Clinical trial NCT04253717: Motor Control Exercise Program for Pregnant Women With a History of Lumbopelvic Pain
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbopelvic Pain
Keywords: Physical activity
Non-invasive treatment
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline (Pre-intervention)
measure: Retention rate
timeFrame: Baseline (Post-intervention)
measure: Adherence rate
timeFrame: Baseline (Post-intervention)
measure: Safety of the intervention
timeFrame: 16 weeks follow-up
measure: Safety of the intervention
timeFrame: Week 16 (Post-intervention)
measure: Acceptability of the intervention
timeFrame: 16 weeks follow-up
measure: Acceptability of the intervention
timeFrame: Week 16 (Post-intervention)
Secondary outcomes:
measure: Functional disability
timeFrame: Baseline (Pre-intervention) and week 16 (Post-intervention)
measure: Fear avoidance behaviors
timeFrame: Baseline (Pre-intervention) and week 16 (Post-intervention)
measure: Level of anxiety
timeFrame: Baseline (Pre-intervention) and week 16 (Post-intervention)
measure: Depression
timeFrame: Baseline (Pre-intervention) and week 16 (Post-intervention)
measure: Physical activity levels
timeFrame: Baseline (Pre-intervention) and week 16 (Post-intervention)
measure: Lumbopelvic pain (incidence and frequency)
timeFrame: Baseline (Pre-intervention)
measure: Lumbopelvic pain (incidence and frequency)
timeFrame: 16 weeks follow-up
measure: Lumbopelvic pain (incidence and frequency)
timeFrame: Week 16 (Post-intervention)
measure: Lumbopelvic pain (intensity)
timeFrame: Baseline (Pre-intervention)
measure: Lumbopelvic pain (intensity)
timeFrame: 16 weeks follow-up
measure: Lumbopelvic pain (intensity)
timeFrame: Week 16 (Post-intervention)
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Martin Descarreaux, DC, PhD
role: STUDY_DIRECTOR
References:
citation: Daneau C, Marchand AA, Bussieres A, O'Shaughnessy J, Ruchat SM, Descarreaux M. Effects of a motor control exercise program on lumbopelvic pain recurrences and intensity in pregnant women with a history of lumbopelvic pain: a study protocol for a randomized controlled feasibility trial. Pilot Feasibility Stud. 2022 Mar 21;8(1):65. doi: 10.1186/s40814-022-01024-0.