Lumbar Spine InstabilityNCT02200913
Effects of Core Stabilization Exercise on Balance
A study testing core stabilization exercise and general trunk strengthening exercise in people with Lumbar Spine Instability, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Recent studies indicate that patients with chronic low back pain (LBP) present problems in balance. Alterations in proprioception are the possible causes of alteration of postural balance in LBP. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lumbar Spine Instability
- What is being tested?
- core stabilization exercise and general trunk strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2014to Jul 2019
- 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
- male or female
- aged between 20-60 years
- low back pain (LBP) with or without radiating leg pain for period of at least 12 weeks
- answer 'yes' at least seven items of questionnaire
- present positive sign of the aberrant movement sign
- Present at least one positive sign from painful catch , prone instability catch test, or apprehension symptom
Who cannot join
- Be pregnant.
- Have serious spinal pathology: spinal fracture, spinal malignancy or spinal infection
- Have quada equina syndrome
- Have neurological deficit (at least 2 of the following signs: weakness of lower limbs (muscle power < grade 3 using manual muscle test), reflex changes, or abnormality or loss of sensation of lower limbs associated with the spinal nerve root
- Have obvious abnormal movement of the lumbar motion segment when assessed by flexion-extension radiographs: sagittal plane translation larger than 4.5mm or 15 percent of vertebral body width according to other vertebral segment, or sagittal plane rotation larger than 15 degrees at L1-L2, L2-L3 or L3-L4, 20 degrees at L4-L5 or 25 degrees at L5-S1
- Have visual disorder, vestibular disorder, neuromuscular diseases such as polyneuropathy, or diabetes neuropathy
- Participate in their intervention less than 5 out of the 10 week of intervention.
- Regularly treat with core stabilization exercise (CSE), or trunk strengthen exercises.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Research Center in Back, Neck, Other Joint Pain and Human Performance
Khon Kaen, 40002
About this study
Official title: Effects of Core Stabilization Exercise on Balance in Low Back Pain Patients With Clinical Lumbar Instability
Recent studies indicate that patients with chronic low back pain (LBP) present problems in balance. Alterations in proprioception are the possible causes of alteration of postural balance in LBP.
Previous studies reported an improvement of CSE on joint mobility, pain, functional disability, and trunk muscle activation pattern in patients with clinical lumbar instability (CLI); however, it was an immediate effect. However, previous studies did not report indirect effect may occur in CLI as postural balance and other kinds of exercise as strengthening in CLI. The general trunk strengthening exercise is common used in physical therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge, the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of balance.
The present study will conduct to fill the gaps of previous studies which will provide immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity and ratio activation of trunk muscles and included blinding process of the assessor.
Read the detailed description
Low back pain (LBP) is the most common musculoskeletal complaint. In most LBPs, it is benign and disappears within six weeks, but approximately 20% of individuals with LBP do not show any improvement in their condition, which may progress to chronic low back pain. LBP not only interferes with biomechanical change, but also causes ability to work leading to reduced productivity, economic burden to individuals and society for medical costs Recent studies indicate that patients with chronic low back pain present diminished postural control, manifesting problems in balance. Postural balance is controlled by sensory information, central processing and neuromuscular responses. Alterations in proprioception are the possible causes of alteration of postural balance in individuals with low back pain.
For clinical studies using core stabilization exercise (CSE) as treatment have revealed conflicting findings on pain, functional disability and muscle responses in chronic LBP. The few studies that investigated CSE as an isolated factor. Kumar (2011) reported an improvement of CSE on joint mobility and pain pressure threshold in patients with clinical lumbar instability; however, it was an immediate effect of CSE and blinding process was not performed. However, an effectiveness of CSE on pain intensity, functional disability, and trunk muscle activation pattern were improved in clinical lumbar instability (CLI). In addition, after 10-week CSE provides greater training and retention effects on pain-related outcomes and induced activation of deep abdominal muscles in CLI compared with conventional treatment (stretching exercise and hot pack). However, previous studies did not report indirect effect may occur in CLI as postural balance and other kinds of exercise as strengthening in CLI. The general trunk strengthening exercise is common used in physical therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge, the usefulness of CSE technique as abdominal drawing-in maneuver (ADIM) has not yet been investigated in CLI patients with outcome measure of balance.
- Conditions
- Lumbar Spine Instability
- Being tested
- core stabilization exercise, general trunk strengthening exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilization exerciseOther
core stabilization exercise, 2 times/week, 10 weeks
general trunk strengthening exerciseOther
general trunk strengthening exercise, 2 times/week, 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| core stabilization exercise | Experimental | core stabilization exercise 2 times/week 10 weeks Receives: Other: general trunk strengthening exercise |
| general trunk strengthening exercise | Experimental | general trunk strengthening exercise, 2 times/week, 10 weeks Receives: Other: core stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
center of pressure
Measured: up to 3-months after the last intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine InstabilityStudies 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
- 60 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, Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200913
- Sponsor's protocol ID
- WYodchaisarn
- Status last verified
- Jan 2020
- First submitted
- 24 Jul 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 24399870
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
- Effects of Core Stabilization Exercise on Balance in Low Back Pain Patients With Clinical Lumbar Instability
- ClinicalTrials.gov ID
- NCT02200913
- Acronym / sponsor ID
- WYodchaisarn
- Conditions
- Lumbar Spine Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 25 Jul 2014 (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.
Recent studies indicate that patients with chronic low back pain (LBP) present problems in balance. Alterations in proprioception are the possible causes of alteration of postural balance in LBP.
Previous studies reported an improvement of CSE on joint mobility, pain, functional disability, and trunk muscle activation pattern in patients with clinical lumbar instability (CLI); however, it was an immediate effect. However, previous studies did not report indirect effect may occur in CLI as postural balance and other kinds of exercise as strengthening in CLI. The general trunk strengthening exercise is common used in physical therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge, the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of balance.
The present study will conduct to fill the gaps of previous studies which will provide immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity and ratio activation of trunk muscles and included blinding process of the assessor.
Detailed description
Low back pain (LBP) is the most common musculoskeletal complaint. In most LBPs, it is benign and disappears within six weeks, but approximately 20% of individuals with LBP do not show any improvement in their condition, which may progress to chronic low back pain. LBP not only interferes with biomechanical change, but also causes ability to work leading to reduced productivity, economic burden to individuals and society for medical costs Recent studies indicate that patients with chronic low back pain present diminished postural control, manifesting problems in balance. Postural balance is controlled by sensory information, central processing and neuromuscular responses. Alterations in proprioception are the possible causes of alteration of postural balance in individuals with low back pain.
For clinical studies using core stabilization exercise (CSE) as treatment have revealed conflicting findings on pain, functional disability and muscle responses in chronic LBP. The few studies that investigated CSE as an isolated factor. Kumar (2011) reported an improvement of CSE on joint mobility and pain pressure threshold in patients with clinical lumbar instability; however, it was an immediate effect of CSE and blinding process was not performed. However, an effectiveness of CSE on pain intensity, functional disability, and trunk muscle activation pattern were improved in clinical lumbar instability (CLI). In addition, after 10-week CSE provides greater training and retention effects on pain-related outcomes and induced activation of deep abdominal muscles in CLI compared with conventional treatment (stretching exercise and hot pack). However, previous studies did not report indirect effect may occur in CLI as postural balance and other kinds of exercise as strengthening in CLI. The general trunk strengthening exercise is common used in physical therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge, the usefulness of CSE technique as abdominal drawing-in maneuver (ADIM) has not yet been investigated in CLI patients with outcome measure of balance.
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 | Experimental | Other: general trunk strengthening exercisecore stabilization exercise 2 times/week 10 weeks |
| general trunk strengthening exercise | Experimental | Other: core stabilization exercisegeneral trunk strengthening exercise, 2 times/week, 10 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male or female
- aged between 20-60 years
- low back pain (LBP) with or without radiating leg pain for period of at least 12 weeks
- answer 'yes' at least seven items of questionnaire
- present positive sign of the aberrant movement sign
Key exclusion criteria (8 listed)
- Be pregnant.
- Have serious spinal pathology: spinal fracture, spinal malignancy or spinal infection
- Have quada equina syndrome
- Have neurological deficit (at least 2 of the following signs: weakness of lower limbs (muscle power < grade 3 using manual muscle test), reflex changes, or abnormality or loss of sensation of lower limbs associated with the spinal nerve root
- Have obvious abnormal movement of the lumbar motion segment when assessed by flexion-extension radiographs: sagittal plane translation larger than 4.5mm or 15 percent of vertebral body width according to other vertebral segment, or sagittal plane rotation larger than 15 degrees at L1-L2, L2-L3 or L3-L4, 20 degrees at L4-L5 or 25 degrees at L5-S1
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 exercisecore stabilization exercise, 2 times/week, 10 weeks | Other | general trunk strengthening exercise |
| general trunk strengthening exercisegeneral trunk strengthening exercise, 2 times/week, 10 weeks | Other | core stabilization exercise |
Primary outcome
center of pressure
Time frame: up to 3-months after the last intervention 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.
- Results publication: 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.
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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
Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
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 trunk strengthening exercise in people with Lumbar Spine Instability, 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 6 inclusion and 8 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?
center of pressure (time frame: up to 3-months after the last intervention 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 NCT02200913, which also lists 1 linked publication.
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.