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

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

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.

Study Overview

• Status: Completed
• Conditions: Exercise
• Intervention / Treatment: Other: exercise with ball; Other: exercise without ball

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 with ball; exercise with ball
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.	Other: exercise without ball; exercise without ball

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	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	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Apinkarn Jaroenlarp, MSc, Mahidol University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: May 4, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: MahidolU_Wunpen1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO