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Naprapathy Training for Postpartum DRAM Prevention

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04652830
Acronym
NapraDRAM
Enrollment
70
Registered
2020-12-03
Start date
2021-03-01
Completion date
2026-10-31
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastasis Recti

Keywords

Diastasis Recti, Naprapathy

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.

Interventions

BEHAVIORALNaprapathy training

Active training aimed at strengthening the abdominal muscles

OTHERControl group

No change of daily routines in regard to training

Sponsors

Hela Kvinnans Klinik
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors performing the follow-up ultrasound and clinical examination are blinded to the allocation

Intervention model description

Single-blinded parallel randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Abdominal Trunk FunctionOne yearAbdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.

Secondary

MeasureTime frameDescription
Urinary IncontinenceOne yearUrinary incontinence rated with UDI-6 (urinary distress inventory). Rates ranging from 0 to 18, where high rates indicate worse outcome.
Health-related Quality of LifeOne yearQuality of Life rated with EQ-5D
DisabilityOne yearDisability rated with the Disability Rating index (DRI). Rates ranging from 0 to 1200, where high ratings indicate worse outcome.
Linea alba distortion indexOne yearDistortion 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.
Urinary incontinenceOne yearIncontinence symptoms rated with the IID-7 (incontinence impact questionnaire). Rates ranging from 0 to 21, where high rates indicate worse outcome.
Width of the diastasisOne yearWidth measured with ultrasound

Countries

Sweden

Contacts

Primary ContactKatarina Woxnerud, Naprapath
katarina@woxnerud.se+46 702694900
Backup ContactGabriel Sandblom, Ass Prof
gabriel.sandblom@ki.se+46 86162362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026