<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/NCT04492774</url>
  </required_header>
  <id_info>
    <org_study_id>SMC2020002</org_study_id>
    <nct_id>NCT04492774</nct_id>
  </id_info>
  <brief_title>Degenerative Lumbar Stenosis Conservative Treatment</brief_title>
  <acronym>GOLDSTEN</acronym>
  <official_title>GOLDIC Therapy in Lumbar Degenerative Spinal Stenosis - Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sutherland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sutherland Medical Center</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 trial aims to compare the effectiveness of three methods of conservative treatment of&#xD;
      degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections,&#xD;
      steroid epidural injections and manual therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for&#xD;
      patients over 65 years of age. It is assumed that in the United States alone, it affects&#xD;
      about 200 thousand patients causing significant impairment of their quality of life. Although&#xD;
      it is relatively easy to confirm the nature of spinal canal encroaching (disc protrusion,&#xD;
      facet hypertrophy, ligamentous folding) by several methods of imaging, the golden standard of&#xD;
      DLSS management, especially in the group of older patients, is still the matter of debate.&#xD;
      Three main concepts of conservative treatment are considered: 1) pharmacological care -&#xD;
      symptom-oriented systemic anty-inflammatory and analgesic agents or local steroid injections,&#xD;
      2) rehabilitations protocols and mechanical devices like traction facilities or corsets to&#xD;
      decompress spinal canal or support in case of instability, 3) biological - stimulation of&#xD;
      anti-inflammatory action and regeneration capacity by biologically active substances. All&#xD;
      methods are offered without strong evidence of its efficacy.&#xD;
&#xD;
      AIM: Comparison of the effectiveness of three treatment protocols in DLSS: epidural&#xD;
      injections of autologous serum (Gold Induced Cytokines, Goldic), epidural steroid injections,&#xD;
      manual therapy in the concept of spinal canal venous drainage.&#xD;
&#xD;
      Research hypothesis: The use of Goldic serum in epidural injections improves the condition of&#xD;
      patients with DLSS during the observation period longer than steroid injections and the&#xD;
      rehabilitation protocol.&#xD;
&#xD;
      DESIGN: Randomized prospective trial without blinding. SETTING: Open study for outpatients,&#xD;
      single-centre study. POPULATION: the local adult population METHODS: Three groups of patients&#xD;
      (A, B, C) with confirmed DLSS in MRI, without limiting sex, age, meeting health conditions&#xD;
      according to the inclusion and exclusion criteria. There will be 30 people in each group (90&#xD;
      people in total).&#xD;
&#xD;
      Group A - Goldic serum therapy - 4 injections at 3-day intervals containing single doses of&#xD;
      serum (4 doses of 3 ml in total), injections performed into the epidural space under&#xD;
      ultrasound control by the same operator.&#xD;
&#xD;
      Group B - steroid therapy with Dexaven 4 mg / 1 ml - 2 injections at weekly intervals&#xD;
      containing single doses of dexamethasone (total dose of 8 mg), injections will be performed&#xD;
      into the epidural space under ultrasound control by the same operator.&#xD;
&#xD;
      Group C - manual therapy according to the concept of venous drainage - a repeatable treatment&#xD;
      scheme for each patient; decompression of the thoracic outlet, diaphragm release, sacroiliac&#xD;
      joints (SI) mobilizations, rib-sternum release, rib raising technique - 4 sessions (1 x&#xD;
      weekly - approx. 40 min).&#xD;
&#xD;
      Control tools: NRS Pain Scale (0-10), Oswestry Disability Index, Zurich Claudication&#xD;
      Questionnaire (ZCQ), EQ-5D-5L, Control points: Initial Assessment (IA), 4,12, 24 weeks after&#xD;
      last intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>None (Open label)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in EQ-5D-5L index from baseline to 24 weeks</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Oswestry Disability Index from baseline to 24 weeks</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity according to Numeric Rating Scale</measure>
    <time_frame>Change from baseline to 4 weeks</time_frame>
    <description>Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity according to Numeric Rating Scale</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity according to Numeric Rating Scale</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D-5L index from baseline to 4 weeks</measure>
    <time_frame>Change from baseline to 4 weeks</time_frame>
    <description>EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D-5L index from baseline to 12 weeks</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry Disability Index from baseline to 4 weeks</measure>
    <time_frame>Change from baseline to 4 weeks</time_frame>
    <description>Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry Disability Index from baseline to 12 weeks</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks</measure>
    <time_frame>Change from baseline to 4 weeks</time_frame>
    <description>Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks</measure>
    <time_frame>Change from baseline to 12 weeks</time_frame>
    <description>Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Spinal Stenosis Lumbar</condition>
  <condition>Spinal Canal Stenosis</condition>
  <arm_group>
    <arm_group_label>GOLDIC serum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Epidural ultrasound guided injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Steroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural ultrasound guided injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>veno-lymphatic spinal drainage</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Goldic serum</intervention_name>
    <description>epidural injections</description>
    <arm_group_label>GOLDIC serum</arm_group_label>
    <other_name>Autologous serum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Steroid injections</intervention_name>
    <description>epidural injections</description>
    <arm_group_label>Steroid</arm_group_label>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Manual therapy</intervention_name>
    <description>Veno-lymphatic drainage</description>
    <arm_group_label>Manual therapy</arm_group_label>
    <other_name>drainage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical signs of lumbar spinal stenosis&#xD;
&#xD;
          2. Radiological signs of lumbar spinal stenosis confirmed by MRI&#xD;
&#xD;
          3. No contraindications to steroid therapy or spinal epidural injections (glaucoma, high&#xD;
             RR values, diabetes, anticoagulants, active infections, etc.)&#xD;
&#xD;
          4. Mental state allowing cooperation during manual therapy&#xD;
&#xD;
          5. An adult who consents to participate in the study&#xD;
&#xD;
          6. No previous surgery or spinal epidural injections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The presence of serious neurological deficits&#xD;
&#xD;
          2. Stenosis of other origin - post-traumatic, spondylolisthesis, cancer, infection&#xD;
&#xD;
          3. Contraindications to steroid therapy or spinal injections (glaucoma, high RR values,&#xD;
             diabetes, anticoagulants, active infections, etc.)&#xD;
&#xD;
          4. Previous surgery or spinal epidural injections of lumbar spine&#xD;
&#xD;
          5. Mental state preventing cooperation during manual therapy&#xD;
&#xD;
          6. Lack of consent to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Piotr Godek, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sutherland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sutherland Medical Center</name>
      <address>
        <city>Warszawa</city>
        <state>Mazovia</state>
        <zip>04-036</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sutherland Medical Center</investigator_affiliation>
    <investigator_full_name>Piotr Godek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_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/NCT04492774
org study id: SMC2020002
nct id: NCT04492774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial aims to compare the effectiveness of three methods of conservative treatment of
      degenerative lumbar spine stenosis (DLSS): GOLDIC autologous serum epidural injections,
      steroid epidural injections and manual therapy.
BACKGROUND: Degenerative Lumbar Spinal Stenosis (DLSS) is a serious health problem for
      patients over 65 years of age. It is assumed that in the United States alone, it affects
      about 200 thousand patients causing significant impairment of their quality of life. Although
      it is relatively easy to confirm the nature of spinal canal encroaching (disc protrusion,
      facet hypertrophy, ligamentous folding) by several methods of imaging, the golden standard of
      DLSS management, especially in the group of older patients, is still the matter of debate.
      Three main concepts of conservative treatment are considered: 1) pharmacological care -
      symptom-oriented systemic anty-inflammatory and analgesic agents or local steroid injections,
      2) rehabilitations protocols and mechanical devices like traction facilities or corsets to
      decompress spinal canal or support in case of instability, 3) biological - stimulation of
      anti-inflammatory action and regeneration capacity by biologically active substances. All
      methods are offered without strong evidence of its efficacy.

      AIM: Comparison of the effectiveness of three treatment protocols in DLSS: epidural
      injections of autologous serum (Gold Induced Cytokines, Goldic), epidural steroid injections,
      manual therapy in the concept of spinal canal venous drainage.

      Research hypothesis: The use of Goldic serum in epidural injections improves the condition of
      patients with DLSS during the observation period longer than steroid injections and the
      rehabilitation protocol.

      DESIGN: Randomized prospective trial without blinding. SETTING: Open study for outpatients,
      single-centre study. POPULATION: the local adult population METHODS: Three groups of patients
      (A, B, C) with confirmed DLSS in MRI, without limiting sex, age, meeting health conditions
      according to the inclusion and exclusion criteria. There will be 30 people in each group (90
      people in total).

      Group A - Goldic serum therapy - 4 injections at 3-day intervals containing single doses of
      serum (4 doses of 3 ml in total), injections performed into the epidural space under
      ultrasound control by the same operator.

      Group B - steroid therapy with Dexaven 4 mg / 1 ml - 2 injections at weekly intervals
      containing single doses of dexamethasone (total dose of 8 mg), injections will be performed
      into the epidural space under ultrasound control by the same operator.

      Group C - manual therapy according to the concept of venous drainage - a repeatable treatment
      scheme for each patient; decompression of the thoracic outlet, diaphragm release, sacroiliac
      joints (SI) mobilizations, rib-sternum release, rib raising technique - 4 sessions (1 x
      weekly - approx. 40 min).

      Control tools: NRS Pain Scale (0-10), Oswestry Disability Index, Zurich Claudication
      Questionnaire (ZCQ), EQ-5D-5L, Control points: Initial Assessment (IA), 4,12, 24 weeks after
      last intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: None (Open label)
measure: Change in EQ-5D-5L index from baseline to 24 weeks
time frame: Change from baseline to 24 weeks
description: EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
measure: Change in Oswestry Disability Index from baseline to 24 weeks
time frame: Change from baseline to 24 weeks
description: Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
measure: Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 24 weeks
time frame: Change from baseline to 24 weeks
description: Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
measure: Change in pain intensity according to Numeric Rating Scale
time frame: Change from baseline to 4 weeks
description: Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
measure: Change in pain intensity according to Numeric Rating Scale
time frame: Change from baseline to 12 weeks
description: Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
measure: Change in pain intensity according to Numeric Rating Scale
time frame: Change from baseline to 24 weeks
description: Generic outcome measure. Range: 0 (no pain) - 10 (the worst possible pain).
measure: Change in EQ-5D-5L index from baseline to 4 weeks
time frame: Change from baseline to 4 weeks
description: EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
measure: Change in EQ-5D-5L index from baseline to 12 weeks
time frame: Change from baseline to 12 weeks
description: EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
measure: Change in Oswestry Disability Index from baseline to 4 weeks
time frame: Change from baseline to 4 weeks
description: Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
measure: Change in Oswestry Disability Index from baseline to 12 weeks
time frame: Change from baseline to 12 weeks
description: Disease-specific questionnaire. Range: 0 (the best score) - 50 (the worst score).
measure: Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 4 weeks
time frame: Change from baseline to 4 weeks
description: Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
measure: Change in Zurich Claudication Questionnaire (ZCQ) from baseline to 12 weeks
time frame: Change from baseline to 12 weeks
description: Disease-specific questionnaire. Range: 12 (the best score) - 55 (the worst score).
arm group label: GOLDIC serum
arm group type: Experimental
description: Epidural ultrasound guided injections
arm group label: Steroid
arm group type: Active Comparator
description: Epidural ultrasound guided injections
arm group label: Manual therapy
arm group type: Active Comparator
description: veno-lymphatic spinal drainage
intervention type: Combination Product
intervention name: Goldic serum
description: epidural injections
arm group label: GOLDIC serum
other name: Autologous serum
intervention type: Drug
intervention name: Steroid injections
description: epidural injections
arm group label: Steroid
other name: Dexamethasone
intervention type: Procedure
intervention name: Manual therapy
description: Veno-lymphatic drainage
arm group label: Manual therapy
other name: drainage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Piotr Godek, PhD
role: Principal Investigator
affiliation: Sutherland Medical Center
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Sutherland Medical Center
investigator full name: Piotr Godek
investigator title: Principal Investigator
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic
mesh term: Dexamethasone
sharing ipd: No