Protocol summary
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Study aim
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The purpose of this study was to compare the effects of trunk balance exercises and whole body vibration on postural control in patients with chronic non-specific LBP.
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Design
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The Randomized Clinical Trial consisted of two groups of patients (balance training group and whole body vibration group) and consist of 50 patients.
The study was single blind.
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Settings and conduct
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The study was performed at physiotherapy clinics of Shiraz University of Medical Sciences. both groups performed trunk balance training or whole body vibration. The randomization method was performed by a person who had no role in the evaluation and intervention.
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Participants/Inclusion and exclusion criteria
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Fifty patients aged 20–50 years were recruited. Individuals were included if they had local pain in the lumbar and sacroiliac joint regions of at least 4 months duration, pain severity according to a numerical rating scale (NRS) between 3 and 7, and functional disability with a score greater than 8 on the Persian version of the Roland–Morris Disability Questionnaire (PRMDQ). General exclusion criteria were any dysfunctional entrapment of the nerve roots or history of radicular pain, history of lower extremity orthopedic surgery, chronic ankle instability, any vestibular and neurological disease that could negatively influence postural stability.
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Intervention groups
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Patients were randomly allocated to either a trunk balance exercises or whole body vibration group. Both groups performed training three times a week for six weeks. At the beginning of each session, both groups received routine physical therapy. The trunk balance exercise group performed exercise protocol for 20 min in each session. The whole body vibration group performed static or dynamic training 5-10 min with whole body vibration device according to training stage.
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Main outcome variables
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static balance; Dynamic balance
General information
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Reason for update
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Having finished the study, the purpose of updating is to complete and edit the information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016072229029N1
Registration date:
2016-09-06, 1395/06/16
Registration timing:
prospective
Last update:
2020-12-04, 1399/09/14
Update count:
1
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Registration date
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2016-09-06, 1395/06/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Shiraz University of Medical Sciences
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Expected recruitment start date
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2016-09-22, 1395/07/01
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Expected recruitment end date
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2017-10-22, 1396/07/30
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Actual recruitment start date
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2016-09-26, 1395/07/05
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Actual recruitment end date
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2017-10-12, 1396/07/20
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Trial completion date
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2017-10-12, 1396/07/20
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Scientific title
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The comparison of trunk balance exercises and whole body vibration on the postural control of the patients with chronic non-specific low back pain.
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Public title
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The effect of trunk balance exercises and whole body vibration on the low back pain.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with chronic non-specific low back pain longer than four months duration
Pain severity according to a numerical rating scale (NRS) between 3 and 7
Functional disability with a score greater than 8 on the Persian version of the Roland–Morris Disability Questionnaire (PRMDQ)
Exclusion criteria:
Any dysfunctional entrapment of the nerve roots or history of radicular pain
Leg length discrepancy
Aَny history of hip or knee surgery
َAnkle or foot problems
History of lower extremity orthopedic surgery
Chronic ankle instability
Vestibular and neurological disease
Any uncorrected auditory or visual impairment
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the randomization with block size of four was used. One group was indicated with the letter A and the other with the letter B. Then different blocks of AABB was written. They were assigned the number of 1-6. For example(AABB=1,ABAB=2,BABA=3,BBAA=4,BAAB=5, ABBA=6
A number was randomly selected between 1-6 and the selected number indicated the pattern of assigning individuals to groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The assessment of ultrasound measurements(muscle thickness and cross sectional area) were conducted by an assessor who was blinded to interventions
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-17, 1395/04/27
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Ethics committee reference number
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IR.SUMS.REC.1395.72
Health conditions studied
1
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Description of health condition studied
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low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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low back pain
Primary outcomes
1
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Description
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Dynamic balance
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Timepoint
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Baseline, End of study
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Method of measurement
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Y- balance test
2
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Description
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Static balance
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Timepoint
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Baseline, End of study
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Method of measurement
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Single leg stance test
Secondary outcomes
1
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Description
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Differences of thickness of TrA, Internal oblique, External obliqe and multifidus muscles bilaterally
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Timepoint
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Baseline, End of study
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Method of measurement
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Rehabilitation Ultrasonography Imaging
2
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Description
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Pain intensity
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Timepoint
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Baseline, End of study, One month after the end of study
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Method of measurement
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Visual Analog Scale( VAS)
3
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Description
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Functional disability
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Timepoint
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Baseline, End of study, One month after the end of study
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Method of measurement
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Persian version of the Roland–Morris Disability Questionnaire (PRMDQ)
4
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Description
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Differences of cross sectional area of multifidus muscle bilaterally
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Timepoint
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Baseline, End of study
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Method of measurement
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Rehabilitative Ultrasonography Imaging
Intervention groups
1
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Description
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In balance training group intervention consists of 18 sessions,3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 micro sec, amplitude as tolerated, hot pack, US = 1 MHz ,intensity 1.5 w/cm2) are used. After that, patients execute trunk balance exercises in 5 levels. The levels of exercises are simple to difficult, and if his/her pain increases, the patient remains at the same level of exercises. The total duration of treatment is 6 weeks ,3 times per week .
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Category
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Treatment - Other
2
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Description
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For the whole body vibration group intervention consists of 18 sessions, 3 times and 6 weeks. Modalities ( TENS : low frequency=1-4 Hz, duration =100-400 micro sec, amplitude as tolerated, hot pack, US = 1 MHz, intensity 1.5 w/cm2) are used. After that , whole body vibration device (sinusoidal mode, frequency= 20 Hz, amplitude= 4mm, a= 5.8 g) is used for them. The patients stands with 20 flexion of knee joints on plate form. 5 boot uses in each session with 1 minute rest between them. Duration of each boot in first 2 week is 30 seconds, in second 2 week 45 seconds and in the last 2 week is 1 minute. The total duration of intervention is the same as other group.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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To fully protect the data of the participants
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2020-12-04, 1399/09/14
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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2018-07-22, 1397/04/31
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Abstract of published paper
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Patients with low back pain (LBP) have reduced core muscle geometry and impaired postural balance. Impaired trunk control was shown to be associated with poor balance and limited functional mobility in these patients. However, the relationship between muscle geometry and postural balance is unclear. This study aimed to determine the correlation of core muscle geometry with pain intensity, functional disability and postural balance in patients with chronic nonspecific mechanical LBP. Thirty patients aged 20–50 years were enrolled. Ultrasound imaging was used to assess their muscle geometry. The participants completed a numerical rating scale (NRS) for pain severity, and the Persian version of the Roland–Morris Disability Questionnaire (PRMDQ). To estimate static balance, they were asked to perform the single leg stance test. Dynamic balance was assessed with the Y-balance test. Significant correlations were found between NRS scores and bilateral multifidus cross-sectional area during rest ( r ≥−0.31, P ≤0.04) and con- traction ( r ≥−0.37, P ≤0.02). NRS scores correlated significantly with bilateral multifidus thickness during rest ( r ≥−0.31, P ≤0.04) and contraction ( r ≥−0.28, P ≤0.04). Significant correlations were also observed for PRMDQ scores with thickness ( r ≥−0.35, P = 0.04) and cross-sectional area of the multifidus muscles ( r ≥−0.33, P = 0.04) bilaterally during contraction. A significant correlation was found between Y-balance scores and right abdominal muscle thickness during rest and contraction ( r ≥0.34, P ≤0.04). Core muscle geometry correlated with pain, functional disability indices and dynamic balance in these patients.