Clinical trial NCT03807908: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Low Back Pain
Pelvic Girdle Pain
Keywords: Pregnancy
Low back pain
Pelvic girdle pain
Kinesiotape
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2019-01-17
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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

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

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

Primary outcomes:
measure: Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later
timeFrame: 7 days
measure: Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Canadian Memorial Chiropractic College
name: Carol Ann Weis, MSc, DC
role: PRINCIPAL_INVESTIGATOR
References: