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/NCT06039345</url>
    </required_header>
    <id_info>
      <org_study_id>159158</org_study_id>
      <nct_id>NCT06039345</nct_id>
    </id_info>
    <brief_title>Shoulder RFA Pilot Study</brief_title>
    <official_title>The Effectiveness of Shoulder Terminal Sensory Articular Nerve Radiofrequency Ablation for Non-surgical Refractory Shoulder Pain Due to Rotator Cuff Pathology and Osteoarthritis; A Prospective Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Utah</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Through this prospective, single-arm cohort pilot study, we plan to explore the safety and&#xD;
        effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative&#xD;
        chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be one of the first collaborative prospective, single-arm cohort using a&#xD;
        standardized selection protocol and comprehensive SRFA protocol to treat chronic, refractory&#xD;
        shoulder pain due radiographically confirmed glenohumeral joint OA with or without RTC pain,&#xD;
        in patients deemed non-surgical candidates by a board-certified orthopedic shoulder surgeon.&#xD;
        Upon completing the proposed research, we expect our contribution to fill the knowledge gap&#xD;
        on whether SRFA is a potentially viable treatment option for this patient population. This&#xD;
        contribution is expected to be substantial because SRFA may be a safe and effective treatment&#xD;
        option for many people suffering shoulder pain and debility who are sub-optimal surgical&#xD;
        candidates and have historically either been undertreated to have less than ideal treatments&#xD;
        options, including opioid-based pain management in particular.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA</measure>
      <time_frame>1, 3, 6 and 12 months</time_frame>
      <description>Pain reduction will be measured by calculating the proportion of participants who experienced ≥50% reduction of their shoulder pain on the Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Myotomal strength at 1, 3, 6 and 12 months after SRFA</measure>
      <time_frame>1, 3, 6 and 12 months after SRFA</time_frame>
      <description>We will calculate the proportion of participants who experience a minimal clinically important difference (MCID) in shoulder abduction, elbow flexion, wrist extension, elbow extension and hand grip measured by dynamometer after SRFA. We will do this by calculating the proportion of participants who experience ≥20% change (MCID) in myotomal strength at 1, 3, 6 and 12 months after SRFA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA</measure>
      <time_frame>1, 3, 6 and 12 months after SRFA</time_frame>
      <description>We will use the validated American Shoulder and Elbow Surgeons Score (ASES) questionnaire to calculate the proportion of participants who experience an MCID on ASES (defined as a score of ≥ 7) at 1,3, 6 and 12 months after SRFA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Change (PGIC) at 1,3, 6 and 12 months after SRFA</measure>
      <time_frame>1, 3, 6 and 12 months after SRFA</time_frame>
      <description>We will use the validated Patient Global Impression of Change (PGIC) questionnaire to calculate the proportion of participants who experience an MCID on PGIC (defined as a score of ≥ 5) at 1,3, 6 and 12 months after SRFA.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Shoulder Pain</condition>
    <condition>Rotator Cuff Injuries</condition>
    <eligibility>
      <study_pop>
        <textblock>
          We will explore the effectiveness of SRFA to reduce chronic shoulder pain in 10&#xD;
          participants who were deemed non-surgical candidates by an orthopedic surgeon and who&#xD;
          experienced ≥80% pain relief after a single shoulder joint anesthetic block.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥50 years old capable of understanding and providing consent in English, and capable&#xD;
               of complying with the outcome instruments used&#xD;
  &#xD;
            2. ≥3 months of shoulder pain refractory to conventional treatment (i.e., physiotherapy,&#xD;
               medication, steroid injections)&#xD;
  &#xD;
            3. Persistent shoulder pain ≥ 4/10 in intensity on a 7-day average&#xD;
  &#xD;
            4. Shoulder pain refractory to conventional treatment (i.e., physical therapy, oral&#xD;
               analgesics, steroid injection)&#xD;
  &#xD;
            5. Prior consultation with a board-certified orthopedic shoulder surgeon, deemed a&#xD;
               non-surgical candidate for the primary diagnosis of glenohumeral joint pain +/-&#xD;
               rotator cuff pain&#xD;
  &#xD;
            6. ≥80% pain relief for at least 30 minutes after a single fluoroscopically-guided block&#xD;
               of the sensory branches of the SN, AN, and LPN with 0.5 mL of lidocaine at each nerve&#xD;
  &#xD;
            7. Scheduled for procedure of interest&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Infection&#xD;
  &#xD;
            2. Allergy to any medication needed to participate in this study&#xD;
  &#xD;
            3. Previous partial/total/reverse shoulder arthroplasty. Participants with a history of&#xD;
               RTC repair will not be excluded.&#xD;
  &#xD;
            4. Neurologic disorders including radiculopathy, connective tissue/inflammatory joint&#xD;
               disease/widespread soft tissue pain disorder&#xD;
  &#xD;
            5. Severe, uncontrolled psychiatric disorder requiring hospitalization within 6 months&#xD;
  &#xD;
            6. Intraarticular or subacromial injection to the study shoulder within 3 months before&#xD;
               C-SRFA&#xD;
  &#xD;
            7. Uncontrolled bleeding diathesis&#xD;
  &#xD;
            8. Pregnancy&#xD;
  &#xD;
            9. Pacemaker, neurostimulator, or other implanted device potentially sensitive to RF&#xD;
               energy&#xD;
  &#xD;
           10. Active Worker's compensation claim, litigation, or other possible reason for secondary&#xD;
               gain.&#xD;
  &#xD;
           11. Prior shoulder radiofrequency ablation&#xD;
  &#xD;
           12. Daily opioid use&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Amanda Cooper, PhD</last_name>
      <phone>985-516-2225</phone>
      <email>amanda.cooper@utah.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Taylor Burnham, DO</last_name>
      <phone>801-587-5488</phone>
      <email>taylor.burnham@hsc.utah.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Utah Farmington Health Center</name>
        <address>
          <city>Farmington</city>
          <state>Utah</state>
          <zip>84025</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amanda Cooper, PhD</last_name>
        <phone>985-516-2225</phone>
        <email>amanda.cooper@utah.edu</email>
      </contact>
      <contact_backup>
        <last_name>Taylor Burnham, DO</last_name>
        <phone>801-587-5488</phone>
        <email>taylor.burnham@hsc.utah.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University of Utah Orthopaedic Center</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amanda Cooper, PhD</last_name>
        <phone>985-516-2225</phone>
        <email>amanda.cooper@utah.edu</email>
      </contact>
      <contact_backup>
        <last_name>Taylor Burnham, DO</last_name>
        <phone>801-587-5488</phone>
        <email>taylor.burnham@hsc.utah.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Taylor Burnham, DO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Utah South Jordan Health Center</name>
        <address>
          <city>South Jordan</city>
          <state>Utah</state>
          <zip>84009</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amanda Cooper, PhD</last_name>
        <phone>985-516-2225</phone>
        <email>amanda.cooper@utah.edu</email>
      </contact>
      <contact_backup>
        <last_name>Taylor Burnham, DO</last_name>
        <phone>801-587-5488</phone>
        <email>taylor.burnham@hsc.utah.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. doi: 10.1097/00002508-199309000-00004.</citation>
      <PMID>8219517</PMID>
    </reference>
    <reference>
      <citation>Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB. Shoulder disorders in the elderly: a community survey. Arthritis Rheum. 1991 Jun;34(6):766-9. doi: 10.1002/art.1780340619.</citation>
      <PMID>2053923</PMID>
    </reference>
    <reference>
      <citation>Allander E. Prevalence, incidence, and remission rates of some common rheumatic diseases or syndromes. Scand J Rheumatol. 1974;3(3):145-53. doi: 10.3109/03009747409097141. No abstract available.</citation>
      <PMID>4428194</PMID>
    </reference>
    <reference>
      <citation>Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.</citation>
      <PMID>15163107</PMID>
    </reference>
    <reference>
      <citation>Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.</citation>
      <PMID>22325050</PMID>
    </reference>
    <reference>
      <citation>Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652.</citation>
      <PMID>28786899</PMID>
    </reference>
    <reference>
      <citation>Eckmann MS, Johal J, Bickelhaupt B, McCormick Z, Abdallah RT, Menzies R, Soliman S, Nagpal AS. Terminal Sensory Articular Nerve Radiofrequency Ablation for the Treatment of Chronic Intractable Shoulder Pain: A Novel Technique and Case Series. Pain Med. 2020 Apr 1;21(4):868-871. doi: 10.1093/pm/pnz335. No abstract available.</citation>
      <PMID>31851366</PMID>
    </reference>
    <reference>
      <citation>Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.</citation>
      <PMID>9014953</PMID>
    </reference>
    <reference>
      <citation>Bohannon RW. Grip strength impairments among older adults receiving physical therapy in a home-care setting. Percept Mot Skills. 2010 Dec;111(3):761-4. doi: 10.2466/03.10.15.PMS.111.6.761-764.</citation>
      <PMID>21319615</PMID>
    </reference>
    <reference>
      <citation>Hayes K, Walton JR, Szomor ZL, Murrell GA. Reliability of 3 methods for assessing shoulder strength. J Shoulder Elbow Surg. 2002 Jan-Feb;11(1):33-9. doi: 10.1067/mse.2002.119852.</citation>
      <PMID>11845146</PMID>
    </reference>
    <reference>
      <citation>Kolber MJ, Beekhuizen K, Cheng MS, Fiebert IM. The reliability of hand-held dynamometry in measuring isometric strength of the shoulder internal and external rotator musculature using a stabilization device. Physiother Theory Pract. 2007 Mar-Apr;23(2):119-24. doi: 10.1080/09593980701213032.</citation>
      <PMID>17530541</PMID>
    </reference>
    <reference>
      <citation>Awatani T, Mori S, Shinohara J, Koshiba H, Nariai M, Tatsumi Y, Nagata A, Morikita I. Same-session and between-day intra-rater reliability of hand-held dynamometer measurements of isometric shoulder extensor strength. J Phys Ther Sci. 2016 Mar;28(3):936-9. doi: 10.1589/jpts.28.936. Epub 2016 Mar 31.</citation>
      <PMID>27134388</PMID>
    </reference>
    <reference>
      <citation>Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. doi: 10.1067/mse.2002.127096.</citation>
      <PMID>12469084</PMID>
    </reference>
    <reference>
      <citation>Jones IA, Togashi R, Heckmann N, Vangsness CT Jr. Minimal clinically important difference (MCID) for patient-reported shoulder outcomes. J Shoulder Elbow Surg. 2020 Jul;29(7):1484-1492. doi: 10.1016/j.jse.2019.12.033. Epub 2020 Apr 3.</citation>
      <PMID>32249146</PMID>
    </reference>
    <reference>
      <citation>Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.</citation>
      <PMID>34308957</PMID>
    </reference>
    <reference>
      <citation>Conger A, Cushman DM, Walker K, Petersen R, Walega DR, Kendall R, McCormick ZL. A Novel Technical Protocol for Improved Capture of the Genicular Nerves by Radiofrequency Ablation. Pain Med. 2019 Nov 1;20(11):2208-2212. doi: 10.1093/pm/pnz124.</citation>
      <PMID>31131850</PMID>
    </reference>
    <reference>
      <citation>Koshi E, Cheney CW, Sperry BP, Conger A, McCormick ZL. Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. Pain Med. 2020 Dec 25;21(12):3344-3349. doi: 10.1093/pm/pnaa204.</citation>
      <PMID>32984887</PMID>
    </reference>
    <reference>
      <citation>McCormick ZL, Cohen SP, Walega DR, Kohan L. Technical considerations for genicular nerve radiofrequency ablation: optimizing outcomes. Reg Anesth Pain Med. 2021 Jun;46(6):518-523. doi: 10.1136/rapm-2020-102117. Epub 2021 Jan 22.</citation>
      <PMID>33483425</PMID>
    </reference>
    <reference>
      <citation>McCormick ZL, Reddy R, Korn M, Dayanim D, Syed RH, Bhave M, Zhukalin M, Choxi S, Ebrahimi A, Kendall MC, McCarthy RJ, Khan D, Nagpal G, Bouffard K, Walega DR. A Prospective Randomized Trial of Prognostic Genicular Nerve Blocks to Determine the Predictive Value for the Outcome of Cooled Radiofrequency Ablation for Chronic Knee Pain Due to Osteoarthritis. Pain Med. 2018 Aug 1;19(8):1628-1638. doi: 10.1093/pm/pnx286.</citation>
      <PMID>29300971</PMID>
    </reference>
    <reference>
      <citation>Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.</citation>
      <PMID>31407791</PMID>
    </reference>
    <reference>
      <citation>Tran A, Reiter DA, Fritz J, Cruz AR, Reimer NB, Lamplot JD, Gonzalez FM. Pilot study for treatment of symptomatic shoulder arthritis utilizing cooled radiofrequency ablation: a novel technique. Skeletal Radiol. 2022 Aug;51(8):1563-1570. doi: 10.1007/s00256-022-03993-y. Epub 2022 Jan 14.</citation>
      <PMID>35029737</PMID>
    </reference>
    <reference>
      <citation>Eckmann MS, McCormick ZL, Beal C, Julia J, Cheney CW, Nagpal AS. Putting Our Shoulder to the Wheel: Current Understanding and Gaps in Nerve Ablation for Chronic Shoulder Pain. Pain Med. 2021 Jul 25;22(Suppl 1):S2-S8. doi: 10.1093/pm/pnab152.</citation>
      <PMID>34308959</PMID>
    </reference>
    <reference>
      <citation>Bogduk N. On diagnostic blocks for lumbar zygapophysial joint pain. F1000 Med Rep. 2010 Aug 9;2:57. doi: 10.3410/M2-57.</citation>
      <PMID>21173871</PMID>
    </reference>
    <reference>
      <citation>Schneider BJ, Joshi M, Ehsanian R, et al. Patient-perceived duration of effect of lidocaine and bupivacaine following diagnostic medial branch blocks; a multicenter study. Interventional Pain Medicine. 2022;1(2):100083. doi:10.1016/j.inpm.2022.100083</citation>
    </reference>
    <reference>
      <citation>Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis - PMC. Accessed June 22, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925407/</citation>
    </reference>
    <reference>
      <citation>Diagnosis and treatment of incomplete rotator cuff tears - PubMed. Accessed June 22, 2022. https://pubmed.ncbi.nlm.nih.gov/2182260/</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Utah</investigator_affiliation>
      <investigator_full_name>Taylor Burnham</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>shoulder radiofrequency ablation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shoulder Pain</mesh_term>
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_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/NCT06039345
  org study id: 159158
  nct id: NCT06039345
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Through this prospective, single-arm cohort pilot study, we plan to explore the safety and
        effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative
        chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears.
  This will be one of the first collaborative prospective, single-arm cohort using a
        standardized selection protocol and comprehensive SRFA protocol to treat chronic, refractory
        shoulder pain due radiographically confirmed glenohumeral joint OA with or without RTC pain,
        in patients deemed non-surgical candidates by a board-certified orthopedic shoulder surgeon.
        Upon completing the proposed research, we expect our contribution to fill the knowledge gap
        on whether SRFA is a potentially viable treatment option for this patient population. This
        contribution is expected to be substantial because SRFA may be a safe and effective treatment
        option for many people suffering shoulder pain and debility who are sub-optimal surgical
        candidates and have historically either been undertreated to have less than ideal treatments
        options, including opioid-based pain management in particular.
  observational model: Case-Only
  time perspective: Prospective
  measure: Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA
  time frame: 1, 3, 6 and 12 months
  description: Pain reduction will be measured by calculating the proportion of participants who experienced ≥50% reduction of their shoulder pain on the Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA.
  measure: Myotomal strength at 1, 3, 6 and 12 months after SRFA
  time frame: 1, 3, 6 and 12 months after SRFA
  description: We will calculate the proportion of participants who experience a minimal clinically important difference (MCID) in shoulder abduction, elbow flexion, wrist extension, elbow extension and hand grip measured by dynamometer after SRFA. We will do this by calculating the proportion of participants who experience ≥20% change (MCID) in myotomal strength at 1, 3, 6 and 12 months after SRFA.
  measure: American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA
  time frame: 1, 3, 6 and 12 months after SRFA
  description: We will use the validated American Shoulder and Elbow Surgeons Score (ASES) questionnaire to calculate the proportion of participants who experience an MCID on ASES (defined as a score of ≥ 7) at 1,3, 6 and 12 months after SRFA.
  measure: Patient Global Impression of Change (PGIC) at 1,3, 6 and 12 months after SRFA
  time frame: 1, 3, 6 and 12 months after SRFA
  description: We will use the validated Patient Global Impression of Change (PGIC) questionnaire to calculate the proportion of participants who experience an MCID on PGIC (defined as a score of ≥ 5) at 1,3, 6 and 12 months after SRFA.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amanda Cooper, PhD
  phone: 985-516-2225
  email: amanda.cooper@utah.edu
  last name: Taylor Burnham, DO
  phone: 801-587-5488
  email: taylor.burnham@hsc.utah.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  citation: Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. doi: 10.1097/00002508-199309000-00004.
  PMID: 8219517
  citation: Chard MD, Hazleman R, Hazleman BL, King RH, Reiss BB. Shoulder disorders in the elderly: a community survey. Arthritis Rheum. 1991 Jun;34(6):766-9. doi: 10.1002/art.1780340619.
  PMID: 2053923
  citation: Allander E. Prevalence, incidence, and remission rates of some common rheumatic diseases or syndromes. Scand J Rheumatol. 1974;3(3):145-53. doi: 10.3109/03009747409097141. No abstract available.
  PMID: 4428194
  citation: Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
  PMID: 15163107
  citation: Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.
  PMID: 22325050
  citation: Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652.
  PMID: 28786899
  citation: Eckmann MS, Johal J, Bickelhaupt B, McCormick Z, Abdallah RT, Menzies R, Soliman S, Nagpal AS. Terminal Sensory Articular Nerve Radiofrequency Ablation for the Treatment of Chronic Intractable Shoulder Pain: A Novel Technique and Case Series. Pain Med. 2020 Apr 1;21(4):868-871. doi: 10.1093/pm/pnz335. No abstract available.
  PMID: 31851366
  citation: Bohannon RW. Reference values for extremity muscle strength obtained by hand-held dynamometry from adults aged 20 to 79 years. Arch Phys Med Rehabil. 1997 Jan;78(1):26-32. doi: 10.1016/s0003-9993(97)90005-8.
  PMID: 9014953
  citation: Bohannon RW. Grip strength impairments among older adults receiving physical therapy in a home-care setting. Percept Mot Skills. 2010 Dec;111(3):761-4. doi: 10.2466/03.10.15.PMS.111.6.761-764.
  PMID: 21319615
  citation: Hayes K, Walton JR, Szomor ZL, Murrell GA. Reliability of 3 methods for assessing shoulder strength. J Shoulder Elbow Surg. 2002 Jan-Feb;11(1):33-9. doi: 10.1067/mse.2002.119852.
  PMID: 11845146
  citation: Kolber MJ, Beekhuizen K, Cheng MS, Fiebert IM. The reliability of hand-held dynamometry in measuring isometric strength of the shoulder internal and external rotator musculature using a stabilization device. Physiother Theory Pract. 2007 Mar-Apr;23(2):119-24. doi: 10.1080/09593980701213032.
  PMID: 17530541
  citation: Awatani T, Mori S, Shinohara J, Koshiba H, Nariai M, Tatsumi Y, Nagata A, Morikita I. Same-session and between-day intra-rater reliability of hand-held dynamometer measurements of isometric shoulder extensor strength. J Phys Ther Sci. 2016 Mar;28(3):936-9. doi: 10.1589/jpts.28.936. Epub 2016 Mar 31.
  PMID: 27134388
  citation: Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002 Nov-Dec;11(6):587-94. doi: 10.1067/mse.2002.127096.
  PMID: 12469084
  citation: Jones IA, Togashi R, Heckmann N, Vangsness CT Jr. Minimal clinically important difference (MCID) for patient-reported shoulder outcomes. J Shoulder Elbow Surg. 2020 Jul;29(7):1484-1492. doi: 10.1016/j.jse.2019.12.033. Epub 2020 Apr 3.
  PMID: 32249146
  citation: Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.
  PMID: 34308957
  citation: Conger A, Cushman DM, Walker K, Petersen R, Walega DR, Kendall R, McCormick ZL. A Novel Technical Protocol for Improved Capture of the Genicular Nerves by Radiofrequency Ablation. Pain Med. 2019 Nov 1;20(11):2208-2212. doi: 10.1093/pm/pnz124.
  PMID: 31131850
  citation: Koshi E, Cheney CW, Sperry BP, Conger A, McCormick ZL. Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series. Pain Med. 2020 Dec 25;21(12):3344-3349. doi: 10.1093/pm/pnaa204.
  PMID: 32984887
  citation: McCormick ZL, Cohen SP, Walega DR, Kohan L. Technical considerations for genicular nerve radiofrequency ablation: optimizing outcomes. Reg Anesth Pain Med. 2021 Jun;46(6):518-523. doi: 10.1136/rapm-2020-102117. Epub 2021 Jan 22.
  PMID: 33483425
  citation: McCormick ZL, Reddy R, Korn M, Dayanim D, Syed RH, Bhave M, Zhukalin M, Choxi S, Ebrahimi A, Kendall MC, McCarthy RJ, Khan D, Nagpal G, Bouffard K, Walega DR. A Prospective Randomized Trial of Prognostic Genicular Nerve Blocks to Determine the Predictive Value for the Outcome of Cooled Radiofrequency Ablation for Chronic Knee Pain Due to Osteoarthritis. Pain Med. 2018 Aug 1;19(8):1628-1638. doi: 10.1093/pm/pnx286.
  PMID: 29300971
  citation: Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.
  PMID: 31407791
  citation: Tran A, Reiter DA, Fritz J, Cruz AR, Reimer NB, Lamplot JD, Gonzalez FM. Pilot study for treatment of symptomatic shoulder arthritis utilizing cooled radiofrequency ablation: a novel technique. Skeletal Radiol. 2022 Aug;51(8):1563-1570. doi: 10.1007/s00256-022-03993-y. Epub 2022 Jan 14.
  PMID: 35029737
  citation: Eckmann MS, McCormick ZL, Beal C, Julia J, Cheney CW, Nagpal AS. Putting Our Shoulder to the Wheel: Current Understanding and Gaps in Nerve Ablation for Chronic Shoulder Pain. Pain Med. 2021 Jul 25;22(Suppl 1):S2-S8. doi: 10.1093/pm/pnab152.
  PMID: 34308959
  citation: Bogduk N. On diagnostic blocks for lumbar zygapophysial joint pain. F1000 Med Rep. 2010 Aug 9;2:57. doi: 10.3410/M2-57.
  PMID: 21173871
  citation: Schneider BJ, Joshi M, Ehsanian R, et al. Patient-perceived duration of effect of lidocaine and bupivacaine following diagnostic medial branch blocks; a multicenter study. Interventional Pain Medicine. 2022;1(2):100083. doi:10.1016/j.inpm.2022.100083
  citation: Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis - PMC. Accessed June 22, 2022. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4925407/
  citation: Diagnosis and treatment of incomplete rotator cuff tears - PubMed. Accessed June 22, 2022. https://pubmed.ncbi.nlm.nih.gov/2182260/
  responsible party type: Principal Investigator
  investigator affiliation: University of Utah
  investigator full name: Taylor Burnham
  investigator title: Assistant Professor
  mesh term: Shoulder Pain
  mesh term: Rotator Cuff Injuries
  sharing ipd: No