Abdominal Hypopressive Technique on Postpartum Low Back Pain

February 20, 2023 updated by: Riphah International University

Effects of Abdominal Hypopressive Technique on Postpartum Low Back Pain

Postpartum Low back pain (PP-LBP) is more common and can lead to limitations to women's daily activity. Pregnancy related low back pain has been reported to occur in 55% to 78% women worldwide.This study is planned to determine the effects of abdominal hypopressive technique on postpartum low back pain, mobility and disability.

Study Overview

Detailed Description

literature suggests the use of hypopressive abdominal techniques to be effective in increasing the thickness of the abdominal muscles and hence add to the stability of the spine and alleviation of low back pain in the postpartum period. This will be a randomized controlled trial, with two groups.

Participants in the experimental group will learn how to perform the "hypopressive maneuver", which consisted of exhaling to their expiratory reserve volume, then holding their breath (apnea), and expanding their rib cage, to draw their abdominal wall inward and cranially without inhalation. control group will perform general exercises. Both groups will be assessed at pre and post test (after 6weeks)

Study Type

Interventional

Enrollment (Actual)

31

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 Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Holy Family Hospital

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postpartum non-radiating low back Pain
  • LBP severity >3 on numeric pain rating scale (NPRS)
  • Spontaneous vaginal delivery

Exclusion Criteria:

  • Prenatal history of low back pain
  • Caesarean section
  • Hypertension
  • Puerperium period
  • Arterial complications
  • Neurological deficit
  • Disc Bulge
  • Lumbar Radiculopathy

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: AHT group
This group will receive Abdominal hypopressive exercises. Each AHT will be repeated 3-5 times with 1 min rest between exercises (shift to new posture, lying,sitting and standing). Between 6 and 15 hypopressive exercises (HEs) will be performed within each session based on the participant's mastery of the exercises and readiness to progress, for 6 weeks.
Active and specific Therapeutic exercises will be used to treat postpartum low back pain in this study. AHE consisted of exhaling to their expiratory reserve volume, then holding their breath (apnea), and expanding their rib cage, to draw their abdominal wall inward and cranially without inhalation. Each exercise will have a specific frequency, intensity, and duration.
Active Comparator: General exercise group
This group will receive general exercises (Bridging, knee to chest, Straight leg rise) these will be repeated 3-5 times with 1 min rest between exercises. Between 6 and 15 repetitions will be performed within each session based on the participant's mastery of the exercises and readiness to progress. Each exercise to be repeated 3-5 times per set, and participants will be asked to perform technique once daily for 6 weeks
General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Changes from Baseline to 6th week
The pain score was assessed using the numeric pain rating scale (NPRS) is a scoring system, wherein the pain level was quantified on a scale of 0 (no pain) to 10 (worst possible pain). The NPRS is a valid and frequently employed method of musculoskeletal pain assessment.
Changes from Baseline to 6th week
Pregnancy Mobility Index
Time Frame: Changes from Baseline to 6th week

It is self-report mobility scale designed specifically for the pregnant women. The internal consistency (Cronbach's alpha) is 0.8 or higher indicating a good construct validity. The assumptions that the Pregnancy Mobility Index scores increase during pregnancy and decrease after delivery and that women with back or pelvic problems scored higher on the Pregnancy Mobility Index domains than women without back or pelvic pain were confirmed, indicating a good criterion validation.

Its scores range from 0 to 100, in which 0 equals 'normal performance' and 100 indicates 'maximum disability

Changes from Baseline to 6th week
Maternal Postpartum Quality of Life Index
Time Frame: Changes from Baseline to 6th week
It is a sixteen-item scale, which is a valid and reliable instrument for postpartum QOL assessment. It includes items on the different aspects of postpartum QOL and can be used for the early diagnosis of impaired postpartum QOL. The QoL score ranges from 0 to 30, with higher scores indicating higher QoL.
Changes from Baseline to 6th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Low Back Pain Disability Index(ODI)
Time Frame: Changes from Baseline to 6th week
The Oswestry Low Back Pain Disability Index is a validated, 10-point patient-reported outcome questionnaire. It is considered the 'gold standard for measuring disability and quality of life (QoL) impairment for adults with low back pain. The Cronbach-α for the ODI is 0.75. The ODI showed excellent test- retest reliability (intraclass correlation coefficient = 0.91)
Changes from Baseline to 6th week

Collaborators and Investigators

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

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 (Actual)

June 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 31, 2022

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RiphahIU Asma Bhatti

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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