- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02895828
Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability
January 22, 2020 updated by: Wantanee Yodchaisarn, Khon Kaen University
Clinical Practice Guideline With Core Stabilization and Strengthening Exercise Programs for Low Back Pain With Clinical Lumbar Instability
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Khon Kaen, Thailand, 40000
- Research Center in Back, Neck, Other Joint Pain and Human Performance
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic low back pain due to clinical lumbar instability
Exclusion Criteria:
- Specific low back pain
- Cuada equine syndrome
- Neurological deficit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core Stabilization Exercise (CSE)
The participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
|
the participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
|
|
Experimental: General Strengthening Exercise (GSE)
The participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks.
|
the participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of 2-exercise on quality of life
Time Frame: Change from baseline at 10-week after training session, and follow up session
|
health-related quality of life was measured by using SF-36 questionnaire
|
Change from baseline at 10-week after training session, and follow up session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of 2-exercise on physical disability
Time Frame: Change from baseline at 10-week after training session, and follow up session
|
Physical disability was measured by using Oswestry disability index
|
Change from baseline at 10-week after training session, and follow up session
|
|
Effect of 2-exercise on trunk muscle activity
Time Frame: Change from baseline at 10-week after training session, and follow up session
|
Trunk muscle activity was measured by using surface EMG
|
Change from baseline at 10-week after training session, and follow up session
|
|
Effect of 2-exercise on lumbar segmental motion
Time Frame: Change from baseline at 10-week after training session, and follow up session
|
Lumbar segmental motion was measured by using radiography
|
Change from baseline at 10-week after training session, and follow up session
|
|
Effect of 2-exercise on pain intensity
Time Frame: Change from baseline at 10-week after training session, and follow up session
|
Pain intensity was measured by using numeric rating scale
|
Change from baseline at 10-week after training session, and follow up session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wantanee Yodchaisarn, M.Sc., The Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Thailand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
November 24, 2014
First Submitted That Met QC Criteria
September 6, 2016
First Posted (Estimate)
September 12, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2020
Last Update Submitted That Met QC Criteria
January 22, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE562257
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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