Clinical trial NCT06723353: Effects of Visceral Manipulation Combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women
Official title: Effects of Visceral Manipulation Combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diastasis Recti
Diastasis Recti Abdominis (DRA)
Keywords: Diastasis Recti Abdominis (DRA)
Postpartum Recovery
Visceral Manipulation (VM)
Kinesio Taping (KT)
Core Strengthening Exercises
Pelvic Floor Dysfunction
Inter-Recti Distance (IRD)
Urinary Incontinence
Pain Management
Physical Therapy for Postpartum Women
Lead sponsor: Health and Research-Insights
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 72
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the effectiveness of different therapies for treating Diastasis Recti Abdominis (DRA) in postpartum women. DRA, commonly experienced after childbirth, involves the separation of abdominal muscles, which can lead to discomfort and decreased core stability. The main questions this study seeks to answer are:

How effective are Visceral Manipulation (VM), Kinesio Taping (KT), and core strengthening exercises in reducing the gap between abdominal muscles (Inter-Recti Distance or IRD)? Do these treatments improve pain levels, pelvic floor muscle strength, and urinary incontinence? This study will compare the effects of VM, KT, a combination of both, and core strengthening exercises to determine which therapy-or combination of therapies-most effectively treats DRA.

Participants will:

Be randomly assigned to one of four treatment groups: VM, KT, VM combined with KT, or core strengthening exercises.

Undergo their designated treatments for a period of 6 weeks. Visit the clinic for assessments at the start, mid-point, and end of the treatment period.

Complete surveys and undergo physical tests to measure changes in IRD, pain levels, pelvic floor strength, and urinary function.

This research will provide valuable insights into the most effective treatments for DRA, aiming to enhance the well-being and recovery of postpartum women.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Post-partum female will be included on the basis of:

* DRA: Finger width palpation shows \>2.5 cm
* Postpartum females bearing at least 1 child
* Age between 35 to 45 years old
* Post-partum females who had gone through normal vaginal delivery, vacuum delivery, forceps delivery, and lower section caesarian section (at least 1 month after)

Exclusion Criteria:

Postpartum female will be excluded if she has:

* Any other abdominal surgery
* Sensitivity with taping (specific for those will have KT)
* Diagnosed with abdominal hernia
* Open abdominal wound

Primary outcomes:
measure: Reduction in Inter-Recti Distance (IRD)
timeFrame: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)
Secondary outcomes:
measure: Improvement in Pelvic Floor Muscle Strength
timeFrame: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jinnah Postgraduate Medical Center
state: Sindh
Study officials:
References: