- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05397899
Abdominal Hypopressive Technique on Postpartum Low Back Pain
Effects of Abdominal Hypopressive Technique on Postpartum Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Holy Family Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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|
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
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General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.
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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.
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Changes from Baseline to 6th week
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Pregnancy Mobility Index
Time Frame: Changes from Baseline to 6th week
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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
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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.
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Changes from Baseline to 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Low Back Pain Disability Index(ODI)
Time Frame: Changes from Baseline to 6th week
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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)
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Changes from Baseline to 6th week
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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