<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/NCT04487327</url>
  </required_header>
  <id_info>
    <org_study_id>albin2020</org_study_id>
    <nct_id>NCT04487327</nct_id>
  </id_info>
  <brief_title>The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional Outcomes in Individuals With Injury to the Ankle and/or Hindfoot</brief_title>
  <official_title>The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regis University</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>
      The purpose of this randomized controlled trial is to assess the effect of DN at either the&#xD;
      site of the identified myofascial trigger point/s (MTrP) of in the same muscle, but away from&#xD;
      the MTrP site/s in individuals with ankle and/or hindfoot injury. Assessments will be of&#xD;
      self-reported outcomes, self-reported pain, gait, balance, muscle stiffness, and pain&#xD;
      pressure threshold. The secondary purpose of this study is to determine the validity of dry&#xD;
      needling specific muscles of the lower extremity based upon needle placement, location&#xD;
      relative to anatomical structures and accuracy of needle placement in muscle using ultrasound&#xD;
      imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Few studies have assessed the validity of needling muscles of the lower extremity. For&#xD;
      muscles such as the tibialis posterior that are not easily accessible or directly palpable&#xD;
      secondary to the deep anatomical position and due to the proximity of the tibial nerve and&#xD;
      the posterior tibial artery within the deep compartment, examining accurate needle placement&#xD;
      is clinically relevant. In addition, DN has been shown to be a beneficial management strategy&#xD;
      for individuals with lower extremity condition; however, the investigators may be able to&#xD;
      optimize these beneficial effects by performing DN on the MTrP versus other sites within the&#xD;
      same muscle.&#xD;
&#xD;
      If needling directly into the MTrP is more effective than needling away from the MTrP but&#xD;
      into the same muscle, it is possible that the improved efficiency could help to optimize&#xD;
      management of patients with injury to the ankle/hindfoot with less visits and potentially&#xD;
      decreasing health care costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Specific Aim 1: To evaluate if DN has an effect on muscle stiffness, gait, pain pressure threshold, and balance in individuals with injuries to the ankle and/or hindfoot.&#xD;
The dependent variables for Aim1 are: muscle stiffness, plantar pressure, PPT, and balance. The independent variables for Aim1 are Group (MTrP needling versus away from the MTrP site) and Time. The primary aim will be examined using linear mixed modeling with any baseline differences between groups used as a co-variate. A separate model will be created for each dependent variable.&#xD;
Specific Aim 2: To determine the validity of dry needling specific muscles of the lower extremity based upon needle placement, location relative to anatomical structures and accuracy of needle placement in muscle with in vivo ultrasound imaging.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Study investigators collecting outcome assessments will be blinded to group allocation. Participants will be asked not to reveal what group they believe they were randomized to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>DN location effect on self-reported and clinical outcomes</measure>
    <time_frame>2 year</time_frame>
    <description>Foot and Ankle Ability Measure (FAAM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DN location effect on clinical outcomes - Muscle Stiffness</measure>
    <time_frame>2 year</time_frame>
    <description>Muscle Stiffness Measured with the MyotonPro</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DN location effect on clinical outcomes - Gait</measure>
    <time_frame>2 year</time_frame>
    <description>Plantar pressure during gait measured by the EMED system and GAITRite</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DN location effect on clinical outcomes - Dynamic Balance</measure>
    <time_frame>2 year</time_frame>
    <description>Balance measured by the Y-balance test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DN location effect on clinical outcomes - PPT</measure>
    <time_frame>2 year</time_frame>
    <description>Pain pressure threshold measured by an algometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Validation of needle placement in lower extremity muscles</measure>
    <time_frame>6 month</time_frame>
    <description>Individuals will receive dry needling with the aseptic technique previously described. With the needle in place, diagnostic ultrasound will be performed. The accuracy of the needle placement will be assessed and the distance from the needle to major arteries, nerve, and veins will be measured in millimeters and documented. Only one visit lasting approximately 30 minutes will be required for this portion of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Ankle and or Hindfoot Injury</condition>
  <arm_group>
    <arm_group_label>Dry Needling within the Myofascial Trigger Point</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized to receive DN at the site of the MTrP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dry Needling away from Myofascial Trigger Point Site</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needling</intervention_name>
    <description>The dry-needling treatment will consist of inserting a sterile needle into 2-4 muscles of the participant either at the MTrP or 2 cm away from the MTrP, but within the same muscle. To assist in the reduction of infection risk and protection of the participants, the site will be cleaned with alcohol prior to treatment and investigators performing the needling treatment will wear gloves and handle needles using aseptic technique throughout the procedure. Each needle insertion will last approximately 5 seconds using a &quot;pistoning&quot; (in and out) technique.</description>
    <arm_group_label>Dry Needling away from Myofascial Trigger Point Site</arm_group_label>
    <arm_group_label>Dry Needling within the Myofascial Trigger Point</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with a previous lower extremity injury occurring to the ankle and/or&#xD;
             hindfoot within the previous 12 months AND&#xD;
&#xD;
          -  pain greater than 3 out of 10 on the numeric pain rating scale (NPRS) OR&#xD;
&#xD;
          -  limited weightbearing dorsiflexion range of motion of greater than 2.0 cm side-to-side&#xD;
             difference as measured by the ankle lunge test (ALT) OR&#xD;
&#xD;
          -  greater than 3.5% side-to-side difference as assessed by the Y-balance test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Operative fixation within the past 3 months to the lower extremity&#xD;
&#xD;
          -  Have received DN of the lower extremity within the past 30 days&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Have a history of systemic disorders in which DN would be contraindicated (bleeding&#xD;
             disorders or current anticoagulant medication use)&#xD;
&#xD;
          -  Immunocompromised&#xD;
&#xD;
          -  Decline participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie Albin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regis University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephanie Albin</last_name>
    <phone>303-964-6501</phone>
    <email>albin149@regis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Larisa Hoffman</last_name>
    <phone>303-964-5203</phone>
    <email>lhoffman@regis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Regis University</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80221</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stephanie Albin, PhD</last_name>
      <phone>303-964-6501</phone>
      <email>albin149@regis.edu</email>
    </contact>
    <contact_backup>
      <last_name>Larisa Hoffman, PhD</last_name>
      <phone>3039646501</phone>
      <email>lhoffman@regis.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.</citation>
    <PMID>25582412</PMID>
  </reference>
  <reference>
    <citation>Fernandez-de-Las-Penas C, Mesa-Jimenez JA, Paredes-Mancilla JA, Koppenhaver SL, Fernandez-Carnero S. Cadaveric and Ultrasonographic Validation of Needling Placement in the Cervical Multifidus Muscle. J Manipulative Physiol Ther. 2017 Jun;40(5):365-370. doi: 10.1016/j.jmpt.2017.03.002. Epub 2017 Apr 13.</citation>
    <PMID>28413118</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>March 12, 2022</last_update_submitted>
  <last_update_submitted_qc>March 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Regis University</investigator_affiliation>
    <investigator_full_name>Stephanie Albin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>dry needling</keyword>
  <keyword>muscle stiffness</keyword>
  <keyword>ankle injury</keyword>
  <keyword>hindfoot injury</keyword>
  <keyword>plantar pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and 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>


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/NCT04487327
org study id: albin2020
nct id: NCT04487327
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized controlled trial is to assess the effect of DN at either the
      site of the identified myofascial trigger point/s (MTrP) of in the same muscle, but away from
      the MTrP site/s in individuals with ankle and/or hindfoot injury. Assessments will be of
      self-reported outcomes, self-reported pain, gait, balance, muscle stiffness, and pain
      pressure threshold. The secondary purpose of this study is to determine the validity of dry
      needling specific muscles of the lower extremity based upon needle placement, location
      relative to anatomical structures and accuracy of needle placement in muscle using ultrasound
      imaging.
Few studies have assessed the validity of needling muscles of the lower extremity. For
      muscles such as the tibialis posterior that are not easily accessible or directly palpable
      secondary to the deep anatomical position and due to the proximity of the tibial nerve and
      the posterior tibial artery within the deep compartment, examining accurate needle placement
      is clinically relevant. In addition, DN has been shown to be a beneficial management strategy
      for individuals with lower extremity condition; however, the investigators may be able to
      optimize these beneficial effects by performing DN on the MTrP versus other sites within the
      same muscle.

      If needling directly into the MTrP is more effective than needling away from the MTrP but
      into the same muscle, it is possible that the improved efficiency could help to optimize
      management of patients with injury to the ankle/hindfoot with less visits and potentially
      decreasing health care costs.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Specific Aim 1: To evaluate if DN has an effect on muscle stiffness, gait, pain pressure threshold, and balance in individuals with injuries to the ankle and/or hindfoot.
The dependent variables for Aim1 are: muscle stiffness, plantar pressure, PPT, and balance. The independent variables for Aim1 are Group (MTrP needling versus away from the MTrP site) and Time. The primary aim will be examined using linear mixed modeling with any baseline differences between groups used as a co-variate. A separate model will be created for each dependent variable.
Specific Aim 2: To determine the validity of dry needling specific muscles of the lower extremity based upon needle placement, location relative to anatomical structures and accuracy of needle placement in muscle with in vivo ultrasound imaging.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Study investigators collecting outcome assessments will be blinded to group allocation. Participants will be asked not to reveal what group they believe they were randomized to.
measure: DN location effect on self-reported and clinical outcomes
time frame: 2 year
description: Foot and Ankle Ability Measure (FAAM)
measure: DN location effect on clinical outcomes - Muscle Stiffness
time frame: 2 year
description: Muscle Stiffness Measured with the MyotonPro
measure: DN location effect on clinical outcomes - Gait
time frame: 2 year
description: Plantar pressure during gait measured by the EMED system and GAITRite
measure: DN location effect on clinical outcomes - Dynamic Balance
time frame: 2 year
description: Balance measured by the Y-balance test
measure: DN location effect on clinical outcomes - PPT
time frame: 2 year
description: Pain pressure threshold measured by an algometer
measure: Validation of needle placement in lower extremity muscles
time frame: 6 month
description: Individuals will receive dry needling with the aseptic technique previously described. With the needle in place, diagnostic ultrasound will be performed. The accuracy of the needle placement will be assessed and the distance from the needle to major arteries, nerve, and veins will be measured in millimeters and documented. Only one visit lasting approximately 30 minutes will be required for this portion of the study.
arm group label: Dry Needling within the Myofascial Trigger Point
arm group type: Experimental
description: Randomized to receive DN at the site of the MTrP
arm group label: Dry Needling away from Myofascial Trigger Point Site
arm group type: Active Comparator
description: Randomized to receive DN 2 cm away from the site of the MTrP but within the same muscle
intervention type: Other
intervention name: Dry Needling
description: The dry-needling treatment will consist of inserting a sterile needle into 2-4 muscles of the participant either at the MTrP or 2 cm away from the MTrP, but within the same muscle. To assist in the reduction of infection risk and protection of the participants, the site will be cleaned with alcohol prior to treatment and investigators performing the needling treatment will wear gloves and handle needles using aseptic technique throughout the procedure. Each needle insertion will last approximately 5 seconds using a "pistoning" (in and out) technique.
arm group label: Dry Needling away from Myofascial Trigger Point Site
arm group label: Dry Needling within the Myofascial Trigger Point
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Stephanie Albin
role: Principal Investigator
affiliation: Regis University
last name: Stephanie Albin
phone: 303-964-6501
email: albin149@regis.edu
last name: Larisa Hoffman
phone: 303-964-5203
email: lhoffman@regis.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Pecos-Martin D, Montanez-Aguilera FJ, Gallego-Izquierdo T, Urraca-Gesto A, Gomez-Conesa A, Romero-Franco N, Plaza-Manzano G. Effectiveness of dry needling on the lower trapezius in patients with mechanical neck pain: a randomized controlled trial. Arch Phys Med Rehabil. 2015 May;96(5):775-81. doi: 10.1016/j.apmr.2014.12.016. Epub 2015 Jan 9.
PMID: 25582412
citation: Fernandez-de-Las-Penas C, Mesa-Jimenez JA, Paredes-Mancilla JA, Koppenhaver SL, Fernandez-Carnero S. Cadaveric and Ultrasonographic Validation of Needling Placement in the Cervical Multifidus Muscle. J Manipulative Physiol Ther. 2017 Jun;40(5):365-370. doi: 10.1016/j.jmpt.2017.03.002. Epub 2017 Apr 13.
PMID: 28413118
responsible party type: Principal Investigator
investigator affiliation: Regis University
investigator full name: Stephanie Albin
investigator title: Principal Investigator
mesh term: Wounds and Injuries
sharing ipd: No