Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females

• Sponsor: Riphah International University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05707143
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: home based stabilization exercises; Other: kegel exercises	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Effects of Home Based Stabilization and Kegel Exercises on Low Back Pain, Disability and Quality of Life in Postnatal Females
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: home based stabilization exercises knee rolls, the cat, spine curl, bridging, single knee to chest, pelvic tilt	Other: home based stabilization exercises; 3 times per day with 10 repetitions and holding time will be 5-10 sec
Experimental: kegel exercises kegel exercises	Other: kegel exercises; 3 times per day with 10 repetitions and holding time will be 5-10 sec

Outcome Measures

Primary Outcome Measures

1. Visual analogue scale [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

2. Short form 36 [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

3. Oswestry disability index [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	gynecological department of Services hospital	Lahore	Punjab	Pakistan	64000

Sponsors and Collaborators

• Riphah International University

Investigators

• Principal Investigator: Hina Gul, MS-OMPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05707143
• Other Study ID Numbers: Mehak Hassan
• First Posted: Jan 31, 2023
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: disability; low back pain; females; quality of life; stabilization exercises
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Jan 31, 2023