Lumbopelvic Pain
Conditions
Keywords
Physical activity, Non-invasive treatment
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.
Interventions
OTHERMotor 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.
Sponsors
Université du Québec à Trois-Rivières
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Baseline (Pre-intervention) | Defined as the ability to recruit 40 eligible women, willing to participate to the study |
| Retention rate | Baseline (Post-intervention) | Defined as the completion of follow-up questionnaire by ≥ 80% of women |
| Adherence rate | Baseline (Post-intervention) | Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions |
| Safety of the intervention | 16 weeks follow-up | Determined based on the number of adverse events and defined as nature of adverse events |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Lumbopelvic pain (intensity) | Baseline (Pre-intervention) | Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
Canada
Outcome results
None listed