<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/NCT04469192</url>
  </required_header>
  <id_info>
    <org_study_id>212358</org_study_id>
    <nct_id>NCT04469192</nct_id>
  </id_info>
  <brief_title>The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain</brief_title>
  <official_title>The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loyola 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>
      The findings from this project may result in pain reduction and improved mobility in pregnant&#xD;
      women with pelvic girdle pain in their second and third trimester.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this unblinded randomized controlled trial is to determine whether&#xD;
      superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among&#xD;
      pregnant women with posterior pelvic girdle pain. The investigators hypothesize that&#xD;
      superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in&#xD;
      improved NPRS scores compared to receipt of an educational pamphlet alone.&#xD;
&#xD;
      This study will include English-speaking pregnant women presenting to Loyola University&#xD;
      Medical Center obstetrics or rehabilitation clinics in their second or third trimester with&#xD;
      posterior pelvic girdle pain, defined as an NPRS score &gt; 2 onset within the past 3 months and&#xD;
      pain experienced between the posterior iliac crest and the gluteal fold, particularly in the&#xD;
      vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can&#xD;
      also occur in conjunction with/or separately in the [pubic] symphysis. NPRS scores will be&#xD;
      measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of&#xD;
      10 (Worst possible pain).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>
    <intervention_model_description>Study participants will then be randomized to cryotherapy + education vs. education alone. The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture.&#xD;
Those randomized to the intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) at this initial visit where they will be monitored for any adverse response as well as for any immediate change to the NPRS and PGQ. The participant will place the icepack over the low back region and the sacrum if the pain is bilateral. If the pain is unilateral will place the icepack over just that side.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pelvic girdle pain using the Numeric Pain Rating Scale</measure>
    <time_frame>On day 6</time_frame>
    <description>The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pelvic girdle pain using the Pelvic Girdle Questionnaire</measure>
    <time_frame>On day 6</time_frame>
    <description>The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Pelvic Girdle Pain</condition>
  <arm_group>
    <arm_group_label>cryotherapy + education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>education alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cryotherapy</intervention_name>
    <description>intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture</description>
    <arm_group_label>cryotherapy + education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture</description>
    <arm_group_label>cryotherapy + education</arm_group_label>
    <arm_group_label>education alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking pregnant women presenting in their second or third trimester with&#xD;
             acute posterior PGP (occurring within the last 3 months). Trimester will be determined&#xD;
             from the date of last menses or ultrasound date.&#xD;
&#xD;
          -  Current VAS pain score between 2-4&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking pregnant women &lt;18 or &gt;50 years old&#xD;
&#xD;
          -  Women presenting with low back pain, or posterior pelvic pain in the first trimester&#xD;
             (&lt;13 weeks gestation).&#xD;
&#xD;
          -  Women with acute low back pain in 2nd and 3rd trimester&#xD;
&#xD;
          -  Women with anterior pelvic girdle pain (pubic symphysis) alone&#xD;
&#xD;
          -  Chronic low back pain (current or past history, defined as &gt; 6 weeks of low back pain)&#xD;
&#xD;
          -  History of lumbar or pelvic fracture; degenerative disc disease; neoplasm;&#xD;
             inflammatory disease; active urogenital infection or active gastrointestinal illness;&#xD;
             previous surgery of the lumbar spine, pelvic girdle, hip joint or femur&#xD;
&#xD;
          -  History or signs of radiculopathy or other systemic neurologic disease&#xD;
&#xD;
          -  Narcotic medication use&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen Fitzgwerald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary Tulke, RN</last_name>
    <phone>708-476-2186</phone>
    <email>mtulke@luc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary J Tulke, R.N.</last_name>
      <phone>708-216-2067</phone>
      <email>mtulke@luc.edu</email>
    </contact>
    <investigator>
      <last_name>Colleen Fitzgerald, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loyola University</investigator_affiliation>
    <investigator_full_name>Colleen M. Fitzgerald, MD, MS</investigator_full_name>
    <investigator_title>MD, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Girdle Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469192
org study id: 212358
nct id: NCT04469192
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The findings from this project may result in pain reduction and improved mobility in pregnant
      women with pelvic girdle pain in their second and third trimester.
The primary objective of this unblinded randomized controlled trial is to determine whether
      superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among
      pregnant women with posterior pelvic girdle pain. The investigators hypothesize that
      superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in
      improved NPRS scores compared to receipt of an educational pamphlet alone.

      This study will include English-speaking pregnant women presenting to Loyola University
      Medical Center obstetrics or rehabilitation clinics in their second or third trimester with
      posterior pelvic girdle pain, defined as an NPRS score > 2 onset within the past 3 months and
      pain experienced between the posterior iliac crest and the gluteal fold, particularly in the
      vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can
      also occur in conjunction with/or separately in the [pubic] symphysis. NPRS scores will be
      measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of
      10 (Worst possible pain).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study participants will then be randomized to cryotherapy + education vs. education alone. The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture.
Those randomized to the intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) at this initial visit where they will be monitored for any adverse response as well as for any immediate change to the NPRS and PGQ. The participant will place the icepack over the low back region and the sacrum if the pain is bilateral. If the pain is unilateral will place the icepack over just that side.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in pelvic girdle pain using the Numeric Pain Rating Scale
time frame: On day 6
description: The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain).
measure: Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
time frame: On day 6
description: The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent).
arm group label: cryotherapy + education
arm group type: Experimental
description: intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
arm group label: education alone
arm group type: Active Comparator
description: The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
intervention type: Other
intervention name: Cryotherapy
description: intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
arm group label: cryotherapy + education
intervention type: Other
intervention name: Education
description: The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
arm group label: cryotherapy + education
arm group label: education alone
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Colleen Fitzgwerald, MD
role: Principal Investigator
affiliation: Loyola Medical Center
last name: Mary Tulke, RN
phone: 708-476-2186
email: mtulke@luc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loyola University
investigator full name: Colleen M. Fitzgerald, MD, MS
investigator title: MD, Professor
mesh term: Pelvic Girdle Pain