<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/NCT01678586</url>
  </required_header>
  <id_info>
    <org_study_id>2012P-001795</org_study_id>
    <secondary_id>5R01AT005819-04</secondary_id>
    <nct_id>NCT01678586</nct_id>
  </id_info>
  <brief_title>Effect of Acupuncture and Pain Medication on Radicular Pain Using QST</brief_title>
  <official_title>Effect of Acupuncture and Pain Medication on Radicular Pain Using QST</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized&#xD;
      clinical trial to compare the clinical effectiveness of radicular pain relief by either&#xD;
      acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative&#xD;
      Sensory Testing (QST).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">December 2021</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>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in QST measures in response to acupuncture or gabapentin</measure>
    <time_frame>3 weeks</time_frame>
    <description>Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>True Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gabapentin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Gabapentin</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>In true acupuncture the needles penetrate the skin.</description>
    <arm_group_label>True Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Acupuncture</intervention_name>
    <description>In sham acupuncture the needles do not penetrate the skin.</description>
    <arm_group_label>Sham Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Gabapentin is a commonly prescribed drug used to treat neuropathic pain.</description>
    <arm_group_label>Gabapentin</arm_group_label>
    <other_name>Neurontin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sham Gabapentin</intervention_name>
    <description>Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)</description>
    <arm_group_label>Sham Gabapentin</arm_group_label>
    <other_name>Benadryl, diphenhydramine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject will be between ages 18 to 75 years. Both male and female subjects will be&#xD;
             recruited.&#xD;
&#xD;
          2. Subject should have had cervical or lumbar radicular pain for at least two months.&#xD;
             This requirement is to avoid the uncertainty of an unstable pain condition and to&#xD;
             minimize the study variation.&#xD;
&#xD;
          3. Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain&#xD;
             to worst pain).&#xD;
&#xD;
          4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical&#xD;
             conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to&#xD;
             such conditions resulting from neurological diseases or medical conditions causing&#xD;
             peripheral polyneuropathy and sensory changes, which include but are not limited to&#xD;
             diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease,&#xD;
             and severe liver or kidney disorders.&#xD;
&#xD;
          2. Subject has scar tissue, infection, or acute injury at the site of QST.&#xD;
&#xD;
          3. Subject is pregnant.&#xD;
&#xD;
          4. Subject tests positive for illicit drugs.&#xD;
&#xD;
          5. Subject has a pacemaker.&#xD;
&#xD;
          6. Subject is currently taking gabapentin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianren Mao, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MGH Center for Translational Pain Research</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Jianren Mao, MD, PhD</investigator_full_name>
    <investigator_title>M.D., Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Pain management</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diphenhydramine</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01678586
org study id: 2012P-001795
secondary id: 5R01AT005819-04
nct id: NCT01678586
lead sponsor: 
collaborator: 
has dmc: Yes
In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized
      clinical trial to compare the clinical effectiveness of radicular pain relief by either
      acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative
      Sensory Testing (QST).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Changes in QST measures in response to acupuncture or gabapentin
time frame: 3 weeks
description: Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen.
arm group label: True Acupuncture
arm group type: Active Comparator
description: Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
arm group label: Sham Acupuncture
arm group type: Sham Comparator
description: Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
arm group label: Gabapentin
arm group type: Active Comparator
description: Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
arm group label: Sham Gabapentin
arm group type: Sham Comparator
description: Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
intervention type: Other
intervention name: Acupuncture
description: In true acupuncture the needles penetrate the skin.
arm group label: True Acupuncture
intervention type: Other
intervention name: Sham Acupuncture
description: In sham acupuncture the needles do not penetrate the skin.
arm group label: Sham Acupuncture
intervention type: Drug
intervention name: Gabapentin
description: Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
arm group label: Gabapentin
other name: Neurontin
intervention type: Drug
intervention name: Sham Gabapentin
description: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
arm group label: Sham Gabapentin
other name: Benadryl, diphenhydramine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jianren Mao, M.D., Ph.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Jianren Mao, MD, PhD
investigator title: M.D., Ph.D.
mesh term: Diphenhydramine
mesh term: Gabapentin