Effects of Taping on Pregnancy-related Back Pain

NCT03807908 | Unknown

• 1 other identifier: 182028
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Low Back Pain; Pelvic Girdle Pain

Keywords

Pregnancy; Low back pain; Pelvic girdle pain; Kinesiotape

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention Tape

EXPERIMENTAL

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

Sham Tape

SHAM COMPARATOR

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

Interventions

Tape OTHER

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).

Also known as: Kinesiotape

Intervention Tape

Sham Tape OTHER

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).

Also known as: Kinesiotape

Sham Tape

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participants must be experiencing a healthy, non-complicated pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead
• Sunnybrook Health Sciences Centre: collaborator

MeSH Terms

Conditions

Low Back Pain; Pelvic Girdle Pain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Pain; Pelvic Pain

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies; Orthotic Devices; Orthopedic Equipment; Surgical Equipment

Study Officials

• Carol Ann Weis, MSc, DC

  Canadian Memorial Chiropractic College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Ann Weis, MSc, DC

CONTACT

416 738 2058; cweis@cmcc.ca

Mark Fillery, MSc

CONTACT

416 482 2340; mfillery@cmcc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2019
• First Posted: January 17, 2019
• Study Start: July 31, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share