<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/NCT04507074</url>
  </required_header>
  <id_info>
    <org_study_id>PoznanUPhyEd no. 3</org_study_id>
    <nct_id>NCT04507074</nct_id>
  </id_info>
  <brief_title>The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain</brief_title>
  <official_title>The Effect of Traction Forces on Changes in Biochemical Markers of Degeneration and Functional Parameters of the Spine in People With Obesity Suffering From Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Physical Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poznan University of Physical Education</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the research study is to assess the impact of traction forces on changes in&#xD;
      systemic markers concentrations of spinal structure damage in people with obesity. The&#xD;
      research group will include 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and&#xD;
      chronic lumbar spine pain syndrome.&#xD;
&#xD;
      The control group will consist of 20 subjects with normal body weight suffering from the same&#xD;
      pain, at a similar age to the patients in the study group. Persons will be qualified for&#xD;
      examination by a specialist in internal medicine and a physiotherapist.&#xD;
&#xD;
      To assess the degree of structural damage within the intervertebral disc and adjacent&#xD;
      anatomical structures, patients will undergo magnetic resonance imaging of the lumbosacral&#xD;
      spine (MRI 1.5T, standard in 3 projections). Patients will undergo traction therapy under the&#xD;
      supervision of a physiotherapist. The application of traction forces on the traction table&#xD;
      (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with&#xD;
      a maximum strength of 30% of the patient's body weight).&#xD;
&#xD;
      Twice, before and after therapy, the following will be assessed: (1) body composition (by DXA&#xD;
      method), (2) other anthropometric indicators, (3) functional parameters of the spine:&#xD;
      mobility (electrogoniometer), muscle bioelectric signal amplitude (electromyograph), soft&#xD;
      tissue biophysical parameters (myotonometer), (4) pain threshold and intensity in the lumbar&#xD;
      region (using an algometer and validated questionnaires), (5) disability caused by pain in&#xD;
      the spine (Oswestry questionnaire), (6) blood biochemical indicators selected on the basis of&#xD;
      the latest research on biomarkers of spinal damage (for this purpose, 25ml venous blood will&#xD;
      be taken from the subjects).&#xD;
&#xD;
      Blood levels of interleukin-17, interleukin-4, interleukin-2 (IL-2), interleukin-10 (IL-10),&#xD;
      differentiating growth factor 15 (GDF-15), leptin, adipsin, chemokine CCL5 (RANTES), stem&#xD;
      cell growth factor β (SCGF-β), vascular endothelial growth factor (VEGF), neuropeptide Y, and&#xD;
      chondroitin sulfate CS846 will be determined in the blood of the subjects. It is planned to&#xD;
      assess the relationship of the studied biomarkers with the degree of disk degeneration,&#xD;
      obesity, lean and fat body mass, pain intensity, and functional indicators of the spine.&#xD;
      Patients will be asked to stop taking anti-inflammatory drugs during therapy and at least 24&#xD;
      hours prior to blood sampling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People suffering from obesity are particularly vulnerable to mechanical compression of the&#xD;
      intervertebral discs, and as a result their degeneration, hernia and pressure on the nerve&#xD;
      roots, which together cause inflammation and pain in the damaged area. This is a significant&#xD;
      public health problem due to the 100% incidence of pain syndrome among people with obesity.&#xD;
      The use of traction forces has beneficial effects on degenerated intervertebral discs, but&#xD;
      there are no studies assessing the effectiveness of the traction method in relation to a&#xD;
      group of obese people with back pain syndrome.&#xD;
&#xD;
      Beneficial biochemical changes in the blood, alleviation of pain, improvement of functional&#xD;
      parameters of the spine are expected after application of traction forces to the patients in&#xD;
      the mechanism of decompression of the destroyed and being in chronic inflammation&#xD;
      intervertebral discs. Identification of biomarkers enabling to monitor the effects of&#xD;
      therapies in patients with chronic back pain can become a contribution to change standards in&#xD;
      the diagnosis of back pain and reorientation in its treatment to real causes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stem cell growth factor β [ng/ml]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stem cell growth factor β [ng/ml]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leptin [ng/ml]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leptin [ng/ml]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adipsin [pg/ml]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adipsin [pg/ml]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropeptide Y [pg/ml]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuropeptide Y [pg/ml]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vascular Endothelial Growth Factor [pg/ml]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vascular Endothelial Growth Factor [pg/ml]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chondroitin sulfate CS846 [ng/mL]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chondroitin sulfate CS846 [ng/mL]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>ELISA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance imaging of the lumbosacral spine</measure>
    <time_frame>pre-intervention</time_frame>
    <description>MRI 1.5T</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body fat content [%]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>dual energy X-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body fat content [%]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>dual energy X-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean body mass [kg]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>dual energy X-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean body mass [kg]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>dual energy X-ray absorptiometry (DXA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility of the spine</measure>
    <time_frame>pre-intervention</time_frame>
    <description>electrogoniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility of the spine</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>electrogoniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle bioelectric signal amplitude</measure>
    <time_frame>pre-intervention</time_frame>
    <description>electromyograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle bioelectric signal amplitude</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>electromyograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State of tension of erector spinae muscles [Hz]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic stiffness of erector spinae muscles [N/m]</measure>
    <time_frame>pre-intervention</time_frame>
    <description>Biomechanical properties will be assessed with myotonometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles</measure>
    <time_frame>pre-intervention</time_frame>
    <description>Biomechanical properties will be assessed with myotonometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State of tension of erector spinae muscles [Hz]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic stiffness of erector spinae muscles [N/m]</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>Biomechanical properties will be assessed with myotonometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>Biomechanical properties will be assessed with myotonometer device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>pre-intervention</time_frame>
    <description>algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>algometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity: questionnaire</measure>
    <time_frame>pre-intervention</time_frame>
    <description>visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity: questionnaire</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability caused by pain in the spine</measure>
    <time_frame>pre-intervention</time_frame>
    <description>Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disability caused by pain in the spine</measure>
    <time_frame>48 hours after the intervention</time_frame>
    <description>Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Patients With Obesity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal-Weight Patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 subjects aged 35-60 with normal body weight (BMI ≤ 24.9 and ≥ 18.5 kg/m2) suffering from chronic low back pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lumbar traction therapy</intervention_name>
    <description>The application of traction forces on the traction table (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with a maximum strength of 30% of the patient's body weight).</description>
    <arm_group_label>Normal-Weight Patients</arm_group_label>
    <arm_group_label>Patients With Obesity</arm_group_label>
    <other_name>lumbar traction</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written consent to participate in the study,&#xD;
&#xD;
          2. Age: 35 - 60 years,&#xD;
&#xD;
          3. Obesity (BMI ≥ 30 kg / m2) or normal weight (BMI 18,5-29,9 kg/m2),&#xD;
&#xD;
          4. Stable body weight in the last month ± 2 kg,&#xD;
&#xD;
          5. Chronic low back pain.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Secondary form of obesity;&#xD;
&#xD;
          2. Serious neurological defects (including large muscle losses, sensory disturbances in a&#xD;
             large area of the lower limb, occurrence of cauda equina syndrome);&#xD;
&#xD;
          3. Surgery, post-accident mechanical injuries, history of spine fractures;&#xD;
&#xD;
          4. History of rheumatic disease (RA, ankylosing spondylitis, systemic lupus);&#xD;
&#xD;
          5. Osteoporosis;&#xD;
&#xD;
          6. Pain located in a location other than the spine which is more severe than the low back&#xD;
             pain;&#xD;
&#xD;
          7. Poorly controlled type 2 diabetes;&#xD;
&#xD;
          8. Poorly controlled hypertension (mean systolic blood pressure&gt; 140mmHg and / or average&#xD;
             diastolic blood pressure&gt; 90mmHg) during the last month and / or the necessity of&#xD;
             modification of pharmacological treatment;&#xD;
&#xD;
          9. Lipid disorders requiring the introduction of pharmacological treatment in the last 3&#xD;
             months before observation or during observation;&#xD;
&#xD;
         10. Acute coronary event, unstable angina, stroke or transient cerebral ischemia in the&#xD;
             last 6 months;&#xD;
&#xD;
         11. Features of heart failure in physical examination and / or additional tests (chest&#xD;
             X-ray, echocardiography);&#xD;
&#xD;
         12. Clinically significant arrhythmias, conduction disorders, pacemaker implantation;&#xD;
&#xD;
         13. Fainting in an interview,&#xD;
&#xD;
         14. Chronic kidney disease with creatinine clearance &lt;60mL / min / 1.73m2;&#xD;
&#xD;
         15. Clinically significant liver dysfunction (transaminases exceeding 3 times the normal&#xD;
             range);&#xD;
&#xD;
         16. Acute or chronic, clinically apparent inflammatory process of the respiratory tract,&#xD;
             inflammatory processes of the genitourinary system, inflammatory process in the head&#xD;
             and neck;&#xD;
&#xD;
         17. Acute infection in the last month;&#xD;
&#xD;
         18. Cancer;&#xD;
&#xD;
         19. Alcohol abuse, drug addiction;&#xD;
&#xD;
         20. Pregnancy;&#xD;
&#xD;
         21. Uncontrolled mental illness that may falsify test results;&#xD;
&#xD;
         22. Other conditions which may pose any risk to the patient during the observation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marzena Ratajczak, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poznan University of Physical Education</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Małgorzata Waszak, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Poznan University of Physical Education</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Poznan University of Physical Education</name>
      <address>
        <city>Poznań</city>
        <zip>61-871</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Chow DHK, Yuen EMK, Xiao L, Leung MCP. Mechanical effects of traction on lumbar intervertebral discs: A magnetic resonance imaging study. Musculoskelet Sci Pract. 2017 Jun;29:78-83. doi: 10.1016/j.msksp.2017.03.007. Epub 2017 Mar 20.</citation>
    <PMID>28347933</PMID>
  </reference>
  <reference>
    <citation>Omarker K, Myers RR. Pathogenesis of sciatic pain: role of herniated nucleus pulposus and deformation of spinal nerve root and dorsal root ganglion. Pain. 1998 Nov;78(2):99-105. doi: 10.1016/S0304-3959(98)00119-5.</citation>
    <PMID>9839819</PMID>
  </reference>
  <reference>
    <citation>Maciaszek J, Skrypnik D, Ratajczak M, Stemplewski R, Osiński W, Bogdański P, Mądry E, Walkowiak J, Karolkiewicz J. Two aerobic exercise programs in management of back pain among middle-aged obese women: A randomized controlled study. Human Movement. 2016; 17(2): 72-79.</citation>
  </reference>
  <reference>
    <citation>Weber KT, Satoh S, Alipui DO, Virojanapa J, Levine M, Sison C, Quraishi S, Bloom O, Chahine NO. Exploratory study for identifying systemic biomarkers that correlate with pain response in patients with intervertebral disc disorders. Immunol Res. 2015 Dec;63(1-3):170-80. doi: 10.1007/s12026-015-8709-2.</citation>
    <PMID>26440592</PMID>
  </reference>
  <reference>
    <citation>Tarabeih N, Shalata A, Trofimov S, Kalinkovich A, Livshits G. Growth and differentiation factor 15 is a biomarker for low back pain-associated disability. Cytokine. 2019 May;117:8-14. doi: 10.1016/j.cyto.2019.01.011. Epub 2019 Feb 15.</citation>
    <PMID>30776685</PMID>
  </reference>
  <reference>
    <citation>Sowa GA, Perera S, Bechara B, Agarwal V, Boardman J, Huang W, Camacho-Soto A, Vo N, Kang J, Weiner D. Associations between serum biomarkers and pain and pain-related function in older adults with low back pain: a pilot study. J Am Geriatr Soc. 2014 Nov;62(11):2047-55. doi: 10.1111/jgs.13102. Epub 2014 Nov 3.</citation>
    <PMID>25367206</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Physical Education</investigator_affiliation>
    <investigator_full_name>Marzena Ratajczak</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>biomarkers of low back pain</keyword>
  <keyword>inflammation</keyword>
  <keyword>disk degeneration</keyword>
  <keyword>traction therapy</keyword>
  <keyword>lumbar traction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04507074
org study id: PoznanUPhyEd no. 3
nct id: NCT04507074
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the research study is to assess the impact of traction forces on changes in
      systemic markers concentrations of spinal structure damage in people with obesity. The
      research group will include 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and
      chronic lumbar spine pain syndrome.

      The control group will consist of 20 subjects with normal body weight suffering from the same
      pain, at a similar age to the patients in the study group. Persons will be qualified for
      examination by a specialist in internal medicine and a physiotherapist.

      To assess the degree of structural damage within the intervertebral disc and adjacent
      anatomical structures, patients will undergo magnetic resonance imaging of the lumbosacral
      spine (MRI 1.5T, standard in 3 projections). Patients will undergo traction therapy under the
      supervision of a physiotherapist. The application of traction forces on the traction table
      (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with
      a maximum strength of 30% of the patient's body weight).

      Twice, before and after therapy, the following will be assessed: (1) body composition (by DXA
      method), (2) other anthropometric indicators, (3) functional parameters of the spine:
      mobility (electrogoniometer), muscle bioelectric signal amplitude (electromyograph), soft
      tissue biophysical parameters (myotonometer), (4) pain threshold and intensity in the lumbar
      region (using an algometer and validated questionnaires), (5) disability caused by pain in
      the spine (Oswestry questionnaire), (6) blood biochemical indicators selected on the basis of
      the latest research on biomarkers of spinal damage (for this purpose, 25ml venous blood will
      be taken from the subjects).

      Blood levels of interleukin-17, interleukin-4, interleukin-2 (IL-2), interleukin-10 (IL-10),
      differentiating growth factor 15 (GDF-15), leptin, adipsin, chemokine CCL5 (RANTES), stem
      cell growth factor β (SCGF-β), vascular endothelial growth factor (VEGF), neuropeptide Y, and
      chondroitin sulfate CS846 will be determined in the blood of the subjects. It is planned to
      assess the relationship of the studied biomarkers with the degree of disk degeneration,
      obesity, lean and fat body mass, pain intensity, and functional indicators of the spine.
      Patients will be asked to stop taking anti-inflammatory drugs during therapy and at least 24
      hours prior to blood sampling.
People suffering from obesity are particularly vulnerable to mechanical compression of the
      intervertebral discs, and as a result their degeneration, hernia and pressure on the nerve
      roots, which together cause inflammation and pain in the damaged area. This is a significant
      public health problem due to the 100% incidence of pain syndrome among people with obesity.
      The use of traction forces has beneficial effects on degenerated intervertebral discs, but
      there are no studies assessing the effectiveness of the traction method in relation to a
      group of obese people with back pain syndrome.

      Beneficial biochemical changes in the blood, alleviation of pain, improvement of functional
      parameters of the spine are expected after application of traction forces to the patients in
      the mechanism of decompression of the destroyed and being in chronic inflammation
      intervertebral discs. Identification of biomarkers enabling to monitor the effects of
      therapies in patients with chronic back pain can become a contribution to change standards in
      the diagnosis of back pain and reorientation in its treatment to real causes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
time frame: pre-intervention
description: ELISA
measure: Interleukin-2, interleukin-4, interleukin-10, interleukin-17, RANTES, differentiating growth factor 15 (GDF-15) [pg/ml]
time frame: 48 hours after the intervention
description: ELISA
measure: Stem cell growth factor β [ng/ml]
time frame: pre-intervention
description: ELISA
measure: Stem cell growth factor β [ng/ml]
time frame: 48 hours after the intervention
description: ELISA
measure: Leptin [ng/ml]
time frame: pre-intervention
description: ELISA
measure: Leptin [ng/ml]
time frame: 48 hours after the intervention
description: ELISA
measure: Adipsin [pg/ml]
time frame: pre-intervention
description: ELISA
measure: Adipsin [pg/ml]
time frame: 48 hours after the intervention
description: ELISA
measure: Neuropeptide Y [pg/ml]
time frame: pre-intervention
description: ELISA
measure: Neuropeptide Y [pg/ml]
time frame: 48 hours after the intervention
description: ELISA
measure: Vascular Endothelial Growth Factor [pg/ml]
time frame: pre-intervention
description: ELISA
measure: Vascular Endothelial Growth Factor [pg/ml]
time frame: 48 hours after the intervention
description: ELISA
measure: Chondroitin sulfate CS846 [ng/mL]
time frame: pre-intervention
description: ELISA
measure: Chondroitin sulfate CS846 [ng/mL]
time frame: 48 hours after the intervention
description: ELISA
measure: Magnetic resonance imaging of the lumbosacral spine
time frame: pre-intervention
description: MRI 1.5T
measure: Total body fat content [%]
time frame: pre-intervention
description: dual energy X-ray absorptiometry (DXA)
measure: Total body fat content [%]
time frame: 48 hours after the intervention
description: dual energy X-ray absorptiometry (DXA)
measure: Lean body mass [kg]
time frame: pre-intervention
description: dual energy X-ray absorptiometry (DXA)
measure: Lean body mass [kg]
time frame: 48 hours after the intervention
description: dual energy X-ray absorptiometry (DXA)
measure: Mobility of the spine
time frame: pre-intervention
description: electrogoniometer
measure: Mobility of the spine
time frame: 48 hours after the intervention
description: electrogoniometer
measure: Muscle bioelectric signal amplitude
time frame: pre-intervention
description: electromyograph
measure: Muscle bioelectric signal amplitude
time frame: 48 hours after the intervention
description: electromyograph
measure: State of tension of erector spinae muscles [Hz]
time frame: pre-intervention
description: Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.
measure: Dynamic stiffness of erector spinae muscles [N/m]
time frame: pre-intervention
description: Biomechanical properties will be assessed with myotonometer device.
measure: Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
time frame: pre-intervention
description: Biomechanical properties will be assessed with myotonometer device.
measure: State of tension of erector spinae muscles [Hz]
time frame: 48 hours after the intervention
description: Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.
measure: Dynamic stiffness of erector spinae muscles [N/m]
time frame: 48 hours after the intervention
description: Biomechanical properties will be assessed with myotonometer device.
measure: Logarithmic decrement of natural oscillation, characterizing elasticity of erector spinae muscles
time frame: 48 hours after the intervention
description: Biomechanical properties will be assessed with myotonometer device.
measure: Pain threshold
time frame: pre-intervention
description: algometer
measure: Pain threshold
time frame: 48 hours after the intervention
description: algometer
measure: Pain intensity: questionnaire
time frame: pre-intervention
description: visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable
measure: Pain intensity: questionnaire
time frame: 48 hours after the intervention
description: visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable
measure: Disability caused by pain in the spine
time frame: pre-intervention
description: Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.
measure: Disability caused by pain in the spine
time frame: 48 hours after the intervention
description: Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.
arm group label: Patients With Obesity
arm group type: Experimental
description: 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic low back pain.
arm group label: Normal-Weight Patients
arm group type: Active Comparator
description: 20 subjects aged 35-60 with normal body weight (BMI ≤ 24.9 and ≥ 18.5 kg/m2) suffering from chronic low back pain.
intervention type: Device
intervention name: lumbar traction therapy
description: The application of traction forces on the traction table (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with a maximum strength of 30% of the patient's body weight).
arm group label: Normal-Weight Patients
arm group label: Patients With Obesity
other name: lumbar traction
criteria: 
gender: All
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: No
last name: Marzena Ratajczak, PhD
role: Principal Investigator
affiliation: Poznan University of Physical Education
last name: Małgorzata Waszak, PhD
role: Study Chair
affiliation: Poznan University of Physical Education
facility: 
country: Poland
citation: Chow DHK, Yuen EMK, Xiao L, Leung MCP. Mechanical effects of traction on lumbar intervertebral discs: A magnetic resonance imaging study. Musculoskelet Sci Pract. 2017 Jun;29:78-83. doi: 10.1016/j.msksp.2017.03.007. Epub 2017 Mar 20.
PMID: 28347933
citation: Omarker K, Myers RR. Pathogenesis of sciatic pain: role of herniated nucleus pulposus and deformation of spinal nerve root and dorsal root ganglion. Pain. 1998 Nov;78(2):99-105. doi: 10.1016/S0304-3959(98)00119-5.
PMID: 9839819
citation: Maciaszek J, Skrypnik D, Ratajczak M, Stemplewski R, Osiński W, Bogdański P, Mądry E, Walkowiak J, Karolkiewicz J. Two aerobic exercise programs in management of back pain among middle-aged obese women: A randomized controlled study. Human Movement. 2016; 17(2): 72-79.
citation: Weber KT, Satoh S, Alipui DO, Virojanapa J, Levine M, Sison C, Quraishi S, Bloom O, Chahine NO. Exploratory study for identifying systemic biomarkers that correlate with pain response in patients with intervertebral disc disorders. Immunol Res. 2015 Dec;63(1-3):170-80. doi: 10.1007/s12026-015-8709-2.
PMID: 26440592
citation: Tarabeih N, Shalata A, Trofimov S, Kalinkovich A, Livshits G. Growth and differentiation factor 15 is a biomarker for low back pain-associated disability. Cytokine. 2019 May;117:8-14. doi: 10.1016/j.cyto.2019.01.011. Epub 2019 Feb 15.
PMID: 30776685
citation: Sowa GA, Perera S, Bechara B, Agarwal V, Boardman J, Huang W, Camacho-Soto A, Vo N, Kang J, Weiner D. Associations between serum biomarkers and pain and pain-related function in older adults with low back pain: a pilot study. J Am Geriatr Soc. 2014 Nov;62(11):2047-55. doi: 10.1111/jgs.13102. Epub 2014 Nov 3.
PMID: 25367206
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Physical Education
investigator full name: Marzena Ratajczak
investigator title: assistant professor
mesh term: Obesity
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No