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
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Low back pain, Pelvic girdle pain, Kinesiotape
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
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
NCT ID
NCT03807908
First Posted
January 12, 2019
Last Updated
July 24, 2019
Sponsor
Canadian Memorial Chiropractic College
Collaborators
Sunnybrook Health Sciences Centre
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
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Effects of Taping on Pregnancy-related Back Pain
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