Back to resultsEffect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain
Primary Purpose
Exercise
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise with ball
exercise without ball
Sponsored by
About this trial
This is an interventional health services research trial for Exercise focused on measuring exercise
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
exercise with ball
exercise without ball
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Questionnaire scores of functional disability measure
Thai modified Oswestry Disability Low Back Pain Disability Questionnaire
Levels of lumbar stability
isometric abdominal contraction assessing lumbar stability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03527524
Brief Title
Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise
Keywords
exercise
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise with ball
Arm Type
Experimental
Arm Description
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.
Arm Title
exercise without ball
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercise with ball
Intervention Description
exercise with ball
Intervention Type
Other
Intervention Name(s)
exercise without ball
Intervention Description
exercise without ball
Primary Outcome Measure Information:
Title
Pain scale
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Questionnaire scores of functional disability measure
Description
Thai modified Oswestry Disability Low Back Pain Disability Questionnaire
Time Frame
4 weeks
Title
Levels of lumbar stability
Description
isometric abdominal contraction assessing lumbar stability
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apinkarn Jaroenlarp, MSc
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain
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