<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/NCT03012503</url>
  </required_header>
  <id_info>
    <org_study_id>HR-2355</org_study_id>
    <nct_id>NCT03012503</nct_id>
  </id_info>
  <brief_title>The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain</brief_title>
  <official_title>The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marquette University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marquette University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Neck pain effects a significant number of individuals and is commonly treated&#xD;
      with chiropractic cervical manipulation. The temporary increases in neck pain following&#xD;
      cervical manipulation may contribute to a lack of compliance with prescribed therapy that&#xD;
      following this therapy which in turn commonly contributes to protracted symptoms. Topical&#xD;
      menthol has previously been shown to decrease pain shortly following application. The purpose&#xD;
      of this study was to determine if patients with mechanical neck pain who received topical&#xD;
      menthol gel applied to their neck prior to cervical manipulation would have less pain and&#xD;
      increased neck range of motion following cervical manipulation than patients who did not&#xD;
      receive menthol.&#xD;
&#xD;
      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were&#xD;
      randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before&#xD;
      cervical manipulation, controls received a placebo gel applied to their neck while the&#xD;
      treatment group received a menthol containing gel (Biofreeze®) applied to their neck.&#xD;
      Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at&#xD;
      one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical&#xD;
      manipulation. Six measures of neck range of motion were assessed prior to topical&#xD;
      applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain&#xD;
      ratings and neck range of motion following manipulation while controlling for Pre measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Neck pain effects a significant number of individuals and is commonly treated&#xD;
      with chiropractic cervical manipulation. The temporary increases in neck pain following&#xD;
      cervical manipulation may contribute to a lack of compliance with prescribed therapy that&#xD;
      following this therapy which in turn commonly contributes to protracted symptoms. Topical&#xD;
      menthol has previously been shown to decrease pain shortly following application. The purpose&#xD;
      of this study was to determine if patients with mechanical neck pain who received topical&#xD;
      menthol gel applied to their neck prior to cervical manipulation would have less pain and&#xD;
      increased neck range of motion following cervical manipulation than patients who did not&#xD;
      receive menthol.&#xD;
&#xD;
      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were&#xD;
      randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before&#xD;
      cervical manipulation, controls received a placebo gel applied to their neck while the&#xD;
      treatment group received a menthol containing gel (Biofreeze®) applied to their neck.&#xD;
      Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at&#xD;
      one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical&#xD;
      manipulation. Six measures of neck range of motion were assessed prior to topical&#xD;
      applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain&#xD;
      ratings and neck range of motion following manipulation while controlling for Pre measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain over 5 time points</measure>
    <time_frame>Prior to gel application (Pre) and at one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical manipulation</time_frame>
    <description>Participants rated their neck pain on a 10-point scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neck range of motion</measure>
    <time_frame>Prior to gel application (Pre) and at one minute (T1), and 30 minutes (T4) post cervical manipulation</time_frame>
    <description>Six measures of neck range of motion were assessed in the sagittal, frontal, and horizontal planes using the Acumar DataCapture hand-held dual inclinometer. This device has demonstrated a high degree of reliability (.87 - .92) without requiring calibration 21. These assessments included the neck motions of flexion, extension, right side bending, left side bending, left rotation and right rotation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Five minutes before cervical manipulation, controls received a placebo gel applied to their neck.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five minutes before cervical manipulation the treatment group received a menthol containing gel (Biofreeze®) applied to their neck.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BioFreeze</intervention_name>
    <description>The estimated surface area of the average adult's neck is 350cm and the standard dose of Biofreeze® to achieve a clinically significant effect has been sited to be 1ml/200cm2 of skin surface area. Using this data approximately 1.75 ml of the assigned gel was applied to each participant's neck (posterior, anterior, left lateral and right lateral) by the same member of the research team, 5 minutes prior to an independent practitioner performing cervical manipulation on the participant.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>control gel with a similar packaging, texture, and scent as Brand X but without the active ingredient of menthol</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals were included in the study if they were between the ages of 18-65 years&#xD;
             old, presented to their with initial clinic visit with non-radicular mechanical neck&#xD;
             pain greater than 3 on a 1-10 pain scale, and were prescribed by the clinical staff to&#xD;
             receive a cervical manipulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients not receiving a cervical manipulation&#xD;
&#xD;
          2. Patients with radicular signs and/or symptoms&#xD;
&#xD;
          3. Patients who did not consent to be in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Marquette University</investigator_affiliation>
    <investigator_full_name>Robert Topp</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Through publication and/or requests to the PI</ipd_description>
  </patient_data>
  <!-- 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/NCT03012503
org study id: HR-2355
nct id: NCT03012503
lead sponsor: 
has dmc: No
Background: Neck pain effects a significant number of individuals and is commonly treated
      with chiropractic cervical manipulation. The temporary increases in neck pain following
      cervical manipulation may contribute to a lack of compliance with prescribed therapy that
      following this therapy which in turn commonly contributes to protracted symptoms. Topical
      menthol has previously been shown to decrease pain shortly following application. The purpose
      of this study was to determine if patients with mechanical neck pain who received topical
      menthol gel applied to their neck prior to cervical manipulation would have less pain and
      increased neck range of motion following cervical manipulation than patients who did not
      receive menthol.

      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were
      randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before
      cervical manipulation, controls received a placebo gel applied to their neck while the
      treatment group received a menthol containing gel (Biofreeze®) applied to their neck.
      Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at
      one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical
      manipulation. Six measures of neck range of motion were assessed prior to topical
      applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain
      ratings and neck range of motion following manipulation while controlling for Pre measures.
Background: Neck pain effects a significant number of individuals and is commonly treated
      with chiropractic cervical manipulation. The temporary increases in neck pain following
      cervical manipulation may contribute to a lack of compliance with prescribed therapy that
      following this therapy which in turn commonly contributes to protracted symptoms. Topical
      menthol has previously been shown to decrease pain shortly following application. The purpose
      of this study was to determine if patients with mechanical neck pain who received topical
      menthol gel applied to their neck prior to cervical manipulation would have less pain and
      increased neck range of motion following cervical manipulation than patients who did not
      receive menthol.

      Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were
      randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before
      cervical manipulation, controls received a placebo gel applied to their neck while the
      treatment group received a menthol containing gel (Biofreeze®) applied to their neck.
      Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at
      one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical
      manipulation. Six measures of neck range of motion were assessed prior to topical
      applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain
      ratings and neck range of motion following manipulation while controlling for Pre measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Pain over 5 time points
time frame: Prior to gel application (Pre) and at one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical manipulation
description: Participants rated their neck pain on a 10-point scale
measure: neck range of motion
time frame: Prior to gel application (Pre) and at one minute (T1), and 30 minutes (T4) post cervical manipulation
description: Six measures of neck range of motion were assessed in the sagittal, frontal, and horizontal planes using the Acumar DataCapture hand-held dual inclinometer. This device has demonstrated a high degree of reliability (.87 - .92) without requiring calibration 21. These assessments included the neck motions of flexion, extension, right side bending, left side bending, left rotation and right rotation.
arm group label: Control
arm group type: Placebo Comparator
description: Five minutes before cervical manipulation, controls received a placebo gel applied to their neck.
arm group label: Treatment
arm group type: Experimental
description: Five minutes before cervical manipulation the treatment group received a menthol containing gel (Biofreeze®) applied to their neck.
intervention type: Drug
intervention name: BioFreeze
description: The estimated surface area of the average adult's neck is 350cm and the standard dose of Biofreeze® to achieve a clinically significant effect has been sited to be 1ml/200cm2 of skin surface area. Using this data approximately 1.75 ml of the assigned gel was applied to each participant's neck (posterior, anterior, left lateral and right lateral) by the same member of the research team, 5 minutes prior to an independent practitioner performing cervical manipulation on the participant.
arm group label: Treatment
intervention type: Drug
intervention name: Placebos
description: control gel with a similar packaging, texture, and scent as Brand X but without the active ingredient of menthol
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Marquette University
investigator full name: Robert Topp
investigator title: Professor
mesh term: Neck Pain
sharing ipd: No
ipd description: Through publication and/or requests to the PI