Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

home based stabilization exercises

kegel exercises

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring disability, low back pain, females, quality of life, stabilization exercises

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

gynecological department of Services hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

home based stabilization exercises

kegel exercises

Arm Description

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

kegel exercises

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05707143

First Posted

January 23, 2023

Last Updated

July 31, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05707143

Brief Title

Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females

Official Title

Comparative Effects of Home Based Stabilization and Kegel Exercises on Low Back Pain, Disability and Quality of Life in Postnatal Females

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

disability, low back pain, females, quality of life, stabilization exercises

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

home based stabilization exercises

Arm Type

Active Comparator

Arm Description

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

Arm Title

kegel exercises

Arm Type

Experimental

Arm Description

kegel exercises

Intervention Type

Other

Intervention Name(s)

home based stabilization exercises

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

kegel exercises

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual analogue scale

Description

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

Time Frame

6th week

Title

Short form 36

Description

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

Time Frame

6th week

Title

Oswestry disability index

Description

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

Time Frame

6th week

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

post partum females

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hina Gul, MS-OMPT

Phone

03214979172

Email

hina.gul@riphah.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hina Gul, MS-OMPT

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

gynecological department of Services hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

64000

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

hina gul, MS-OMPT

Phone

03214979172

Email

hina.gul@riphah.edu.pk

First Name & Middle Initial & Last Name & Degree

Mehak Hassan, MSWHPT

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

32274521

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

29979205

Citation

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.

Results Reference

background

PubMed Identifier

27157173

Citation

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.

Results Reference

background

PubMed Identifier

26612732

Citation

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.

Results Reference

background

Low Back Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial