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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Lumbopelvic Pain

Intervention / Treatment
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* Other: Motor control exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor control exercise program<br>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<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive the standard care including basic information on what to do when suffering from lumbopelvic pain. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional disability | Assessed using the Pelvic Girdle Questionnaire (PGQ) (score range from 0 (minimum) to 75 (maximum) : higher score mean a worst outcome) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Week 16 (Post-intervention) | 
| Lumbopelvic pain (intensity) | Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale | Baseline (Pre-intervention) | 
| Lumbopelvic pain (intensity) | Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale | 16 weeks follow-up | 
| Lumbopelvic pain (intensity) | Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale | Week 16 (Post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Non-invasive treatment