Low Back Pain and Motor Control Dysfunction After Pregnancy- the Possible Role of Abdominal Rectus Muscle Diastasis

NCT ID: NCT05485844

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-03-21

Brief Summary

The aim of this study was to compare participants with increased symptoms after index pregnancy with those reporting no change in back pain or subjective movement control and analyzed their inter rectus distance (IRD). This study is a case-control study of a cohort of women who had delivered a year earlier. We recruited participants with increased symptoms (n=14) after index pregnancy and controls (n=41) and recorded their inter rectus distance with ultrasound. A questionnaire was filled, and an ultrasound was performed two times for the study groups.

Detailed Description

A case control study was conducted in Helsinki University Hospital during 1.1.2018-31.3.2021.

Participants were enrolled in pregnancy screening unit. Exclusion criteria was pregnancy during the second questionnaire and body mass index over 28kg/m2. The first questionnaire was filled and the baseline width of linea alba was measured by abdominal ultrasound (US) in connection of the first early pregnancy screening during 1.1.2018-8.3.2019. The second electronic questionnaire was sent a year after the expected delivery timing. Two screening questions were used to grade the participants. Altogether 36 individuals scored at least five points reflecting to substantial increase in symptoms in screening questions in the second questionnaire after pregnancy out of which fourteen participants were randomly recruited. Another 94 individuals scored the lowest possible two points implicating no change in ones bodily experience. Three controls per case were recruited, altogether 42 controls and with one dropout the total number of controls was 41. All participants had at least 12 months from the last delivery.

Two physiotherapists conducted motor control tests and the width of linea alba was measured with a high-end ultrasound. The physiotherapists were blinded with group allocation and the previous IRD measurement. Participants did not know their own exposure status or their IRD when answering the questionnaires.

Conditions

Diastasis Recti

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Symptomatic

Individuals reporting increased back pain and/or decreased motor control function in a second questionnaire conducted a year after index pregnancy

No interventions assigned to this group

Controls

Controls reporting no change in their bodily experience between the two questionnaires

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age over 18 years

Exclusion Criteria

• Body mass index (BMI) over 28 kg/m2 ( weight and height combined to report BMI in kg/m^2
• Ongoing pregnancy during the second questionnaire, a year after the index pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jaana Vironen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helsinki University Central Hospital, Jorvi Hospital

Espoo, HUS, Finland

Countries

Finland

Other Identifiers

HUS/3331/2017

Identifier Type: -

Identifier Source: org_study_id