Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04652830

Naprapathy Training for Postpartum DRAM Prevention

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hela Kvinnans Klinik

Stockholm, 116 37, Sweden

Location status: Recruiting

Location contact

Katarina Woxnerud, Naprapath

CONTACT

[email protected]

+46702694900

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Naprapathy training

Behavioral

Active training aimed at strengthening the abdominal muscles

Control Group

Other

No change of daily routines in regard to training

Primary outcomes

  1. Abdominal Trunk Function

    Time frame: One year

    Abdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.

Secondary outcomes

  1. Disability

    Time frame: One year

    Disability rated with the Disability Rating index (DRI). Rates ranging from 0 to 1200, where high ratings indicate worse outcome.

  2. Urinary Incontinence

    Time frame: One year

    Urinary incontinence rated with UDI-6 (urinary distress inventory). Rates ranging from 0 to 18, where high rates indicate worse outcome.

  3. Health-related Quality of Life

    Time frame: One year

    Quality of Life rated with EQ-5D

  4. Width of the diastasis

    Time frame: One year

    Width measured with ultrasound

  5. Linea alba distortion index

    Time frame: One year

    Distortion of the linea alba at rest and under tension assessed with ultrasound. Distortion index: average deviation of the LA from the shortest path between the recti, ranging from 0 to 1, higher index indicating greater distortion.

  6. Urinary incontinence

    Time frame: One year

    Incontinence symptoms rated with the IID-7 (incontinence impact questionnaire). Rates ranging from 0 to 21, where high rates indicate worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Sandblom, Ass Prof

CONTACT

[email protected]

+46 86162362

Katarina Woxnerud, Naprapath

CONTACT

[email protected]

+46 702694900

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Hela Kvinnans Klinik

Registry information

Official study title

Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems from Rectus Abdominis Diastasis

Acronym: NapraDRAM

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2020
Registry last updated
Jan 3, 2025

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.

Published trials that share one or more normalized conditions with this study.