Clinical trial NCT04652830: Naprapathy Training for Postpartum DRAM Prevention
Official title: Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems from Rectus Abdominis Diastasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diastasis Recti
Keywords: Diastasis Recti
Naprapathy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Hela Kvinnans Klinik
First posted: 2020-12-03
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded parallel randomized controlled trial
Primary purpose: PREVENTION

Brief summary: A randomised controlled trial with the aim of analysing the effectiveness of a training program intended to prevent symptoms related to DRAM in the postpartum period.

Detailed description: Diastasis of the rectus abdominis muscles (DRAM) is a common condition after pregnancy and after great loss of weight. Distension of linea alba is a normal process during pregnancy caused by the growing fetus as well as from hormonal changes.

In the majority of cases, DRAM regresses during the postpartum period and the abdomen resumes its normal function. I some cases, however, the DRAM persists for a long period. This may result in trunk instability, back pain and decreased abdominal muscle strength. Risk factors for persisting DRAM are multiparity, high maternal age and cesarean delivery.

Little is known about how DRAM affects abdominal function. The lack of studies on the impact of DRAM on trunk instability and back pain has made it difficult to evaluate studies aiming at reducing the problems caused by DRAM.

Conservative management, including training aiming at strengthening the abdominal muscles, is usually considered the first hand alternative. There are, however, few studies on the effectiveness of training programs for the purpose of preventing DRAM.

The purpose of the present trial is to evaluate the effectiveness of a specific training program during a limited period of time postpartum in women with DRAM. The investigators also intend to study the changes in anatomy of linea alba during the postpartum period and explore whether the changes are affected by the training.

The study will be conducted as a randomized single-blind controlled trial. Women with diastasis of \> 3 cm will be invited. The aim is to include 70 women. Half of them will be randomized to a training program for 3 month and the other half will be followed as a control group.

At the start of the study, the line alba is examined with ultrasound. The width of the diastasis is registered. The laxity and thickness of line alba are also evaluated. The abdominal circumference is measured at rest and under straining, in different postures.

At the start of the study, the woman is request to rate her level of physical activity (Baecke questionnaire) pain, self-assessed functional level (DRI), back pain (Oswestry low back disability index), urinary incontinence (UDI-6, IID-7) and quality of life (EQ-5D). The Abdominal Trunk Function Protocol (ATFP) is also registered at the start.

The assessors performing the ultrasound examination and physical examinations are blinded to the allocation. Women allocated to the training program perform exercises with a duration of ten minutes 6 days a week. They also perform 3 exercises with a duration of 60 seconds three times a day. The exercises are continued for three months. All women, those allocated to training as well as the control group, are invited to follow-up examinations 6 and 12 months after inclusion.

At both follow-up examinations the abdominal wall is investigated with ultrasound, the abdominal circumference is measured and the woman is requested to respond to all the questionnaires that she received at the start of the study.

Analyses will focus on the effect of the training program on the width and laxity of the linea alba as well as symptoms of back pain, trunk instability and incontinence.

Eligibility criteria: Inclusion Criteria:

* Uni- and multiparous women 3-12 months postpartum
* Ability to understand Swedish language
* Ability participate in a three months follow-up program
* Diastasis of the rectus abdominis muscles \> 3 cm

Exclusion Criteria:

* Ongoing pregnancy
* Age \<18 years or \>50 years
* \< 3 months or \>12 months post partum
* History of neurologic, musculoskeletal or psychiatric disorders
* Interrectal diastasis \< 3 cm

Primary outcomes:
measure: Abdominal Trunk Function
timeFrame: One year
Secondary outcomes:
measure: Disability
timeFrame: One year
measure: Urinary Incontinence
timeFrame: One year
measure: Health-related Quality of Life
timeFrame: One year
measure: Width of the diastasis
timeFrame: One year
measure: Linea alba distortion index
timeFrame: One year
measure: Urinary incontinence
timeFrame: One year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Hela Kvinnans Klinik
Study officials:
affiliation: Karolinska Institutet
name: Gabriel Sandblom, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: