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

Not Applicable

Completed

• Conditions: Lumbar Pain Syndrome; Activation, Patient; Postpartum Disorder
• Interventions: Other: assisted sit-up exercises; Other: swiss ball pikes exercises

• Registration Number: NCT05355246
• Lead Sponsor: Riphah International University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-26
• Study Start: 2022-04-27
• Study First Posted: 2022-05-02
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
assisted sit-up exercises Group	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 a maximum of 10 repetitions, two times a day and two days a week.
swiss ball pikes exercises Group	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 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.

Primary Outcome Measures

Name	Time	Method
Numeric pain rating scale (NPRS)	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.
Ronald Morris Disability (RMD) questionnaire	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.

Trial Locations

Locations (1)

Victoria Hospital; 🇵🇰 Bahawalpur, Punjab, Pakistan