Effects of Visceral Manipulation combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women
To investigate the combined and individual effects of Visceral Manipulation (VM) and Kinesiotaping (KT) on Diastasis Recti Abdominis (DRA), overall wellness, pain intensity, stress incontinence, and pelvic floor strength in postpartum women through a randomized controlled trial.
Design
randomized controlled trial (RCT) design
Settings and conduct
Research setting and duration
This study will be conducted across four major maternity hospitals in Karachi, Pakistan, namely Jinnah Post Graduate Medical Centre, National Medical Centre, Ashfaque Memorial Hospital, and Naila Maternity and General Hospital.
Participants/Inclusion and exclusion 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)
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
Intervention groups
Group A: This group will be treated with Kinesio Taping (KT) alone.
Group B: Participants in this group will receive Visceral Manipulation (VM) alone.
Group C: This group will receive a combined treatment of Visceral Manipulation (VM) and Kinesio Taping (KT).
Group D: Known as the Exercise group, participants here will engage in core strengthening exercises specifically designed for postpartum rehabilitation.
Main outcome variables
Pain
Urinary Distress Inventory-6 (UDI-6)
General information
Reason for update
Acronym
VITAL-MOMS
IRCT registration information
IRCT registration number:IRCT20241104063588N1
Registration date:2024-12-06, 1403/09/16
Registration timing:retrospective
Last update:2024-12-06, 1403/09/16
Update count:0
Registration date
2024-12-06, 1403/09/16
Registrant information
Name
Hafiz Sheraz Arshad Arshad
Name of organization / entity
Health and Research Insights
Country
Pakistan
Phone
+92 333 4605590
Email address
admin@hrinsights.link
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-01, 1403/01/13
Expected recruitment end date
2024-09-30, 1403/07/09
Actual recruitment start date
2024-04-01, 1403/01/13
Actual recruitment end date
2024-09-30, 1403/07/09
Trial completion date
2024-09-30, 1403/07/09
Scientific 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
Public title
Effects of Visceral Manipulation and Kinesio Taping on Abdominal Separation, Pain, Bladder Control, Pelvic Strength, and Overall Wellness in Postpartum Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• 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:
• Any other abdominal surgery
• Sensitivity with taping (specific for those will have KT)
• Diagnosed with abdominal hernia
• Open abdominal wound
Age
From 35 years old to 45 years old
Gender
Female
Phase
1
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
all participants in the groups to which they were originally assigned, regardless of whether they completed the intervention or followed the protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
double -blind experiment where participants & treatment provider will be unaware of the specific treatment group to which they have been assigned. The trial will include four distinct groups to compare the effects of different treatment modalities on Diastasis Recti Abdominis (DRA) and overall well-being in postpartum women. The groups are organized as follows:
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lincoln University College
Street address
2, Jalan Stadium SS 7/15, Ss 7, 47301 Petaling Jaya, Selangor
City
Petaling Jaya
Postal code
47301
Approval date
2024-03-29, 1403/01/10
Ethics committee reference number
LUC/CPGS/PHDE/PTR/20240329/001
Health conditions studied
1
Description of health condition studied
Diastasis Recti
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PAIN
Timepoint
Before the Intervention (Baseline), 2 Weeks, 4 Weeks, 6 Weeks After the Intervention Commences
Method of measurement
viual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Kinesio Taping (KT) Alone. Designation: Experimental. Description: This group will receive Kinesio Taping (KT) as the sole intervention. Kinesio Tape will be applied directly to the abdominal area affected by Diastasis Recti Abdominis (DRA). The taping will be done using a crisscross pattern to provide mechanical support to the weakened abdominal muscles, aiming to decrease the Inter-Recti Distance (IRD) and alleviate associated discomfort such as lower back pain and pelvic instability. Taping will be applied by trained professionals and maintained throughout the study period, with changes and adjustments made during weekly visits over the six-week intervention period. This method is expected to improve muscle functionality and contribute to the recovery of abdominal integrity postpartum.
Category
Rehabilitation
2
Description
Intervention Group 2: Visceral Manipulation (VM) Alone. Designation: Experimental. Description: Participants in this group will undergo Visceral Manipulation (VM) therapy, which involves gentle manual techniques aimed at restoring the natural mobility of the internal organs and associated connective tissues. This intervention focuses on addressing the structural and functional aspects of abdominal health affected by Diastasis Recti Abdominis (DRA). The manipulation will be performed by a skilled physical therapist with expertise in visceral techniques. Treatments will occur once a week over a six-week period, with each session designed to progressively enhance organ function and support abdominal recovery.
Category
Rehabilitation
3
Description
Intervention Group 3: Visceral Manipulation (VM) and Kinesio Taping (KT). Designation: Experimental. Description: This group will receive a combined treatment of Visceral Manipulation (VM) and Kinesio Taping (KT). The dual approach aims to synergize the benefits of manual therapy with supportive taping. VM will address the internal dynamics of the abdominal cavity, improving organ mobility and reducing tension, while KT will provide external support to the abdominal muscles, enhancing muscle function and stability. The combination is intended to offer comprehensive treatment for DRA, potentially leading to improved outcomes in terms of abdominal muscle separation and overall postpartum recovery. Therapy sessions will be administered weekly for six weeks.
Category
Rehabilitation
4
Description
Intervention Group 4: Core Strengthening Exercises. Designation: Active Comparator. Description: This group, known as the Exercise group, will participate in a series of core strengthening exercises specifically tailored for postpartum rehabilitation. The exercise regimen will focus on strengthening the transverse abdominis, multifidus, pelvic floor muscles, and other core muscles critical for postpartum recovery. The exercises will be supervised by a physical therapist to ensure proper form and progression, aiming to enhance core stability and reduce IRD. Participants will engage in these exercises three times per week over a six-week period, designed to incrementally build core strength and support overall pelvic and abdominal health.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Naila Maternity Hospital
Full name of responsible person
Dr Naila
Street address
Address: Plot 3 A, Block, 1, Block 1 Shah Faisal Colony 1 Shah Faisal Colony, Karachi, Karachi City, Sindh 75230, Pakistan
City
Karachi
Postal code
75230
Phone
+92 21 34573114
Email
fahadfarooqlasi85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lincoln University College
Full name of responsible person
Prof. Dr. Sandeep Poddar
Street address
Wisma Lincoln, No. 12-18, Jalan SS 6/12, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
City
Petaling Jaya
Postal code
47301
Phone
+60 3-7886 7315
Email
info@lincoln.edu.my
Grant name
NA
Grant code / Reference number
NA
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NA
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Lincoln University College
Full name of responsible person
Mehwish Khan
Position
PhD Scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Wisma Lincoln, No. 12-18, Jalan SS 6/12, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
City
Patelang Jaya
Province
Salenger
Postal code
47301
Phone
+92 307 2910332
Email
drduakhan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lincoln University College
Full name of responsible person
Mehwish Khan
Position
PhD Scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Wisma Lincoln, No. 12-18, Jalan SS 6/12, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
City
Patelang Jaya
Province
Salenger
Postal code
47301
Phone
+92 307 2910332
Email
drduakhan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Lincoln University College
Full name of responsible person
Mehwish Khan
Position
PhD Scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Wisma Lincoln, No. 12-18, Jalan SS 6/12, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
City
Patelang Jaya
Province
Salenger
Postal code
47301
Phone
+92 307 2910332
Email
drduakhan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
demographics and outcomes
When the data will become available and for how long
March 2025
2 years after publication
To whom data/document is available
open access
Under which criteria data/document could be used
open access policy
From where data/document is obtainable
DOI number
What processes are involved for a request to access data/document