Low Back PainNCT05707143
Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females
A study testing home based stabilization exercises and kegel exercises in people with Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of home based stabilization exercises and kegel exercises on low back pain, disability and quality of life in postnatal females. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- home based stabilization exercises and kegel exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Aug 2023
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Cesarean delivery.
- Multi gravida females.
- Postpartum low back pain last for 1 year
Who cannot join
- Low back pain before pregnancy.
- Urogenital infections.
- History of pelvic floor or lumber surgery.
- Malignancy.
- Pelvic or lumber fractures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
gynecological department of Services hospital
Lahore, Punjab Province, 64000
About this study
Official title: Comparative Effects of Home Based Stabilization and Kegel Exercises on Low Back Pain, Disability and Quality of Life in Postnatal Females
To compare the effects of home based stabilization exercises and kegel exercises on low back pain, disability and quality of life in postnatal females.
- Conditions
- Low Back Pain
- Being tested
- home based stabilization exercises, kegel exercises
- Keywords
- disability, low back pain, females, quality of life, stabilization exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home based stabilization exercisesOther
3 times per day with 10 repetitions and holding time will be 5-10 sec
kegel exercisesOther
3 times per day with 10 repetitions and holding time will be 5-10 sec
| Study group | Role | What they receive |
|---|---|---|
| home based stabilization exercises | Active comparator | knee rolls, the cat, spine curl, bridging, single knee to chest, pelvic tilt Receives: Other: home based stabilization exercises |
| kegel exercises | Experimental | kegel exercises Receives: Other: kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
A tool used to help a person rate the intensity of pain. The visual analogue scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. High reliability when it is used for acute abdominal pain and moderate to good reliability for disability in patient with chronic musculoskeletal pain. It is a validated, subjective measure for acute and chronic pain
Measured: 6th week
Short form 36
The Short form 36 health survey questionnaire is used to indicate the health status of particular population, to help with service planning and to measure the impact of clinical and social intervention.
The SF-36 is considered to be a valid, reliable, concise and generic measure of state of health
Measured: 6th week
Oswestry disability index
The Oswestry disability index is a self-rating condition-specific outcome measure for evaluation of low back pain disability. It is a validated, 10-point patient-reported outcome questionnaire. It is considered the Gold standard for measuring disability and quality of life, impairment for adult with low back pain. The ODI ca be used to assess both chronic and acute conditions of varying severity. It has a high test-retest reliability and takes around 5 min for a patient to complete
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 posted31 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hina Gul, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707143
- Sponsor's protocol ID
- Mehak Hassan
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khorasani F, Ghaderi F, Bastani P, Sarbakhsh P, Berghmans B. The Effects of home-based stabilization exercises focusing on the pelvic floor on postnatal stress urinary incontinence and low back pain: a randomized controlled trial. Int Urogynecol J. 2020 Nov;31(11):2301-2307. doi: 10.1007/s00192-020-04284-7. Epub 2020 Apr 10.
PubMed 32274521Urme NA, Alam F, Jahan N. Effectiveness of Specific Lumbar Stabilization Exercise for LBP among Postpartum Women: A Quasi-Experimental Study. Journal of Advanced Academic Research. 2021;8(1):79-95
Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
PubMed 29979205Unsgaard-Tondel M, Vasseljen O, Woodhouse A, Morkved S. Exercises for Women with Persistent Pelvic and Low Back Pain after Pregnancy. Glob J Health Sci. 2016 Sep 1;8(9):54311. doi: 10.5539/gjhs.v8n9p107.
PubMed 27157173Tseng PC, Puthussery S, Pappas Y, Gau ML. A systematic review of randomised controlled trials on the effectiveness of exercise programs on Lumbo Pelvic Pain among postnatal women. BMC Pregnancy Childbirth. 2015 Nov 26;15:316. doi: 10.1186/s12884-015-0736-4.
PubMed 26612732
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Home Based Stabilization and Kegel Exercises on Low Back Pain, Disability and Quality of Life in Postnatal Females
- ClinicalTrials.gov ID
- NCT05707143
- Acronym / sponsor ID
- Mehak Hassan
- Conditions
- Low Back Pain
- Keywords
- disability, low back pain, females, quality of life, stabilization exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 31 Jan 2023 (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.
To compare the effects of home based stabilization exercises and kegel exercises on low back pain, disability and quality of life in postnatal females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home based stabilization exercises | Active comparator | Other: home based stabilization exercisesknee rolls, the cat, spine curl, bridging, single knee to chest, pelvic tilt |
| kegel exercises | Experimental | Other: kegel exerciseskegel exercises |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cesarean delivery.
- Multi gravida females.
- Postpartum low back pain last for 1 year
Key exclusion criteria (5 listed)
- Low back pain before pregnancy.
- Urogenital infections.
- History of pelvic floor or lumber surgery.
- Malignancy.
- Pelvic or lumber fractures
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 |
|---|---|---|
| home based stabilization exercises3 times per day with 10 repetitions and holding time will be 5-10 sec | Other | home based stabilization exercises |
| kegel exercises3 times per day with 10 repetitions and holding time will be 5-10 sec | Other | kegel exercises |
Primary outcome
Visual analogue scale
Time frame: 6th week
A tool used to help a person rate the intensity of pain. The visual analogue scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. High reliability when it is used for acute abdominal pain and moderate to good reliability for disability in patient with chronic musculoskeletal pain. It is a validated, subjective measure for acute and chronic pain
Short form 36
Time frame: 6th week
The Short form 36 health survey questionnaire is used to indicate the health status of particular population, to help with service planning and to measure the impact of clinical and social intervention. The SF-36 is considered to be a valid, reliable, concise and generic measure of state of health
Oswestry disability index
Time frame: 6th week
The Oswestry disability index is a self-rating condition-specific outcome measure for evaluation of low back pain disability. It is a validated, 10-point patient-reported outcome questionnaire. It is considered the Gold standard for measuring disability and quality of life, impairment for adult with low back pain. The ODI ca be used to assess both chronic and acute conditions of varying severity. It has a high test-retest reliability and takes around 5 min for a patient to complete
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 5 Mar 2024.
- Background: PubMed 32274521Khorasani F, Ghaderi F, Bastani P, Sarbakhsh P, Berghmans B. The Effects of home-based stabilization exercises focusing on the pelvic floor on postnatal stress urinary incontinence and low back pain: a randomized controlled trial. Int Urogynecol J. 2020 Nov;31(11):2301-2307. doi: 10.1007/s00192-020-04284-7. Epub 2020 Apr 10.
- BackgroundUrme NA, Alam F, Jahan N. Effectiveness of Specific Lumbar Stabilization Exercise for LBP among Postpartum Women: A Quasi-Experimental Study. Journal of Advanced Academic Research. 2021;8(1):79-95
- Background: PubMed 29979205Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
- Background: PubMed 27157173Unsgaard-Tondel M, Vasseljen O, Woodhouse A, Morkved S. Exercises for Women with Persistent Pelvic and Low Back Pain after Pregnancy. Glob J Health Sci. 2016 Sep 1;8(9):54311. doi: 10.5539/gjhs.v8n9p107.
- Background: PubMed 26612732Tseng PC, Puthussery S, Pappas Y, Gau ML. A systematic review of randomised controlled trials on the effectiveness of exercise programs on Lumbo Pelvic Pain among postnatal women. BMC Pregnancy Childbirth. 2015 Nov 26;15:316. doi: 10.1186/s12884-015-0736-4.
- 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.
Hina Gul, MS-OMPT 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 home based stabilization exercises and kegel exercises in people with 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 5 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 5 Mar 2024. 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?
Visual analogue scale (time frame: 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 NCT05707143, which also lists 5 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 5 Mar 2024.