Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain.

November 19, 2024 updated by: Riphah International University

Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain, Disability and Function.

The study will be a Randomized controlled trial to check the combined effects of Core Stability Exercises with and without Back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females Non-probability convenience sampling technique will be used, subject following eligibility criteria from Society Hospital Nabipura Lahore will be randomly allocated in two groups. Group A participants will be given core stability exercises with back strengthening exercises, Group B participants will be given core stability exercises for 4 weeks. Assessment will be done via, Numeric Pain Rating Scale, Oswestry disability index questionnaire and Back pain Functional Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pregnancy-inducedBack pain causes weakness of abdominal muscles and pelvic muscles which affects core stability and back strength of pregnant women. In this study, the effects of Core Stability Exercises with and without Back strengthening exercises in pregnancy-induced back pain population will be analyzed. This study will be a randomized controlled trial. Core stability exercises and Strengthening exercises program would be applied to pregnant females with pregnancy-induced back pain. Subjects meeting the predetermined inclusion criteria will be divided into two groups. Assessment will be done using the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index Questionnaire, and Back Pain Functional Scale (BPFS). Subjects in one group will be treated with core stability exercises with back strengthening exercises, and the other will be treated with core stability exercises only. Each subject will receive a total of 20 treatment sessions, with 05 treatment sessions per week. Measurements will be recorded at the start and end of the treatment session. Recorded values will be analyzed for any change using SPSS.

Study Type

Interventional

Enrollment (Actual)

34

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Society Hospital Nabipura

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant females
  • Pregnant female in their second and third trimester.
  • Multi gravida patient
  • Low back pain intensity greater than 4 out of 10 on NPRS, indicating moderate to severe.

Exclusion Criteria:

  • Placenta previa
  • Bleeding or spotting
  • Low back pain before pregnancy
  • Pregnancy-induced hypertension
  • Pudendal nerve entrapment syndrome.
  • Not simultaneously partaking in pelvic floor physical therapy.
  • No evoked tenderness upon palpation of levatorani sling at examination.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Core Stability Exercises and Back Strengthening exercises group:
we will ask the patient to perform a combined exercise program of core stability exercises program with a back strengthening exercises program. 5 sessions per week and post-intervention assessment after 4 weeks follow-up
Other: Core Stability Exercises
Core stability exercises will be used to strengthen the core muscles, which includes sets of exercises like pelvic tilts, wall squatting, bridging, bird dog and heel walking which targets core muscles.
Other: Back Strengthening exercises
Back strengthening exercises will be used to strengthen the back muscles which include sets of exercises that target back muscles like cat-cow exercise, child pose, heel sits, and kegels.
Active Comparator: Core Stability Exercise group
In this group, patients will only perform the Core Stability Exercises program. 5 sessions per week and post-intervention assessment after 4 weeks follow-up
Other: Core Stability Exercises
Core stability exercises will be used to strengthen the core muscles, which includes sets of exercises like pelvic tilts, wall squatting, bridging, bird dog and heel walking which targets core muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: up to 4 weeks
The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes. changes from Baseline to 4 week
up to 4 weeks
Oswestry Disability Index Questionnaire
Time Frame: up to 4 weeks
The Oswestry disability index questionnaire gives subjective percentage score of level of function(disability) in activities of daily living in those rehabilitating from low back pain with level of disability in 10 everyday activities. Each item consists of 6 options with score 0-5. With 0 indicating least disability and 5 greater then total score will be calculated as percentage. 0% indicating no disability and 100% highest level of disability.
up to 4 weeks
Back Pain Functional Scale (BPFS):
Time Frame: up to 4 weeks
The BPFS is a subjective scale used to measure the patient physical function after low back pain. It consists of 12 items and total score of 60. The maximum score indicates maximum physical abilities of patient. 0 being no physical abilities and 60 being no difficulty in any activity
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Marwa Shafiq Dar, MS*, Riphah International University, Lahore, Pakistan

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

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)

April 5, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 15, 2024

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0568

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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