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

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: Completed
• Conditions: Lumbopelvic Pain
• Intervention / Treatment: Other: Motor control exercise program

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Defined as the ability to recruit 40 eligible women, willing to participate to the study	Baseline (Pre-intervention)
Retention rate	Defined as the completion of follow-up questionnaire by ≥ 80% of women	Baseline (Post-intervention)
Adherence rate	Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions	Baseline (Post-intervention)
Safety of the intervention	Determined based on the number of adverse events and defined as nature of adverse events	16 weeks follow-up
Safety of the intervention	Determined based on the number of adverse events and defined as nature of adverse events	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)	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)	Week 16 (Post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional disability	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	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	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	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	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)	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)	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)	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)	Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale	Baseline (Pre-intervention)
Lumbopelvic pain (intensity)	Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale	16 weeks follow-up
Lumbopelvic pain (intensity)	Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale	Week 16 (Post-intervention)

Collaborators and Investigators

• Sponsor: Université du Québec à Trois-Rivières
• Investigators: Study Director: Martin Descarreaux, DC, PhD, Université du Québec à Trois-Rivières

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Non-invasive treatment
• Other Study ID 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