Protocol summary
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Study aim
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This study aimed to investigate the effects of a comprehensive rehabilitation protocol for treating diastasis recti and improving postpartum low back pain, and to investigate the relationship of these changes with brain and muscle activity patterns in women with postpartum low back pain.
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Design
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Randomized clinical trial with three parallel arms and double-blinded.
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Settings and conduct
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Participants will be recruited from gynecology and obstetrics clinics, health centers, and social media platforms within Hamadan city. Initial evaluations will take place at the Sports Rehabilitation Laboratory of Bu-Ali Sina University. Before enrollment, all participants will receive clear and comprehensive information regarding the study’s procedures, duration, objectives, potential benefits, and possible risks.
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Participants/Inclusion and exclusion criteria
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Inclusion: Women with postpartum LBP, with multiparity, and diastasis recti greater than 2 cm above, below, and umbilicus. Exclusion: cardiac and respiratory diseases, acute LBP, rheumatic spinal diseases, CNS and PNS diseases, abdominal hernia, lumbar surgery, gestational diabetes, and sports activities.
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Intervention groups
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Exercise Group 1: Participants will undergo a structured diastasis recti rehabilitation program incorporating progressive core-trunk exercises.
Exercise Group 2: A structured rehabilitation program incorporating progressive core-trunk exercises combined with release techniques for erector spinae muscles and TLF.
Control Group: Participants will maintain their usual daily routines throughout the study period.
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Main outcome variables
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Low back pain and disability, Inter-rectus distance, Core muscle thickness, Thoracolumbar fascia flexibility, EMG-based core muscle activation patterns, EEG-based brain activity patterns
General information
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Reason for update
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Changes in study design and the number of groups to two experimental groups and one control group
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250104064273N1
Registration date:
2025-10-30, 1404/08/08
Registration timing:
prospective
Last update:
2026-07-06, 1405/04/15
Update count:
1
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Registration date
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2025-10-30, 1404/08/08
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-06-22, 1405/04/01
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Expected recruitment end date
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2026-12-21, 1405/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of diastasis recti abdominis rehabilitation exercises on postpartum low back pain and inter-recti distance in affected women: A randomized controlled trial
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Public title
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Effect of Core exercises on postpartum low back pain and DRA
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with postpartum low back pain
Age range of 20-45
Having DRA above 2 cm in the 4.5 cm upper, below, and the umbilicus.
The vaginal and caesarean delivery
Exclusion criteria:
Cardiovascular diseases
Acute low back pain (e.g., spondylolisthesis, herniation, etc.)
Rheumatic diseases of the spine
CNS and PNS diseases (Parkinson, MS, etc.)
Abdominal herniation
low back surgery
Gestational diabetes
Doing sports activities
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, subjects will be randomized based on the Random Number Generator software and then assigned to three groups based on allocation concealment using the SNOSE method. Participants will be randomly assigned to one of the experimental groups (n=2 * 30) or the control group (n=30).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The assessors and study participants are blinded to the allocation and randomization of groups. Participants will be fully informed of the study’s purpose and inclusion rationale, while remaining blinded to group allocation to minimize bias and ensure methodological integrity.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Design of Comprehensive Exercises for Diastasis Recti
Ethics committees
1
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Ethics committee
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Approval date
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2025-10-05, 1404/07/13
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Ethics committee reference number
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IR.BASU.REC.1404.037
Health conditions studied
1
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Description of health condition studied
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Diastasis recti abdominis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Postpartum low back pain
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Timepoint
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Pre- and Post-test of 8 weeks intervention
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Method of measurement
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VAS scale
Secondary outcomes
1
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Description
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Diastasis recti abdominis
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Timepoint
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pre- and post-intervention
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Method of measurement
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Ultrasonography
2
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Description
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thickness of core muscles
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Timepoint
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pre- and post-intervention
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Method of measurement
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Ultrasonography
3
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Description
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Brain activity patterns
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Timepoint
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pre- and post-intervention
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Method of measurement
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EEG
4
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Description
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Core muscle activity patterns
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Timepoint
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pre- and post-intervention
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Method of measurement
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EMG
5
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Description
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functional disability
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Timepoint
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pre- and post-intervention
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Method of measurement
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Oswestry Questionnaire
6
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Description
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Postpartum Low Back Pain
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Timepoint
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pre- and post-intervention
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Method of measurement
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VAS scale
Intervention groups
1
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Description
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Intervention groups: 8-10 weeks of comprehensive rehabilitation exercises, including core strengthening exercises from beginner to advanced
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Category
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Rehabilitation
2
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Description
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Control group: No intervention
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Category
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Rehabilitation
3
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Description
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Intervention group: 8-10 weeks of comprehensive rehabilitation exercises, including core strengthening exercises from beginner to advanced, with release of TLF and Erector Spine.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Bu Ali Sina University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Only data related to demographic information and outcomes will be shared.
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When the data will become available and for how long
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After publishing the article/articles extracted from the study
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To whom data/document is available
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The data can be displayed and shared upon reasonable request by the Iranian Clinical Trial Registry Center, journals, and individuals/academic researchers who are conducting research and scientific activities in this field.
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Under which criteria data/document could be used
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Data analysis and use of documentation can only be done on the condition that their results are stated in systematic review articles conducted by researchers and academic authors. Conditions for registering the submission of data and documentation include: 1. Sending an email (preferably with valid academic addresses) to one of the study researchers. 2. A brief and logical explanation regarding how the data or documentation will be used. 3. Ensuring the registration of the protocol of systematic review studies that have given access to the data or documentation.
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From where data/document is obtainable
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By requesting from the study researcher, Nahid Bigdeli, by email n.bigdeli@phe.basu.ac.ir
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What processes are involved for a request to access data/document
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The applicant can request details from the researchers using an email message within 7 to 10 days.
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Comments
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