NCT05707143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

January 23, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

disabilitylow back painfemalesquality of lifestabilization exercises

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    6th week

Study Arms (2)

home based stabilization exercises

ACTIVE COMPARATOR

knee rolls, the cat, spine curl, bridging, single knee to chest, pelvic tilt

Other: home based stabilization exercises

kegel exercises

EXPERIMENTAL

kegel exercises

Other: kegel exercises

Interventions

3 times per day with 10 repetitions and holding time will be 5-10 sec

home based stabilization exercises

3 times per day with 10 repetitions and holding time will be 5-10 sec

kegel exercises

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspost partum females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cesarean delivery.
  • Multi gravida females.
  • Postpartum low back pain last for 1 year

You may not qualify if:

  • Low back pain before pregnancy.
  • Urogenital infections.
  • History of pelvic floor or lumber surgery.
  • Malignancy.
  • Pelvic or lumber fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

gynecological department of Services hospital

Lahore, Punjab Province, 64000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 32274521BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29979205BACKGROUND
  • 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.

    PMID: 27157173BACKGROUND
  • 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.

    PMID: 26612732BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hina Gul, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

January 31, 2023

Study Start

October 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations