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Completed

NCT Number: NCT05355246

Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on 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.

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Key information

Conditions

Postpartum Disorder Activation, Patient Behavior Female Urogenital Diseases and Pregnancy Complications Health Behavior Lumbar Pain Syndrome Mental Disorders Patient Acceptance of Health Care Patient Participation Pregnancy Complications Puerperal Disorders Somatoform Disorders Treatment Adherence and Compliance Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Victoria Hospital

Bahawalpur, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

assisted sit-up exercises

Other

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.

swiss ball pikes exercises

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 2, 2022
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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