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Effects of Taping on Pregnancy-related Back Pain

Primary Purpose

Pregnancy, Low Back Pain, Pelvic Girdle Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tape
Sham Tape
Sponsored by
Canadian Memorial Chiropractic College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Low back pain, Pelvic girdle pain, Kinesiotape

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy females of childbearing age
  • Currently experiencing a healthy, singleton pregnancy and are at 28 weeks of gestation or later
  • Proficient competency in the English language

Exclusion Criteria:

  • Does not wish to participate
  • Carrying multiples
  • Inability to understand the questionnaire due to a lack of understanding of the English language
  • Allergy to tape and/or adhesives (acrylic copolymer)
  • Prior spinal surgery
  • A known and current disc pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention Tape

    Sham Tape

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later
    Intensity of pain on a 0-10 scale; 0=no pain; 10=most severe pain
    Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
    Measure of a patient's functional disability

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2019
    Last Updated
    July 24, 2019
    Sponsor
    Canadian Memorial Chiropractic College
    Collaborators
    Sunnybrook Health Sciences Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03807908
    Brief Title
    Effects of Taping on Pregnancy-related Back Pain
    Official Title
    The Short-term Effects of Taping During Pregnancy-related Low Back Pain, Pelvic Girdle Pain or Combined Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 31, 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Canadian Memorial Chiropractic College
    Collaborators
    Sunnybrook Health Sciences Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pregnancy, Low Back Pain, Pelvic Girdle Pain
    Keywords
    Pregnancy, Low back pain, Pelvic girdle pain, Kinesiotape

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Tape
    Arm Type
    Experimental
    Arm 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 Title
    Sham Tape
    Arm Type
    Sham Comparator
    Arm 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(s)
    Tape
    Other Intervention Name(s)
    Kinesiotape
    Intervention 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).
    Intervention Type
    Other
    Intervention Name(s)
    Sham Tape
    Other Intervention Name(s)
    Kinesiotape
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later
    Description
    Intensity of pain on a 0-10 scale; 0=no pain; 10=most severe pain
    Time Frame
    7 days
    Title
    Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
    Description
    Measure of a patient's functional disability
    Time Frame
    7 days

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Participants must be experiencing a healthy, non-complicated pregnancy
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy females of childbearing age Currently experiencing a healthy, singleton pregnancy and are at 28 weeks of gestation or later Proficient competency in the English language Exclusion Criteria: Does not wish to participate Carrying multiples Inability to understand the questionnaire due to a lack of understanding of the English language Allergy to tape and/or adhesives (acrylic copolymer) Prior spinal surgery A known and current disc pathology
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carol Ann Weis, MSc, DC
    Phone
    416 738 2058
    Email
    cweis@cmcc.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark Fillery, MSc
    Phone
    416 482 2340
    Email
    mfillery@cmcc.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carol Ann Weis, MSc, DC
    Organizational Affiliation
    Canadian Memorial Chiropractic College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Taping on Pregnancy-related Back Pain

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