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

May 8, 2023 updated by: Martin Descarreaux, Université du Québec à Trois-Rivières

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Trois-Rivières, Quebec, Canada, G8Z 4M3
        • Universite du Quebec à Trois-Rivieres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Motor control exercise program
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.
Other: Motor control exercise program
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.
No Intervention: Control
Participants will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Baseline (Pre-intervention)
Defined as the ability to recruit 40 eligible women, willing to participate to the study
Baseline (Pre-intervention)
Retention rate
Time Frame: Baseline (Post-intervention)
Defined as the completion of follow-up questionnaire by ≥ 80% of women
Baseline (Post-intervention)
Adherence rate
Time Frame: Baseline (Post-intervention)
Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions
Baseline (Post-intervention)
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
16 weeks follow-up
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
Week 16 (Post-intervention)
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)
16 weeks follow-up
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)
Week 16 (Post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional disability
Time Frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Assessed using the Pelvic Girdle Questionnaire (PGQ) (score range from 0 (minimum) to 75 (maximum) : higher score mean a worst outcome)
Baseline (Pre-intervention) and week 16 (Post-intervention)
Fear avoidance behaviors
Time Frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Assessed using the Tampa Scale of Kinesiophobia (TSK) (score range from 17 (minimum) to 68 (maximum) : higher score mean a worst outcome)
Baseline (Pre-intervention) and week 16 (Post-intervention)
Level of anxiety
Time Frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Assessed using the State-Trait Anxiety Inventory (STAI) (score range from 20 (minimum) to 80 (maximum) : higher score mean a worst outcome)
Baseline (Pre-intervention) and week 16 (Post-intervention)
Depression
Time Frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
Assessed using the Beck Depression Inventory (BDI) (score range from 0 (minimum) to 63 (maximum) : higher score mean a worst outcome)
Baseline (Pre-intervention) and week 16 (Post-intervention)
Physical activity levels
Time Frame: Baseline (Pre-intervention) and week 16 (Post-intervention)
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)
Baseline (Pre-intervention) and week 16 (Post-intervention)
Lumbopelvic pain (incidence and frequency)
Time Frame: Baseline (Pre-intervention)
Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
Baseline (Pre-intervention)
Lumbopelvic pain (incidence and frequency)
Time Frame: 16 weeks follow-up
Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
16 weeks follow-up
Lumbopelvic pain (incidence and frequency)
Time Frame: Week 16 (Post-intervention)
Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)
Week 16 (Post-intervention)
Lumbopelvic pain (intensity)
Time Frame: Baseline (Pre-intervention)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Baseline (Pre-intervention)
Lumbopelvic pain (intensity)
Time Frame: 16 weeks follow-up
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
16 weeks follow-up
Lumbopelvic pain (intensity)
Time Frame: Week 16 (Post-intervention)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Week 16 (Post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université du Québec à Trois-Rivières

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Martin Descarreaux, DC, PhD, Universite du Quebec à Trois-Rivieres

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UQTR-2019-LBPP-Intervention

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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