Clinical trial NCT05485844: Low Back Pain and Motor Control Dysfunction After Pregnancy- the Possible Role of Abdominal Rectus Muscle Diastasis
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastasis Recti
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were enrolled in pregnancy screening unit during the first pregnancy screening ultra sound.

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.

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

Primary outcomes:
measure: Inter rectus diameter
timeFrame: A year after index pregnancy
Secondary outcomes:
measure: Waiter's bow
timeFrame: A year after index pregnancy
measure: Pelvic tilt
timeFrame: A year after index pregnancy
measure: One leg stance-test
timeFrame: A year after index pregnancy
measure: Active straight leg test
timeFrame: A year after index pregnancy
measure: Sit up test
timeFrame: A year after index pregnancy
measure: RAND36 HRQoL
timeFrame: A year after index pregnancy
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Central Hospital, Jorvi Hospital
state: HUS
Study officials:
References: