Naprapathy Training for Postpartum DRAM Prevention (NapraDRAM)
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|ClinicalTrials.gov Identifier: NCT04652830|
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diastasis Recti||Behavioral: Naprapathy training Other: Control group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-blinded parallel randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessors performing the follow-up ultrasound and clinical examination are blinded to the allocation|
|Official Title:||Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems From Rectus Abdominis Diastasis|
|Estimated Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Active Comparator: Naprapathy training
Training program for three months
Behavioral: Naprapathy training
Active training aimed at strengthening the abdominal muscles
Placebo Comparator: Control group
No change of daily routines
Other: Control group
No change of daily routines in regard to training
- Abdominal Trunk Function [ Time Frame: One year ]Abdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.
- 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.
- 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.
- Health-related Quality of Life [ Time Frame: One year ]Quality of Life rated with EQ-5D
- Width of the diastasis [ Time Frame: One year ]Width measured with ultrasound
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652830
|Contact: Katarina Woxnerud, Naprapath||+46 email@example.com|
|Contact: Gabriel Sandblom, Ass Prof||+46 firstname.lastname@example.org|
|Principal Investigator:||Gabriel Sandblom, Ass Prof||Karolinska Institutet|