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Completed

NCT Number: NCT05485844

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

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.

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Key information

Conditions

Diastasis Recti

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Helsinki University Central Hospital, Jorvi Hospital

Espoo, HUS, 00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inter rectus diameter

    Time frame: A year after index pregnancy

    Ultra sound measurement of linea alba widht

Secondary outcomes

  1. Waiter's bow

    Time frame: A year after index pregnancy

    Lumbar flexion motor control test performed in a standardized manner, with dichotomous rating of correct and non-correct performance. Rating was performed by a blinded specialist of physiotherapy from video recording.

  2. Pelvic tilt

    Time frame: A year after index pregnancy

    Lumbar extension motor control test performed in a standardized manner, with dichotomous rating of correct and non-correct performance. Rating was performed by a blinded specialist of physiotherapy from video recording.

  3. One leg stance-test

    Time frame: A year after index pregnancy

    Postural and balance control control test performed in a standardized manner, with dichotomous rating of correct and non-correct performance. Rating was performed by a blinded specialist of physiotherapy from video recording.

  4. Active straight leg test

    Time frame: A year after index pregnancy

    Lumbar spine stability and abdominal bracing ability test performed in a standardized manner, with dichotomous rating of correct and non-correct performance. Rating was performed by a blinded specialist of physiotherapy from video recording.

  5. Sit up test

    Time frame: A year after index pregnancy

    Arms crossed in front of the chest, elbows touch the knees in upright position. Sole can rise from the floor only slightly so that the angle of the hip does not change. Performance was video recorded and rating was performed by a blinded specialist of physiotherapy.

  6. RAND36 HRQoL

    Time frame: A year after index pregnancy

    RAND36 HRQoL survey each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

A Case-control Study Comparing Women With Increased Symptoms (Back Pain and Core Stability Problems) and Inter Rectus Diameter a Year After Index Pregnancy.

Acronym: D2

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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