Lumbopelvic PainNCT04253717

Motor Control Exercise Program for Pregnant Women With a History of Lumbopelvic Pain

A study of Lumbopelvic Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Lumbopelvic Pain
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: 2 Apr 2021to 14 Dec 2022
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 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Being pregnant of one fetus
Being ≤ 20 weeks pregnant
Presenting a history of lumbopelvic pain

Who cannot join

Inflammatory rheumatic disease
Infectious disease
Neuromuscular disease
Vascular disease
Connective tissue disease
Severe disabling pain
Neurologic signs and symptoms

Trial locations and contacts

1 site in 1 country.

Canada1 site

Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3

Other trials in Canada

About this study

Official title: Effects of a Motor Control Exercise Program on Lumbopelvic Pain Occurrence and Intensity in Pregnant Women With a History of Lumbopelvic Pain: a Study Protocol for a Randomized Controlled Feasibility Trial.

This study protocol was designed to establish the feasibility of conducting a motor control exercise program with pregnant women presenting a history of lumbopelvic pain (LBPP) in order to reduce LBPP occurrence or limit its intensity. This randomized controlled trial also aims to preliminary assess the effectiveness of the program. To do so, 40 pregnant women with a history of LBPP will be recruited and randomly allocated to one of 2 groups: control (20 participants) or intervention (20 participants). The control group will receive standard care, including basic information on what to do when suffering from LBPP. The intervention group will participate in a weekly 40-minute group session and two more 40-minute weekly home exercise sessions. The motor control exercise program will be designed to target strengthening of the lumbo-pelvic-hip core muscles in order to improve stabilization and protection of the spine and pelvis. Participants of this group will also receive standard care. Adequate prevention and treatment of LBPP, experienced by women during pregnancy, should help reduce LBPP occurrence or limit its intensity during pregnancy.

Conditions: Lumbopelvic Pain
Being tested: Motor control exercise program
Keywords: Physical activity, Non-invasive treatment
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motor control exercise programOther
Structure physical training aimed at strengthening muscles of the lumbo-pelvic-hip core complex in order to improve stabilization and alignment of the spine and pelvis.

Study groups in NCT04253717
Study group	Role	What they receive
Motor control exercise program	Experimental	Participants will be physically trained during pregnancy and will receive the standard care including basic information on what to do when suffering from lumbopelvic pain. Receives: Other: Motor control exercise program
Control	No intervention	Participants will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.

What is being measured

The primary outcome is the main question the study is designed to answer.

Recruitment rate
Defined as the ability to recruit 40 eligible women, willing to participate to the study
Measured: Baseline (Pre-intervention)
Retention rate
Defined as the completion of follow-up questionnaire by ≥ 80% of women
Measured: Baseline (Post-intervention)
Adherence rate
Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions
Measured: Baseline (Post-intervention)
Safety of the intervention
Determined based on the number of adverse events and defined as nature of adverse events
Measured: 16 weeks follow-up
Safety of the intervention
Determined based on the number of adverse events and defined as nature of adverse events
Measured: Week 16 (Post-intervention)
Acceptability of the intervention
Determined based on how the intervention is perceived by pregnant women (assessed using a 5-point Likert scale : higher score mean a better outcome)
Measured: 16 weeks follow-up
Acceptability of the intervention
Determined based on how the intervention is perceived by pregnant women (assessed using a 5-point Likert scale : higher score mean a better outcome)
Measured: Week 16 (Post-intervention)

Secondary outcomes (11)

Functional disability
Assessed using the Pelvic Girdle Questionnaire (PGQ) (score range from 0 (minimum) to 75 (maximum) : higher score mean a worst outcome)
Measured: Baseline (Pre-intervention) and week 16 (Post-intervention)
Fear avoidance behaviors
Assessed using the Tampa Scale of Kinesiophobia (TSK) (score range from 17 (minimum) to 68 (maximum) : higher score mean a worst outcome)
Measured: Baseline (Pre-intervention) and week 16 (Post-intervention)
Level of anxiety
Assessed using the State-Trait Anxiety Inventory (STAI) (score range from 20 (minimum) to 80 (maximum) : higher score mean a worst outcome)
Measured: Baseline (Pre-intervention) and week 16 (Post-intervention)
Depression
Assessed using the Beck Depression Inventory (BDI) (score range from 0 (minimum) to 63 (maximum) : higher score mean a worst outcome)
Measured: Baseline (Pre-intervention) and week 16 (Post-intervention)
Physical activity levels
Assessed using the Pregnancy Physical Activity Questionnaire (PPAQ) (weekly energy expenditure (MET-h·week-1), score range from 0 (minimum) to 1631 (maximum) : higher score mean a more active person)
Measured: Baseline (Pre-intervention) and week 16 (Post-intervention)
Lumbopelvic pain (incidence and frequency)
Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
Measured: Baseline (Pre-intervention)
Lumbopelvic pain (incidence and frequency)
Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
Measured: 16 weeks follow-up
Lumbopelvic pain (incidence and frequency)
Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
Measured: Week 16 (Post-intervention)
Lumbopelvic pain (intensity)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Measured: Baseline (Pre-intervention)
Lumbopelvic pain (intensity)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Measured: 16 weeks follow-up
Lumbopelvic pain (intensity)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Measured: Week 16 (Post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202114 Dec 2022

First posted5 Feb 2020
Study start2 Apr 2021
Primary completion14 Dec 2022
Study completion14 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Lumbopelvic PainStudies 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: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04253717
Sponsor's protocol ID: UQTR-2019-LBPP-Intervention
Status last verified: May 2023
First submitted: 28 Jan 2020
Last updated: 9 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Daneau C, Babineau V, Marchand AA, Bussieres A, O'Shaughnessy J, Descarreaux M, Ruchat SM. Motor control exercise program versus standard care in the treatment of lumbopelvic pain in pregnant women: a randomized controlled pilot trial. Chiropr Man Therap. 2026 May 30;34(1):30. doi: 10.1186/s12998-026-00655-x.
PubMed 42218482
Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.
PubMed 35313988

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Not yet recruiting
Visual Feedback-Assisted Sensorimotor Training in Chronic Nonspecific Low Back Pain
Chronic Low Back Pain
Recruiting
Effects of MET With and Without Lumbopelvic Manipulation
Anterior Pelvic Tilt
Active, not recruiting
Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain

All Lumbopelvic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Motor Control Exercise Program on Lumbopelvic Pain Occurrence and Intensity in Pregnant Women With a History of Lumbopelvic Pain: a Study Protocol for a Randomized Controlled Feasibility Trial.
ClinicalTrials.gov ID: NCT04253717
Acronym / sponsor ID: UQTR-2019-LBPP-Intervention
Conditions: Lumbopelvic Pain
Keywords: Physical activity, Non-invasive treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Université du Québec à Trois-RivièresUniversity, hospital or other
Study start: 2 Apr 2021 (actual)
Primary completion: 14 Dec 2022 (actual)
Study completion: 14 Dec 2022 (actual)
First posted: 5 Feb 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Motor control exercise program	Experimental	Other: Motor control exercise programParticipants will be physically trained during pregnancy and will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.
Control	No intervention	–Participants will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Being pregnant of one fetus
Being ≤ 20 weeks pregnant
Presenting a history of lumbopelvic pain

Key exclusion criteria (7 listed)

Inflammatory rheumatic disease
Infectious disease
Neuromuscular disease
Vascular disease
Connective tissue disease

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
Motor control exercise programStructure physical training aimed at strengthening muscles of the lumbo-pelvic-hip core complex in order to improve stabilization and alignment of the spine and pelvis.	Other	Motor control exercise program

Primary outcome

Recruitment rate
Time frame: Baseline (Pre-intervention)
Defined as the ability to recruit 40 eligible women, willing to participate to the study
Retention rate
Time frame: Baseline (Post-intervention)
Defined as the completion of follow-up questionnaire by ≥ 80% of women
Adherence rate
Time frame: Baseline (Post-intervention)
Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions
Safety of the intervention
Time frame: 16 weeks follow-up
Determined based on the number of adverse events and defined as nature of adverse events
Safety of the intervention
Time frame: Week 16 (Post-intervention)
Determined based on the number of adverse events and defined as nature of adverse events
Acceptability of the intervention
Time frame: 16 weeks follow-up
Determined based on how the intervention is perceived by pregnant women (assessed using a 5-point Likert scale : higher score mean a better outcome)
Acceptability of the intervention
Time frame: Week 16 (Post-intervention)
Determined based on how the intervention is perceived by pregnant women (assessed using a 5-point Likert scale : higher score mean a better outcome)

11 secondary outcomes

Functional disability
Time frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Fear avoidance behaviors
Time frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Level of anxiety
Time frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Depression
Time frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Physical activity levels
Time frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Lumbopelvic pain (incidence and frequency)
Time frame: Baseline (Pre-intervention)
Lumbopelvic pain (incidence and frequency)
Time frame: 16 weeks follow-up
Lumbopelvic pain (incidence and frequency)
Time frame: Week 16 (Post-intervention)
Lumbopelvic pain (intensity)
Time frame: Baseline (Pre-intervention)
Lumbopelvic pain (intensity)
Time frame: 16 weeks follow-up
Lumbopelvic pain (intensity)
Time frame: Week 16 (Post-intervention)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Derived from this study: PubMed 42218482Daneau C, Babineau V, Marchand AA, Bussieres A, O'Shaughnessy J, Descarreaux M, Ruchat SM. Motor control exercise program versus standard care in the treatment of lumbopelvic pain in pregnant women: a randomized controlled pilot trial. Chiropr Man Therap. 2026 May 30;34(1):30. doi: 10.1186/s12998-026-00655-x.
Derived from this study: PubMed 35313988Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.

Related trials for Lumbopelvic Pain

Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Not yet recruiting
Visual Feedback-Assisted Sensorimotor Training in Chronic Nonspecific Low Back Pain
Chronic Low Back Pain
Recruiting
Effects of MET With and Without Lumbopelvic Manipulation
Anterior Pelvic Tilt
Active, not recruiting
Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain

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.

Martin Descarreaux, DC, PhD study director

Université du Québec à Trois-Rivières

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Lumbopelvic Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.

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 7 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: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Baseline (Pre-intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04253717, which also lists 2 linked publications.

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 9 May 2023.