<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/NCT03807908</url>
  </required_header>
  <id_info>
    <org_study_id>182028</org_study_id>
    <nct_id>NCT03807908</nct_id>
  </id_info>
  <brief_title>Effects of Taping on Pregnancy-related Back Pain</brief_title>
  <official_title>The Short-term Effects of Taping During Pregnancy-related Low Back Pain, Pelvic Girdle Pain or Combined Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canadian Memorial Chiropractic College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Canadian Memorial Chiropractic College</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>
      Back pain during pregnancy is common with up to 90% of pregnant women experiencing either low&#xD;
      back pain (PLBP), pelvic girdle pain (PGP) or a combination of both pains. Although pregnant&#xD;
      women seek out various forms of pain relief methods such as pain medication, exercise,&#xD;
      education, pelvic support belts, and chiropractic treatments, there is limited evidence with&#xD;
      regards to the efficacy of these treatments. Recently manual therapists, such as&#xD;
      chiropractors, have used tape in an effort to relieve pain from musculoskeletal injuries with&#xD;
      varying results. In the pregnant population, there have been limited studies to date on the&#xD;
      role of taping and pregnancy-related back pain and none of this research delineates the&#xD;
      efficacy of tape with respect to the 3 pain patterns experienced by pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized control trial with 3 main parts associated. 1) Initial visit:&#xD;
      Potential participants will be recruited from 2 antenatal clinics at the participating&#xD;
      hospital. A person from the circle of care will ask if they are interested in participating&#xD;
      in a study regarding pregnancy-related LBP. Participants are pre-screened by a research&#xD;
      investigator, If patients meet the eligibility criteria, they will be invited to participate.&#xD;
      Research personnel will explain the study in full including the rationale (per the Project&#xD;
      Consent Form), visit requirement, treatment protocol and follow-up. Once consent is obtained,&#xD;
      a Pre-Visit Questionnaire will be administered while they are awaiting their antenatal&#xD;
      appointment. 2) Physical exam and treatment: Following their appointment, research personnel&#xD;
      will walk the participant to the Obstetrical Day Unit where the chiropractor will review the&#xD;
      consent and questionnaire, perform a brief physical exam to ensure proper stratification of&#xD;
      pain, randomized the participant (as pre-determined by the biostatistician) and apply the&#xD;
      appropriate taping protocol (intervention vs sham). 3) Follow-up: Five to 7 days later,&#xD;
      research personnel will follow-up with the participant by phone and administer a&#xD;
      questionnaire pertaining to their experience with the taping protocol. The total visit should&#xD;
      take no more than 30 minute&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 31, 2019</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Single Group Assignment</intervention_model>
    <intervention_model_description>The study will be a randomized clinical trial. As none of the current research delineates the 3 pains during pregnancy, it would be beneficial to further investigate the use of tape for LBP, PGP or combined pain during pregnancy. As such, the participants will be stratified upon pain presentation (via history and physical exam) and then randomized into either a treatment or sham protocol.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Once consent has been obtained the senior chiropractors will review the intake questionnaire with the patients, ask any pertinent questions they may have regarding the patient's personal medical history and current pain pattern and perform a physical exam to differentiate pain patterns for each participant.&#xD;
Following completion of baseline assessment and consent, participants will be stratified by their type of pain presentation and then be randomly allocated to 1 of the 2 intervention arms. Central randomization will be performed using stratified block randomization by the study biostatistician (SHJ) using SAS software*. To ensure that the allocation sequence is concealed from the researchers varying block sizes of 2, 4 and 6 will be used and the biostatistician will provide the trial coordinator with 3 series (1 for each stratum) of sequentially numbered sealed opaque envelopes containing the intervention allocations.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later</measure>
    <time_frame>7 days</time_frame>
    <description>Intensity of pain on a 0-10 scale; 0=no pain; 10=most severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later</measure>
    <time_frame>7 days</time_frame>
    <description>Measure of a patient's functional disability</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Pregnancy</condition>
  <condition>Low Back Pain</condition>
  <condition>Pelvic Girdle Pain</condition>
  <arm_group>
    <arm_group_label>Intervention Tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention includes 3 strips of tape; 2 (1 on each side) placed vertically along the lumbar erectors and 1 horizontally at the posterior superior iliac spine.&#xD;
Subjects will wear the tape for as long as possible up to 5-7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Tape</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>One strip of tape will be applied horizontally to the thoracolumbar junction.&#xD;
Subjects will wear the tape for as long as possible up to 5-7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tape</intervention_name>
    <description>The patient will be placed into maximal flexion of the lumbar spine prior to the tape being applied. The vertical strips will be applied on either side of spine, on the erector muscle group; from the lower PSIS with and end around the twelfth rib. The third strip of tape will be applied horizontally to superior to the posterior superior iliac spines (PSIS) and extend over the 2 vertical strips of tape. The tape will be gently rubbed to activate the adhesive.&#xD;
Five to 7 days later, one of the investigators will follow up with the subjects over the phone and administer a questionnaire that will assess their experience with the tape as well as the outcome measures (numeric rating scale and Oswestry Disability Index).</description>
    <arm_group_label>Intervention Tape</arm_group_label>
    <other_name>Kinesiotape</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Tape</intervention_name>
    <description>One strip of tape will be applied horizontally to the thoracolumbar junction (at the level of the lower rib cage over the T12-L1 spinous processes) with no tape-tension. The tape will be gently rubbed to activate the adhesive.&#xD;
Five to 7 days later, one of the investigators will follow up with the subjects over the phone and administer a questionnaire that will assess their experience with the tape as well as the outcome measures (numeric rating scale and Oswestry Disability Index).</description>
    <arm_group_label>Sham Tape</arm_group_label>
    <other_name>Kinesiotape</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy females of childbearing age&#xD;
&#xD;
          -  Currently experiencing a healthy, singleton pregnancy and are at 28 weeks of gestation&#xD;
             or later&#xD;
&#xD;
          -  Proficient competency in the English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not wish to participate&#xD;
&#xD;
          -  Carrying multiples&#xD;
&#xD;
          -  Inability to understand the questionnaire due to a lack of understanding of the&#xD;
             English language&#xD;
&#xD;
          -  Allergy to tape and/or adhesives (acrylic copolymer)&#xD;
&#xD;
          -  Prior spinal surgery&#xD;
&#xD;
          -  A known and current disc pathology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants must be experiencing a healthy, non-complicated pregnancy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carol Ann Weis, MSc, DC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canadian Memorial Chiropractic College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carol Ann Weis, MSc, DC</last_name>
    <phone>416 738 2058</phone>
    <email>cweis@cmcc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Fillery, MSc</last_name>
    <phone>416 482 2340</phone>
    <email>mfillery@cmcc.ca</email>
  </overall_contact_backup>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Canadian Memorial Chiropractic College</investigator_affiliation>
    <investigator_full_name>Carol Ann Weis</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Low back pain</keyword>
  <keyword>Pelvic girdle pain</keyword>
  <keyword>Kinesiotape</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Pelvic Girdle Pain</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/NCT03807908
org study id: 182028
nct id: NCT03807908
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Back pain during pregnancy is common with up to 90% of pregnant women experiencing either low
      back pain (PLBP), pelvic girdle pain (PGP) or a combination of both pains. Although pregnant
      women seek out various forms of pain relief methods such as pain medication, exercise,
      education, pelvic support belts, and chiropractic treatments, there is limited evidence with
      regards to the efficacy of these treatments. Recently manual therapists, such as
      chiropractors, have used tape in an effort to relieve pain from musculoskeletal injuries with
      varying results. In the pregnant population, there have been limited studies to date on the
      role of taping and pregnancy-related back pain and none of this research delineates the
      efficacy of tape with respect to the 3 pain patterns experienced by pregnant women.
This study is a randomized control trial with 3 main parts associated. 1) Initial visit:
      Potential participants will be recruited from 2 antenatal clinics at the participating
      hospital. A person from the circle of care will ask if they are interested in participating
      in a study regarding pregnancy-related LBP. Participants are pre-screened by a research
      investigator, If patients meet the eligibility criteria, they will be invited to participate.
      Research personnel will explain the study in full including the rationale (per the Project
      Consent Form), visit requirement, treatment protocol and follow-up. Once consent is obtained,
      a Pre-Visit Questionnaire will be administered while they are awaiting their antenatal
      appointment. 2) Physical exam and treatment: Following their appointment, research personnel
      will walk the participant to the Obstetrical Day Unit where the chiropractor will review the
      consent and questionnaire, perform a brief physical exam to ensure proper stratification of
      pain, randomized the participant (as pre-determined by the biostatistician) and apply the
      appropriate taping protocol (intervention vs sham). 3) Follow-up: Five to 7 days later,
      research personnel will follow-up with the participant by phone and administer a
      questionnaire pertaining to their experience with the taping protocol. The total visit should
      take no more than 30 minute
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: The study will be a randomized clinical trial. As none of the current research delineates the 3 pains during pregnancy, it would be beneficial to further investigate the use of tape for LBP, PGP or combined pain during pregnancy. As such, the participants will be stratified upon pain presentation (via history and physical exam) and then randomized into either a treatment or sham protocol.
primary purpose: Treatment
masking: Single (Participant)
masking description: Once consent has been obtained the senior chiropractors will review the intake questionnaire with the patients, ask any pertinent questions they may have regarding the patient's personal medical history and current pain pattern and perform a physical exam to differentiate pain patterns for each participant.
Following completion of baseline assessment and consent, participants will be stratified by their type of pain presentation and then be randomly allocated to 1 of the 2 intervention arms. Central randomization will be performed using stratified block randomization by the study biostatistician (SHJ) using SAS software*. To ensure that the allocation sequence is concealed from the researchers varying block sizes of 2, 4 and 6 will be used and the biostatistician will provide the trial coordinator with 3 series (1 for each stratum) of sequentially numbered sealed opaque envelopes containing the intervention allocations.
measure: Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later
time frame: 7 days
description: Intensity of pain on a 0-10 scale; 0=no pain; 10=most severe pain
measure: Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
time frame: 7 days
description: Measure of a patient's functional disability
arm group label: Intervention Tape
arm group type: Experimental
description: The intervention includes 3 strips of tape; 2 (1 on each side) placed vertically along the lumbar erectors and 1 horizontally at the posterior superior iliac spine.
Subjects will wear the tape for as long as possible up to 5-7 days.
arm group label: Sham Tape
arm group type: Sham Comparator
description: One strip of tape will be applied horizontally to the thoracolumbar junction.
Subjects will wear the tape for as long as possible up to 5-7 days.
intervention type: Other
intervention name: Tape
description: The patient will be placed into maximal flexion of the lumbar spine prior to the tape being applied. The vertical strips will be applied on either side of spine, on the erector muscle group; from the lower PSIS with and end around the twelfth rib. The third strip of tape will be applied horizontally to superior to the posterior superior iliac spines (PSIS) and extend over the 2 vertical strips of tape. The tape will be gently rubbed to activate the adhesive.
Five to 7 days later, one of the investigators will follow up with the subjects over the phone and administer a questionnaire that will assess their experience with the tape as well as the outcome measures (numeric rating scale and Oswestry Disability Index).
arm group label: Intervention Tape
other name: Kinesiotape
intervention type: Other
intervention name: Sham Tape
description: One strip of tape will be applied horizontally to the thoracolumbar junction (at the level of the lower rib cage over the T12-L1 spinous processes) with no tape-tension. The tape will be gently rubbed to activate the adhesive.
Five to 7 days later, one of the investigators will follow up with the subjects over the phone and administer a questionnaire that will assess their experience with the tape as well as the outcome measures (numeric rating scale and Oswestry Disability Index).
arm group label: Sham Tape
other name: Kinesiotape
criteria: 
gender: Female
gender based: Yes
gender description: Participants must be experiencing a healthy, non-complicated pregnancy
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carol Ann Weis, MSc, DC
role: Principal Investigator
affiliation: Canadian Memorial Chiropractic College
last name: Carol Ann Weis, MSc, DC
phone: 416 738 2058
email: cweis@cmcc.ca
last name: Mark Fillery, MSc
phone: 416 482 2340
email: mfillery@cmcc.ca
responsible party type: Principal Investigator
investigator affiliation: Canadian Memorial Chiropractic College
investigator full name: Carol Ann Weis
investigator title: Researcher
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Pelvic Girdle Pain
sharing ipd: No