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OpenTrials
Completed

NCT Number: NCT03527524

Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain

The purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain.

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Key information

Conditions

Exercise Behavior Motor Activity

Age range

20 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

For Patient Registries:

The participant was screened for inclusion criteria and was asked to sign the informed consent prior to participate. A randomized control trial was performed with participants randomly divided into one of the two treatment groups: core stabilization exercise with ball and core stabilization exercise without ball by using sealed envelopes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female with low back pain (LBP) > 3 months
  • Body mass index (BMI) = 18-25 kg/m2
  • Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold)
  • Willing and able to perform exercise programs
  • No cognitive impairment
  • Age at least 19 years

Exclusion criteria

  • Having experiences in the core stabilization exercise and Swiss ball exercises
  • Past history of back and abdomen surgery
  • Recent fractures of spine, hip or lower limb
  • Current use of steroids or any other drugs for resolving back pain
  • Red flags (fractures, cancer, infection, cauda equine syndrome)
  • Pregnancy
  • Neuromuscular or respiratory disorders
  • Rheumatologic disorders
  • Hip and knee stiffness
  • Pain intensity > 60 of 100 mm assessed by the VAS

Treatment and study plan

exercise with ball

Other

exercise with ball

exercise without ball

Other

exercise without ball

Primary outcomes

  1. Pain scale

    Time frame: 4 weeks

    a 0-100 mm of horizontal line (Visual analog scale) assessing pain intensity - reported the distance measured in millimeters from the left hand side of this line to the point that participant marked

Secondary outcomes

  1. Questionnaire scores of functional disability measure

    Time frame: 4 weeks

    Thai modified Oswestry Disability Low Back Pain Disability Questionnaire

  2. Levels of lumbar stability

    Time frame: 4 weeks

    isometric abdominal contraction assessing lumbar stability

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effects of Core Stabilization Exercises With and Without Ball on Pain, Functional Disability and Level of Lumbar Stability in Patients With Non-specific Chronic Low Back Pain

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 17, 2018
Registry last updated
May 17, 2018

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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