search
Back to results

Abdominal Hypopressive Technique on Postpartum Low Back Pain

Primary Purpose

Postpartum

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Abdominal hypopressive Exercises (AHE)
General exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Holy Family Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AHT group

General exercise group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
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.
Pregnancy Mobility Index
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
Maternal Postpartum Quality of Life Index
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

Oswestry Low Back Pain Disability Index(ODI)
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)

Full Information

First Posted
May 25, 2022
Last Updated
February 20, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05397899
Brief Title
Abdominal Hypopressive Technique on Postpartum Low Back Pain
Official Title
Effects of Abdominal Hypopressive Technique on Postpartum Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Masking
Outcomes Assessor
Masking Description
outcome assessor will be kept blind about the group of patients and treatment received.
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AHT group
Arm Type
Experimental
Arm Description
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.
Arm Title
General exercise group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Abdominal hypopressive Exercises (AHE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General exercises
Intervention Description
General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Changes from Baseline to 6th week
Title
Pregnancy Mobility Index
Description
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
Time Frame
Changes from Baseline to 6th week
Title
Maternal Postpartum Quality of Life Index
Description
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.
Time Frame
Changes from Baseline to 6th week
Secondary Outcome Measure Information:
Title
Oswestry Low Back Pain Disability Index(ODI)
Description
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)
Time Frame
Changes from Baseline to 6th week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holy Family Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29681973
Citation
Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Gomez-Benitez MA, De-La-Casa-Almeida M, Rebollo-Salas M. Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Feb 22;2018:3684194. doi: 10.1155/2018/3684194. eCollection 2018. Erratum In: Evid Based Complement Alternat Med. 2018 Sep 6;2018:3601984.
Results Reference
background
PubMed Identifier
30282349
Citation
Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
Results Reference
background
PubMed Identifier
30337344
Citation
Davenport MH, Marchand AA, Mottola MF, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Sobierajski F, James M, Meah VL, Skow RJ, Riske L, Nuspl M, Nagpal TS, Courbalay A, Slater LG, Adamo KB, Davies GA, Barakat R, Ruchat SM. Exercise for the prevention and treatment of low back, pelvic girdle and lumbopelvic pain during pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2019 Jan;53(2):90-98. doi: 10.1136/bjsports-2018-099400. Epub 2018 Oct 18.
Results Reference
background
PubMed Identifier
34356983
Citation
Da Cuna-Carrera I, Alonso-Calvete A, Soto-Gonzalez M, Lantaron-Caeiro EM. How Do the Abdominal Muscles Change during Hypopressive Exercise? Medicina (Kaunas). 2021 Jul 9;57(7):702. doi: 10.3390/medicina57070702.
Results Reference
background
PubMed Identifier
31297874
Citation
Juez L, Nunez-Cordoba JM, Couso N, Auba M, Alcazar JL, Minguez JA. Hypopressive technique versus pelvic floor muscle training for postpartum pelvic floor rehabilitation: A prospective cohort study. Neurourol Urodyn. 2019 Sep;38(7):1924-1931. doi: 10.1002/nau.24094. Epub 2019 Jul 11.
Results Reference
background
PubMed Identifier
32707289
Citation
Soriano L, Gonzalez-Millan C, Alvarez Saez MM, Curbelo R, Carmona L. Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial. Physiotherapy. 2020 Sep;108:37-44. doi: 10.1016/j.physio.2020.02.004. Epub 2020 Feb 19.
Results Reference
background

Learn more about this trial

Abdominal Hypopressive Technique on Postpartum Low Back Pain

We'll reach out to this number within 24 hrs