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

NCT04253717 | Completed

• 1 other identifier: UQTR-2019-LBPP-Intervention
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Physical activity; Non-invasive treatment

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (11)

• Functional disability

  Baseline (Pre-intervention) and week 16 (Post-intervention)

• Fear avoidance behaviors

  Baseline (Pre-intervention) and week 16 (Post-intervention)

• Level of anxiety

  Baseline (Pre-intervention) and week 16 (Post-intervention)

• Depression

  Baseline (Pre-intervention) and week 16 (Post-intervention)

• Physical activity levels

  Baseline (Pre-intervention) and week 16 (Post-intervention)

Study Arms (2)

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.

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.

Interventions

Motor control exercise program OTHER

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.

Motor control exercise program

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Location

Related Publications (1)

• 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.

  PMID: 35313988 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Martin Descarreaux, DC, PhD

  Université du Québec à Trois-Rivières

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: April 2, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

CA (1)