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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
Sponsor:
Collaborator:
Hela Kvinnans Klinik
Information provided by (Responsible Party):
Gabriel Sandblom, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Diastasis Recti Behavioral: Naprapathy training Other: Control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
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
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Abdominal Trunk Function [ Time Frame: One year ]
    Abdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females after childbirth
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Katarina Woxnerud, Naprapath +46 702694900 katarina@woxnerud.se
Contact: Gabriel Sandblom, Ass Prof +46 86162362 gabriel.sandblom@ki.se

Sponsors and Collaborators
Karolinska Institutet
Hela Kvinnans Klinik
Investigators
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Principal Investigator: Gabriel Sandblom, Ass Prof Karolinska Institutet
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Responsible Party: Gabriel Sandblom, Research group leader, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04652830    
Other Study ID Numbers: NapraDRAM
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabriel Sandblom, Karolinska Institutet:
Diastasis Recti
Naprapathy