Abdominal Hypopressive Technique on Postpartum Low Back Pain

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05397899
Collaborator
(none)
31
1
2
7
4.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Abdominal hypopressive Exercises (AHE)
  • Other: General exercises
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Masking:
Single (Outcomes Assessor)
Masking Description:
outcome assessor will be kept blind about the group of patients and treatment received.
Primary Purpose:
Treatment
Official Title:
Effects of Abdominal Hypopressive Technique on Postpartum Low Back Pain
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Other: Abdominal hypopressive Exercises (AHE)
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

Other: General exercises
General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.

Outcome Measures

Primary Outcome Measures

  1. Numeric Pain Rating Scale (NPRS) [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.

  2. Pregnancy Mobility Index [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

  3. Maternal Postpartum Quality of Life Index [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.

Secondary Outcome Measures

  1. Oswestry Low Back Pain Disability Index(ODI) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Holy Family Hospital Rawalpindi Punjab Pakistan 46000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Huma Riaz, PHD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05397899
Other Study ID Numbers:
  • RiphahIU Asma Bhatti
First Posted:
May 31, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022