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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 2015

Detailed Description

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.

Interventions

  • Other: exercise with ball
    • exercise with ball
  • Other: exercise without ball
    • exercise without ball

Arms, Groups and Cohorts

  • Experimental: exercise with ball
    • The participant in core stabilization exercise with ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.
  • Other: exercise without ball
    • The participant in core stabilization exercise without ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Questionnaire scores of functional disability measure
    • Time Frame: 4 weeks
    • Thai modified Oswestry Disability Low Back Pain Disability Questionnaire
  • Levels of lumbar stability
    • Time Frame: 4 weeks
    • isometric abdominal contraction assessing lumbar stability

Participating in This Clinical Trial

Inclusion Criteria

1. Male and female with low back pain (LBP) > 3 months 2. Body mass index (BMI) = 18-25 kg/m2 3. Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold) 4. Willing and able to perform exercise programs 5. No cognitive impairment 6. Age at least 19 years Exclusion Criteria:

1. Having experiences in the core stabilization exercise and Swiss ball exercises 2. Past history of back and abdomen surgery 3. Recent fractures of spine, hip or lower limb 4. Current use of steroids or any other drugs for resolving back pain 5. Red flags (fractures, cancer, infection, cauda equine syndrome) 6. Pregnancy 7. Neuromuscular or respiratory disorders 8. Rheumatologic disorders 9. Hip and knee stiffness 10. Pain intensity > 60 of 100 mm assessed by the VAS

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 68 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Apinkarn Jaroenlarp, MSc, Principal Investigator, Mahidol University

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