Back to resultsEffects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Core Stabilization Exercise
General Strengthening Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Chronic low back pain due to clinical lumbar instability
Exclusion Criteria:
- Specific low back pain
- Cuada equine syndrome
- Neurological deficit
Sites / Locations
- Research Center in Back, Neck, Other Joint Pain and Human Performance
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Core Stabilization Exercise (CSE)
General Strengthening Exercise (GSE)
Arm Description
The participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
The participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks.
Outcomes
Primary Outcome Measures
Effect of 2-exercise on quality of life
health-related quality of life was measured by using SF-36 questionnaire
Secondary Outcome Measures
Effect of 2-exercise on physical disability
Physical disability was measured by using Oswestry disability index
Effect of 2-exercise on trunk muscle activity
Trunk muscle activity was measured by using surface EMG
Effect of 2-exercise on lumbar segmental motion
Lumbar segmental motion was measured by using radiography
Effect of 2-exercise on pain intensity
Pain intensity was measured by using numeric rating scale
Full Information
NCT ID
NCT02895828
First Posted
November 24, 2014
Last Updated
January 22, 2020
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT02895828
Brief Title
Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability
Official Title
Clinical Practice Guideline With Core Stabilization and Strengthening Exercise Programs for Low Back Pain With Clinical Lumbar Instability
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will compare the effects of 2 exercise programs including core stabilization exercise and general trunk strengthening exercise programs on trunk muscle activity, physical dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar instability.
Detailed Description
Clinical lumbar instability is the one of causes of chronic low back pain, that affects to pain intensity and quality of life. For clinical studies using core stabilization exercise (CSE) as treatment have revealed conflicting findings on pain, functional disability and muscle responses in chronic low back pain. The CSE promotes local muscle system that to provide lumbar stability. However, the stability of spine related to global muscle system, that using in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core Stabilization Exercise (CSE)
Arm Type
Experimental
Arm Description
The participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
Arm Title
General Strengthening Exercise (GSE)
Arm Type
Experimental
Arm Description
The participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks.
Intervention Type
Other
Intervention Name(s)
Core Stabilization Exercise
Intervention Description
the participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
Intervention Type
Other
Intervention Name(s)
General Strengthening Exercise
Intervention Description
the participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks
Primary Outcome Measure Information:
Title
Effect of 2-exercise on quality of life
Description
health-related quality of life was measured by using SF-36 questionnaire
Time Frame
Change from baseline at 10-week after training session, and follow up session
Secondary Outcome Measure Information:
Title
Effect of 2-exercise on physical disability
Description
Physical disability was measured by using Oswestry disability index
Time Frame
Change from baseline at 10-week after training session, and follow up session
Title
Effect of 2-exercise on trunk muscle activity
Description
Trunk muscle activity was measured by using surface EMG
Time Frame
Change from baseline at 10-week after training session, and follow up session
Title
Effect of 2-exercise on lumbar segmental motion
Description
Lumbar segmental motion was measured by using radiography
Time Frame
Change from baseline at 10-week after training session, and follow up session
Title
Effect of 2-exercise on pain intensity
Description
Pain intensity was measured by using numeric rating scale
Time Frame
Change from baseline at 10-week after training session, and follow up session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic low back pain due to clinical lumbar instability
Exclusion Criteria:
Specific low back pain
Cuada equine syndrome
Neurological deficit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wantanee Yodchaisarn, M.Sc.
Organizational Affiliation
The Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Center in Back, Neck, Other Joint Pain and Human Performance
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
24399870
Citation
Puntumetakul R, Areeudomwong P, Emasithi A, Yamauchi J. Effect of 10-week core stabilization exercise training and detraining on pain-related outcomes in patients with clinical lumbar instability. Patient Prefer Adherence. 2013 Nov 19;7:1189-99. doi: 10.2147/PPA.S50436. eCollection 2013.
Results Reference
background
PubMed Identifier
22935853
Citation
Javadian Y, Behtash H, Akbari M, Taghipour-Darzi M, Zekavat H. The effects of stabilizing exercises on pain and disability of patients with lumbar segmental instability. J Back Musculoskelet Rehabil. 2012;25(3):149-55. doi: 10.3233/BMR-2012-0321.
Results Reference
background
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Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability
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