<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/NCT04494698</url>
  </required_header>
  <id_info>
    <org_study_id>DuoThermChronic</org_study_id>
    <secondary_id>4R44DA049631</secondary_id>
    <nct_id>NCT04494698</nct_id>
  </id_info>
  <brief_title>Impact of DuoTherm on Opioid Use and Chronic Low Back Pain</brief_title>
  <official_title>Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Clinical Evaluation of DuoTherm for Opioid-Sparing in Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MMJ Labs LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sport and Spine Rehab Clinical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>MMJ Labs LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Active&#xD;
      Control&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 patients with chronic low back pain presenting for chiropractic and rehabilitation care&#xD;
      will be stratified by gender and randomized to one of two conditions: a pain relief belt&#xD;
      device incorporating multiple speeds of vibration and optional heat, cold, and pressure&#xD;
      delivered through a sculpted metal plate; or an 8 channel TENS unit. Patients will be&#xD;
      prompted by a Qualtrics text link to a secure data recording site collecting pain and&#xD;
      medication use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 23, 2022</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2023</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Participants will be instructed that there are interventions being evaluated for low back pain and the impact of the medical device on medication use and pain, and that they will be self-assessing pain and use of prescribed and over the counter medications. Study staff will train them on the device or TENS unit via an online video they will access in clinic, but care providers will not be informed of the study arm. An assessment for blinding will be adminstered at the end of the data collection for care providers and participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total Opioid use in morphine equivalent doses</measure>
    <time_frame>6 months</time_frame>
    <description>Daily diary of analgesic use and dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in opioid use in morphine equivalent doses</measure>
    <time_frame>Difference between first 2 weeks and last 2 weeks over 6 month period</time_frame>
    <description>Daily diary of analgesic use and dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in current weekly pain from initial to final</measure>
    <time_frame>Weekly for 3 weeks, then monthly at 1,3, and 6 months</time_frame>
    <description>Self-rated current pain on Numeric Rating Scale with 0 no pain and 11 maximum pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24 hour average pain weekly from initial to final</measure>
    <time_frame>Weekly for 3 weeks, then monthly at 1,3, and 6 months</time_frame>
    <description>Self-rated pain over past 24 hours on Numeric Rating Scale with 0 no pain and 11 maximum pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study</measure>
    <time_frame>Initial, 1 month, 3 months, completed at the end of 6 months</time_frame>
    <description>Response formats for all scales are a 5-point ordinal rating scale of &quot;Not at all,&quot; &quot;A little bit,&quot; &quot;Somewhat,&quot; &quot;Quite a bit,&quot; and &quot;Very much,&quot; where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest), Pain Intensity (2 questions, yielding possible scores of 2(low) and 10 (highest), and Depression scores (4 questions, yielding possible scores of 4(low) and 20 (most depressed).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duotherm use</measure>
    <time_frame>6 months</time_frame>
    <description>Daily diary of study device or TENS unit</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Chronic Low-back Pain</condition>
  <condition>Opioid Use</condition>
  <condition>Opioid Dependence</condition>
  <arm_group>
    <arm_group_label>DuoTherm VibraCool Back Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice daily for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multimodal TENS Unit</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LG SMART TENS stimulator is a portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duotherm VibraCool Back Device</intervention_name>
    <description>Active New multimodal pain device</description>
    <arm_group_label>DuoTherm VibraCool Back Device</arm_group_label>
    <other_name>Vibracool plus heat or pressure</other_name>
    <other_name>Buzzy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS 8-channel unit</intervention_name>
    <description>LG Smart TENS unit</description>
    <arm_group_label>Multimodal TENS Unit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with chronic low back pain by clinician&#xD;
&#xD;
          -  Pain duration &gt;3 months with or without opioid prescription for this exacerbation&#xD;
&#xD;
          -  Self-report NRS measures &gt;4&#xD;
&#xD;
          -  Capacity to understand all relevant risks and potential benefits of the study&#xD;
             (informed consent)&#xD;
&#xD;
          -  Willingness to communicate information on prescription pill # and dose, or dose and&#xD;
             pill type if medication is prescribed by someone else.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pacemaker&#xD;
&#xD;
          -  Radicular pain likely reflecting a surgical or mechanical problem&#xD;
&#xD;
          -  BMI greater than 30 (device won't fit)&#xD;
&#xD;
          -  Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)&#xD;
&#xD;
          -  Diabetic neuropathy rendering a patient unable to determine if the device is too hot&#xD;
&#xD;
          -  New neurologic deficits&#xD;
&#xD;
          -  Skin lesions over the low back area&#xD;
&#xD;
          -  Contraindication to any medication for pain management that would impact analgesic use&#xD;
             record&#xD;
&#xD;
          -  Inability to apply DuoTherm or Sham Device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Yes, eligibility is based on self-representation of gender identity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy Baxter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pain Care Labs (a dba of MMJ Labs)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Baxter, MD</last_name>
    <phone>8778052899</phone>
    <email>abaxter@mmjlabs.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jena Slaski</last_name>
    <phone>301-577-1115</phone>
    <email>landoverclinic@ssrehab.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sport and Spine Rehab Clinics</name>
      <address>
        <city>Landover</city>
        <state>Maryland</state>
        <zip>20785</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jena Slaski</last_name>
      <phone>301-577-1115</phone>
      <email>landoverclinic@ssrehab.com</email>
    </contact>
    <investigator>
      <last_name>Jena Slaski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sport and Spine Rehab Clinic</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jena Slaski</last_name>
      <phone>301-251-2777</phone>
      <email>fairfaxclinic@ssrehab.com</email>
    </contact>
    <investigator>
      <last_name>Jena Slaski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.</citation>
    <PMID>25639530</PMID>
  </reference>
  <reference>
    <citation>Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.</citation>
    <PMID>11690728</PMID>
  </reference>
  <reference>
    <citation>Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.</citation>
    <PMID>28017184</PMID>
  </reference>
  <reference>
    <citation>Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.</citation>
    <PMID>30146045</PMID>
  </reference>
  <reference>
    <citation>Davis CS, Lieberman AJ, Hernandez-Delgado H, Suba C. Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review. Drug Alcohol Depend. 2019 Jan 1;194:166-172. doi: 10.1016/j.drugalcdep.2018.09.022. Epub 2018 Nov 3.</citation>
    <PMID>30445274</PMID>
  </reference>
  <reference>
    <citation>Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.</citation>
    <PMID>26329399</PMID>
  </reference>
  <reference>
    <citation>Maddalozzo GF, Kuo B, Maddalozzo WA, Maddalozzo CD, Galver JW. Comparison of 2 Multimodal Interventions With and Without Whole Body Vibration Therapy Plus Traction on Pain and Disability in Patients With Nonspecific Chronic Low Back Pain. J Chiropr Med. 2016 Dec;15(4):243-251. doi: 10.1016/j.jcm.2016.07.001. Epub 2016 Aug 25.</citation>
    <PMID>27857632</PMID>
  </reference>
  <reference>
    <citation>Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.</citation>
    <PMID>32245841</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MMJ Labs LLC</investigator_affiliation>
    <investigator_full_name>Amy Lynn Baxter</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>opioid use</keyword>
  <keyword>pain</keyword>
  <keyword>medical device</keyword>
  <keyword>analgesia</keyword>
  <keyword>vibration</keyword>
  <keyword>thermal</keyword>
  <keyword>Buzzy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>up to 36 months after publication of results</ipd_time_frame>
    <ipd_access_criteria>researchers providing approved methodologically sound proposals or requests</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 13, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT04494698/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04494698
org study id: DuoThermChronic
secondary id: 4R44DA049631
nct id: NCT04494698
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Active
      Control
100 patients with chronic low back pain presenting for chiropractic and rehabilitation care
      will be stratified by gender and randomized to one of two conditions: a pain relief belt
      device incorporating multiple speeds of vibration and optional heat, cold, and pressure
      delivered through a sculpted metal plate; or an 8 channel TENS unit. Patients will be
      prompted by a Qualtrics text link to a secure data recording site collecting pain and
      medication use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Participants will be instructed that there are interventions being evaluated for low back pain and the impact of the medical device on medication use and pain, and that they will be self-assessing pain and use of prescribed and over the counter medications. Study staff will train them on the device or TENS unit via an online video they will access in clinic, but care providers will not be informed of the study arm. An assessment for blinding will be adminstered at the end of the data collection for care providers and participants.
measure: Total Opioid use in morphine equivalent doses
time frame: 6 months
description: Daily diary of analgesic use and dose
measure: Change in opioid use in morphine equivalent doses
time frame: Difference between first 2 weeks and last 2 weeks over 6 month period
description: Daily diary of analgesic use and dose
measure: Change in current weekly pain from initial to final
time frame: Weekly for 3 weeks, then monthly at 1,3, and 6 months
description: Self-rated current pain on Numeric Rating Scale with 0 no pain and 11 maximum pain
measure: Change in 24 hour average pain weekly from initial to final
time frame: Weekly for 3 weeks, then monthly at 1,3, and 6 months
description: Self-rated pain over past 24 hours on Numeric Rating Scale with 0 no pain and 11 maximum pain
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain measures from initial to completion of study
time frame: Initial, 1 month, 3 months, completed at the end of 6 months
description: Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest), Pain Intensity (2 questions, yielding possible scores of 2(low) and 10 (highest), and Depression scores (4 questions, yielding possible scores of 4(low) and 20 (most depressed).
measure: Duotherm use
time frame: 6 months
description: Daily diary of study device or TENS unit
arm group label: DuoTherm VibraCool Back Device
arm group type: Active Comparator
description: A low back pain relief device incorporating multiple speeds and patterns of vibration and optional heat, cold, or pressure delivered through a sculpted metal plate attached with a belt and controlled by buttons on the belt. Patients will be instructed to use the device twice daily for 20 minutes.
arm group label: Multimodal TENS Unit
arm group type: Active Comparator
description: LG SMART TENS stimulator is a portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.
intervention type: Device
intervention name: Duotherm VibraCool Back Device
description: Active New multimodal pain device
arm group label: DuoTherm VibraCool Back Device
other name: Vibracool plus heat or pressure
other name: Buzzy
intervention type: Device
intervention name: TENS 8-channel unit
description: LG Smart TENS unit
arm group label: Multimodal TENS Unit
criteria: 
gender: All
gender based: Yes
gender description: Yes, eligibility is based on self-representation of gender identity
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Amy Baxter, MD
role: Principal Investigator
affiliation: Pain Care Labs (a dba of MMJ Labs)
last name: Amy Baxter, MD
phone: 8778052899
email: abaxter@mmjlabs.com
last name: Jena Slaski
phone: 301-577-1115
email: landoverclinic@ssrehab.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.
PMID: 25639530
citation: Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PMID: 11690728
citation: Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.
PMID: 28017184
citation: Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.
PMID: 30146045
citation: Davis CS, Lieberman AJ, Hernandez-Delgado H, Suba C. Laws limiting the prescribing or dispensing of opioids for acute pain in the United States: A national systematic legal review. Drug Alcohol Depend. 2019 Jan 1;194:166-172. doi: 10.1016/j.drugalcdep.2018.09.022. Epub 2018 Nov 3.
PMID: 30445274
citation: Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
PMID: 26329399
citation: Maddalozzo GF, Kuo B, Maddalozzo WA, Maddalozzo CD, Galver JW. Comparison of 2 Multimodal Interventions With and Without Whole Body Vibration Therapy Plus Traction on Pain and Disability in Patients With Nonspecific Chronic Low Back Pain. J Chiropr Med. 2016 Dec;15(4):243-251. doi: 10.1016/j.jcm.2016.07.001. Epub 2016 Aug 25.
PMID: 27857632
citation: Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.
PMID: 32245841
responsible party type: Principal Investigator
investigator affiliation: MMJ Labs LLC
investigator full name: Amy Lynn Baxter
investigator title: Principal Investigator
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Opioid-Related Disorders
sharing ipd: Yes
ipd description: Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: up to 36 months after publication of results
ipd access criteria: researchers providing approved methodologically sound proposals or requests
provided document: 