PostpartumNCT05397899
Abdominal Hypopressive Technique on Postpartum Low Back Pain
A study testing Abdominal hypopressive Exercises (AHE) and General exercises in people with Postpartum, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum
- What is being tested?
- Abdominal hypopressive Exercises (AHE) and General exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum non-radiating low back Pain
- LBP severity >3 on numeric pain rating scale (NPRS)
- Spontaneous vaginal delivery
Who cannot join
- Prenatal history of low back pain
- Caesarean section
- Hypertension
- Puerperium period
- Arterial complications
- Neurological deficit
- Disc Bulge
- Lumbar Radiculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Postpartum
- Being tested
- Abdominal hypopressive Exercises (AHE), General exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal hypopressive Exercises (AHE)Other
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.
General exercisesOther
General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.
| Study group | Role | What they receive |
|---|---|---|
| AHT group | Experimental | 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. Receives: Other: Abdominal hypopressive Exercises (AHE) |
| General exercise group | Active comparator | 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 Receives: Other: General exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from Baseline to 6th week
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
Measured: Changes from Baseline to 6th week
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.
Measured: Changes from Baseline to 6th week
Secondary outcomes (1)
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)
Measured: Changes from Baseline to 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jun 2022
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397899
- Sponsor's protocol ID
- RiphahIU Asma Bhatti
- Status last verified
- Feb 2023
- First submitted
- 25 May 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29681973Saleh 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.
PubMed 30282349Davenport 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.
PubMed 30337344Da 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.
PubMed 34356983Juez 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.
PubMed 31297874Soriano 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.
PubMed 32707289
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Hypopressive Technique on Postpartum Low Back Pain
- ClinicalTrials.gov ID
- NCT05397899
- Acronym / sponsor ID
- RiphahIU Asma Bhatti
- Conditions
- Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.
| Arm | Type | Receives |
|---|---|---|
| AHT group | Experimental | Other: Abdominal hypopressive Exercises (AHE)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. |
| General exercise group | Active comparator | Other: General exercisesThis 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postpartum non-radiating low back Pain
- LBP severity >3 on numeric pain rating scale (NPRS)
- Spontaneous vaginal delivery
Key exclusion criteria (8 listed)
- Prenatal history of low back pain
- Caesarean section
- Hypertension
- Puerperium period
- Arterial complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | AHT group |
| General exercisesGeneral exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain. | Other | General exercise group |
Primary outcome
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.
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
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.
1 secondary outcome
Oswestry Low Back Pain Disability Index(ODI)
Time frame: Changes from Baseline to 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 29681973Bellido-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.
- Background: PubMed 30282349Saleh 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.
- Background: PubMed 30337344Davenport 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.
- Background: PubMed 34356983Da 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.
- Background: PubMed 31297874Juez 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.
- Background: PubMed 32707289Soriano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal hypopressive Exercises (AHE) and General exercises in people with Postpartum, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Changes from Baseline to 6th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05397899, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.