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

Sponsor
Université du Québec à Trois-Rivières (Other)
Overall Status
Recruiting
CT.gov ID
NCT04253717
Collaborator
(none)
40
1
2
16
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Motor control exercise program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 2, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment rate [Baseline (Pre-intervention)]

    Defined as the ability to recruit 40 eligible women, willing to participate to the study

  2. Retention rate [Baseline (Post-intervention)]

    Defined as the completion of follow-up questionnaire by ≥ 80% of women

  3. Adherence rate [Baseline (Post-intervention)]

    Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions

  4. Safety of the intervention [16 weeks follow-up]

    Determined based on the number of adverse events and defined as nature of adverse events

  5. Safety of the intervention [Week 16 (Post-intervention)]

    Determined based on the number of adverse events and defined as nature of adverse events

  6. Acceptability of the intervention [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)

  7. Acceptability of the intervention [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)

Secondary Outcome Measures

  1. Functional disability [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)

  2. Fear avoidance behaviors [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)

  3. Level of anxiety [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)

  4. Depression [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)

  5. Physical activity levels [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)

  6. Lumbopelvic pain (incidence and frequency) [Baseline (Pre-intervention)]

    Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)

  7. Lumbopelvic pain (incidence and frequency) [16 weeks follow-up]

    Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)

  8. Lumbopelvic pain (incidence and frequency) [Week 16 (Post-intervention)]

    Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)

  9. Lumbopelvic pain (intensity) [Baseline (Pre-intervention)]

    Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale

  10. Lumbopelvic pain (intensity) [16 weeks follow-up]

    Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale

  11. Lumbopelvic pain (intensity) [Week 16 (Post-intervention)]

    Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université du Québec à Trois-Rivières Trois-Rivières Quebec Canada G8Z 4M3

Sponsors and Collaborators

  • Université du Québec à Trois-Rivières

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martin Descarreaux, Principal investigator, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier:
NCT04253717
Other Study ID Numbers:
  • UQTR-2019-LBPP-Intervention
First Posted:
Feb 5, 2020
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Martin Descarreaux, Principal investigator, Université du Québec à Trois-Rivières

Study Results

No Results Posted as of May 18, 2022