An interventional study of Motor control exercise program in Lumbopelvic Pain, sponsored by Université du Québec à Trois-Rivières. Completed at 1 site in Canada. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Université du Québec à Trois-Rivières · Not applicable, Interventional, and Treatment
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.
Université du Québec à Trois-Rivières is the lead sponsor of 40 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.
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.
Recruitment rate
Defined as the ability to recruit 40 eligible women, willing to participate to the study
Time frame: Baseline (Pre-intervention)
Retention rate
Defined as the completion of follow-up questionnaire by ≥ 80% of women
Time frame: Baseline (Post-intervention)
Adherence rate
Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions
Time frame: Baseline (Post-intervention)
Safety of the intervention
Determined based on the number of adverse events and defined as nature of adverse events
Time frame: 16 weeks follow-up
Safety of the intervention
Determined based on the number of adverse events and defined as nature of adverse events
Time frame: 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)
Time frame: 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)
Time frame: Week 16 (Post-intervention)
Functional disability
Assessed using the Pelvic Girdle Questionnaire (PGQ) (score range from 0 (minimum) to 75 (maximum) : higher score mean a worst outcome)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Week 16 (Post-intervention)
Lumbopelvic pain (intensity)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Time frame: Baseline (Pre-intervention)
Lumbopelvic pain (intensity)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Time frame: 16 weeks follow-up
Lumbopelvic pain (intensity)
Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale
Time frame: Week 16 (Post-intervention)
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Université du Québec à Trois-Rivières