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

Not Applicable

Completed

• Conditions: Exercise
• Interventions: Other: exercise without ball; Other: exercise with ball

• Registration Number: NCT03527524
• Lead Sponsor: Mahidol University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2017-01-05
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-04
• Last Update Submitted: 2018-05-04
• Study First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise without ball	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.
exercise with ball	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.

Primary Outcome Measures

Name	Time	Method
Pain scale	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 Outcome Measures

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