- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200913
Effects of Core Stabilization Exercise on Balance
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Research Center in Back, Neck, Other Joint Pain and Human Performance
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: core stabilization exercise
core stabilization exercise 2 times/week 10 weeks
|
general trunk strengthening exercise, 2 times/week, 10 weeks
|
EXPERIMENTAL: general trunk strengthening exercise
general trunk strengthening exercise, 2 times/week, 10 weeks
|
core stabilization exercise, 2 times/week, 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
center of pressure
Time Frame: up to 3-months after the last intervention session
|
up to 3-months after the last intervention session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wantanee Yodchaisarn, M.Sc., Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WYodchaisarn
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.
Clinical Trials on Lumbar Spine Instability
-
Riphah International UniversityCompleted
-
Jyväskylä Central HospitalCompletedInstability of Lumbar SpineFinland
-
Duke UniversityRecruitingLumbar Spondylosis | Lumbar Spine Degeneration | Lumbar Spine InstabilityUnited States
-
Unit of neurosurgery, Departement of Neurosciences...University of Roma La Sapienza; University of Pavia; Fondazione IRCCS Ca' Granda... and other collaboratorsActive, not recruitingLumbar Spine Disease | Lumbar Spine Instability | Instabilities LumbarItaly
-
Bioventus LLCRecruitingDegenerative Disc Disease | Lumbar Spondylolisthesis | Lumbar Spondylosis | Lumbar Spine Disease | Lumbar Spine InstabilityUnited States
-
Bursa City HospitalCompletedLumbar Spinal Stenosis | Lumbar Spine Degeneration | Lumbar Spine InstabilityTurkey
-
Brugmann University HospitalActive, not recruitingLumbar Spine InstabilityBelgium
-
Medipol UniversityWithdrawnLumbar Spinal Stenosis | Lumbar Disc Disease | Lumbar Spine Degeneration | Lumbar Spine InstabilityTurkey
-
University of Roma La SapienzaRecruitingLumbar Spinal Stenosis | Lumbar Spondylolisthesis | Lumbar Spine Degeneration | Lumbar Spine InstabilityItaly
-
Johns Hopkins UniversityNorth American Spine SocietyCompletedLumbar Spinal Stenosis | Lumbar Spine Degeneration | Lumbar Spinal InstabilityUnited States
Clinical Trials on general trunk strengthening exercise
-
Inje UniversityUnknown
-
University of VermontEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
University of ValenciaCompletedPostpartum WomenSpain
-
Khon Kaen UniversityCompletedChronic Low Back PainThailand
-
Riphah International UniversityRecruitingPosture Disorders in ChildrenPakistan
-
Beirut Arab UniversityRecruitingForward Head PostureLebanon
-
Dow University of Health SciencesCompletedOsteoarthritis, KneePakistan
-
Taichung Veterans General HospitalRecruitingStroke | Arthroplasty, Replacement, Knee | Resistance Training | Arthroplasty, Replacement, HipTaiwan
-
Universidade Federal do PiauíCompletedTransversus Abdominis ActivationBrazil
-
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...Taipei Medical UniversityCompletedStroke | Balancing Interference | Walking, DifficultyTaiwan