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

Lumbopelvic Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253717
• Other study ID #: UQTR-2019-LBPP-Intervention
• Status: Completed
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: May 2023
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbopelvic Pain

Intervention

Other:
• Motor 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.

Locations

Country	Name	City	State
Canada	Université du Québec à Trois-Rivières	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Defined as the ability to recruit 40 eligible women, willing to participate to the study	Baseline (Pre-intervention)
Primary	Retention rate	Defined as the completion of follow-up questionnaire by = 80% of women	Baseline (Post-intervention)
Primary	Adherence rate	Defined as attendance to =75% of group sessions and = 75% completion of home sessions	Baseline (Post-intervention)
Primary	Safety of the intervention	Determined based on the number of adverse events and defined as nature of adverse events	16 weeks follow-up
Primary	Safety of the intervention	Determined based on the number of adverse events and defined as nature of adverse events	Week 16 (Post-intervention)
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	Lumbopelvic pain (intensity)	Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale	Baseline (Pre-intervention)
Secondary	Lumbopelvic pain (intensity)	Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale	16 weeks follow-up
Secondary	Lumbopelvic pain (intensity)	Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale	Week 16 (Post-intervention)