Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on Postpartum Low Back Pain.

March 31, 2023 updated by: Riphah International University

Effects of Assisted Sit-up Exercise Versus Swiss Ball Pikes on Pain and Disability in Patients With Postpartum Low Back Pain.

The aim of this study is to evaluate and compare the effectiveness of assisted sit-up exercise and swiss ball pikes on the treatment of pain and disability of postpartum low back pain. The current study will compare the use of assisted sit-up exercise and swiss ball pikes. The current study is novel in a way that there is limited literature about treating postpartum low back pain with physical strengthening exercises. These two methods will be employed to see if they improve ranges along with accompanying pain and disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized clinical trial. Subjects with postpartum low back pain meeting the predetermined inclusion and exclusion criteria will divide into two groups. Pre-assessment will be done using the Numeric Pain Rating Scale & Roland-Morris Questionnaire as subjective measurements. Subjects in one group will be treated with assisted sit-up exercise and the other will be treated with swiss ball pikes. Each subject will receive a total of 12 treatment sessions, with 2 treatment sessions per week. Post-treatment reading for numeric pain rating scale and Roland-Morris questionnaire will be recorded after the end of the 4th, 8th, and 12th treatment session.

Study Type

Interventional

Enrollment (Actual)

21

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
      • Bahawalpur, Punjab, Pakistan, 54700
        • Victoria 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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 20 to 40 years.
  • Back pain without leg pain for at least three months postpartum period.
  • Pain intensity of numeric pain rating scale ranges between 6 to 10.
  • Intensity of pain limited daily work activities.

Exclusion Criteria:

  • Any kind of infection, malignancy, inflammation, and structural deformity present in the lumbar and pelvic region.
  • Neurologic signs
  • Trauma history of the lumbar and pelvic region
  • Any lumber or abdominal surgery
  • Pregnancy.

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: assisted sit-up exercises Group
Group A patients will be instructed to perform assisted sit-up exercises by lying on their back and lifting their torso. They will use their body weight to strengthen and tone the core stabilizing abdominal muscles. This exercise will perform a minimum of five and a maximum of 10 repetitions, two times a day and two days a week.
Other: assisted sit-up exercises
Group A patients will be instructed to perform assisted sit-up exercises by lying on their back and lifting their torso. They will use their body weight to strengthen and tone the core stabilizing abdominal muscles. This exercise will perform a minimum of five and maximum of 10 repetitions, two times a day and two days a week. Isometrics, back stretching, and strengthening exercises will be given as a common intervention for both groups before starting treatment session.
Active Comparator: swiss ball pikes exercises Group
Group B patients will be instructed to perform swiss ball pikes by getting into the pushup position, the rest of the tops of their feet on a swiss ball. Each patient should keep her legs as straight as possible, bend their hips and try to pull their feet towards their chest so that the ball rolls forward. Hold at the top for three to four seconds, then slowly roll back to the starting position. This exercise will perform a minimum of one or two and a maximum of 10 repetitions, two times a day and two days a week. Both exercises will be performed for 12 weeks in both groups.
Other: swiss ball pikes exercises
Group B patients will be instructed to perform swiss ball pikes by getting into the pushup position, the rest of the tops of their feet on a swiss ball. Each patient should keep her legs as straight as possible, bend her hips and try to pull her feet towards their chest so that the ball rolls forward. Hold at the top for three to four seconds, then slowly roll back to the starting position. This exercise will perform a minimum of one or two and a maximum of 10 repetitions, two times a day and two days a week. Both exercises will be performed for 12 weeks in both groups. Isometrics, back stretching, and strengthening exercises will be given as a common intervention for both groups before starting the treatment session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale (NPRS)
Time Frame: up to 6 weeks
An outcome measure that is a segmented numeric version of visual analogue scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient's pain. The common format is horizontal bar or line and NPRS is anchored by terms describing pain and severity extremes.
up to 6 weeks
Ronald Morris Disability (RMD) questionnaire
Time Frame: up to 6 weeks
a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. This questionnaire has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain.
up to 6 weeks

Collaborators and Investigators

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

Sponsor

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

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 27, 2022

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/22/0503 Romaisa

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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