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

Diastasis Recti Clinical Trial

— D2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485844
• Other study ID #: HUS/3331/2017
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: March 21, 2021

Study information

• Verified date: August 2022
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 21, 2021
• Est. primary completion date: March 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Diastasis Recti

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Jorvi Hospital	Espoo	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter rectus diameter	Ultra sound measurement of linea alba widht	A year after index pregnancy
Secondary	Waiter's bow	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.	A year after index pregnancy
Secondary	Pelvic tilt	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.	A year after index pregnancy
Secondary	One leg stance-test	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.	A year after index pregnancy
Secondary	Active straight leg test	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.	A year after index pregnancy
Secondary	Sit up test	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.	A year after index pregnancy
Secondary	RAND36 HRQoL	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	A year after index pregnancy