Effects of Taping on Pregnancy-related Back Pain

Canadian Memorial Chiropractic College

Status: Unknown

Conditions: Pelvic Girdle Pain; Low Back Pain; Pregnancy

Treatments: Other: Tape; Other: Sham Tape

Study type: Interventional

Funder types: Other

Identifiers

NCT03807908

182028

Details and patient eligibility

About

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.

Full 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

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Intervention Tape

Experimental group

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.

Treatment:

Other: Tape

Sham Tape

Sham Comparator group

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.

Treatment:

Other: Sham Tape