Diastasis RectiD2NCT05485844
Low Back Pain and Motor Control Dysfunction After Pregnancy- the Possible Role of Abdominal Rectus Muscle Diastasis
An observational study of Diastasis Recti, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Recti
- How many people
- 42 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2018to 21 Mar 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants were enrolled in pregnancy screening unit during the first pregnancy screening ultra sound.
Who may be able to join
- Age over 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Jorvi Hospital
Espoo, HUS, 00029
About this study
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.
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | Individuals reporting increased back pain and/or decreased motor control function in a second questionnaire conducted a year after index pregnancy | |
| Controls | Controls reporting no change in their bodily experience between the two questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter rectus diameter
Ultra sound measurement of linea alba widht
Measured: A year after index pregnancy
Secondary outcomes (6)
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.
Measured: A year after index pregnancy
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.
Measured: A year after index pregnancy
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.
Measured: A year after index pregnancy
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.
Measured: A year after index pregnancy
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.
Measured: A year after index pregnancy
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
Measured: A year after index pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Jan 2018
- Primary completion21 Mar 2021
- Study completion21 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaana Vironen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485844
- Sponsor's protocol ID
- HUS/3331/2017
- Acronym
- D2
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05485844
- Acronym / sponsor ID
- D2 / HUS/3331/2017
- Conditions
- Diastasis Recti
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 21 Mar 2021 (actual)
- Study completion
- 21 Mar 2021 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | – | –Individuals reporting increased back pain and/or decreased motor control function in a second questionnaire conducted a year after index pregnancy |
| Controls | – | –Controls reporting no change in their bodily experience between the two questionnaires |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants were enrolled in pregnancy screening unit during the first pregnancy screening ultra sound.
Key inclusion criteria (1 listed)
- Age over 18 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter rectus diameter
Time frame: A year after index pregnancy
Ultra sound measurement of linea alba widht
6 secondary outcomes
Waiter's bow
Time frame: A year after index pregnancy
Pelvic tilt
Time frame: A year after index pregnancy
One leg stance-test
Time frame: A year after index pregnancy
Active straight leg test
Time frame: A year after index pregnancy
Sit up test
Time frame: A year after index pregnancy
RAND36 HRQoL
Time frame: A year after index pregnancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastasis Recti, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter rectus diameter (time frame: A year after index pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.