Diastasis Recti

Investigate whether surgical reconstruction with laparoscopic technique can lead to improved quality of Life, trunk stability and reduced pain in patients with symptomatic rectus diastasis. The study will also compare two different laparoscopic surgery methods for abdominal wall reconstruction: narrowing of linea alba with continuous suture with or without mesh.

The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion. All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.

Participants will: Receive NMES combined with massage therapy or the addition of stone needles therapy on a sub-basis every day for 10 days. Abdominal circumference, inner rectus distance will be measured and recorded after each treatment Body imagery satisfaction, low back pain and dysfunction scores, anxiety, depression scores, and quality of life scores will be measured after all treatments are completed.

Objectives of the Biomedical Research: * To evaluate gynaecological examination data at 6-8 weeks postpartum, with additional assessment of: experienced pelvic floor dysfunction (PFD) symptoms and their impact on quality of life, pelvic organ positioning (Pelvic Organ Prolapse Quantification system - POP-Q), pelvic floor muscle (PFM) strength, fecal incontinence, diastasis recti abdominis (DRA), and pelvic/perineal ultrasound findings. * To evaluate patient examination data conducted by a physical medicine and rehabilitation physician and a physiotherapist at 6-10 weeks postpartum. * To assess changes in pelvic floor muscle activity, PFD symptoms, pelvic organ position, following the training procedures and at 6 and 12 months post-intervention. * To compare changes among two groups: Supervised training (specialist-led); Self-training at home (based on specialist recommendations); * To compare gynecological examination data, Oxford Scale scores, and St. Mark's scores among the study groups. * To compare changes in women's quality of life, sexual function, and clinical outcomes between the study groups based on validated questionnaires. * To develop recommendations for specialists and the public regarding the prevention of postpartum pelvic floor dysfunction based on the study findings. Comprehensive Description of Evaluated Outcomes Primary and Secondary Study Endpoints Primary Endpoints: Changes indicating the effect of applied rehabilitation measures on the reduction and prevention of pelvic dysfunction symptoms: Change in PFM contraction force and strength according to the Modified Oxford Scale. Change in POP-Q scores. St. Mark's Score for fecal incontinence: evaluating the change in score over the course of the study. Pelvic and perineal ultrasound data: assessing symmetrical PFM contraction, changes in vaginal hiatus width, and urethral mobility. Comparison of results between study groups. Persistence of PFD symptoms as reported by patients. Changes in Quality of Life (QoL) and clinical outcome questionnaires: \* ICIQ-UI SF (International Consultation on Incontinence Questionnaire Short Form); P-QoL (Prolapse Quality-of-Life Questionnaire); PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised); FSFI (Female Sexual Function Index); MOS-SF36 (Medical Outcomes Study Short Form-36). Changes in musculoskeletal functions: \* Objective assessment of PFM state via contraction force and Pressure Biofeedback activity evaluation. Assessment of diastasis recti abdominis using palpation and ultrasound. Pain assessment (abdominal, perineal, pelvic, pubic symphysis, and lumbosacral) using the Visual Analogue Scale (VAS). Evaluation of gait, balance, and coordination. Core stability and transversus abdominis activity (using a stabilizer); static endurance tests for abdominal and back muscles. Secondary Endpoints: Factors potentially influencing the effectiveness of the rehabilitation program: Demographics and History: Mean age, BMI, parity (number of pregnancies/deliveries), neonatal weight, and head circumference. Obstetric Factors: Mode of delivery, delivery-related factors (induction, gestational age, fetal presentation, delivery method: natural, ventouse, c-section). Pathologies: Pregnancy-related diseases (nausea/vomiting, intrahepatic cholestasis, preeclampsia, gestational diabetes), infectious/inflammatory diseases during pregnancy.

Diastasis recti abdominis (DRA) is a common postpartum condition, characterized by stretching and thinning of the linea alba and separation of the two rectus abdominis muscles along the midline of the abdomen. Beyond cosmetic concerns, DRA has been associated with impaired abdominal wall function, altered trunk stability, and potential changes in respiratory mechanics due to the close anatomical and functional relationship between the abdominal muscles and the diaphragm. The diaphragm plays a central role in respiration and trunk stabilization, working synergistically with the abdominal wall to regulate intra-abdominal pressure (IAP) and postural control. Alterations in abdominal wall integrity, such as those observed in DRA, may therefore influence diaphragm function and mobility, as well as overall respiratory muscle performance. However, evidence regarding the relationship between DRA and diaphragm function currently remains limited. This observational, cross-sectional study aims to examine diaphragm characteristics and inspiratory muscle strength in parous women with and without DRA. Participants are allocated into two predefined groups according to the presence or absence of DRA, based on a standardized imaging assessment. Diaphragm function is assessed using rehabilitative ultrasound imaging (RUSI) techniques, performed by a trained physiotherapist, following standardized procedures. Ultrasound images are obtained during specific breathing maneuvers to determine diaphragm thickness and excursion. Inspiratory muscle strength is assessed using a standardized procedure to test maximal inspiratory pressure (MIP), S-Index and Peak Inspiratory Pressure (PIF) using a POWERbreathe KH2 device. All measurements are conducted during a single assessment session, and are led by three experienced physiotherapists. Furthermore, demographic data and relevant obstetric and clinical characteristics, such as age, body mass index (BMI), parity, and time since last delivery, are recorded to describe the study population. The study aims to explore whether women with DRA demonstrate differences in diaphragm-related parameters and inspiratory muscle strength compared with women without DRA. By improving understanding of the interaction between the abdominal wall and respiratory muscles after childbirth, this research may contribute to the development of more targeted assessment strategies and rehabilitation approaches in postpartum care.

This study will be randomized clinical trial and will be conducted in Services Hospital and poly clinics. The total duration of treatment will be 12 weeks. Non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. The participants are randomly assigned to one of two groups: Group A performs corrective exercises focused on deep core engagement, while Group B performs plank exercises aimed at overall abdominal activation. Each group follows their respective regimen three times per week for 12 weeks. Baseline EMS and pelvic floor exercises are conducted for all participants to ensure core stability before the interventions begin. Outcome measures, including manual muscle testing (MMT) for strength, and the Numerical Pain Rating Scale (NPRS) for pain, are recorded both before and after the 12-week intervention. After data collection data will be analyzed by using SPSS version 25.

Overview This clinical trial is designed to investigate the efficacy of various interventions in treating Diastasis Recti Abdominis (DRA) among postpartum women. DRA is a condition characterized by the separation of the left and right sides of the rectus abdominis muscle, commonly occurring during and after pregnancy. This separation can lead to functional impairments such as lower back pain, pelvic floor dysfunctions, and a decrease in core stability, which significantly affects a woman's quality of life. Purpose The study aims to assess and compare the effectiveness of four different treatment modalities: Visceral Manipulation (VM), Kinesio Taping (KT), a combination of both VM and KT, and core strengthening exercises. The primary goal is to determine which treatment(s) most effectively reduce the inter-recti distance (IRD), thus alleviating the physical and functional symptoms associated with DRA. Secondary objectives include evaluating the impact of these treatments on associated pain levels, pelvic floor muscle strength, and urinary incontinence, which are common concerns among affected postpartum women. Study Design This randomized controlled trial will enroll participants from four major maternity hospitals across Karachi, Pakistan, ensuring a diverse participant pool. Upon meeting inclusion criteria, participants will be randomly assigned to one of the four intervention groups. Each group will receive a specific treatment protocol for six weeks, with assessments scheduled at baseline, the three-week midpoint, and upon completion at six weeks. Group A: Participants will receive Kinesio Taping applied with approximately 70% tension in a crisscross pattern over the rectus abdominis muscle. Group B: Participants will undergo Visceral Manipulation, focusing on enhancing the mobility and function of abdominal and pelvic organs. Group C: This group will receive both VM and KT as combined therapies to maximize the therapeutic benefits. Group D: Participants in this group will perform targeted core strengthening exercises designed to enhance muscle function and support abdominal healing. Methodology Treatment efficacy will be evaluated through a series of quantitative and qualitative measurements: Inter-Recti Distance (IRD): Measured using the finger-width palpation method, this metric will directly assess the physical gap between the rectus abdominis muscles. Pain Level: Assessed using the Visual Analogue Scale (VAS), allowing participants to report the intensity of their pain. Pelvic Floor Muscle Strength: Evaluated using pressure biofeedback units, providing objective data on muscle functionality. Urinary Incontinence: Measured via the Urinary Distress Inventory-6 (UDI-6), which quantifies symptoms of urinary incontinence. Data Analysis Data will be processed and analyzed using the Statistical Package for the Social Sciences (SPSS), version 21.0. Analysis of Covariance (ANCOVA) will be used to compare treatment effects across the groups, adjusting for potential confounders like age and BMI. Repeated measures ANOVA will be employed to evaluate changes within each group over time. Ethical Considerations The study has been reviewed and approved by an Institutional Review Board, ensuring that all procedures adhere to ethical guidelines. Participants will provide informed consent before participating, with a guarantee of confidentiality and the right to withdraw from the study at any time without penalty. Significance By rigorously evaluating these interventions, the study aims to provide clear, evidence-based guidance on the most effective treatment strategies for managing DRA in postpartum women. This research is crucial not only for enhancing individual patient care but also for informing clinical practices and potentially influencing public health policies related to maternal health and recovery.

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.

A longitudinal randomized controlled experimental study will be carried out. The sample will be composed of 34 postpartum women, randomly distributed in two groups: i) diathermy + exercise group (GDE) (n=17), and ii) placebo diathermy + exercise group (GPE) (n=17). The evaluations will be performed at two time points: i) before the intervention (T1), and ii) after the last session (T2).

The primary objective of the study is to develop and assess a comprehensive rehabilitation program for Diastasis Recti Abdominis (DRA) and associated dysfunctions, through a prospective randomized controlled trial (RCT). The study is aimed at (a) implementing exercise of the superficial and deep abdominal muscles in both concentric and eccentric contractions targeting muscle strength, development, and arrangement of muscle fibers, potentially facilitating the closure of DRA , as well as pelvic floor muscle exercises with adequate loading and progression aiming for optimal muscular adaptations, (b) integrating exercises strengthening the diaphragm and accessory inspiratory muscles (Inspiratory Muscle Training - IMT), to improve diaphragm function (thickness, mobility/excursion) and contribute to the overall optimal function of the trunk, facilitating force transfer through the abdominal wall, especially when combined with exercises tensing the linea alba (transversus abdominis and pelvic floor muscle exercises), (c) progressing simple contraction exercises into functional, according to loading and progression principles for optimal function in static and dynamic conditions, and (d) developing a flexible exercise program that can also be accessed remotely, aiming to enhance women's access to rehabilitation services, potentially enhancing compliance as well. The study adheres to ethical considerations and the Helsinki Declaration and is approved by the Research Ethics Committee (R.E.C.) of the University of Patras (internal code: 16192/18-12-2023). All participants will be thoroughly informed about the procedure and will be invited to complete the consent form after receiving complete written information about the study and the protection of their data. All patient data will be stored anonymously/coded in a secure cloud platform accessed only by the research team members. Imputation methods will be applied to address situations where variables are missing, uninterpretable, or inconsistent. Any adverse events will be addressed and documented, while medical consultation will be accessible during patient assessment/rehabilitation hours. Any modifications to the study protocol, data collection methods, or other aspects of the study will be reviewed thoroughly among researchers and the Internal Review Board of the R.E.C., and the study protocol as well as study registration will be adjusted accordingly. The accuracy, completeness, and representativeness of registry data is assured by the research team. A comprehensive data dictionary is established among the research team, containing detailed variable descriptions, coding information, and normal ranges, ensuring consistency and clarity in data collection. Sample recruitment will be through leaflets and posters placed in various areas of the University campus, the University General Hospital of Patras, and the wider region of Achaia, as well as publicizing this research in professional associations (Panhellenic Medical Association, Panhellenic Physiotherapists' Association) and healthcare professionals (obstetricians, gynecologists, urologists, surgeons, etc.) who may encounter such cases. Additionally, informational events will be planned in various areas of Achaia for the general public, and the study will also be promoted on the university website (Department of Physiotherapy webpage), social media, and conferences. Based on the power analysis conducted using GPowerSoftware 3.1.9.7, considering previous studies of good methodological quality and the same primary outcome, a power of 95%, effect size of 0.30, and a significance level of 5% were established. Including an expected dropout rate of up to 20% of the total sample, a total of 48 women are required (39 according to GPowerSoftware plus an additional 20% for possible dropouts). Consequently, each group is estimated to include 16-20 women. The allocation of participants into different intervention groups (TEG, IMT+TEG, or CG) will be done by a researcher "blinded" to the interventions and assessment methods, using block randomization, creating a sequence of random numbers through specific software. Each participant will be randomly assigned a number from this sequence through a sealed, opaque envelope. Then participants will be randomly allocated to the intervention groups via sealed, opaque envelopes. To ensure homogeneous distribution of the sample among the intervention groups, each block will contain equal number of envelopes for each intervention group. This method ensures both randomization and concealment of allocation, maintaining the integrity and unbiased distribution of the sample. Due to the nature of the treatment, clinicians cannot be "blinded" to the intervention. However, the analysis of the data will be 'blind' (blind assessor). Analysis will be based on data resulting from the initial grouping of patients by treatment protocol (intention-to-treat analysis). Both assessment and intervention will take place at the Physiotherapy Department of the University of Patras, in the Clinical Physiotherapy and Research Laboratory (CPRlab). Primary outcome measures will be inter-recti distance (IRD), assessed using diagnostic ultrasound (Versana Active™, GE Healthcare, Illinois, US). Secondary outcome measures will include: a) diaphragmatic thickness (inspiratory \& expiratory) and excursion measured via diagnostic ultrasound (Versana Active™, GE Healthcare, Illinois, US), b) strength of the inspiratory muscles (measured by MIP, S-Index, PIF) assessed using the POWERbreathe KH2 (HaB International Ltd., Warwickshire, United Kingdom), c) Trunk function, assessed through functional motor control tests including trunk flexion, plank, side plank, McGill's trunk flexor endurance test, and d) specific questionnaires: i) Body Image States Scale (BISS), ii) Activity Assessment Scale (AAS), and iii) Hernia-Related Quality-of-Life Survey (HerQLes). Prior to the study, pilot reliability studies of all assessment tools and feasibility pilot studies will be completed. Ultrasound measurements will be conducted by two experienced physiotherapists specializing in womens' health and musculoskeletal dysfunctions, who are adequately trained by a radiologist specializing in diagnostic ultrasound and by a fellow physiotherapist who is experienced in using these imaging techniques (Rehabilitative Ultrasound Imaging - RUSI) in daily clinical practice. Both of these healthcare professionals will supervise the assessment procedure and resolve any issues that may arise during the measurements and/or individual analyses. Before the measurements, the examiners will train the participants in diaphragmatic breathing, contraction of deep abdominal muscles (drawing-in maneuver), and pelvic floor muscles (PFM). Women who demonstrate satisfactory control of these muscles will take part in the intervention. Women will also be asked questions regarding their demographics (age, height/weight, etc.), physical condition, and health history. They will subsequently complete the Australian Pelvic Floor Questionnaire (APFQ-GR), which includes questions about bladder and bowel function, sexual health, and potential symptoms related to the pelvic floor. Additionally, they will fill out the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF-GR). In cases where abdominal wall or lower back pain is reported, patients will be asked to rate the intensity of this pain according to the Numeric Pain Rating Scale (NPRS). Intervention groups (TEG and IMT+TEG) will follow a comprehensive exercise program that will last 12 weeks and will include the following components: (a) progressive exercises for retraining deep abdominal muscles (transversus abdominis), (b) progressive exercises for retraining pelvic floor muscles, (c) abdominal muscle strengthening exercises (rectus abdominis, obliques), (d) combination of abdominal muscle control and distal extremity movements, and (e) progressive functional exercises. Each session will range from 20 to 45 minutes, with a progressive increase in duration over the weeks. Participants will exercise three times a week, with one or two in-person sessions per 2 weeks at our department's laboratory (CPRlab) under the supervision of experienced physiotherapists, and the rest of the sessions conducted via teleconference, either synchronous or asynchronous. The in-person sessions will occur in small groups of patients and will be supervised by experienced physiotherapists who will adjust or modify exercise progression according to the patients' needs. Teleconference sessions will be conducted via Zoom communications platform (Zoom Video Communications, California, US). Session scheduling, patient communication, and coordination will be facilitated through a blended learning platform (Classroom, Google, California, US), which the research team modified accordingly to present a patient-friendly interface containing useful tools such as leaflets, information, educational videos etc. Exercise compliance will be assessed through exercise diaries uploaded on the platform. If a participant misses a scheduled online session, the exercise session will be recorded and uploaded to the platform. Women will be encouraged to repeat the exercise program as many times as desired during the week, beyond the scheduled sessions supervised by a physiotherapist. Successful completion of the program will require supervised attendance at a minimum of two out of three sessions per week (i.e., \>70% attendance). The exercise program's progression will focus on increasing sets, repetitions, exercise complexity, load, and overall program duration. Simple equipment will be used, such as mats, resistance bands, dumbbells, towels, and pillows. Trunk Exercise and Inspiratory Muscle Training Group (IMT+TEG) will also perform breathing exercises using inspiratory muscle training (IMT) for 12 weeks. Women will perform IMT three times per week. One training session will be in-person (either weekly or 1 in two weeks) using the POWERbreathe Classic IMT (HaB International Ltd.,Warwickshire, United Kingdom) device under the supervision of an experienced physiotherapist. The other two sessions will be conducted via teleconference from home (using the same device) to ensure the adequacy of the training load. Inspiratory muscle exercises will be performed at an intensity of 50-80% of maximum inspiratory pressure (MIP) and will last 5-10 minutes. There will be a total of 3 sets with 8-10 repetitions, performed twice per session. Inspiratory resistance will progressively increase at a rate of 2-3cm H2O per week. Remote IMT sessions will be scheduled before the trunk exercise program to prevent potential patient fatigue. The control group will not participate in the 12-week exercise program, but will receive a single training session, general information on managing DRA, along with written instructions for proper abdominal and pelvic floor muscle contraction. Statistical Analysis Data collected will be processed and analyzed using the SPSS program (version 28 for Windows IBM, Armonk, NY, USA). Statistical analysis will identify correlations between the studied variables, and repeated measures ANOVA will be used to identify statistically significant differences among sample groups. Effect sizes with 95% confidence intervals will be calculated for each outcome measure. Effect sizes will be considered large if ≥0.8, moderate if ≥0.5 and small if ≥0.2.