xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992883</url>
    </required_header>
    <id_info>
      <org_study_id>22-005275</org_study_id>
      <nct_id>NCT05992883</nct_id>
    </id_info>
    <brief_title>NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis</brief_title>
    <official_title>NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Researchers are trying to compare two different types of intraarticular injections&#xD;
        (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb&#xD;
        arthritis. One injection is ketorolac (an NSAID) and the other is triamcinolone (a&#xD;
        corticosteroid).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cartilage degeneration resulting in osteoarthritis is the most common and costly&#xD;
        musculoskeletal disorder in the United States, with basilar thumb arthritis being one of the&#xD;
        most common manifestations of this disease. Despite its prevalence and previous research on&#xD;
        treatments for the disease, there is a dearth of efficacious and low-cost interventions for&#xD;
        trapeziometacarpal arthritis. Of these nonoperative interventions, intraarticular&#xD;
        corticosteroid injections are the most popular and have the most evidence indicating their&#xD;
        benefit. However, long-term use of corticosteroids has a well-established degenerative effect&#xD;
        that is counterproductive to preserving cartilage and bone of the CMC joint. Novel,&#xD;
        disease-modifying osteoarthritis treatments such as platelet rich plasma and human&#xD;
        recombinant bone morphogenic protein 7, among others, are alternative options for patients.&#xD;
        Many of these are currently in advanced development, but to date none have achieved FDA&#xD;
        approval, and all are significantly more expensive and have limited availability compared to&#xD;
        intraarticular corticosteroids.&#xD;
  &#xD;
        Although used infrequently, non-steroidal anti-inflammatory drugs (NSAIDs) are another&#xD;
        modality of nonoperative intervention for basilar thumb arthritis. Intraarticular injections&#xD;
        of NSAIDs have demonstrated success in alleviating the symptoms of primary arthritis in the&#xD;
        hip and knee without concern of systemic side effects compared to oral NSAID use.&#xD;
        Additionally, injectable NSAIDs are significantly more cost-effective compared to other&#xD;
        injectables and do not have the chondrotoxic profile of corticosteroids. However, there are&#xD;
        few studies directly comparing intraarticular NSAID use to other injectable therapies.&#xD;
  &#xD;
        Given the potential clinical and economic benefits of injectable NSAID therapy, we propose a&#xD;
        clinical trial investigation examining the efficacy of intraarticular ketorolac versus&#xD;
        intraarticular triamcinolone in treating symptoms of moderate to advanced primary&#xD;
        osteoarthritis of the basilar thumb. The prospect of successfully alleviating symptoms of&#xD;
        joint degeneration without propagating the progression of disease would be invaluable to the&#xD;
        thousands of patients in the Mayo Clinic system and elsewhere afflicted with basilar thumb&#xD;
        arthritis without the means or ability to pursue stem cell therapeutics or more definitive,&#xD;
        operative intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This trial will be a single center, comparative, randomized (1:1 ratio), prospective, double-blind trial with two groups evaluated concurrently. One group will be given triamcinolone injections while the second, experimental group will receive ketorolac injections.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>After enrollment and completion of the initial clinical evaluation, patients will undergo the injection procedure while blinded to the medication they receive. The injecting physician will also be blinded to the medication being administered.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS) of Pain</measure>
      <time_frame>At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.</time_frame>
      <description>Patient-reported VAS score with both motion and rest of the CMC joint.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Michigan Hand Outcomes Questionnaire (MHQ)</measure>
      <time_frame>At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.</time_frame>
      <description>Patient-reported MHQ score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Grip Strength</measure>
      <time_frame>At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.</time_frame>
      <description>Grip strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apposition Strength</measure>
      <time_frame>At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.</time_frame>
      <description>Apposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opposition Strength</measure>
      <time_frame>At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.</time_frame>
      <description>Opposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Thumb Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Non-steroidal anti-inflammatory drug (NSAID)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Corticosteroid</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketorolac</intervention_name>
      <description>Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).</description>
      <arm_group_label>Non-steroidal anti-inflammatory drug (NSAID)</arm_group_label>
      <other_name>Toradol</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Triamcinolone</intervention_name>
      <description>Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).</description>
      <arm_group_label>Corticosteroid</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt; 40 years of age&#xD;
  &#xD;
            -  Pain at the thumb base brought on by direct pressure (grind test) and with movement&#xD;
  &#xD;
            -  Pain resistant to previous conservative management with oral analgesics, NSAIDs,&#xD;
               icing, and splinting&#xD;
  &#xD;
            -  Radiological observation indicative of arthritis based on the Eaton-Littler&#xD;
               classification system (stages 1 through 4)&#xD;
  &#xD;
            -  Patient could understand the protocol and signed the informed consent&#xD;
  &#xD;
            -  Patient was covered by health insurance&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known allergy to either of the treatment products&#xD;
  &#xD;
            -  Patient's analgesic treatment regimen was modified within four weeks before trial&#xD;
               inclusion&#xD;
  &#xD;
            -  Scaphoid-trapezial arthritis present&#xD;
  &#xD;
            -  Localized or systemic infection&#xD;
  &#xD;
            -  Previous thumb surgery on study thumb&#xD;
  &#xD;
            -  Previous thumb injury on study thumb&#xD;
  &#xD;
            -  Patient with inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)&#xD;
  &#xD;
            -  Severe and/or uncontrolled hypertension&#xD;
  &#xD;
            -  De Quervain tendinopathy present&#xD;
  &#xD;
            -  Previous injections to the trapeziometacarpal joint on study thumb&#xD;
  &#xD;
            -  Uncontrolled diabetes&#xD;
  &#xD;
            -  Pregnant or lactating females&#xD;
  &#xD;
            -  Immunodeficient patients&#xD;
  &#xD;
            -  Patients that are currently using nicotine products, or who have quit in the last 12&#xD;
               months&#xD;
  &#xD;
            -  Patients under guardianship, curatorship, or are otherwise not self-sufficient&#xD;
  &#xD;
            -  Patients participating in another clinical research trial which interferes with this&#xD;
               study protocol or outcomes&#xD;
  &#xD;
            -  Patients unable to follow the protocol in the investigators' judgement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marco Rizzo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lindsey Hobbs</last_name>
      <phone>15072262669</phone>
      <email>hobbs.lindsey@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lindsey Hobbs</last_name>
        <phone>507-226-2669</phone>
        <email>hobbs.lindsey@mayo.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>Marco Rizzo</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Injection</keyword>
    <keyword>Steroid</keyword>
    <keyword>NSAID</keyword>
    <keyword>Thumb Arthritis</keyword>
    <keyword>CMC Arthritis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triamcinolone</mesh_term>
      <mesh_term>Ketorolac</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992883
  org study id: 22-005275
  nct id: NCT05992883
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The Researchers are trying to compare two different types of intraarticular injections
        (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb
        arthritis. One injection is ketorolac (an NSAID) and the other is triamcinolone (a
        corticosteroid).
  Cartilage degeneration resulting in osteoarthritis is the most common and costly
        musculoskeletal disorder in the United States, with basilar thumb arthritis being one of the
        most common manifestations of this disease. Despite its prevalence and previous research on
        treatments for the disease, there is a dearth of efficacious and low-cost interventions for
        trapeziometacarpal arthritis. Of these nonoperative interventions, intraarticular
        corticosteroid injections are the most popular and have the most evidence indicating their
        benefit. However, long-term use of corticosteroids has a well-established degenerative effect
        that is counterproductive to preserving cartilage and bone of the CMC joint. Novel,
        disease-modifying osteoarthritis treatments such as platelet rich plasma and human
        recombinant bone morphogenic protein 7, among others, are alternative options for patients.
        Many of these are currently in advanced development, but to date none have achieved FDA
        approval, and all are significantly more expensive and have limited availability compared to
        intraarticular corticosteroids.
  
        Although used infrequently, non-steroidal anti-inflammatory drugs (NSAIDs) are another
        modality of nonoperative intervention for basilar thumb arthritis. Intraarticular injections
        of NSAIDs have demonstrated success in alleviating the symptoms of primary arthritis in the
        hip and knee without concern of systemic side effects compared to oral NSAID use.
        Additionally, injectable NSAIDs are significantly more cost-effective compared to other
        injectables and do not have the chondrotoxic profile of corticosteroids. However, there are
        few studies directly comparing intraarticular NSAID use to other injectable therapies.
  
        Given the potential clinical and economic benefits of injectable NSAID therapy, we propose a
        clinical trial investigation examining the efficacy of intraarticular ketorolac versus
        intraarticular triamcinolone in treating symptoms of moderate to advanced primary
        osteoarthritis of the basilar thumb. The prospect of successfully alleviating symptoms of
        joint degeneration without propagating the progression of disease would be invaluable to the
        thousands of patients in the Mayo Clinic system and elsewhere afflicted with basilar thumb
        arthritis without the means or ability to pursue stem cell therapeutics or more definitive,
        operative intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This trial will be a single center, comparative, randomized (1:1 ratio), prospective, double-blind trial with two groups evaluated concurrently. One group will be given triamcinolone injections while the second, experimental group will receive ketorolac injections.
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: After enrollment and completion of the initial clinical evaluation, patients will undergo the injection procedure while blinded to the medication they receive. The injecting physician will also be blinded to the medication being administered.
  measure: Visual Analogue Scale (VAS) of Pain
  time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
  description: Patient-reported VAS score with both motion and rest of the CMC joint.
  measure: Michigan Hand Outcomes Questionnaire (MHQ)
  time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
  description: Patient-reported MHQ score
  measure: Grip Strength
  time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
  description: Grip strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.
  measure: Apposition Strength
  time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
  description: Apposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.
  measure: Opposition Strength
  time frame: At initial evaluation and then 1 month, 3 months, 6 months, and 1 year post-injection.
  description: Opposition strength measured with a dynamometer, reported in kilograms. Measurements will be performed three times, with the mean value of the three repetitions used as the reported value.
  arm group label: Non-steroidal anti-inflammatory drug (NSAID)
  arm group type: Experimental
  description: Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
  arm group label: Corticosteroid
  arm group type: Active Comparator
  description: Patients will proceed to their injection appointment within 4 weeks of their initial evaluation. At the injection appointment, patients will receive an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).
  intervention type: Drug
  intervention name: Ketorolac
  description: Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
  arm group label: Non-steroidal anti-inflammatory drug (NSAID)
  other name: Toradol
  intervention type: Drug
  intervention name: Triamcinolone
  description: Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).
  arm group label: Corticosteroid
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marco Rizzo, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Lindsey Hobbs
  phone: 15072262669
  email: hobbs.lindsey@mayo.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: Marco Rizzo
  investigator title: Principal Investigator
  mesh term: Arthritis
  mesh term: Triamcinolone
  mesh term: Ketorolac
  sharing ipd: No