PregnancyNCT03807908
Effects of Taping on Pregnancy-related Back Pain
A study testing Tape in people with Pregnancy and Low Back Pain, run by Canadian Memorial Chiropractic College.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Low Back Pain, Pelvic Girdle Pain
- What is being tested?
- Tape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Pregnancy, Low Back Pain, Pelvic Girdle Pain
- Being tested
- Tape, Sham Tape
- Keywords
- Pregnancy, Low back pain, Pelvic girdle pain, Kinesiotape
- Medical subject headings
- Low Back Pain, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapeOther
Also called Kinesiotape
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 TapeOther
Also called Kinesiotape
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
Measure of a patient's functional disability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start31 Jul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Carol Ann Weis, Canadian Memorial Chiropractic College
- Investigators
- Carol Ann Weis, MSc, DC, Principal investigator, Canadian Memorial Chiropractic College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807908
- Sponsor's protocol ID
- 182028
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effects of Taping During Pregnancy-related Low Back Pain, Pelvic Girdle Pain or Combined Pain
- ClinicalTrials.gov ID
- NCT03807908
- Acronym / sponsor ID
- 182028
- Conditions
- Pregnancy, Low Back Pain, Pelvic Girdle Pain
- Keywords
- Pregnancy, Low back pain, Pelvic girdle pain, Kinesiotape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 31 Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Tape | Experimental | Other: TapeThe 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. |
| Sham Tape | Sham comparator | Other: Sham TapeOne 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TapeAlso: KinesiotapeThe 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 | Intervention Tape |
| Sham TapeAlso: KinesiotapeOne 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 | Sham Tape |
Primary outcome
Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later
Time frame: 7 days
Intensity of pain on a 0-10 scale; 0=no pain; 10=most severe pain
Change from baseline Oswestry Back Disability Index (ODI) to ODI 5-7 days later
Time frame: 7 days
Measure of a patient's functional disability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Ann Weis, MSc, DC principal investigator
Canadian Memorial Chiropractic College
Questions about this trial
What is this clinical trial studying?
A study testing Tape in people with Pregnancy and Low Back Pain, run by Canadian Memorial Chiropractic College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol Ann Weis, MSc, DC (416 738 2058, cweis@cmcc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Numeric Pain Scale (Pain) to Numeric Pain Scale (Pain) 5-7 days later (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.