xml: <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/NCT05976269</url>
    </required_header>
    <id_info>
      <org_study_id>2020H0332</org_study_id>
      <nct_id>NCT05976269</nct_id>
    </id_info>
    <brief_title>Bilateral Knee Pain and Dry Needling</brief_title>
    <official_title>The Effects of Bilateral Knee Pain &amp; Dry Needling on Laterality Recognition, Movement, &amp; Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University</source>
    <oversight_info>
      <has_dmc>No</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>
        This project will evaluate the effects of bilateral knee pain and dry needling (DN) on&#xD;
        laterality recognition, movement and muscle function. The objective is to determine if&#xD;
        laterality recognition accuracy deficits are present in individuals with bilateral chronic&#xD;
        knee pain and if DN affects 'central' and 'peripheral' musculoskeletal measurements. Chronic&#xD;
        musculoskeletal pain results in changes to the way the brain perceives pain and left-right&#xD;
        discrimination between body parts. This phenomenon has been established for individuals with&#xD;
        chronic back pain and chronic regional pain syndrome, but has not been described for&#xD;
        individuals with bilateral knee pain without the presence of knee OA. Dry needling involves&#xD;
        the insertion of a small diameter monofilament needle into muscle, and has been purported to&#xD;
        affect the neuromuscular system both centrally and peripherally. Sixty individuals between 18&#xD;
        and 40 years old will be recruited and allocated into three groups. The first group will&#xD;
        consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of&#xD;
        movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37. The&#xD;
        second group with consist of 20 subjects with bilateral chronic anterior knee pain and low&#xD;
        fear of movement between ages of 18 and 40 years old, and the third group will consist of&#xD;
        healthy controls without knee pain between 18 and 40 years old. All subjects will undergo&#xD;
        baseline testing consisting of laterality recognition, movement analysis, muscle force&#xD;
        production, and ultrasound imaging. Subjects will undergo laterality recognition testing&#xD;
        using the Neuro Orthopaedic Institute (NOI) Recognise Knee phone application. 2D video&#xD;
        analysis of the lateral step down test will be performed followed by peak isometric force&#xD;
        production assessment of knee extension and flexion. Muscle function of the vastus medialis&#xD;
        will be measured with ultrasound imaging where cross-sectional area and other measurements&#xD;
        (tendon length, muscle thickness, etc) will be captured with Lumify ultrasound imaging&#xD;
        transducer. Then DN to the quadriceps will be performed. After DN procedure, subjects will&#xD;
        undergo aforementioned measurements from baseline testing. Testing will require only one&#xD;
        appointment by the subject, which will last approximately 2 hours an include baseline&#xD;
        testing, dry needling, and post testing. No follow up will occur afterwards.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary purpose of this study is to identify if a loss of laterality recognition is&#xD;
        present in individuals with bilateral chronic knee pain with kinesiophobia and if DN affects&#xD;
        short term central and peripheral neuromuscular measurements. The goal of this project is to&#xD;
        recruit 20 individuals with bilateral knee pain greater than three months between the ages of&#xD;
        18 and 40 years old without evidence of knee OA and with fear of movement as evidenced by the&#xD;
        Tampa Scale of Kinesiophobia with the following aims: [1] Determine if these individuals have&#xD;
        a loss of laterality recognition associated with chronic pain that affects the way the brain&#xD;
        processes images of a left or right knee using the Neuro Orthopaedic Institute (NOI)&#xD;
        Recogonise Knee phone application for iPhone or Android. [2] Assess muscle force production&#xD;
        by measuring peak knee extension and flexion isometric force production on a Biodex System II&#xD;
        dynamometer (Biodex Medical Systems, Inc. Shirley, New York, USA). [3] Measure muscle&#xD;
        function of the quadriceps using ultrasound imaging to assess for changes in cross sectional&#xD;
        area, tendon length, muscle thickness, and other relevant measurements that could be captured&#xD;
        (i.e. pennation angle) of the vastus medialis (VM) muscle. [4] Assess movement quality with&#xD;
        the lateral step down test and using 2D video analysis measure trunk flexion, knee flexion,&#xD;
        closed chain dorsiflexion, pelvic drop and patellar projection angle. [5] Determine if DN&#xD;
        causes an immediate change on the central (laterality recognition) and peripheral (muscle&#xD;
        force production, function, movement) neuromuscular system. [6] Elucidate if there are&#xD;
        differences between individuals with bilateral knee pain and high fear of movement and&#xD;
        bilateral knee pain and low fear of movement. We also will recruit 20 subjects with bilateral&#xD;
        knee pain and low fear of movement, and 20 subjects who are healthy without any knee pain. To&#xD;
        the authors knowledge only one study has identified laterality recognition deficits in a&#xD;
        population with knee OA. Currently there is not a single publication that assesses laterality&#xD;
        recognition deficits for individuals with bilateral knee pain without the presence of knee&#xD;
        OA. This study has the potential to inform physical therapists that deliver interventions&#xD;
        such as pain neuroscience education, graded motor imagery (left-right discrimination,&#xD;
        explicit motor imagery, mirror therapy), movement/muscle function assessment, and DN, to&#xD;
        improve their decision-making, evaluation, and treatment skills.&#xD;
  &#xD;
        To facilitate recruitment we are applying for a partial HIPAA waiver for this project in&#xD;
        order to recruit patients undergoing/seeking care for their knee pain with a physician or&#xD;
        physical therapist. The only pertinent PHI to be screened will be age, diagnosis codes&#xD;
        related to knee pain, and factors related to inclusion and exclusion criteria. Of this&#xD;
        information, only eligibility criteria (inclusion/exclusion factors) will be screened by the&#xD;
        research team. This information screened in the electronic medical record will not be written&#xD;
        down or stored anywhere. Once a research associate identifies a patient that may qualify for&#xD;
        the study, the patient will fill out a survey link from REDCap, where the data will be stored&#xD;
        containing their name, contact information, and screening questions related to their&#xD;
        eligibility of the study (inclusion/exclusion criteria). This information will be preserved&#xD;
        in REDCap, a secure online platform for data storage, for the sole purpose of avoiding&#xD;
        contacting subjects repetitively regarding interest in study participation. Only pertinent&#xD;
        PHI will be screened such as age, diagnosis codes related to knee pain, and factors related&#xD;
        to inclusion and exclusion criteria. None of this information will be stored by the research&#xD;
        team. Once a research associate identifies a patient that may qualify for the study, the&#xD;
        patient will fill out a survey link from REDCap, where the data will be stored containing&#xD;
        their name, contact information, and screening questions related to their eligibility of the&#xD;
        study. Participants in this study do not have to be current patients. If a potential&#xD;
        participant who is not a current patient reaches out to the research team, they will be given&#xD;
        the survey link from REDCap. After this survey is completed, a research associate will&#xD;
        determine their eligibility for the study. This means recruits for the study may come from&#xD;
        the community who have not necessarily seen a PT, MD, or DO. All interventions, including dry&#xD;
        needling, and outcomes measured (pain, outcome questionnaires, strength, range of motion,&#xD;
        functional assessment, etc.) are commonly performed during current physical therapy practice&#xD;
        and treatment. For this study the investigators are formalizing the collection of these&#xD;
        measures. Testing will require only one appointment by the subject, which will last&#xD;
        approximately 2 hours an include baseline testing, dry needling, and post testing. No follow&#xD;
        up will occur afterwards. Specific testing procedures related to this protocol include the&#xD;
        following: 1) Laterality recognition testing, where the subject will look through an&#xD;
        application called NOI Recognoise Knee on an iPhone or iPad and select if the image they are&#xD;
        looking at is a left or right knee. 2) Cross-sectional area and other measurements (tendon&#xD;
        length, muscle thickness, etc) of vastus medialis muscle measured in supine with Lumify&#xD;
        ultrasound imaging transducer. 3) 2D movement analysis will be performed of subjects&#xD;
        performing the lateral step down test. 4) Peak knee extension and flexion isometric force&#xD;
        production will be captured using the Biodex. 5) Dry needling will be provided to all&#xD;
        subjects using a clean technique commonly used in clinical care. Dry needling intervention&#xD;
        will be provided to the quadriceps muscle using a standardized protocol. Dry needle will be&#xD;
        inserted in and out and/or twisted clockwise for a maximum of 30&quot; at the discretion of the&#xD;
        researcher and tolerance of participant, and then the needle will be left in situ for 15&#xD;
        minutes. Several studies have demonstrated the safety of this technique. If participant is&#xD;
        unable to tolerate the DN procedure, the procedure will be stopped and needles removed. The&#xD;
        participant can stop participation at any time during the study. 6) Step 1-4 will be&#xD;
        repeated. In summary, the process will look like this: Consent, Baseline testing, dry&#xD;
        needling, post testing in a 2 hour session. In addition, specific examination data from the&#xD;
        subjects' will be recorded such as age, height, weight and details about their knee pain.&#xD;
        Both electronic and paper collection of data and questionnaires will be used for the study.&#xD;
        This study will utilize REDCap (Research Electronic Data Capture), a software tool set and&#xD;
        workflow methodology for electronic collection and management of clinical and research data,&#xD;
        to collect and store data. REDCap will be used as the primary tool to collect and manage the&#xD;
        study documentation as it pertains to the screening, data collection, and participant&#xD;
        questionnaires. Paper documentation will also be available. The paper documentation would be&#xD;
        used if the REDCap system could not be accessible for some reason including but not limited&#xD;
        to internet outage, computer technical difficulties (hardware and/or software), loss of&#xD;
        power, etc.&#xD;
  &#xD;
        Testing will require only one appointment by the subject, which will last approximately 2&#xD;
        hours an include baseline testing, dry needling, and post testing. No follow up will occur&#xD;
        afterwards. Once subjects have been screened and have agreed to be included in the study they&#xD;
        will be scheduled for a 2 hour testing session. The subject will then undergo informed&#xD;
        consent, baseline testing, dry needling, and post testing. Currently we only have funding for&#xD;
        10 subjects who have bilateral knee pain and high fear of movement. They will receive a&#xD;
        consent form that details the honorarium they will receive. Those who meet the inclusion&#xD;
        criteria of the other groups that we don't have funding for, will receive a different consent&#xD;
        and hippa form that has all the same details as the other form without the honorarium&#xD;
        information. Testing will take approximately 2 hours. 10 minutes will be allocated for&#xD;
        consent and questions. 45 minutes will be allocated to the baseline testing. 15 minutes will&#xD;
        be allocated to the dry needling procedure. 45 minutes will be allocated for post testing. 5&#xD;
        minutes will be allocated for concluding the study. Summary of two hour testing session Step&#xD;
        1: Consent Subject: subjects will have already filled out screening questionnaire (inclusions&#xD;
        criteria Table 1). The informed consent process will occur and patients will be given the&#xD;
        option to consent to participate and continue in the study. Step 2: Laterality Recognition:&#xD;
        Basic - Images of left and right knees with plain background Vanilla - Basic images of left&#xD;
        and right knees in different orientations Context - Images of left and right knees in real&#xD;
        life activities Abstract - Images of left and right knees with various artwork and statues&#xD;
        Step 3: Lateral Step Down Test: 2D video analysis performed with two Go Pros to capture the&#xD;
        five repetitions of subject performing lateral step down test in frontal and sagittal plane.&#xD;
        Step 4: Muscle Force Production: Peak knee extension and flexion isometric force production&#xD;
        captured on Biodex. Step 5: Muscle Function: Cross-sectional area of vastus medialis muscle&#xD;
        measured in supine with Lumify ultrasound imaging transducer. Step 6: Dry Needling: Dry&#xD;
        needles inserted into distal vastus lateralis, rectus femoris and vastus medialis muscles.&#xD;
        Needle inserted maximally and left in situ for 15 minutes. Step 7: Repeat steps 2 thru 5:&#xD;
        Repeat laterality recognition testing, lateral step down test, muscle force production, and&#xD;
        muscle function testing.&#xD;
  &#xD;
        We plan to recruit 60 subjects; 40 with bilateral knee pain and divide them in two different&#xD;
        groups: high fear (Tampa Kinesiophobia Scale &gt; 37), low fear (Tampa Kinesiophobia Scale = or&#xD;
        &lt; 37), and 20 healthy controls into a group without knee pain. In order to be adequately&#xD;
        powered, our goal is to recruit 20 subjects per group. Currently we only have funding for 10&#xD;
        subjects who have bilateral knee pain and high fear of movement. They will receive a consent&#xD;
        form that details the honorarium they will receive. Those who meet the inclusion criteria of&#xD;
        the other groups that we don't have funding for, will receive a different consent and hippa&#xD;
        form that has all the same details as the other form without the honorarium information.&#xD;
        Based on previous research and sample size power calculation using the statistical analysis&#xD;
        software STATA, 10 subjects are required to yield a medium effect size, alpha level of 0.01&#xD;
        and power level of 0.80. This meets our goal of being adequately powered to assess for&#xD;
        laterality recognition deficits, however we plan to recruit 60 total subjects with 20&#xD;
        subjects for each group so we can be adequately powered to assess for differences in each&#xD;
        group for all mentioned variables.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 21, 2020</start_date>
    <completion_date type="Anticipated">July 21, 2030</completion_date>
    <primary_completion_date type="Anticipated">July 21, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Accuracy and response time from left right judgement task</measure>
      <time_frame>Complete immediately before, and immediately after dry needling procedure.</time_frame>
      <description>This is referred to as implicit motor imagery performance and participants have to accurately identify if a group of randomized knee images is a left or a right.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>2D Video Assessment of Movement Patterns During Lateral step down test.</measure>
      <time_frame>Complete immediately before, and immediately after dry needling procedure.</time_frame>
      <description>Participant will perform lateral step down test while GoPro videos capture the movement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle depth of of vastus medialis oblique muscle as measured by Lumify US unit</measure>
      <time_frame>Complete immediately before and immediately after dry needling procedure.</time_frame>
      <description>Depth of muscle will be measured with diagnostic US.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Patellofemoral Pain</condition>
    <arm_group>
      <arm_group_label>Bilateral Patellofemoral Pain with Fear of Movement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The first group will consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bilateral Patellofemoral Pain with Low Fear of Movement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The second group with consist of 20 subjects with bilateral chronic anterior knee pain and low fear of movement between ages of 18 and 40 years old.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy controls without knee pain</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The third group will consist of healthy controls without knee pain between 18 and 40 years old.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dry needling</intervention_name>
      <description>Dry needling will be performed by licensed physical therapists who are formally trained in dry needling and meet all of the requirements of the state of Ohio and agree to participate as key personnel in this study. These therapists will receive specialized training in the study protocol including appropriate documentation, standardized dry needling technique/procedures, and study communication. Dry needling will be performed in a clean field using sterile acupuncture needles of appropriate length to pierce muscle bellies based on patient size and muscle mass.</description>
      <arm_group_label>Bilateral Patellofemoral Pain with Fear of Movement</arm_group_label>
      <arm_group_label>Bilateral Patellofemoral Pain with Low Fear of Movement</arm_group_label>
      <arm_group_label>Healthy controls without knee pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For high fear group: Age between 18 and 40 years old, pain greater than or equal to 3&#xD;
               months, Tampa scale of kinesiophobia &gt;37, anterior knee pain scale &lt;90, and no&#xD;
               evidence of knee OA&#xD;
  &#xD;
            -  For low fear group: Age between 18 and 40 years old, pain greater than or equal to 3&#xD;
               months, Tampa scale of kinesiophobia &lt;37, anterior knee pain scale &lt;90, and no&#xD;
               evidence of knee OA&#xD;
  &#xD;
            -  For control group: no surgery in past 6 months, age between 18 and 40 years old, no&#xD;
               knee OA, Tampa Scale &lt;10, and anterior knee pains scale &gt;90&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Knee surgery in past 6 months, previous dry needling or acupuncture to knee,&#xD;
               pregnancy, menicscal/cartilage/ligamentous injury, history of patellar subluxations,&#xD;
               dislocations, or MPFL reconstruction, contraindications to dry needling or&#xD;
               acupuncture, or neurological condition that affects movement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew S Briggs, DPT, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Ohio State University Wexner Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The Ohio State University Wexner Medical Center, Jameson Crane Sports Medicine Institute</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43202</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University</investigator_affiliation>
      <investigator_full_name>Matt Briggs</investigator_full_name>
      <investigator_title>Assistant Professor-Practice</investigator_title>
    </responsible_party>
    <keyword>Knee</keyword>
    <keyword>Dry needling</keyword>
    <keyword>Acupuncture</keyword>
    <keyword>Implicit Motor Imagery</keyword>
    <keyword>Graded Motor Imagery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Patellofemoral Pain Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976269
  org study id: 2020H0332
  nct id: NCT05976269
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This project will evaluate the effects of bilateral knee pain and dry needling (DN) on
        laterality recognition, movement and muscle function. The objective is to determine if
        laterality recognition accuracy deficits are present in individuals with bilateral chronic
        knee pain and if DN affects 'central' and 'peripheral' musculoskeletal measurements. Chronic
        musculoskeletal pain results in changes to the way the brain perceives pain and left-right
        discrimination between body parts. This phenomenon has been established for individuals with
        chronic back pain and chronic regional pain syndrome, but has not been described for
        individuals with bilateral knee pain without the presence of knee OA. Dry needling involves
        the insertion of a small diameter monofilament needle into muscle, and has been purported to
        affect the neuromuscular system both centrally and peripherally. Sixty individuals between 18
        and 40 years old will be recruited and allocated into three groups. The first group will
        consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of
        movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37. The
        second group with consist of 20 subjects with bilateral chronic anterior knee pain and low
        fear of movement between ages of 18 and 40 years old, and the third group will consist of
        healthy controls without knee pain between 18 and 40 years old. All subjects will undergo
        baseline testing consisting of laterality recognition, movement analysis, muscle force
        production, and ultrasound imaging. Subjects will undergo laterality recognition testing
        using the Neuro Orthopaedic Institute (NOI) Recognise Knee phone application. 2D video
        analysis of the lateral step down test will be performed followed by peak isometric force
        production assessment of knee extension and flexion. Muscle function of the vastus medialis
        will be measured with ultrasound imaging where cross-sectional area and other measurements
        (tendon length, muscle thickness, etc) will be captured with Lumify ultrasound imaging
        transducer. Then DN to the quadriceps will be performed. After DN procedure, subjects will
        undergo aforementioned measurements from baseline testing. Testing will require only one
        appointment by the subject, which will last approximately 2 hours an include baseline
        testing, dry needling, and post testing. No follow up will occur afterwards.
  The primary purpose of this study is to identify if a loss of laterality recognition is
        present in individuals with bilateral chronic knee pain with kinesiophobia and if DN affects
        short term central and peripheral neuromuscular measurements. The goal of this project is to
        recruit 20 individuals with bilateral knee pain greater than three months between the ages of
        18 and 40 years old without evidence of knee OA and with fear of movement as evidenced by the
        Tampa Scale of Kinesiophobia with the following aims: [1] Determine if these individuals have
        a loss of laterality recognition associated with chronic pain that affects the way the brain
        processes images of a left or right knee using the Neuro Orthopaedic Institute (NOI)
        Recogonise Knee phone application for iPhone or Android. [2] Assess muscle force production
        by measuring peak knee extension and flexion isometric force production on a Biodex System II
        dynamometer (Biodex Medical Systems, Inc. Shirley, New York, USA). [3] Measure muscle
        function of the quadriceps using ultrasound imaging to assess for changes in cross sectional
        area, tendon length, muscle thickness, and other relevant measurements that could be captured
        (i.e. pennation angle) of the vastus medialis (VM) muscle. [4] Assess movement quality with
        the lateral step down test and using 2D video analysis measure trunk flexion, knee flexion,
        closed chain dorsiflexion, pelvic drop and patellar projection angle. [5] Determine if DN
        causes an immediate change on the central (laterality recognition) and peripheral (muscle
        force production, function, movement) neuromuscular system. [6] Elucidate if there are
        differences between individuals with bilateral knee pain and high fear of movement and
        bilateral knee pain and low fear of movement. We also will recruit 20 subjects with bilateral
        knee pain and low fear of movement, and 20 subjects who are healthy without any knee pain. To
        the authors knowledge only one study has identified laterality recognition deficits in a
        population with knee OA. Currently there is not a single publication that assesses laterality
        recognition deficits for individuals with bilateral knee pain without the presence of knee
        OA. This study has the potential to inform physical therapists that deliver interventions
        such as pain neuroscience education, graded motor imagery (left-right discrimination,
        explicit motor imagery, mirror therapy), movement/muscle function assessment, and DN, to
        improve their decision-making, evaluation, and treatment skills.
  
        To facilitate recruitment we are applying for a partial HIPAA waiver for this project in
        order to recruit patients undergoing/seeking care for their knee pain with a physician or
        physical therapist. The only pertinent PHI to be screened will be age, diagnosis codes
        related to knee pain, and factors related to inclusion and exclusion criteria. Of this
        information, only eligibility criteria (inclusion/exclusion factors) will be screened by the
        research team. This information screened in the electronic medical record will not be written
        down or stored anywhere. Once a research associate identifies a patient that may qualify for
        the study, the patient will fill out a survey link from REDCap, where the data will be stored
        containing their name, contact information, and screening questions related to their
        eligibility of the study (inclusion/exclusion criteria). This information will be preserved
        in REDCap, a secure online platform for data storage, for the sole purpose of avoiding
        contacting subjects repetitively regarding interest in study participation. Only pertinent
        PHI will be screened such as age, diagnosis codes related to knee pain, and factors related
        to inclusion and exclusion criteria. None of this information will be stored by the research
        team. Once a research associate identifies a patient that may qualify for the study, the
        patient will fill out a survey link from REDCap, where the data will be stored containing
        their name, contact information, and screening questions related to their eligibility of the
        study. Participants in this study do not have to be current patients. If a potential
        participant who is not a current patient reaches out to the research team, they will be given
        the survey link from REDCap. After this survey is completed, a research associate will
        determine their eligibility for the study. This means recruits for the study may come from
        the community who have not necessarily seen a PT, MD, or DO. All interventions, including dry
        needling, and outcomes measured (pain, outcome questionnaires, strength, range of motion,
        functional assessment, etc.) are commonly performed during current physical therapy practice
        and treatment. For this study the investigators are formalizing the collection of these
        measures. Testing will require only one appointment by the subject, which will last
        approximately 2 hours an include baseline testing, dry needling, and post testing. No follow
        up will occur afterwards. Specific testing procedures related to this protocol include the
        following: 1) Laterality recognition testing, where the subject will look through an
        application called NOI Recognoise Knee on an iPhone or iPad and select if the image they are
        looking at is a left or right knee. 2) Cross-sectional area and other measurements (tendon
        length, muscle thickness, etc) of vastus medialis muscle measured in supine with Lumify
        ultrasound imaging transducer. 3) 2D movement analysis will be performed of subjects
        performing the lateral step down test. 4) Peak knee extension and flexion isometric force
        production will be captured using the Biodex. 5) Dry needling will be provided to all
        subjects using a clean technique commonly used in clinical care. Dry needling intervention
        will be provided to the quadriceps muscle using a standardized protocol. Dry needle will be
        inserted in and out and/or twisted clockwise for a maximum of 30" at the discretion of the
        researcher and tolerance of participant, and then the needle will be left in situ for 15
        minutes. Several studies have demonstrated the safety of this technique. If participant is
        unable to tolerate the DN procedure, the procedure will be stopped and needles removed. The
        participant can stop participation at any time during the study. 6) Step 1-4 will be
        repeated. In summary, the process will look like this: Consent, Baseline testing, dry
        needling, post testing in a 2 hour session. In addition, specific examination data from the
        subjects' will be recorded such as age, height, weight and details about their knee pain.
        Both electronic and paper collection of data and questionnaires will be used for the study.
        This study will utilize REDCap (Research Electronic Data Capture), a software tool set and
        workflow methodology for electronic collection and management of clinical and research data,
        to collect and store data. REDCap will be used as the primary tool to collect and manage the
        study documentation as it pertains to the screening, data collection, and participant
        questionnaires. Paper documentation will also be available. The paper documentation would be
        used if the REDCap system could not be accessible for some reason including but not limited
        to internet outage, computer technical difficulties (hardware and/or software), loss of
        power, etc.
  
        Testing will require only one appointment by the subject, which will last approximately 2
        hours an include baseline testing, dry needling, and post testing. No follow up will occur
        afterwards. Once subjects have been screened and have agreed to be included in the study they
        will be scheduled for a 2 hour testing session. The subject will then undergo informed
        consent, baseline testing, dry needling, and post testing. Currently we only have funding for
        10 subjects who have bilateral knee pain and high fear of movement. They will receive a
        consent form that details the honorarium they will receive. Those who meet the inclusion
        criteria of the other groups that we don't have funding for, will receive a different consent
        and hippa form that has all the same details as the other form without the honorarium
        information. Testing will take approximately 2 hours. 10 minutes will be allocated for
        consent and questions. 45 minutes will be allocated to the baseline testing. 15 minutes will
        be allocated to the dry needling procedure. 45 minutes will be allocated for post testing. 5
        minutes will be allocated for concluding the study. Summary of two hour testing session Step
        1: Consent Subject: subjects will have already filled out screening questionnaire (inclusions
        criteria Table 1). The informed consent process will occur and patients will be given the
        option to consent to participate and continue in the study. Step 2: Laterality Recognition:
        Basic - Images of left and right knees with plain background Vanilla - Basic images of left
        and right knees in different orientations Context - Images of left and right knees in real
        life activities Abstract - Images of left and right knees with various artwork and statues
        Step 3: Lateral Step Down Test: 2D video analysis performed with two Go Pros to capture the
        five repetitions of subject performing lateral step down test in frontal and sagittal plane.
        Step 4: Muscle Force Production: Peak knee extension and flexion isometric force production
        captured on Biodex. Step 5: Muscle Function: Cross-sectional area of vastus medialis muscle
        measured in supine with Lumify ultrasound imaging transducer. Step 6: Dry Needling: Dry
        needles inserted into distal vastus lateralis, rectus femoris and vastus medialis muscles.
        Needle inserted maximally and left in situ for 15 minutes. Step 7: Repeat steps 2 thru 5:
        Repeat laterality recognition testing, lateral step down test, muscle force production, and
        muscle function testing.
  
        We plan to recruit 60 subjects; 40 with bilateral knee pain and divide them in two different
        groups: high fear (Tampa Kinesiophobia Scale > 37), low fear (Tampa Kinesiophobia Scale = or
        < 37), and 20 healthy controls into a group without knee pain. In order to be adequately
        powered, our goal is to recruit 20 subjects per group. Currently we only have funding for 10
        subjects who have bilateral knee pain and high fear of movement. They will receive a consent
        form that details the honorarium they will receive. Those who meet the inclusion criteria of
        the other groups that we don't have funding for, will receive a different consent and hippa
        form that has all the same details as the other form without the honorarium information.
        Based on previous research and sample size power calculation using the statistical analysis
        software STATA, 10 subjects are required to yield a medium effect size, alpha level of 0.01
        and power level of 0.80. This meets our goal of being adequately powered to assess for
        laterality recognition deficits, however we plan to recruit 60 total subjects with 20
        subjects for each group so we can be adequately powered to assess for differences in each
        group for all mentioned variables.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Accuracy and response time from left right judgement task
  time frame: Complete immediately before, and immediately after dry needling procedure.
  description: This is referred to as implicit motor imagery performance and participants have to accurately identify if a group of randomized knee images is a left or a right.
  measure: 2D Video Assessment of Movement Patterns During Lateral step down test.
  time frame: Complete immediately before, and immediately after dry needling procedure.
  description: Participant will perform lateral step down test while GoPro videos capture the movement.
  measure: Muscle depth of of vastus medialis oblique muscle as measured by Lumify US unit
  time frame: Complete immediately before and immediately after dry needling procedure.
  description: Depth of muscle will be measured with diagnostic US.
  arm group label: Bilateral Patellofemoral Pain with Fear of Movement
  arm group type: Experimental
  description: The first group will consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37.
  arm group label: Bilateral Patellofemoral Pain with Low Fear of Movement
  arm group type: Experimental
  description: The second group with consist of 20 subjects with bilateral chronic anterior knee pain and low fear of movement between ages of 18 and 40 years old.
  arm group label: Healthy controls without knee pain
  arm group type: Active Comparator
  description: The third group will consist of healthy controls without knee pain between 18 and 40 years old.
  intervention type: Procedure
  intervention name: Dry needling
  description: Dry needling will be performed by licensed physical therapists who are formally trained in dry needling and meet all of the requirements of the state of Ohio and agree to participate as key personnel in this study. These therapists will receive specialized training in the study protocol including appropriate documentation, standardized dry needling technique/procedures, and study communication. Dry needling will be performed in a clean field using sterile acupuncture needles of appropriate length to pierce muscle bellies based on patient size and muscle mass.
  arm group label: Bilateral Patellofemoral Pain with Fear of Movement
  arm group label: Bilateral Patellofemoral Pain with Low Fear of Movement
  arm group label: Healthy controls without knee pain
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew S Briggs, DPT, PhD
  role: Principal Investigator
  affiliation: The Ohio State University Wexner Medical Center
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University
  investigator full name: Matt Briggs
  investigator title: Assistant Professor-Practice
  mesh term: Patellofemoral Pain Syndrome
  sharing ipd: No