed.


Condition or disease Intervention/treatment Phase
Osteoarthritis Tendinopathy Drug: Triamcinolone injection to the hand or wrist Drug: Ketorolac injection to the hand or wrist Phase 4

Detailed Description:

Osteoarthritis (OA) and inflammatory conditions of the tendons and joints of the hand and wrist are common yet disabling diseases. These pathologic processes are progressive and painful leading to significant impairments on 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 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 duration of symptomatic relief exist for OA or tendinopathy of the smaller structures of the hand/wrist. 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 hand and wrist are lacking. The goal of this study is to evaluate the efficacy of ketorolac and triamcinolone injections for common hand and wrist tendinopathy or arthropathy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Blind Randomized Controlled Trial to Evaluate the Effect of Ketorolac in Hand and Wrist Tendinopathy and Arthropathy.
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : October 2025


Arm Intervention/treatment
Active Comparator: Triamcinolone injection to the hand or wrist
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 hand or wrist
Triamcinolone is a corticosteroid that decreases the inflammatory process by inhibiting the release of arachidonic acid from phospholipids.
Other Name: Triamcinolone

Experimental: Ketorolac injection to the hand or wrist
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 hand or wrist
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.
Other Name: Ketoralac




Primary Outcome Measures :
  1. Changes in Visual Analog Scale (VAS) pain score [ Time Frame: Baseline, 6 weeks, 24 weeks ]
    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).


Secondary Outcome Measures :
  1. Changes in the patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, 6 weeks, 24 weeks ]
    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".

  2. Changes in Hand subjectivity value [ Time Frame: Baseline, 6 weeks, 24 weeks ]
    Participants will provide ratings of their subjective hand function from 0 to 100

  3. Changes in the quick disabilities-arm-shoulder-hand (DASH) assessment [ Time Frame: Baseline, 6 weeks, 24 weeks ]
    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).

  4. Changes in Grip Strength [ Time Frame: Baseline, 6 weeks, 24 weeks ]
    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.

  5. Changes in Key Pinch [ Time Frame: Baseline, 6 weeks, 24 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older,
  • symptomatic tendinopathy or arthropathy of the 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)].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05292339


Contacts
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Contact: Paul A. Ghareeb, MD 404-778-3350 paul.ghareeb@emory.edu

Locations
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United States, Georgia
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30308
Contact: Paul A. Ghareeb, MD    404-778-3350    paul.ghareeb@emory.edu   
Emory University Orthopaedic and Spine Center
Atlanta, Georgia, United States, 30324
Contact: Amanda L Demsey, MD    404-778-6381    amanda.l.dempsey@emory.edu   
12 Executive Park Drive
Atlanta, Georgia, United States, 30329
Contact: Paul A. Ghareeb, MD    404-778-3350    paul.ghareeb@emory.edu   
Emory University Orthopaedic and Spine Hospital
Atlanta, Georgia, United States, 30329
Contact: Paul A. Ghareeb, MD    404-778-3350    paul.ghareeb@emory.edu   
Sponsors and Collaborators
Emory University
American Association for Hand Surgery
Investigators
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Principal Investigator: Paul A. Ghareeb, MD Emory University
Principal Investigator: Amanda L Dempsey Emory University
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Responsible Party: Paul Ghareeb, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT05292339    
Other Study ID Numbers: STUDY00003892
First Posted: March 23, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Ghareeb, Emory University:
First Carpometacarpal Joint
Ketoralac
Additional relevant MeSH terms:
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Tendinopathy
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Ketorolac
Ketorolac Tromethamine
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors