Effects of Taping on Pregnancy-related Back Pain

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03807908
• Other study ID #: 182028
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: July 2020

Study information

• Verified date: July 2019
• Source: Canadian Memorial Chiropractic College
• Contact: Carol Ann Weis, MSc, DC
• Phone: 416 738 2058
• Email: cweis[@]cmcc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Pelvic Girdle Pain
• Pregnancy

Intervention

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).
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	Sunnybrook Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later	Measure of a patient's functional disability	7 days