<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/NCT02244645</url>
  </required_header>
  <id_info>
    <org_study_id>1010803</org_study_id>
    <nct_id>NCT02244645</nct_id>
  </id_info>
  <brief_title>Effects of Yoga Versus Passive Modality on Pain, Disability, Salivary Cortisol Concentrations, Brain- Derived Neurotropic Factor, Heart Rate Variability and Immune Functions Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial</brief_title>
  <official_title>Effects of Yoga Versus Passive Modality on Pain, Disability, Salivary Cortisol Concentrations, Brain- Derived Neurotropic Factor, Heart Rate Variability and Immune Functions Among Patients With Chronic Low Back Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study may clarify a potential promising mechanism and clearest evidence to support the&#xD;
      value of yoga as a therapeutic option for reducing chronic low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain is a common problem, with 70-80% of adults were bothered in their lives, which&#xD;
      influence the work and quality of life. Yoga is one of the most popular complementary and&#xD;
      alternative medicine for back pain, and this mind-body intervention has increasingly chosen&#xD;
      to effectively treat chronic pain.&#xD;
&#xD;
      This is a parallel-arm randomized controlled trial which will compare the outcomes of&#xD;
      participants assigned to the experimental treatment group (yoga, with 36 participants) with&#xD;
      those assigned to a passive modality control group for 3 months (12 weeks). Each group will&#xD;
      receive regular 60-minutes yoga classes or passive modality twice a week. The investigators&#xD;
      confer the difference of pain relief and functional life improvement between passive modality&#xD;
      and yoga. The latter is expected to have positive effects on Chronic low back pain. The&#xD;
      effects and possible mechanisms of action responsible for passive modality and yoga on&#xD;
      salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be&#xD;
      also evaluated. The study's primary endpoints are (1) back pain relief, (2) functional life&#xD;
      improved, (3) Salivary cortisol concentrations decreased, (4) brain-derived neurotrophic&#xD;
      factor improved, (5) heart rate variability improved, and (6) immune function improved&#xD;
      significantly among the participants in the experimental group than the control group.&#xD;
&#xD;
      This study may clarify a potential promising mechanism and clearest evidence to support the&#xD;
      value of yoga as a therapeutic option for reducing chronic low back pain. If the results are&#xD;
      positive, clinicians will attain more options for treating patient with chronic low back.&#xD;
      Furthermore, the positive results from this study will help focus more future in-depth&#xD;
      research on the most promising potential mechanism of action identifies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Back pain relief and functional life improved</measure>
    <time_frame>Change from baseline in back pain and life quality at 6 months</time_frame>
    <description>Back pain relief and functional life improved will assessed by visual analogue scale (VAS) and Roland-Morris disability questionnaire at five different times: (1)baseline data : before intervention, (2)outcome data: 3, 6, 9 and 12 week yoga exercise, right after exercise measure post-test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Salivary cortisol concentrations decreased</measure>
    <time_frame>Change from baseline in salivary cortisol at 6 months</time_frame>
    <description>Cortisol concentrations will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability improved</measure>
    <time_frame>Change from baseline in heart rate variability at 6 months</time_frame>
    <description>Heart rate variability will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune function improved</measure>
    <time_frame>Change from baseline in immune function at 6 months</time_frame>
    <description>Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10), lipid prolife and C-reactive protein at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain-derived neurotrophic factor improved</measure>
    <time_frame>Change from baseline in brain-derived neurotrophic factor at 6 months</time_frame>
    <description>Brain-derived neurotrophic factor will be assessed by blood analysis at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Passive modality control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>passive modality</intervention_name>
    <description>Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.</description>
    <arm_group_label>Passive modality control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga treatment</intervention_name>
    <description>Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.</description>
    <arm_group_label>Yoga treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with idiopathic low back pain of more than 12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Diagnosis of ankylosing spondylitis, osteoporosis, fibromyalgia, failed back syndrome&#xD;
             and other chronic illnesses.&#xD;
&#xD;
          -  Inability to participate yoga exercise regularly.&#xD;
&#xD;
          -  Accept steroid treatment within 3 months.&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuender D. Yang, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shu-Hui Yeh, PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kwan-Yu Chan, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shu-Hui Yeh, PhD</last_name>
    <email>yehshuhui@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kuender D. Yang, PhD</last_name>
      <phone>886-975617006</phone>
      <email>yangkd.yeh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Shu-Hui Yeh</investigator_full_name>
    <investigator_title>RN, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Low back pain, physical therapy, yoga.</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>
  <!-- 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/NCT02244645
org study id: 1010803
nct id: NCT02244645
lead sponsor: 
has dmc: Yes
This study may clarify a potential promising mechanism and clearest evidence to support the
      value of yoga as a therapeutic option for reducing chronic low back pain.
Low back pain is a common problem, with 70-80% of adults were bothered in their lives, which
      influence the work and quality of life. Yoga is one of the most popular complementary and
      alternative medicine for back pain, and this mind-body intervention has increasingly chosen
      to effectively treat chronic pain.

      This is a parallel-arm randomized controlled trial which will compare the outcomes of
      participants assigned to the experimental treatment group (yoga, with 36 participants) with
      those assigned to a passive modality control group for 3 months (12 weeks). Each group will
      receive regular 60-minutes yoga classes or passive modality twice a week. The investigators
      confer the difference of pain relief and functional life improvement between passive modality
      and yoga. The latter is expected to have positive effects on Chronic low back pain. The
      effects and possible mechanisms of action responsible for passive modality and yoga on
      salivary cortisol concentrations, inflammatory cytokines and autonomic nervous tone will be
      also evaluated. The study's primary endpoints are (1) back pain relief, (2) functional life
      improved, (3) Salivary cortisol concentrations decreased, (4) brain-derived neurotrophic
      factor improved, (5) heart rate variability improved, and (6) immune function improved
      significantly among the participants in the experimental group than the control group.

      This study may clarify a potential promising mechanism and clearest evidence to support the
      value of yoga as a therapeutic option for reducing chronic low back pain. If the results are
      positive, clinicians will attain more options for treating patient with chronic low back.
      Furthermore, the positive results from this study will help focus more future in-depth
      research on the most promising potential mechanism of action identifies.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Back pain relief and functional life improved
time frame: Change from baseline in back pain and life quality at 6 months
description: Back pain relief and functional life improved will assessed by visual analogue scale (VAS) and Roland-Morris disability questionnaire at five different times: (1)baseline data : before intervention, (2)outcome data: 3, 6, 9 and 12 week yoga exercise, right after exercise measure post-test.
measure: Salivary cortisol concentrations decreased
time frame: Change from baseline in salivary cortisol at 6 months
description: Cortisol concentrations will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
measure: Heart rate variability improved
time frame: Change from baseline in heart rate variability at 6 months
description: Heart rate variability will be measured at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
measure: Immune function improved
time frame: Change from baseline in immune function at 6 months
description: Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10), lipid prolife and C-reactive protein at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
measure: Brain-derived neurotrophic factor improved
time frame: Change from baseline in brain-derived neurotrophic factor at 6 months
description: Brain-derived neurotrophic factor will be assessed by blood analysis at at three different times: (1)baseline data : before intervention, (2)outcome data: 6 and 12 week yoga exercise, right after exercise measure post-test.
arm group label: Passive modality control group
arm group type: Other
description: Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
arm group label: Yoga treatment group
arm group type: Experimental
description: Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.
intervention type: Behavioral
intervention name: passive modality
description: Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
arm group label: Passive modality control group
intervention type: Behavioral
intervention name: Yoga treatment
description: Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.
arm group label: Yoga treatment group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kuender D. Yang, MD, PhD
role: Study Chair
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Shu-Hui Yeh, PhD.
role: Study Director
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Kwan-Yu Chan, MD.
role: Principal Investigator
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Shu-Hui Yeh, PhD
email: yehshuhui@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Shu-Hui Yeh
investigator title: RN, PhD, Professor
mesh term: Back Pain
mesh term: Low Back Pain