Effects of Taping on Pregnancy-related Back Pain

The Short-term Effects of Taping During Pregnancy-related Low Back Pain, Pelvic Girdle Pain or Combined Pain

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain; Pregnancy; Pelvic Girdle Pain
• Intervention / Treatment: Other: Tape; Other: Sham Tape

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

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol Ann Weis, MSc, DC; Phone Number: 416 738 2058; Email: cweis@cmcc.ca
• Study Contact Backup: Name: Mark Fillery, MSc; Phone Number: 416 482 2340; Email: mfillery@cmcc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Tape; 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.	Other: Tape; 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).; Other Names: Kinesiotape
Sham Comparator: Sham Tape; 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.	Other: Sham Tape; 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).; Other Names: Kinesiotape

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days
Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later	Measure of a patient's functional disability	7 days

Collaborators and Investigators

• Sponsor: Canadian Memorial Chiropractic College
• Collaborators: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Carol Ann Weis, MSc, DC, Canadian Memorial Chiropractic College

Study record dates

Study Major Dates

• Study Start (Anticipated): July 31, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: January 12, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Low back pain; Pregnancy; Pelvic girdle pain; Kinesiotape
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Back Pain; Low Back Pain; Pelvic Girdle Pain
• Other Study ID Numbers: 182028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No