Breathing SoundNCT05405127
Breathing and Core Stability Exercise Effects on Lumbopelvic Pain
A study testing traditional physical therapy and core stability exercises in people with Breathing Sound and Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Lumbopelvic pain refers to self-reported pain in areas of lower region, anterior and posterior pelvic tilt or combination of these. Physical therapy interventions used are breathing exercises with and without core stability exercises. Tool used were Pain Pressure Algometer and Oswestry Disability Index. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breathing Sound, Low Back Pain, Post-operative Pain
- What is being tested?
- traditional physical therapy and core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women had parity (2-4) times
- Body mass index that did not exceed 30 Kg/m
- Lumbopelvic pain at least three months until one year postpartum
Who cannot join
- They were pregnant
- Had systemic inflammatory diseases
- Prolapsed disc
- Neuromuscular disorder
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Services Hospital
Lahore, Punjab Province, 54660
Hafiza Mehjabeen, MSWHPT, 03026577666, hafiza.mehjabeen@riphah.edu.pk
Hafsa Khalid, MS(WHPT)
About this study
Official title: Effects of Breathing Exercises With and Without Core Stability Exercises on Pain Pressure Threshold and Disability in Postpartum Females With Lumbopelvic Pain
Lumbopelvic pain refers to self-reported pain in areas of lower region, anterior and posterior pelvic tilt or combination of these. Physical therapy interventions used are breathing exercises with and without core stability exercises. Tool used were Pain Pressure Algometer and Oswestry Disability Index.
Read the detailed description
Lumbopelvic pain is self-reported pain. It is common complaint for women after labour, and it is found that 25% of newly delivered women experienced low back and pelvic pain. Different interventions have been used to reduce the lumbopelvic pain in general including exercises, drugs, therapies and massage. An increasingly common approach used within physical therapy management are breathing exercises and core stabilization exercises. This study will used to compare the effects of breathing exercises with and without core stability exercise. Pre-assessment will be done using oswestry disability index as subjective measurement and pain pressure algometer as objective measure.
- Conditions
- Breathing Sound, Low Back Pain, Post-operative Pain, Pelvic Pain
- Being tested
- traditional physical therapy, core stability exercises
- Keywords
- breathing exercises, low back pain, post-partum pain, lumbopelvic pain
- Medical subject headings
- Respiratory Sounds, Low Back Pain, Pain, Postoperative, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physical therapyOther
breathing exercises 10 repetitions, 1set, 3 days/week and targeted abdominal muscles. Total 6 sessions were given each consisting of 30 minutes.
core stability exercisesOther
core stability along with breathing exercise 10 repetitions, 1set, 3 days/week and targeted core muscles. Total 6 sessions were given consisting of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy | Active comparator | breathing exercises Receives: Other: traditional physical therapy |
| Core stability exercise | Experimental | core stability exercise along with breathing exercises and pain pressure algometer is used Receives: Other: core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
Changes from base line Oswestry disability index was developed first by Fairbank et al. It was designed to measure the back pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section in all the female patients, total score was considered as 45 instead of 50.
Measured: 6th week
Secondary outcomes (3)
Pain Pressure Algometer
Changes from base line Pain Pressure Algometer was developed first by Baba et al. The pressure algometer has linear response to force application between 0 and 1,300 kilopascal.
Measured: 6th week
ROM Back region (flexion)
Changes from the Baseline ROM range of motion of back region flexion was taken.
Measured: 6th week
ROM Back region (extension)
Changes from the baseline ROM range of motion of back region extension was taken.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start30 May 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breathing SoundStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Mehjabeen, MSWHPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405127
- Sponsor's protocol ID
- REC/RCR&AHS/22/0518
- Status last verified
- May 2022
- First submitted
- 31 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergstrom C, Persson M, Nergard KA, Mogren I. Prevalence and predictors of persistent pelvic girdle pain 12 years postpartum. BMC Musculoskelet Disord. 2017 Sep 16;18(1):399. doi: 10.1186/s12891-017-1760-5.
PubMed 28915804Stuber KJ, Wynd S, Weis CA. Adverse events from spinal manipulation in the pregnant and postpartum periods: a critical review of the literature. Chiropr Man Therap. 2012 Mar 28;20:8. doi: 10.1186/2045-709X-20-8.
PubMed 22455720Gutke A, Lundberg M, Ostgaard HC, Oberg B. Impact of postpartum lumbopelvic pain on disability, pain intensity, health-related quality of life, activity level, kinesiophobia, and depressive symptoms. Eur Spine J. 2011 Mar;20(3):440-8. doi: 10.1007/s00586-010-1487-6. Epub 2010 Jul 1.
PubMed 20593205Robinson HS, Vollestad NK, Veierod MB. Clinical course of pelvic girdle pain postpartum - impact of clinical findings in late pregnancy. Man Ther. 2014 Jun;19(3):190-6. doi: 10.1016/j.math.2014.01.004. Epub 2014 Jan 22.
PubMed 24508067Malmqvist S, Kjaermann I, Andersen K, Okland I, Bronnick K, Larsen JP. Prevalence of low back and pelvic pain during pregnancy in a Norwegian population. J Manipulative Physiol Ther. 2012 May;35(4):272-8. doi: 10.1016/j.jmpt.2012.04.004.
PubMed 22632586O'Sullivan PB, Beales DJ. Diagnosis and classification of pelvic girdle pain disorders--Part 1: a mechanism based approach within a biopsychosocial framework. Man Ther. 2007 May;12(2):86-97. doi: 10.1016/j.math.2007.02.001.
PubMed 17449432Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010 Jan-Feb;10(1):60-71. doi: 10.1111/j.1533-2500.2009.00327.x. Epub 2010 Oct 26.
PubMed 19863747
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Exercises With and Without Core Stability Exercises on Pain Pressure Threshold and Disability in Postpartum Females With Lumbopelvic Pain
- ClinicalTrials.gov ID
- NCT05405127
- Acronym / sponsor ID
- REC/RCR&AHS/22/0518
- Conditions
- Breathing Sound, Low Back Pain, Post-operative Pain, Pelvic Pain
- Keywords
- breathing exercises, low back pain, post-partum pain, lumbopelvic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jun 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.
Lumbopelvic pain refers to self-reported pain in areas of lower region, anterior and posterior pelvic tilt or combination of these. Physical therapy interventions used are breathing exercises with and without core stability exercises. Tool used were Pain Pressure Algometer and Oswestry Disability Index.
Detailed description
Lumbopelvic pain is self-reported pain. It is common complaint for women after labour, and it is found that 25% of newly delivered women experienced low back and pelvic pain. Different interventions have been used to reduce the lumbopelvic pain in general including exercises, drugs, therapies and massage. An increasingly common approach used within physical therapy management are breathing exercises and core stabilization exercises. This study will used to compare the effects of breathing exercises with and without core stability exercise. Pre-assessment will be done using oswestry disability index as subjective measurement and pain pressure algometer as objective measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy | Active comparator | Other: traditional physical therapybreathing exercises |
| Core stability exercise | Experimental | Other: core stability exercisescore stability exercise along with breathing exercises and pain pressure algometer is used |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women had parity (2-4) times
- Body mass index that did not exceed 30 Kg/m
- Lumbopelvic pain at least three months until one year postpartum
Key exclusion criteria (4 listed)
- They were pregnant
- Had systemic inflammatory diseases
- Prolapsed disc
- Neuromuscular disorder
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 |
|---|---|---|
| traditional physical therapybreathing exercises 10 repetitions, 1set, 3 days/week and targeted abdominal muscles. Total 6 sessions were given each consisting of 30 minutes. | Other | Traditional physical therapy |
| core stability exercisescore stability along with breathing exercise 10 repetitions, 1set, 3 days/week and targeted core muscles. Total 6 sessions were given consisting of 30 minutes. | Other | Core stability exercise |
Primary outcome
Oswestry disability index
Time frame: 6th week
Changes from base line Oswestry disability index was developed first by Fairbank et al. It was designed to measure the back pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section in all the female patients, total score was considered as 45 instead of 50.
3 secondary outcomes
Pain Pressure Algometer
Time frame: 6th week
ROM Back region (flexion)
Time frame: 6th week
ROM Back region (extension)
Time frame: 6th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Background: PubMed 28915804Bergstrom C, Persson M, Nergard KA, Mogren I. Prevalence and predictors of persistent pelvic girdle pain 12 years postpartum. BMC Musculoskelet Disord. 2017 Sep 16;18(1):399. doi: 10.1186/s12891-017-1760-5.
- Background: PubMed 22455720Stuber KJ, Wynd S, Weis CA. Adverse events from spinal manipulation in the pregnant and postpartum periods: a critical review of the literature. Chiropr Man Therap. 2012 Mar 28;20:8. doi: 10.1186/2045-709X-20-8.
- Background: PubMed 20593205Gutke A, Lundberg M, Ostgaard HC, Oberg B. Impact of postpartum lumbopelvic pain on disability, pain intensity, health-related quality of life, activity level, kinesiophobia, and depressive symptoms. Eur Spine J. 2011 Mar;20(3):440-8. doi: 10.1007/s00586-010-1487-6. Epub 2010 Jul 1.
- Background: PubMed 24508067Robinson HS, Vollestad NK, Veierod MB. Clinical course of pelvic girdle pain postpartum - impact of clinical findings in late pregnancy. Man Ther. 2014 Jun;19(3):190-6. doi: 10.1016/j.math.2014.01.004. Epub 2014 Jan 22.
- Background: PubMed 22632586Malmqvist S, Kjaermann I, Andersen K, Okland I, Bronnick K, Larsen JP. Prevalence of low back and pelvic pain during pregnancy in a Norwegian population. J Manipulative Physiol Ther. 2012 May;35(4):272-8. doi: 10.1016/j.jmpt.2012.04.004.
- Background: PubMed 17449432O'Sullivan PB, Beales DJ. Diagnosis and classification of pelvic girdle pain disorders--Part 1: a mechanism based approach within a biopsychosocial framework. Man Ther. 2007 May;12(2):86-97. doi: 10.1016/j.math.2007.02.001.
- Background: PubMed 19863747Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010 Jan-Feb;10(1):60-71. doi: 10.1111/j.1533-2500.2009.00327.x. Epub 2010 Oct 26.
- 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.
Hafiza Mehjabeen, MSWHPT 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 traditional physical therapy and core stability exercises in people with Breathing Sound and Low Back Pain, 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability index (time frame: 6th week). 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 NCT05405127, which also lists 7 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 6 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.