<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/NCT04491175</url>
  </required_header>
  <id_info>
    <org_study_id>DuothermAcute</org_study_id>
    <secondary_id>4R44DA049631-02</secondary_id>
    <nct_id>NCT04491175</nct_id>
  </id_info>
  <brief_title>Impact of DuoTherm on Acute Opioid Use and 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 Acute 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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate opioid use and pain change in acute Low Back Pain with DuoTherm Compared to TENS&#xD;
      Therapy Unit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patients with acute back pain presenting for chiropractic and rehabilitation care will be&#xD;
      stratified by gender and randomized to one of two conditions: a pain relief belt device&#xD;
      incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered&#xD;
      through a sculpted metal plate; or a TENS unit with 8 channels of stimulation and adjustable&#xD;
      intensity. Patients will be prompted by a Qualtrics text link to a secure data recording site&#xD;
      collecting pain and 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, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2024</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>Prevention</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 units via a pre-made video, but care providers will not be informed of the study arm. An assessment for blinding will be administered at the end of the data collection for care providers and participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid use in morphine equivalent doses</measure>
    <time_frame>3 months</time_frame>
    <description>Daily diary of analgesic use and dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid initiation</measure>
    <time_frame>initial 15 days</time_frame>
    <description>Use of any opioids, prescribed or borrowed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in current weekly pain from initial to resolution</measure>
    <time_frame>3 months</time_frame>
    <description>Self-rated current pain on 0-11 NRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 24 hour average pain weekly from initial to resolution</measure>
    <time_frame>3 months</time_frame>
    <description>Self-rated average pain over past 24 hours on 0-11 NRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Pain Interference measure from initial to completion of study</measure>
    <time_frame>Initial to end of 3 months</time_frame>
    <description>Change in Monthly Pain Interference score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Pain Intensity measure from initial to completion of study</measure>
    <time_frame>Initial to end of 3 months</time_frame>
    <description>Change in Monthly Pain Intensity score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Depression measures from initial to completion of study</measure>
    <time_frame>Initial to end of 3 months</time_frame>
    <description>Change in Monthly Depression score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duotherm use</measure>
    <time_frame>3 months</time_frame>
    <description>Daily diary of use of device or sham</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Opioid Use</condition>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>DuoTherm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A low back pain relief device incorporating multiple speeds of vibration and optional heat, cold, and 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 a day for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multimodal TENS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DuoTherm</intervention_name>
    <description>New combination device comprising a sculpted low back plate with multiple sensory modalities held in place with a neoprene belt capable of being tightened with patient control of variations in sensory modalities.</description>
    <arm_group_label>DuoTherm</arm_group_label>
    <other_name>VibraCool plus heat and pressure</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>LG SMART TENS stimulator is a portable electgrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeitud devcie, 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_label>Multimodal TENS</arm_group_label>
    <other_name>LG Smart TENS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, aged 18-90 diagnosed with acute low back pain by clinician; pain&#xD;
             duration &lt;3 months without opioid prescription for this exacerbation; self-report NRS&#xD;
             measures &gt;4, Capacity to understand all relevant risks and potential benefits of the&#xD;
             study (informed consent); willingness to communicate information on prescription pill&#xD;
             # and dose, or dose and pill type if medication is prescribed by someone else.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Opioid prescription in the past month; Radicular pain likely reflecting a surgical or&#xD;
             mechanical problem; BMI greater than 30 (device won't fit); sensitivity to cold or&#xD;
             vibration (e.g Raynaud's or Sickle Cell Disease); diabetic neuropathy rendering a&#xD;
             patient unable to determine if the device is too hot; new neurologic deficits, skin&#xD;
             lesions over the low back area; a contraindication to any medication for pain&#xD;
             management that would impact analgesic use record; inability to apply DuoTherm or TENS&#xD;
             device; pacemaker that would render patients unable to use the TENS device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>stratified based on the representation of gender identity given and recorded in patients' chart</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jena Slaski</last_name>
    <role>Study Director</role>
    <affiliation>Sport and Spine Clinical Research Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Baxter, MD</last_name>
    <phone>8778052899</phone>
    <email>abaxter@mmjlabs.com</email>
  </overall_contact>
  <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>Kaizo Health Fairfax</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>Edwards RR, Haythornthwaite JA, Smith MT, Klick B, Katz JN. Catastrophizing and depressive symptoms as prospective predictors of outcomes following total knee replacement. Pain Res Manag. 2009 Jul-Aug;14(4):307-11. doi: 10.1155/2009/273783.</citation>
    <PMID>19714271</PMID>
  </reference>
  <reference>
    <citation>Abrecht CR, Cornelius M, Wu A, Jamison RN, Janfaza D, Urman RD, Campbell C, Smith M, Haythornthwaite J, Edwards RR, Schreiber KL. Prediction of Pain and Opioid Utilization in the Perioperative Period in Patients Undergoing Primary Knee Arthroplasty: Psychophysical and Psychosocial Factors. Pain Med. 2019 Jan 1;20(1):161-171. doi: 10.1093/pm/pny020.</citation>
    <PMID>29522115</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>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>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>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>Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.</citation>
    <PMID>22588748</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>French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004750. doi: 10.1002/14651858.CD004750.pub2.</citation>
    <PMID>16437495</PMID>
  </reference>
  <reference>
    <citation>Farber K, Wieland LS. Massage for Low-back Pain. Explore (NY). 2016 May-Jun;12(3):215-7. doi: 10.1016/j.explore.2016.02.014. Epub 2016 Mar 2.</citation>
    <PMID>27033320</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>Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003 Mar;84(3):335-42. doi: 10.1053/apmr.2003.50103.</citation>
    <PMID>12638100</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 15, 2019</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</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>CEO</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>analgesia</keyword>
  <keyword>medical device</keyword>
  <keyword>opioid</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>
  </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>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</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/75/NCT04491175/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/NCT04491175
org study id: DuothermAcute
secondary id: 4R44DA049631-02
nct id: NCT04491175
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Evaluate opioid use and pain change in acute Low Back Pain with DuoTherm Compared to TENS
      Therapy Unit
60 patients with acute 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 a TENS unit with 8 channels of stimulation and adjustable
      intensity. 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: Prevention
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 units via a pre-made video, but care providers will not be informed of the study arm. An assessment for blinding will be administered at the end of the data collection for care providers and participants.
measure: Opioid use in morphine equivalent doses
time frame: 3 months
description: Daily diary of analgesic use and dose
measure: Opioid initiation
time frame: initial 15 days
description: Use of any opioids, prescribed or borrowed
measure: Change in current weekly pain from initial to resolution
time frame: 3 months
description: Self-rated current pain on 0-11 NRS
measure: Change in 24 hour average pain weekly from initial to resolution
time frame: 3 months
description: Self-rated average pain over past 24 hours on 0-11 NRS
measure: Change in PROMIS Pain Interference measure from initial to completion of study
time frame: Initial to end of 3 months
description: Change in Monthly Pain Interference score
measure: Change in PROMIS Pain Intensity measure from initial to completion of study
time frame: Initial to end of 3 months
description: Change in Monthly Pain Intensity score
measure: Change in PROMIS Depression measures from initial to completion of study
time frame: Initial to end of 3 months
description: Change in Monthly Depression score
measure: Duotherm use
time frame: 3 months
description: Daily diary of use of device or sham
arm group label: DuoTherm
arm group type: Active Comparator
description: A low back pain relief device incorporating multiple speeds of vibration and optional heat, cold, and 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 a day for 20 minutes.
arm group label: Multimodal TENS
arm group type: Active Comparator
description: An 8-channel TENS unit (LG Smart). Patients will be instructed to use the TENS twice a day for 20 minutes.
intervention type: Device
intervention name: DuoTherm
description: New combination device comprising a sculpted low back plate with multiple sensory modalities held in place with a neoprene belt capable of being tightened with patient control of variations in sensory modalities.
arm group label: DuoTherm
other name: VibraCool plus heat and pressure
intervention type: Device
intervention name: TENS
description: LG SMART TENS stimulator is a portable electgrotherapy devcie featuring transcutaneous electrical nerve stimulation (TENS) therapeitud devcie, 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.
arm group label: Multimodal TENS
other name: LG Smart TENS
criteria: 
gender: All
gender based: Yes
gender description: stratified based on the representation of gender identity given and recorded in patients' chart
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jena Slaski
role: Study Director
affiliation: Sport and Spine Clinical Research Foundation
last name: Amy Baxter, MD
phone: 8778052899
email: abaxter@mmjlabs.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Edwards RR, Haythornthwaite JA, Smith MT, Klick B, Katz JN. Catastrophizing and depressive symptoms as prospective predictors of outcomes following total knee replacement. Pain Res Manag. 2009 Jul-Aug;14(4):307-11. doi: 10.1155/2009/273783.
PMID: 19714271
citation: Abrecht CR, Cornelius M, Wu A, Jamison RN, Janfaza D, Urman RD, Campbell C, Smith M, Haythornthwaite J, Edwards RR, Schreiber KL. Prediction of Pain and Opioid Utilization in the Perioperative Period in Patients Undergoing Primary Knee Arthroplasty: Psychophysical and Psychosocial Factors. Pain Med. 2019 Jan 1;20(1):161-171. doi: 10.1093/pm/pny020.
PMID: 29522115
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: 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: 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: 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: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
PMID: 22588748
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: French SD, Cameron M, Walker BF, Reggars JW, Esterman AJ. Superficial heat or cold for low back pain. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004750. doi: 10.1002/14651858.CD004750.pub2.
PMID: 16437495
citation: Farber K, Wieland LS. Massage for Low-back Pain. Explore (NY). 2016 May-Jun;12(3):215-7. doi: 10.1016/j.explore.2016.02.014. Epub 2016 Mar 2.
PMID: 27033320
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: Nadler SF, Steiner DJ, Petty SR, Erasala GN, Hengehold DA, Weingand KW. Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil. 2003 Mar;84(3):335-42. doi: 10.1053/apmr.2003.50103.
PMID: 12638100
responsible party type: Principal Investigator
investigator affiliation: MMJ Labs LLC
investigator full name: Amy Lynn Baxter
investigator title: CEO
mesh term: Back Pain
mesh term: Low Back Pain
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: Clinical Study Report (CSR)
ipd time frame: up to 36 months after publication of results
ipd access criteria: researchers providing approved methodologically sound proposals
provided document: 