<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/NCT04493229</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066646</org_study_id>
    <nct_id>NCT04493229</nct_id>
  </id_info>
  <brief_title>A Pilot Feasibility Study of IM OXT on Fear of Pain and Trust in Physical Therapist During OP Rehabilitation After TKA</brief_title>
  <official_title>A Pilot Feasibility Study of Intramuscular Oxytocin on Fear of Pain and Trust in Physical Therapist During Outpatient Rehabilitation After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effect that a dose of intramuscular (IM) oxytocin (naturally&#xD;
      occurring hormone) has on fear of pain and movement and trust in the physical therapist&#xD;
      during outpatient rehabilitation after total knee replacement has been performed.&#xD;
      Investigators will ask participants to answer questions about fear of pain and movement&#xD;
      before several outpatient physical therapy session and investigators will ask participants&#xD;
      questions about trust of the physical therapist several times after the outpatient physical&#xD;
      therapy sessions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine feasibility of this study design and identify&#xD;
      barriers that altered design could bring to overcome these barriers in the design of a large,&#xD;
      pragmatic, multi-center clinical trial. It is also designed to estimate the effect size and&#xD;
      variance of the main outcome measures, trust and fear, in patients undergoing rehabilitation&#xD;
      after total knee arthroplasty (TKA). The study team hypothesizes that intramuscular (IM)&#xD;
      oxytocin, in a dose and time determined by a series of previous studies under this grant to&#xD;
      target the brain, will enhance trust and reduce fear and that these will be associated with&#xD;
      improved outcomes. Again, the study is not designed to test this hypothesis, but to gather&#xD;
      the critical data necessary to test it in a large, multi-center clinical trial that would&#xD;
      follow this grant.&#xD;
&#xD;
      Participants that have decided to undergo unilateral TKA, will come to the Pain Clinical&#xD;
      Research Unit at least 48 hours prior to surgery to confirm consent and complete a series of&#xD;
      questionnaires. Participants surgery, anesthesia, and postoperative medication and therapy&#xD;
      treatment will be routine. On the first outpatient study visit participants will complete a&#xD;
      questionnaire of fear about pain and receive an intramuscular injection of oxytocin or&#xD;
      placebo in a randomized, double blind manner. At the end of this session participants will&#xD;
      complete a questionnaire assessing the degree of trust in the therapist. Physical therapy be&#xD;
      will routine, and the fear and trust questionnaires will be completed at the 2nd, 4th, 8th,&#xD;
      and last physical therapy session as well as routine measures of progress and function. The&#xD;
      primary outcome measure is assessment of effect size and variability of the trust and fear&#xD;
      questionnaires on the 1st and 2nd visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study team decided not to proceed with project&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2024</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Randomized, double-blind study of oxytocin (IM) or placebo given</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia-11 (TSK-11)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline</time_frame>
    <description>TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.&#xD;
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia-11 (TSK-11)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication</time_frame>
    <description>TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.&#xD;
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia-11 (TSK-11)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication</time_frame>
    <description>TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.&#xD;
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia-11 (TSK-11)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication</time_frame>
    <description>TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.&#xD;
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tampa Scale of Kinesiophobia-11 (TSK-11)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication</time_frame>
    <description>TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.&#xD;
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory (WAI)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline</time_frame>
    <description>The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.&#xD;
The WAI will be completed after the outpatient post-operative physical therapy session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory (WAI)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication</time_frame>
    <description>The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.&#xD;
The WAI will be completed after the outpatient post-operative physical therapy session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory (WAI)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication</time_frame>
    <description>The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.&#xD;
The WAI will be completed after the outpatient post-operative physical therapy session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory (WAI)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication</time_frame>
    <description>The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.&#xD;
The WAI will be completed after the outpatient post-operative physical therapy session.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Working Alliance Inventory (WAI)</measure>
    <time_frame>Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication</time_frame>
    <description>The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.&#xD;
The WAI will be completed after the outpatient post-operative physical therapy session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain during straight leg raise</measure>
    <time_frame>Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery</time_frame>
    <description>During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain after straight leg raise</measure>
    <time_frame>Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery</time_frame>
    <description>During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical therapist deems stepping exercise begins; may walk up and down steps</measure>
    <time_frame>Post-operative 24-48 hours after surgery</time_frame>
    <description>During routine physical therapy after this surgery, the therapist determines when the patient is ready to begin stepping exercised during therapy. It is a subjective determination by the therapist. The outcome measure is the number of days since surgery when the therapist notes in the electronic medical record (EMR) that the patient began stepping exercises.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait speed</measure>
    <time_frame>Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery</time_frame>
    <description>Gait speed will be measured by the physical therapist at the first physical therapy session and the last physical therapy session and at varying times during physical therapy after surgery using meters/seconds. Distance in meters is divided by the number of seconds.&#xD;
This data will be recorded in the electronic medical recorded and recorded from the electronic medical record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pain score</measure>
    <time_frame>Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery</time_frame>
    <description>Patients will be asked to verbally state the average pain they have experienced in the 24 hours prior to the scheduled physical therapy session. Average pain will be measured using a verbal pain scale; 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic Consumption</measure>
    <time_frame>Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery</time_frame>
    <description>Analgesic medications will be recorded from the day previous to each therapy session. Analgesic consumption will be converted into morphine equivalents using a standard conversion table.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo IM injection will be given per randomization prior to first outpatient physical therapy session</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>IM Oxytocin</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo IM</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female &gt; 18 and &lt; 75 years of age, Body Mass Index (BMI) &lt;40.&#xD;
&#xD;
          2. Generally in good health as determined by the Principal Investigator based on prior&#xD;
             medical history, American Society of Anesthesiologists physical status 1, 2, or 3.&#xD;
             Scheduled for unilateral TKA and postoperative physical therapy at Davie Medical&#xD;
             Center.&#xD;
&#xD;
          3. Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate&#xD;
             45-100 beats per minute) without medication or for those with hypertension, pressure&#xD;
             controlled with anti-hypertensives and with a resting heart rate 45-100 beats per&#xD;
             minute.&#xD;
&#xD;
          4. Female subjects of child-bearing potential and those &lt; 1 year post-menopausal, must be&#xD;
             practicing highly effective methods of birth control such as hormonal methods (e.g.,&#xD;
             combined oral, implantable, injectable, or transdermal contraceptives), double barrier&#xD;
             methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or&#xD;
             cream), or total abstinence from heterosexual intercourse for a minimum of 1 full&#xD;
             cycle before study drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®&#xD;
&#xD;
          2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the&#xD;
             Principal Investigator, would place the subject at increased risk (active gynecologic&#xD;
             disease in which increased tone would be detrimental e.g., uterine fibroids with&#xD;
             ongoing bleeding), compromise the subject's compliance with study procedures, or&#xD;
             compromise the quality of the data&#xD;
&#xD;
          3. Women who are pregnant (positive result for urine pregnancy test at screening visit),&#xD;
             women who are currently nursing or lactating, women that have been pregnant within 2&#xD;
             years&#xD;
&#xD;
          4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines&#xD;
             or pain medications on a daily basis.&#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>James C Eisenach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_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/NCT04493229
org study id: IRB00066646
nct id: NCT04493229
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will examine the effect that a dose of intramuscular (IM) oxytocin (naturally
      occurring hormone) has on fear of pain and movement and trust in the physical therapist
      during outpatient rehabilitation after total knee replacement has been performed.
      Investigators will ask participants to answer questions about fear of pain and movement
      before several outpatient physical therapy session and investigators will ask participants
      questions about trust of the physical therapist several times after the outpatient physical
      therapy sessions.
The purpose of this study is to determine feasibility of this study design and identify
      barriers that altered design could bring to overcome these barriers in the design of a large,
      pragmatic, multi-center clinical trial. It is also designed to estimate the effect size and
      variance of the main outcome measures, trust and fear, in patients undergoing rehabilitation
      after total knee arthroplasty (TKA). The study team hypothesizes that intramuscular (IM)
      oxytocin, in a dose and time determined by a series of previous studies under this grant to
      target the brain, will enhance trust and reduce fear and that these will be associated with
      improved outcomes. Again, the study is not designed to test this hypothesis, but to gather
      the critical data necessary to test it in a large, multi-center clinical trial that would
      follow this grant.

      Participants that have decided to undergo unilateral TKA, will come to the Pain Clinical
      Research Unit at least 48 hours prior to surgery to confirm consent and complete a series of
      questionnaires. Participants surgery, anesthesia, and postoperative medication and therapy
      treatment will be routine. On the first outpatient study visit participants will complete a
      questionnaire of fear about pain and receive an intramuscular injection of oxytocin or
      placebo in a randomized, double blind manner. At the end of this session participants will
      complete a questionnaire assessing the degree of trust in the therapist. Physical therapy be
      will routine, and the fear and trust questionnaires will be completed at the 2nd, 4th, 8th,
      and last physical therapy session as well as routine measures of progress and function. The
      primary outcome measure is assessment of effect size and variability of the trust and fear
      questionnaires on the 1st and 2nd visit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind study of oxytocin (IM) or placebo given
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Tampa Scale of Kinesiophobia-11 (TSK-11)
time frame: Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline
description: TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
measure: Tampa Scale of Kinesiophobia-11 (TSK-11)
time frame: Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication
description: TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
measure: Tampa Scale of Kinesiophobia-11 (TSK-11)
time frame: Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication
description: TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
measure: Tampa Scale of Kinesiophobia-11 (TSK-11)
time frame: Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication
description: TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
measure: Tampa Scale of Kinesiophobia-11 (TSK-11)
time frame: Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
description: TSK-11 scale ranges from 11 to 44 with a higher score denoting a worse outcome.
The TSK-11 will be completed prior to the outpatient post-operative physical therapy session
measure: Working Alliance Inventory (WAI)
time frame: Postoperative Outpatient Physical Therapy Visit 1/study medication administration visit/Baseline
description: The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
measure: Working Alliance Inventory (WAI)
time frame: Postoperative Outpatient Physical Therapy Visit 2, 1-5 days after study medication
description: The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
measure: Working Alliance Inventory (WAI)
time frame: Postoperative Outpatient Physical Therapy Visit 4, 5-10 days after study medication
description: The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
measure: Working Alliance Inventory (WAI)
time frame: Postoperative Outpatient Physical Therapy Visit 8, 7 -20 days after study medication
description: The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
measure: Working Alliance Inventory (WAI)
time frame: Postoperative Outpatient Physical Therapy Final Visit, 10-60 days after study medication
description: The WAI score ranges from 24 to 72 with a higher score denoting a better outcome.
The WAI will be completed after the outpatient post-operative physical therapy session.
measure: Pain during straight leg raise
time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
description: During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.
measure: Pain after straight leg raise
time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
description: During the postoperative physical therapy sessions, pain using a 0-10 verbal scale, with 0 equivalent to NO PAIN and 10 equivalent to THE WORST PAIN IMAGINABLE will be measured and the data collected from the electronic medical record.
measure: Physical therapist deems stepping exercise begins; may walk up and down steps
time frame: Post-operative 24-48 hours after surgery
description: During routine physical therapy after this surgery, the therapist determines when the patient is ready to begin stepping exercised during therapy. It is a subjective determination by the therapist. The outcome measure is the number of days since surgery when the therapist notes in the electronic medical record (EMR) that the patient began stepping exercises.
measure: Gait speed
time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
description: Gait speed will be measured by the physical therapist at the first physical therapy session and the last physical therapy session and at varying times during physical therapy after surgery using meters/seconds. Distance in meters is divided by the number of seconds.
This data will be recorded in the electronic medical recorded and recorded from the electronic medical record.
measure: Average pain score
time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
description: Patients will be asked to verbally state the average pain they have experienced in the 24 hours prior to the scheduled physical therapy session. Average pain will be measured using a verbal pain scale; 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE.
measure: Analgesic Consumption
time frame: Post-operative outpatient physical therapy sessions, up to 12 weeks post surgery
description: Analgesic medications will be recorded from the day previous to each therapy session. Analgesic consumption will be converted into morphine equivalents using a standard conversion table.
arm group label: Oxytocin
arm group type: Experimental
description: Oxytocin IM injection will be given per randomization prior to first outpatient physical therapy session
arm group label: Placebo
arm group type: Active Comparator
description: Placebo IM injection will be given per randomization prior to first outpatient physical therapy session
intervention type: Drug
intervention name: Oxytocin
description: IM Oxytocin
arm group label: Oxytocin
other name: Pitocin
intervention type: Drug
intervention name: Placebo
description: Placebo IM
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: James C Eisenach, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
mesh term: Oxytocin
sharing ipd: No