Effects of Visceral Manipulation Combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women

NCT06723353 | Recruiting DMC

• 1 other identifier: LUC/CPGS/PHDE/PTR/20240329/001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Reduction in Inter-Recti Distance (IRD)

  This measure assesses the effectiveness of the interventions in reducing the Inter-Recti Distance (IRD) between the rectus abdominis muscles. The IRD will be measured using the finger-width palpation method, which involves placing fingers horizontally across the midline of the participant's abdomen at, above, and below the umbilicus. This method provides a direct and tangible measure of the gap between the rectus abdominis muscles, which is a primary physical manifestation of Diastasis Recti Abdominis (DRA).

  Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)

Secondary Outcomes (1)

• Improvement in Pelvic Floor Muscle Strength

  Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)

Study Arms (4)

Visceral Manipulation

EXPERIMENTAL

Participants in this arm will receive Visceral Manipulation (VM) therapy administered by a trained physical therapist. VM is a gentle manual therapy aimed at releasing restrictions within the visceral system to improve the mobility and function of the internal organs. The therapy sessions will focus on enhancing abdominal organ mobility and will be performed in a clinical setting. This treatment will be administered over a six-week period with sessions occurring once per week.

Other: Visceral Manipulation Therapy

Kinesio Taping

EXPERIMENTAL

This arm involves the application of Kinesio Tape (KT) to the abdominal area to support and stabilize the muscles affected by Diastasis Recti Abdominis. The KT will be applied in a crisscross manner to potentially facilitate muscle function and reduce the Inter-Recti Distance (IRD). Participants will receive taping once a week for six weeks, and the tape will be maintained throughout the week to ensure continuous support.

Other: Abdominal Kinesio Taping

Combined Visceral Manipulation and Kinesio Taping

EXPERIMENTAL

Participants in this arm will receive a combination of Visceral Manipulation and Kinesio Taping. The combination is intended to maximize the therapeutic effects by enhancing organ function with VM and providing muscular support with KT. The treatments will be administered concurrently during the same six-week period, with weekly sessions for both therapies.

Other: Combined Visceral Manipulation and Kinesio Taping

Core Strengthening Exercises

ACTIVE COMPARATOR

This arm involves participants engaging in core strengthening exercises specifically designed for postpartum rehabilitation. The exercises aim to strengthen the transverse abdominis, multifidus, and pelvic floor muscles, which support the abdominal organs and improve core stability. Participants will perform these exercises under the supervision of a physical therapist three times a week for six weeks to ensure proper technique and progression.

Other: Postpartum Core Strengthening Program

Interventions

Visceral Manipulation Therapy OTHER

Visceral Manipulation (VM) is a manual therapy consisting of gentle, specifically placed manipulations that encourage normal mobility, tone, and inherent tissue motion of the viscera and their connective tissues. These manipulations can potentially improve the structural integrity of the abdominal cavity and enhance the physiological functioning of the organs. VM will be administered by certified therapists trained in this specialized technique, focusing on reducing the Inter-Recti Distance (IRD) and associated symptoms of DRA.

Visceral Manipulation

Abdominal Kinesio Taping OTHER

Kinesio Taping (KT) involves the application of a thin, stretchable tape over and around muscles to enhance function, reduce inflammation, and support muscles in movement on a 24hr/day basis. It is non-restrictive, allowing for full range of motion. In this study, KT will be applied in a crisscross pattern across the abdomen to support the abdominal muscles affected by DRA, potentially aiding in muscle function and reducing pain and discomfort.

Kinesio Taping

Combined Visceral Manipulation and Kinesio Taping OTHER

This intervention combines Visceral Manipulation and Kinesio Taping to leverage the benefits of both modalities. The combination aims to enhance the functional and structural support of the abdominal region by improving organ function through VM and providing muscular support through KT. This dual approach is hypothesized to offer a synergistic benefit, potentially providing a more effective treatment for reducing IRD and improving overall abdominal function.

Combined Visceral Manipulation and Kinesio Taping

Postpartum Core Strengthening Program OTHER

The Core Strengthening Program is designed to strengthen the deep core muscles, including the transverse abdominis, multifidus, and the pelvic floor muscles. Exercises will be tailored to accommodate postpartum women and will be progressively adjusted to match improvements in strength and endurance. The program includes supervised training sessions focusing on enhancing core stability, which is crucial for postpartum recovery and long-term spinal and pelvic health.

Core Strengthening Exercises

Eligibility Criteria

• Age: 35 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Health and Research-Insights: lead

Study Sites (1)

Jinnah Postgraduate Medical Center

Karachi, Sindh, 75510, Pakistan

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence; Agnosia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Central Study Contacts

Hafiz Sheraz Arshad, PhD Health Sciences

CONTACT

+923004009429; drhafizsheraz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)