Chronic Low Back PainNCT02895828
Effects of Core Stabilization and Strengthening Exercise on Quality of Life in Clinical Lumbar Instability
A study testing Core Stabilization Exercise and General Strengthening Exercise in people with Chronic Low Back Pain, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Core Stabilization Exercise and General Strengthening Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic low back pain due to clinical lumbar instability
Who cannot join
- Specific low back pain
- Cuada equine syndrome
- Neurological deficit
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Research Center in Back, Neck, Other Joint Pain and Human Performance
Khon Kaen, 40000
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Core Stabilization Exercise, General Strengthening Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExerciseOther
the participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
General Strengthening ExerciseOther
the participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization Exercise (CSE) | Experimental | The participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks Receives: Other: Core Stabilization Exercise |
| General Strengthening Exercise (GSE) | Experimental | The participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks. Receives: Other: General Strengthening Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 2-exercise on quality of life
health-related quality of life was measured by using SF-36 questionnaire
Measured: Change from baseline at 10-week after training session, and follow up session
Secondary outcomes (4)
Effect of 2-exercise on physical disability
Physical disability was measured by using Oswestry disability index
Measured: Change from baseline at 10-week after training session, and follow up session
Effect of 2-exercise on trunk muscle activity
Trunk muscle activity was measured by using surface EMG
Measured: Change from baseline at 10-week after training session, and follow up session
Effect of 2-exercise on lumbar segmental motion
Lumbar segmental motion was measured by using radiography
Measured: Change from baseline at 10-week after training session, and follow up session
Effect of 2-exercise on pain intensity
Pain intensity was measured by using numeric rating scale
Measured: Change from baseline at 10-week after training session, and follow up session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wantanee Yodchaisarn, Khon Kaen University
- Investigators
- Wantanee Yodchaisarn, M.Sc., Principal investigator, The Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895828
- Sponsor's protocol ID
- HE562257
- Status last verified
- Jan 2020
- First submitted
- 24 Nov 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24399870Javadian 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.
PubMed 22935853
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Practice Guideline With Core Stabilization and Strengthening Exercise Programs for Low Back Pain With Clinical Lumbar Instability
- ClinicalTrials.gov ID
- NCT02895828
- Acronym / sponsor ID
- HE562257
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization Exercise (CSE) | Experimental | Other: Core Stabilization ExerciseThe participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks |
| General Strengthening Exercise (GSE) | Experimental | Other: General Strengthening ExerciseThe participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Chronic low back pain due to clinical lumbar instability
Key exclusion criteria (3 listed)
- Specific low back pain
- Cuada equine syndrome
- Neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stabilization Exercisethe participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks | Other | Core Stabilization Exercise (CSE) |
| General Strengthening Exercisethe participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks | Other | General Strengthening Exercise (GSE) |
Primary outcome
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
4 secondary outcomes
Effect of 2-exercise on physical disability
Time frame: 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
Effect of 2-exercise on lumbar segmental motion
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 24399870Puntumetakul 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.
- Background: PubMed 22935853Javadian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wantanee Yodchaisarn, M.Sc. principal investigator
The Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercise and General Strengthening Exercise in people with Chronic Low Back Pain, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of 2-exercise on quality of life (time frame: Change from baseline at 10-week after training session, and follow up session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.