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Completed

NCT Number: NCT04253717

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

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.

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Key information

Conditions

Lumbopelvic Pain Behavior Motor Activity

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline (Pre-intervention)

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

  2. Retention rate

    Time frame: Baseline (Post-intervention)

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

  3. Adherence rate

    Time frame: Baseline (Post-intervention)

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

  4. 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

  5. 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

  6. 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)

  7. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Université du Québec à Trois-Rivières

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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