Combined Effects of Visceral Manipulation and Noble Technique on Post-partum Females With Diastasis Recti

June 11, 2024 updated by: Riphah International University

Combined Effects of Visceral Manipulation and Noble Technique on Inter-rectal Distance, Low Back Pain and Functional Disability in Post-partum Females With Diastasis Recti.

Diastasis recti is characterized by an abnormal expansion of the gap between the medial sides of the rectus abdominis muscle and a lengthening of the linea alba (increased inter-recti distance). It is mainly caused by excessive intra-abdominal pressure. The abdominal muscles and connective structures expand from the growing uterus during pregnancy. Low back pain is a prevalent complaint that can result from various factors, including weakened core muscles and functional disability. The aim of the study would assess of combined effect of visceral manipulation and noble technique on Inter-rectal distance, low back pain and functional disability in post-partum females with diastasis recti.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial will be conducted in DHQ Hospital Toba Tek Singh. A nonprobability convenience sampling technique will be used. There will be 34 participants. Participants will meet with inclusion criteria and be divided into two groups A and B. In Group A 17 participants will receive visceral manipulation technique with noble technique for 30 minutes per session, three sessions per week for 6 weeks. While in Group B 17 participants will just receive noble technique exercises for 15 min per session, three sessions per week for 6 weeks. Participants will be assessed before and after treatment through; Digital nylon calipers for diastasis recti, NPRS for pain, and Quebec Back Pain Disability Scale (QBPDS) to assess LBP-related functional. Data will be analyzed during SPSS software version 21

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Toba Tek Singh, Punjab, Pakistan, 36050
        • DHQ Hospital Toba Tek Singh
        • Contact:
        • Principal Investigator:
          • Noor Fatima, MS-WH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 22 to 35.
  • Primiparous women with vaginal delivery and an IRD of >2 cm.
  • Three to six months postpartum with the presence of diastasis rectus abdominis.
  • Patients having moderate low back pain in NPRS.

Exclusion Criteria:

  • Acute Malignancy
  • Recent Abdominal or Pelvic surgery
  • Having undergone spinal surgery in the previous six months
  • Serious spinal pathology
  • Serious cardiovascular or metabolic disease Pregnancy
  • Herniation pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
This group received three sessions a week for six weeks, with 30 minutes per session given to visceral manipulation and noble technique (15 minutes each technique).
Other: visceral manipulation and noble technique

First, the patient will lie face-up on a massage or exam table. Physiotherapists feel viscera, major internal organs located in the abdomen by lightly pressing through abdominal muscles. Physiotherapist manual poking, pressing, and massage actions do three things:

  1. Reveals visceral adhesions.
  2. Find tender spots.
  3. Breaks up adhesions. Massaging and pressing stretch the collagen fibers that makeup fascia, which loosens tightly bound fibers to break up adhesions. This releases the organs and allows them to move more freely.

Minor adhesions may resolve after one session. Tough, stubborn adhesions may require several sessions plus self-manipulation between sessions
Active Comparator: Group B
This group receives three sessions a week for six weeks, with 15 minutes per session in which noble technique is applied.
Other: noble technique
The patient is positioned in supine with both knees bent and feet flat on a firm surface. The patient then places her crossed hands over her abdomen to support and pull the rectus abdominis muscles towards the midline. Finally, the patient is asked to slowly raise her head until a slight contraction is felt in the abdomen, holding for 20 seconds and repeating the exercise up to 20 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain: NPRS
Time Frame: 6th week
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Cronbach's alpha value of NPRS is 0.88
6th week
disability: Quebec Back Pain Disability Scale (QBPDS)
Time Frame: 6th week
The Quebec Back Pain Disability Scale (QBPDS) measures the extent to which people with low back pain have difficulty with everyday activities. The questionnaire is composed of 20 items on daily activities. The items were selected from 6 relevant subdomains of functional skills for patients with low back pain.
6th week
Muscle separation: Digital nylon calipers
Time Frame: 6th week
The Digital nylon calipers are a valid tool for measuring IRD above the umbilicus. For the caliper measurements with the abdominal muscles at rest, the participant was positioned in hook-lying, arms down by the side, with 1 pillow placed beneath the head. The examiner palpated the medial borders of the right and left rectus abdominis muscle bellies at the marked locations. The inside measurement jaws of the digital nylon calipers were positioned at the locations of the palpating fingers. The intra-class correlation coefficient values exceeded 0.75 for the digital calipers.
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Hafiza Neelam, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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