<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02972073</url>
  </required_header>
  <id_info>
    <org_study_id>TRG5880133</org_study_id>
    <nct_id>NCT02972073</nct_id>
  </id_info>
  <brief_title>Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain</brief_title>
  <official_title>Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study include 1) determine clinical utility of clinical observation of&#xD;
      aberrant movement patterns during functional trunk and pelvic movements in asymptomatic&#xD;
      individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular&#xD;
      control in asymptomatic individuals and patients with non-specific low back pain, and 3)&#xD;
      determine the appropriate physical therapy intervention that addresses trunk neuromuscular&#xD;
      control deficits in patients with non-specific low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use a sample of convenience between the ages of 21 - 65. Patients with&#xD;
      non-specific low back pain (NSLBP) will be recruited by advertisement in 2 Mahidol university&#xD;
      physical therapy clinics and participating clinics and hospitals. Asymptomatic participants&#xD;
      will be also recruited by flyers posted in 2 Mahidol university physical therapy clinics.&#xD;
&#xD;
      Based upon power analysis for change in kinematic pattern in patients with NSLBP after an&#xD;
      8-week core stabilization exercise program, a total required sample size is 29 patients with&#xD;
      NSLBP to detect a medium effect size (Cohen's d) of .48 at level (α) of .05 and power (1-β)&#xD;
      of .80. Fifteen percent drop-out rate is used as a conservative sample size calculation.&#xD;
      Therefore, 34 patients with NSLBP (29 X 15% drop-out) and 34 age-, sex-, and BMI-matched&#xD;
      asymptomatic participants will be included for each independent intervention study (core&#xD;
      stabilization exercise approach, movement system impairment approach, neuromuscular&#xD;
      activation using suspension, and kinematic linkage imbalance approach). Each intervention&#xD;
      will be separately collected and analyzed. The total of 272 participants will be recruited to&#xD;
      fulfill this study project (4 independent intervention studies). However, sample size for&#xD;
      asymptomatic participants can be decreased if participant from one intervention study is&#xD;
      matched with patients with NSLBP in other intervention studies.&#xD;
&#xD;
      Patients with NSLBP who are interested in participation will undergo a screening process&#xD;
      using inclusion-exclusion criteria checklist and receive brief information regarding the&#xD;
      study. If they meet all inclusion criteria, the consent process and biomechanical testing&#xD;
      will be scheduled. On date of consent and biomechanical testing, both asymptomatic&#xD;
      participants and participants with NSLBP will be provided a consent form. To ensure they&#xD;
      understand the study, they will be simply asked regarding the study (i.e. objectives,&#xD;
      benefits, etc.) before signing the consent form. After the participants provide a written&#xD;
      informed consent, they will undergo a standardized physical therapy examination performed by&#xD;
      an experienced physical therapist (PT-A). For patients with NSLBP, they will also complete 3&#xD;
      clinical outcome measures including 1) numeric pain rating scale (Thai version), 2) Oswestry&#xD;
      disability index (Thai version), and 3) general health status questionnaire (Thai version).&#xD;
      This pre-biomechanical data collection process will last approximately 60 minutes.&#xD;
&#xD;
      For biomechanical testing, body landmarks will be identified and marked with a skin pen for 4&#xD;
      motion sensors and 16 pairs of surface electromyography (EMG) electrodes in lower back and&#xD;
      abdominal areas. Any hair in the area around the sensors and electrodes will be shaved.&#xD;
      Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper&#xD;
      and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned&#xD;
      parallel to the muscle fibers. This process will take approximately 30 minutes. Then,&#xD;
      participants will proceed to the biomechanical testing which includes 1) trunk muscle&#xD;
      strength test, 2) functional trunk and pelvic movement tests, and 3) core control tasks.&#xD;
&#xD;
      Trunk muscle strength test Strength test Participants will wear a climbing harness connecting&#xD;
      with a tension load cell and sit in a testing apparatus in a neutral trunk position with&#xD;
      pelvic securely locked. This apparatus intends to reduce compensation from lower extremities&#xD;
      during sub-maximal (15% of body weight) and maximal voluntary isometric contractions.&#xD;
      Participants will be instructed to use their trunk gradually pulling the load cell (isometric&#xD;
      contraction in neutral trunk position) for 10 seconds in forward, backward, and 2 side&#xD;
      bending directions. Participants will be given 2 practice trials in each direction to adjust&#xD;
      the force and reduce a learning effect. Visual feedback of force to sub-maximal target will&#xD;
      be provided. Two trials of sub-maximal voluntary isometric contractions will be collected in&#xD;
      each direction. Only 1 trial of maximal voluntary isometric contraction will be collected to&#xD;
      avoid muscle fatigue (in both asymptomatic participants and patients with NSLBP) and pain&#xD;
      exacerbation (in patients with NSLBP). The intention of collecting maximal contraction data&#xD;
      is to use for EMG standardization. Participants will rest in between each trial to minimize&#xD;
      fatigue. Pain and rating perceived exertion (RPE) will be monitored and recorded at the end&#xD;
      of trunk strength test. This protocol will take approximately 15 minutes.&#xD;
&#xD;
      Functional trunk and pelvic movement tests Participants will stand on a drawing paper with&#xD;
      feet shoulder width apart in front of the motion transmitter. The foot print will be drawn&#xD;
      using a marker. This foot print will be used for post-test positioning. The participants will&#xD;
      stand in a natural stance facing away from the transmitter with arms down by sides.&#xD;
      Participants will be instructed to stand up straight and maintain that position for&#xD;
      digitization. After the completion of digitization, participants will be instructed to&#xD;
      perform functional movements including 1) active forward bend and return to upright position,&#xD;
      2) right and left straight leg raise tests, 3) right and left hip abduction with knee flexion&#xD;
      tests, 4) quadruped backward rock test, 5) prone with right and left knee flexion tests, 6)&#xD;
      prone with right and left hip internal/external rotation tests, and 7) prone with right and&#xD;
      left hip extension tests. Participants will perform 2 trials of 3 consecutive repetitions of&#xD;
      each functional movement tests. Two physical therapists (PT-B and PT-C), who are blinded to&#xD;
      the group membership, will simultaneously observe and independently rate aberrant movement&#xD;
      patterns during biomechanical data collection. This protocol will take approximately 30&#xD;
      minutes.&#xD;
&#xD;
      Core control tasks Participants will sit on an unstable chair with feet supported. The chair&#xD;
      is mounted on a half ball that makes the chair unstable and tilt. Participants will be&#xD;
      instructed to balance the chair without tipping the chair in any direction. The participants&#xD;
      will maintain upright seated balance with crossing both arms in front of their chest. The&#xD;
      participants will have an opportunity to get familiar with the balance testing protocol prior&#xD;
      to the data collection to minimize the learning effect. This core control tasks aim to&#xD;
      investigate the performances that represent static and dynamic stabilities of the trunk. For&#xD;
      static stability, the participants will perform 3 trials of 60-second seated balance tests&#xD;
      with their eyes open, and 3 trials of 60-second seated balance tests with their eyes closed.&#xD;
      The participants will be given a 1-minute rest period between trials to avoid muscle fatigue.&#xD;
      For dynamic stability, the participants will be instructed to perform a dynamic stability&#xD;
      using lumbar spine (without trunk leaning to tilt an unstable chair as far as they can) in 8&#xD;
      different directions (forward, backward, right, left, right diagonal, and left diagonal). The&#xD;
      participants will be given 1 practice trial to reduce possibility of learning effect, and 3&#xD;
      real trials with 1-minute rest period between trials. Pain and RPE will be recorded at the&#xD;
      completion of core control task. This protocol will take approximately 30 minutes.&#xD;
&#xD;
      Patients with NSLBP will be assigned to one of different physical therapy interventions&#xD;
      according to participating clinics and hospitals, while asymptomatic participants will be&#xD;
      encouraged to maintain usual daily activities and avoid participating in activities that&#xD;
      involve trunk muscle exercise. After completion of an 8-week physical therapy intervention,&#xD;
      both asymptomatic participants and patients with NSLBP will undergo the standardized physical&#xD;
      therapy examination and biomechanical data collection again. For patients with NSLBP, they&#xD;
      will also complete clinical outcome measures for post physical therapy intervention.&#xD;
&#xD;
      Physical therapy intervention Patients with NSLBP will be treated with a standard physical&#xD;
      therapy intervention based upon different treatment concepts. In general, these interventions&#xD;
      include strengthening exercise, endurance exercise, stretching exercise, patient education,&#xD;
      patient ergonomics, and home exercise program. There is no reported adverse effect of those&#xD;
      physical therapy interventions. Therefore, those physical therapy interventions are safe for&#xD;
      treating patients with NSLBP. Each patient will be treated 1-2 times per week for 60 minutes&#xD;
      each session for 8 weeks by experienced physical therapists. Patients will be given a home&#xD;
      exercise log for exercise compliance.&#xD;
&#xD;
      All Statistical analyses will be performed using statistical package for the social science&#xD;
      (SPSS) software (IBM SPSS Statistics for Windows, Version 21.0., New York, USA).&#xD;
&#xD;
      Study objective 1 is to determine inter-rater reliability and diagnostic accuracy of clinical&#xD;
      observation of aberrant movement patterns during functional trunk and pelvic movements in&#xD;
      patients with NSLBP. Agreement on the presence/absence of aberrant movement patterns between&#xD;
      physical therapists (PT-B and PT-C) will be determined using separate kappa statistics.&#xD;
      Diagnostic accuracy will be determined using accuracy statistics which include sensitivity,&#xD;
      specificity, and likelihood ratio. Significance level will be held at .05 for all analysis.&#xD;
      Confidence intervals will also be calculated.&#xD;
&#xD;
      Study objective 2 is to characterize neuromuscular control in asymptomatic participants and&#xD;
      patients with NSLBP during functional activities. Each variable will be analyzed separately.&#xD;
      Descriptive statistics (i.e. mean and standard deviation) will be performed and statistical&#xD;
      assumptions (i.e. normal distribution, homogeneity of variance, etc.) related to specific&#xD;
      statistical tests will be performed. Statistical transformation will be performed if&#xD;
      appropriate. Then, statistical test (i.e. independent t-test, Mann-Whitney U-test, etc.) that&#xD;
      appropriate to the data will be performed to determine the difference between asymptomatic&#xD;
      participants and patients with NSLBP. Significance level will be held at .05 for all&#xD;
      analyses. Post-hoc power analysis will also be performed to determine statistical power and&#xD;
      effect size.&#xD;
&#xD;
      Study objective 3 is to determine the appropriate physical therapy intervention that&#xD;
      addresses neuromuscular control deficits in patients with NSLBP. First, the effects of each&#xD;
      physical therapy intervention on trunk neuromuscular control and clinical outcomes will be&#xD;
      determined. Prior to utilization of statistical tests, descriptive statistics will be&#xD;
      performed and statistical assumptions will be tested. Transformation will be performed if the&#xD;
      data are not normally distributed. Appropriate statistical tests will be performed to&#xD;
      determine the effects of each physical therapy intervention on neuromuscular control and&#xD;
      clinical outcome. Significance level will be held at .05 for all analyses. Post-hoc power&#xD;
      analysis will be performed. In addition, this study objective will determine the ability of&#xD;
      physical therapy intervention on matched- and unmatched-intervention patients based upon each&#xD;
      intervention criteria. Each patient with NSLBP will be classified based upon clinical&#xD;
      criteria of each physical therapy intervention. Pre-post difference for matched and unmatched&#xD;
      groups will be compared using appropriate statistical tests. Significance level will be held&#xD;
      at .05 for all analyses. Post-hoc power analysis will also be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyography (EMG) muscle activity</measure>
    <time_frame>Change from baseline muscle activity at 8 weeks after exercise intervention.</time_frame>
    <description>Muscle activity recorded by surface-electromyography (EMG) during functional movements will be used to determine muscle activation pattern changes at 8 weeks after exercise intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic pattern of movement</measure>
    <time_frame>Change from baseline movement pattern at 8 weeks after exercise intervention.</time_frame>
    <description>Patterns of functional movement will be captured using electromagnetic tracking system and used to determine changes in kinematic pattern of movement at 8 weeks after exercise the exercise intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric pain rating scale</measure>
    <time_frame>Change in pain from baseline at 8 weeks after exercise intervention</time_frame>
    <description>Pain assessed by a numeric pain rating scale will be used to determine change in pain at 8 weeks after exercise intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry disability index</measure>
    <time_frame>Change from baseline disability level at 8 weeks after exercise intervention</time_frame>
    <description>Disability level measured by Oswestry disability index will be used to determine change in disability level at 8 weeks after exercise intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-form general heath status (SF-36) questionnaire</measure>
    <time_frame>Change from baseline general health status at 8 weeks after exercise intervention</time_frame>
    <description>General health status assessed by short-form general health status questionnaire (SF-36) will be used to change in general health status at 8 weeks after exercise intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Exercise intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There are 4 different exercise interventions (4 independent intervention studies) based on different concepts in this entire project. Interventions include:&#xD;
core stabilization exercise&#xD;
movement system impairment approach&#xD;
neuromuscular activation using suspension&#xD;
kinematic linkage imbalance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This healthy control group will be informed to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise intervention</intervention_name>
    <description>Physical therapist will provide exercise for patients with low back pain for 60 minutes per day, 2-3 days per week for the total of 8 weeks.</description>
    <arm_group_label>Exercise intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for patients with non-specific low back pain:&#xD;
&#xD;
          -  Between the ages of 21 and 65&#xD;
&#xD;
          -  Current episode of back pain less than 3 months which they seek medical intervention&#xD;
&#xD;
          -  Numeric pain rating scale (NPRS) greater than 5 on an 11-point scale (0 = no pain, 10&#xD;
             = worst pain ever)&#xD;
&#xD;
          -  Oswestry disability score (Thai version) greater than 50%&#xD;
&#xD;
          -  No medical or professional health care intervention including physical therapy for low&#xD;
             back pain in last 6 months&#xD;
&#xD;
        Inclusion Criteria for healthy individual:&#xD;
&#xD;
          -  Between the ages of 21 and 65&#xD;
&#xD;
          -  No episode of back pain for 3 months prior to the participation&#xD;
&#xD;
          -  No regular exercise routine that is composed of core stabilization exercise.&#xD;
&#xD;
        Exclusion Criteria for both groups:&#xD;
&#xD;
          -  Clinical signs of systemic disease&#xD;
&#xD;
          -  Definitive neurologic signs including weakness or numbness in the lower extremity&#xD;
&#xD;
          -  Previous spinal surgery&#xD;
&#xD;
          -  Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any lower extremity condition that would potentially alter trunk movement in standing&#xD;
&#xD;
          -  Vestibular dysfunction&#xD;
&#xD;
          -  Extreme psychosocial involvement&#xD;
&#xD;
          -  Body mass index (BMI) greater than 30 kg/m2&#xD;
&#xD;
          -  Active treatment of another medical illness that would preclude participation in any&#xD;
             aspect of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peemongkon Wattananon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Physical Therapy, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Physical Therapy, Mahidol University</name>
      <address>
        <city>Salaya</city>
        <state>Nakhon Pathom</state>
        <zip>73170</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Biely SA, Silfies SP, Smith SS, Hicks GE. Clinical observation of standing trunk movements: what do the aberrant movement patterns tell us? J Orthop Sports Phys Ther. 2014 Apr;44(4):262-72. doi: 10.2519/jospt.2014.4988. Epub 2014 Jan 22.</citation>
    <PMID>24450372</PMID>
  </reference>
  <reference>
    <citation>Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.</citation>
    <PMID>16181938</PMID>
  </reference>
  <reference>
    <citation>Spinelli BA, Wattananon P, Silfies S, Talaty M, Ebaugh D. Using kinematics and a dynamical systems approach to enhance understanding of clinically observed aberrant movement patterns. Man Ther. 2015 Feb;20(1):221-6. doi: 10.1016/j.math.2014.07.012. Epub 2014 Jul 24.</citation>
    <PMID>25116648</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>March 21, 2018</last_update_submitted>
  <last_update_submitted_qc>March 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Peemongkon Wattananon</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Neuromuscular control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only demographic and clinical outcome data will be made available for other researchers upon request after the end of the study</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972073
org study id: TRG5880133
nct id: NCT02972073
lead sponsor: 
has dmc: No
The purposes of this study include 1) determine clinical utility of clinical observation of
      aberrant movement patterns during functional trunk and pelvic movements in asymptomatic
      individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular
      control in asymptomatic individuals and patients with non-specific low back pain, and 3)
      determine the appropriate physical therapy intervention that addresses trunk neuromuscular
      control deficits in patients with non-specific low back pain.
This study will use a sample of convenience between the ages of 21 - 65. Patients with
      non-specific low back pain (NSLBP) will be recruited by advertisement in 2 Mahidol university
      physical therapy clinics and participating clinics and hospitals. Asymptomatic participants
      will be also recruited by flyers posted in 2 Mahidol university physical therapy clinics.

      Based upon power analysis for change in kinematic pattern in patients with NSLBP after an
      8-week core stabilization exercise program, a total required sample size is 29 patients with
      NSLBP to detect a medium effect size (Cohen's d) of .48 at level (α) of .05 and power (1-β)
      of .80. Fifteen percent drop-out rate is used as a conservative sample size calculation.
      Therefore, 34 patients with NSLBP (29 X 15% drop-out) and 34 age-, sex-, and BMI-matched
      asymptomatic participants will be included for each independent intervention study (core
      stabilization exercise approach, movement system impairment approach, neuromuscular
      activation using suspension, and kinematic linkage imbalance approach). Each intervention
      will be separately collected and analyzed. The total of 272 participants will be recruited to
      fulfill this study project (4 independent intervention studies). However, sample size for
      asymptomatic participants can be decreased if participant from one intervention study is
      matched with patients with NSLBP in other intervention studies.

      Patients with NSLBP who are interested in participation will undergo a screening process
      using inclusion-exclusion criteria checklist and receive brief information regarding the
      study. If they meet all inclusion criteria, the consent process and biomechanical testing
      will be scheduled. On date of consent and biomechanical testing, both asymptomatic
      participants and participants with NSLBP will be provided a consent form. To ensure they
      understand the study, they will be simply asked regarding the study (i.e. objectives,
      benefits, etc.) before signing the consent form. After the participants provide a written
      informed consent, they will undergo a standardized physical therapy examination performed by
      an experienced physical therapist (PT-A). For patients with NSLBP, they will also complete 3
      clinical outcome measures including 1) numeric pain rating scale (Thai version), 2) Oswestry
      disability index (Thai version), and 3) general health status questionnaire (Thai version).
      This pre-biomechanical data collection process will last approximately 60 minutes.

      For biomechanical testing, body landmarks will be identified and marked with a skin pen for 4
      motion sensors and 16 pairs of surface electromyography (EMG) electrodes in lower back and
      abdominal areas. Any hair in the area around the sensors and electrodes will be shaved.
      Before placing surface EMG electrodes, the skin will be lightly abraded using abrasive paper
      and cleaned using cotton with alcohol to lower the skin impedance. Electrodes will be aligned
      parallel to the muscle fibers. This process will take approximately 30 minutes. Then,
      participants will proceed to the biomechanical testing which includes 1) trunk muscle
      strength test, 2) functional trunk and pelvic movement tests, and 3) core control tasks.

      Trunk muscle strength test Strength test Participants will wear a climbing harness connecting
      with a tension load cell and sit in a testing apparatus in a neutral trunk position with
      pelvic securely locked. This apparatus intends to reduce compensation from lower extremities
      during sub-maximal (15% of body weight) and maximal voluntary isometric contractions.
      Participants will be instructed to use their trunk gradually pulling the load cell (isometric
      contraction in neutral trunk position) for 10 seconds in forward, backward, and 2 side
      bending directions. Participants will be given 2 practice trials in each direction to adjust
      the force and reduce a learning effect. Visual feedback of force to sub-maximal target will
      be provided. Two trials of sub-maximal voluntary isometric contractions will be collected in
      each direction. Only 1 trial of maximal voluntary isometric contraction will be collected to
      avoid muscle fatigue (in both asymptomatic participants and patients with NSLBP) and pain
      exacerbation (in patients with NSLBP). The intention of collecting maximal contraction data
      is to use for EMG standardization. Participants will rest in between each trial to minimize
      fatigue. Pain and rating perceived exertion (RPE) will be monitored and recorded at the end
      of trunk strength test. This protocol will take approximately 15 minutes.

      Functional trunk and pelvic movement tests Participants will stand on a drawing paper with
      feet shoulder width apart in front of the motion transmitter. The foot print will be drawn
      using a marker. This foot print will be used for post-test positioning. The participants will
      stand in a natural stance facing away from the transmitter with arms down by sides.
      Participants will be instructed to stand up straight and maintain that position for
      digitization. After the completion of digitization, participants will be instructed to
      perform functional movements including 1) active forward bend and return to upright position,
      2) right and left straight leg raise tests, 3) right and left hip abduction with knee flexion
      tests, 4) quadruped backward rock test, 5) prone with right and left knee flexion tests, 6)
      prone with right and left hip internal/external rotation tests, and 7) prone with right and
      left hip extension tests. Participants will perform 2 trials of 3 consecutive repetitions of
      each functional movement tests. Two physical therapists (PT-B and PT-C), who are blinded to
      the group membership, will simultaneously observe and independently rate aberrant movement
      patterns during biomechanical data collection. This protocol will take approximately 30
      minutes.

      Core control tasks Participants will sit on an unstable chair with feet supported. The chair
      is mounted on a half ball that makes the chair unstable and tilt. Participants will be
      instructed to balance the chair without tipping the chair in any direction. The participants
      will maintain upright seated balance with crossing both arms in front of their chest. The
      participants will have an opportunity to get familiar with the balance testing protocol prior
      to the data collection to minimize the learning effect. This core control tasks aim to
      investigate the performances that represent static and dynamic stabilities of the trunk. For
      static stability, the participants will perform 3 trials of 60-second seated balance tests
      with their eyes open, and 3 trials of 60-second seated balance tests with their eyes closed.
      The participants will be given a 1-minute rest period between trials to avoid muscle fatigue.
      For dynamic stability, the participants will be instructed to perform a dynamic stability
      using lumbar spine (without trunk leaning to tilt an unstable chair as far as they can) in 8
      different directions (forward, backward, right, left, right diagonal, and left diagonal). The
      participants will be given 1 practice trial to reduce possibility of learning effect, and 3
      real trials with 1-minute rest period between trials. Pain and RPE will be recorded at the
      completion of core control task. This protocol will take approximately 30 minutes.

      Patients with NSLBP will be assigned to one of different physical therapy interventions
      according to participating clinics and hospitals, while asymptomatic participants will be
      encouraged to maintain usual daily activities and avoid participating in activities that
      involve trunk muscle exercise. After completion of an 8-week physical therapy intervention,
      both asymptomatic participants and patients with NSLBP will undergo the standardized physical
      therapy examination and biomechanical data collection again. For patients with NSLBP, they
      will also complete clinical outcome measures for post physical therapy intervention.

      Physical therapy intervention Patients with NSLBP will be treated with a standard physical
      therapy intervention based upon different treatment concepts. In general, these interventions
      include strengthening exercise, endurance exercise, stretching exercise, patient education,
      patient ergonomics, and home exercise program. There is no reported adverse effect of those
      physical therapy interventions. Therefore, those physical therapy interventions are safe for
      treating patients with NSLBP. Each patient will be treated 1-2 times per week for 60 minutes
      each session for 8 weeks by experienced physical therapists. Patients will be given a home
      exercise log for exercise compliance.

      All Statistical analyses will be performed using statistical package for the social science
      (SPSS) software (IBM SPSS Statistics for Windows, Version 21.0., New York, USA).

      Study objective 1 is to determine inter-rater reliability and diagnostic accuracy of clinical
      observation of aberrant movement patterns during functional trunk and pelvic movements in
      patients with NSLBP. Agreement on the presence/absence of aberrant movement patterns between
      physical therapists (PT-B and PT-C) will be determined using separate kappa statistics.
      Diagnostic accuracy will be determined using accuracy statistics which include sensitivity,
      specificity, and likelihood ratio. Significance level will be held at .05 for all analysis.
      Confidence intervals will also be calculated.

      Study objective 2 is to characterize neuromuscular control in asymptomatic participants and
      patients with NSLBP during functional activities. Each variable will be analyzed separately.
      Descriptive statistics (i.e. mean and standard deviation) will be performed and statistical
      assumptions (i.e. normal distribution, homogeneity of variance, etc.) related to specific
      statistical tests will be performed. Statistical transformation will be performed if
      appropriate. Then, statistical test (i.e. independent t-test, Mann-Whitney U-test, etc.) that
      appropriate to the data will be performed to determine the difference between asymptomatic
      participants and patients with NSLBP. Significance level will be held at .05 for all
      analyses. Post-hoc power analysis will also be performed to determine statistical power and
      effect size.

      Study objective 3 is to determine the appropriate physical therapy intervention that
      addresses neuromuscular control deficits in patients with NSLBP. First, the effects of each
      physical therapy intervention on trunk neuromuscular control and clinical outcomes will be
      determined. Prior to utilization of statistical tests, descriptive statistics will be
      performed and statistical assumptions will be tested. Transformation will be performed if the
      data are not normally distributed. Appropriate statistical tests will be performed to
      determine the effects of each physical therapy intervention on neuromuscular control and
      clinical outcome. Significance level will be held at .05 for all analyses. Post-hoc power
      analysis will be performed. In addition, this study objective will determine the ability of
      physical therapy intervention on matched- and unmatched-intervention patients based upon each
      intervention criteria. Each patient with NSLBP will be classified based upon clinical
      criteria of each physical therapy intervention. Pre-post difference for matched and unmatched
      groups will be compared using appropriate statistical tests. Significance level will be held
      at .05 for all analyses. Post-hoc power analysis will also be performed.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Electromyography (EMG) muscle activity
time frame: Change from baseline muscle activity at 8 weeks after exercise intervention.
description: Muscle activity recorded by surface-electromyography (EMG) during functional movements will be used to determine muscle activation pattern changes at 8 weeks after exercise intervention.
measure: Kinematic pattern of movement
time frame: Change from baseline movement pattern at 8 weeks after exercise intervention.
description: Patterns of functional movement will be captured using electromagnetic tracking system and used to determine changes in kinematic pattern of movement at 8 weeks after exercise the exercise intervention.
measure: Numeric pain rating scale
time frame: Change in pain from baseline at 8 weeks after exercise intervention
description: Pain assessed by a numeric pain rating scale will be used to determine change in pain at 8 weeks after exercise intervention.
measure: Oswestry disability index
time frame: Change from baseline disability level at 8 weeks after exercise intervention
description: Disability level measured by Oswestry disability index will be used to determine change in disability level at 8 weeks after exercise intervention.
measure: Short-form general heath status (SF-36) questionnaire
time frame: Change from baseline general health status at 8 weeks after exercise intervention
description: General health status assessed by short-form general health status questionnaire (SF-36) will be used to change in general health status at 8 weeks after exercise intervention.
arm group label: Exercise intervention
arm group type: Experimental
description: There are 4 different exercise interventions (4 independent intervention studies) based on different concepts in this entire project. Interventions include:
core stabilization exercise
movement system impairment approach
neuromuscular activation using suspension
kinematic linkage imbalance
arm group label: Healthy control
arm group type: No Intervention
description: This healthy control group will be informed to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise
intervention type: Other
intervention name: Exercise intervention
description: Physical therapist will provide exercise for patients with low back pain for 60 minutes per day, 2-3 days per week for the total of 8 weeks.
arm group label: Exercise intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peemongkon Wattananon, PhD
role: Principal Investigator
affiliation: Faculty of Physical Therapy, Mahidol University
facility: 
country: Thailand
citation: Biely SA, Silfies SP, Smith SS, Hicks GE. Clinical observation of standing trunk movements: what do the aberrant movement patterns tell us? J Orthop Sports Phys Ther. 2014 Apr;44(4):262-72. doi: 10.2519/jospt.2014.4988. Epub 2014 Jan 22.
PMID: 24450372
citation: Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PMID: 16181938
citation: Spinelli BA, Wattananon P, Silfies S, Talaty M, Ebaugh D. Using kinematics and a dynamical systems approach to enhance understanding of clinically observed aberrant movement patterns. Man Ther. 2015 Feb;20(1):221-6. doi: 10.1016/j.math.2014.07.012. Epub 2014 Jul 24.
PMID: 25116648
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Peemongkon Wattananon
investigator title: Principal investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
ipd description: Only demographic and clinical outcome data will be made available for other researchers upon request after the end of the study