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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253717
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Descarreaux, Université du Québec à Trois-Rivières

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.

Condition or disease Intervention/treatment Phase
Lumbopelvic Pain Other: Motor control exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motor control exercise program
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
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.

No Intervention: Control
Participants will receive the standard care including basic information on what to do when suffering from lumbopelvic pain.



Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Baseline (Pre-intervention) ]
    Defined as the ability to recruit 40 eligible women, willing to participate to the study

  2. Retention rate [ Time Frame: Baseline (Post-intervention) ]
    Defined as the completion of follow-up questionnaire by ≥ 80% of women

  3. Adherence rate [ Time Frame: Baseline (Post-intervention) ]
    Defined as attendance to ≥75% of group sessions and ≥ 75% completion of home sessions

  4. Safety of the intervention [ Time Frame: 16 weeks follow-up ]
    Determined based on the number of adverse events and defined as nature of adverse events

  5. Safety of the intervention [ Time Frame: Week 16 (Post-intervention) ]
    Determined based on the number of adverse events and defined as nature of adverse events

  6. Acceptability of the intervention [ Time Frame: 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)

  7. Acceptability of the intervention [ Time Frame: Week 16 (Post-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)


Secondary Outcome Measures :
  1. Functional disability [ Time Frame: 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)

  2. Fear avoidance behaviors [ Time Frame: 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)

  3. Level of anxiety [ Time Frame: 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)

  4. Depression [ Time Frame: 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)

  5. Physical activity levels [ Time Frame: 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)

  6. Lumbopelvic pain (incidence and frequency) [ Time Frame: Baseline (Pre-intervention) ]
    Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)

  7. Lumbopelvic pain (incidence and frequency) [ Time Frame: 16 weeks follow-up ]
    Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)

  8. Lumbopelvic pain (incidence and frequency) [ Time Frame: Week 16 (Post-intervention) ]
    Defined as a weekly self-reported incidence and frequency of lumbopelvic pain (determined based on the number of episode)

  9. Lumbopelvic pain (intensity) [ Time Frame: Baseline (Pre-intervention) ]
    Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale

  10. Lumbopelvic pain (intensity) [ Time Frame: 16 weeks follow-up ]
    Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale

  11. Lumbopelvic pain (intensity) [ Time Frame: Week 16 (Post-intervention) ]
    Defined as a weekly self-reported intensity of lumbopelvic pain using a 100 millimeters visual analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253717


Contacts
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Contact: Stephanie-May Ruchat, PhD 819-376-501 ext 3965 stephanie-may.ruchat@uqtr.ca

Locations
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Canada, Quebec
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada, G8Z 4M3
Principal Investigator: Catherine Daneau, MSc         
Sponsors and Collaborators
Université du Québec à Trois-Rivières
Investigators
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Study Director: Martin Descarreaux, DC, PhD Université du Québec à Trois-Rivières
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Responsible Party: Martin Descarreaux, Principal investigator, Université du Québec à Trois-Rivières
ClinicalTrials.gov Identifier: NCT04253717    
Other Study ID Numbers: UQTR-2019-LBPP-Intervention
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martin Descarreaux, Université du Québec à Trois-Rivières:
Physical activity
Non-invasive treatment