- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707143
Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females
March 4, 2024 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 64000
- gynecological department of Services hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Cesarean delivery.
- Multi gravida females.
- Postpartum low back pain last for 1 year
Exclusion Criteria:
- Low back pain before pregnancy.
- Urogenital infections.
- History of pelvic floor or lumber surgery.
- Malignancy.
- Pelvic or lumber fractures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: home based stabilization exercises
knee rolls, the cat, spine curl, bridging, single knee to chest, pelvic tilt
|
3 times per day with 10 repetitions and holding time will be 5-10 sec
|
|
Experimental: kegel exercises
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3 times per day with 10 repetitions and holding time will be 5-10 sec
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6th week
|
|
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 |
6th week
|
|
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
|
6th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: hina gul, MS-OMPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Urme 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
- Unsgaard-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.
- Tseng 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
January 23, 2023
First Submitted That Met QC Criteria
January 23, 2023
First Posted (Actual)
January 31, 2023
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mehak Hassan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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