xml: <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/NCT06018402</url>
    </required_header>
    <id_info>
      <org_study_id>ozgeilleez1</org_study_id>
      <nct_id>NCT06018402</nct_id>
    </id_info>
    <brief_title>The Effect of Physical Therapy Program and Erector Spina Plane Block in Patients With Degenerative Lumbar Scoliosis</brief_title>
    <official_title>The Effect of Physical Therapy Program in Combination With Erector Spina Plane Block on Pain, Disability and Quality of Life in Patients With Degenerative Lumbar Scoliosis: Prospective, Randomized, Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fatih Sultan Mehmet Training and Research Hospital</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>
        Degenerative (de novo) scoliosis is the result of a long and multifactorial process that&#xD;
        occurs through degenerative change in the aging population without a pre-existing spinal&#xD;
        deformity. Pain is the most important symptom and the major difference from adolescent&#xD;
        idiopathic scoliosis. Treatment is often complex and patient-specific. The first aim of our&#xD;
        study is to evaluate the effectiveness of physical therapy on pain, disability and quality of&#xD;
        life in patients with degenerative lumbar scoliosis and the second aim is to investigate&#xD;
        whether erector spina plan block (ESPB) combined with physical therapy has an effect on the&#xD;
        results.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients over 60 years of age, with low back or low back-leg pain for at least 3 months, who&#xD;
        had received pharmacologic treatment but did not respond, and diagnosed with degenerative&#xD;
        lumbar scoliosis are included in the study. Patients are randomized into to groups according&#xD;
        to the interventions as: physical therapy group (G-1) and physical therapy and ESPB injection&#xD;
        group (G-2). The physical therapy program is planned as a total of 15 sessions in the lumbar&#xD;
        region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse&#xD;
        duration, intensity is increased as much as the patient could tolerate, 20 minutes in total),&#xD;
        hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5&#xD;
        watt/cm2 intensity). Ultrasound-guided lumbar ESPB is performed using an in-line cephalic&#xD;
        approach, and after contacting the corner of the L3 transverse process, a small dose of&#xD;
        saline is injected into the fascial space between the L3 transverse process and the erector&#xD;
        spinae muscles to &quot;lift off&quot; the fascia. After verification, a mixture of 20 mL of 1%&#xD;
        lidocaine and 3 mg betamethasone are administered for unilateral injection. The procedure is&#xD;
        performed bilaterallyThe primary endpoint of the study is pain intensity assasment by using a&#xD;
        numerical rating scale (NRS), and secondary endpoints are functional status, quality of life&#xD;
        and disability status assasment by using SRS-22 and Oswestry disability index. Patients are&#xD;
        evaluated before and 1 week, 1 month and 3 months after treatment. In the 2nd group, pain&#xD;
        intensity at 1 hour after injection is additionally evaluated with a NRS. As a result of the&#xD;
        power analysis, the minimum sample size was planned as a total of 16 patients with 8 patients&#xD;
        in each group with a 15% dropout rate. Shapiro Wilk test is applied to examine the normality&#xD;
        of the data distribution. The difference between groups is evaluated by Mann Whitney U&#xD;
        according to normal distribution and by ANOVA for time-dependent within-group change.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 15, 2024</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>
      <intervention_model_description>Randomised, Single Blinded Study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>NRS (Numeric Rating Scale)</measure>
      <time_frame>Day 0</time_frame>
      <description>Pain Intensity Assessment ( 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NRS (Numeric Rating Scale)</measure>
      <time_frame>1 hour after injection</time_frame>
      <description>Pain Intensity Assessment ( 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NRS (Numeric Rating Scale)</measure>
      <time_frame>1 week after physical treatment</time_frame>
      <description>Pain Intensity Assessment ( 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NRS (Numeric Rating Scale)</measure>
      <time_frame>1 month after physical treatment</time_frame>
      <description>Pain Intensity Assessment ( 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>NRS (Numeric Rating Scale)</measure>
      <time_frame>3 month after physical treatment</time_frame>
      <description>Pain Intensity Assessment ( 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SRS-22</measure>
      <time_frame>Day 0</time_frame>
      <description>22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SRS-22</measure>
      <time_frame>1 week after physical treatment</time_frame>
      <description>22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SRS-22</measure>
      <time_frame>1 month after physical treatment</time_frame>
      <description>22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SRS-22</measure>
      <time_frame>3 month after physical treatment</time_frame>
      <description>22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index</measure>
      <time_frame>Day 0</time_frame>
      <description>Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index</measure>
      <time_frame>1 week after physical treatment</time_frame>
      <description>Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index</measure>
      <time_frame>1 month after physical treatment</time_frame>
      <description>Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index</measure>
      <time_frame>3 month after physical treatment</time_frame>
      <description>Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>physical therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>physical therapy + espb</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to &quot;lift off&quot; the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical therapy</intervention_name>
      <description>The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity).</description>
      <arm_group_label>physical therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>physical therapy + espb</intervention_name>
      <description>the same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to &quot;lift off&quot; the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally.</description>
      <arm_group_label>physical therapy + espb</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being 60 years or older&#xD;
  &#xD;
            -  Having a scoliosis of 10 degrees or more in the lumbar region according to the&#xD;
               measurement made with the cobb method&#xD;
  &#xD;
            -  Having pain in the axial waist or radiating from the waist to the leg&#xD;
  &#xD;
            -  Pain that persists for at least 3 months&#xD;
  &#xD;
            -  NRS &gt; 4&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Systemic or local infection at the injection site&#xD;
  &#xD;
            -  Past or current history of malignant disease&#xD;
  &#xD;
            -  Presence of neurological or orthopedic disease&#xD;
  &#xD;
            -  Presence of uncontrolled hypertension, diabetes mellitus&#xD;
  &#xD;
            -  Presence of severe heart failure&#xD;
  &#xD;
            -  Presence of bleeding diathesis&#xD;
  &#xD;
            -  Anticoagulant use&#xD;
  &#xD;
            -  Lidocaine allergy&#xD;
  &#xD;
            -  Psychiatric disorder or mental problem&#xD;
  &#xD;
            -  inflammatory spine pain&#xD;
  &#xD;
            -  Severe osteoporosis / previous vertebral fracture&#xD;
  &#xD;
            -  Body mass index &gt;35&#xD;
  &#xD;
            -  Having had previous surgery on the lumbar region&#xD;
  &#xD;
            -  Injection was applied to the waist region within 6 months or physical have been&#xD;
               treated&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ozge Gulsum Illeez</last_name>
      <role>Study Director</role>
      <affiliation>Fatih Sultan Mehmet Taining and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ozge Gulsum Illeez</last_name>
      <phone>+905326255684</phone>
      <email>ozgeilleez@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yunus Emre Doğan</last_name>
      <phone>+905060512500</phone>
      <email>ynsemredogan91@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Graham RB, Sugrue PA, Koski TR. Adult Degenerative Scoliosis. Clin Spine Surg. 2016 Apr;29(3):95-107. doi: 10.1097/BSD.0000000000000367.</citation>
      <PMID>26945131</PMID>
    </reference>
    <reference>
      <citation>Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.</citation>
      <PMID>17630141</PMID>
    </reference>
    <reference>
      <citation>Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.</citation>
      <PMID>27501016</PMID>
    </reference>
    <reference>
      <citation>Ahiskalioglu A, Alici HA, Ciftci B, Celik M, Karaca O. Continuous ultrasound guided erector spinae plane block for the management of chronic pain. Anaesth Crit Care Pain Med. 2019 Aug;38(4):395-396. doi: 10.1016/j.accpm.2017.11.014. Epub 2017 Dec 15. No abstract available.</citation>
      <PMID>29253539</PMID>
    </reference>
    <reference>
      <citation>Akyuz ME, Firidin MN. Bilateral ultrasound-guided erector spinae plane block for postoperative persistent low back pain in lumbar disc surgery. Eur Spine J. 2022 Jul;31(7):1873-1878. doi: 10.1007/s00586-022-07212-z. Epub 2022 Apr 14.</citation>
      <PMID>35420380</PMID>
    </reference>
    <reference>
      <citation>Durmus IE, Surucu S, Muz A, Takmaz SA. The effectiveness of erector spinae plane block in patients with chronic low back pain. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):138-143. doi: 10.26355/eurrev_202301_30864.</citation>
      <PMID>36647861</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fatih Sultan Mehmet Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Ozge Illeez, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Degenerative lumbar scoliosis</keyword>
    <keyword>Physical treatment</keyword>
    <keyword>Erector spinae plane block</keyword>
    <keyword>Low back pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scoliosis</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>
  
  
text: 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/NCT06018402
  org study id: ozgeilleez1
  nct id: NCT06018402
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Degenerative (de novo) scoliosis is the result of a long and multifactorial process that
        occurs through degenerative change in the aging population without a pre-existing spinal
        deformity. Pain is the most important symptom and the major difference from adolescent
        idiopathic scoliosis. Treatment is often complex and patient-specific. The first aim of our
        study is to evaluate the effectiveness of physical therapy on pain, disability and quality of
        life in patients with degenerative lumbar scoliosis and the second aim is to investigate
        whether erector spina plan block (ESPB) combined with physical therapy has an effect on the
        results.
  Patients over 60 years of age, with low back or low back-leg pain for at least 3 months, who
        had received pharmacologic treatment but did not respond, and diagnosed with degenerative
        lumbar scoliosis are included in the study. Patients are randomized into to groups according
        to the interventions as: physical therapy group (G-1) and physical therapy and ESPB injection
        group (G-2). The physical therapy program is planned as a total of 15 sessions in the lumbar
        region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse
        duration, intensity is increased as much as the patient could tolerate, 20 minutes in total),
        hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5
        watt/cm2 intensity). Ultrasound-guided lumbar ESPB is performed using an in-line cephalic
        approach, and after contacting the corner of the L3 transverse process, a small dose of
        saline is injected into the fascial space between the L3 transverse process and the erector
        spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1%
        lidocaine and 3 mg betamethasone are administered for unilateral injection. The procedure is
        performed bilaterallyThe primary endpoint of the study is pain intensity assasment by using a
        numerical rating scale (NRS), and secondary endpoints are functional status, quality of life
        and disability status assasment by using SRS-22 and Oswestry disability index. Patients are
        evaluated before and 1 week, 1 month and 3 months after treatment. In the 2nd group, pain
        intensity at 1 hour after injection is additionally evaluated with a NRS. As a result of the
        power analysis, the minimum sample size was planned as a total of 16 patients with 8 patients
        in each group with a 15% dropout rate. Shapiro Wilk test is applied to examine the normality
        of the data distribution. The difference between groups is evaluated by Mann Whitney U
        according to normal distribution and by ANOVA for time-dependent within-group change.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomised, Single Blinded Study
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: NRS (Numeric Rating Scale)
  time frame: Day 0
  description: Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
  measure: NRS (Numeric Rating Scale)
  time frame: 1 hour after injection
  description: Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
  measure: NRS (Numeric Rating Scale)
  time frame: 1 week after physical treatment
  description: Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
  measure: NRS (Numeric Rating Scale)
  time frame: 1 month after physical treatment
  description: Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
  measure: NRS (Numeric Rating Scale)
  time frame: 3 month after physical treatment
  description: Pain Intensity Assessment ( 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
  measure: SRS-22
  time frame: Day 0
  description: 22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
  measure: SRS-22
  time frame: 1 week after physical treatment
  description: 22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
  measure: SRS-22
  time frame: 1 month after physical treatment
  description: 22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
  measure: SRS-22
  time frame: 3 month after physical treatment
  description: 22 questions make up the SRS-22, which covers five domains: function/activity, pain, self-perceived image, mental health, and satisfaction with therapy. Scores range from 1 (worst) to 5 (best) for each item.
  measure: Oswestry Disability Index
  time frame: Day 0
  description: Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
  measure: Oswestry Disability Index
  time frame: 1 week after physical treatment
  description: Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
  measure: Oswestry Disability Index
  time frame: 1 month after physical treatment
  description: Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
  measure: Oswestry Disability Index
  time frame: 3 month after physical treatment
  description: Each item has six statements and is scored between 0 and 5. The overall score is then calculated as a percentage, with 0% denoting no disability and 100% denoting the highest level of disability, with 0 denoting the least disability and 5 denoting the worst.
  arm group label: physical therapy
  arm group type: Active Comparator
  description: The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity)
  arm group label: physical therapy + espb
  arm group type: Active Comparator
  description: same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally.
  intervention type: Other
  intervention name: physical therapy
  description: The physical therapy program is planned as a total of 15 sessions in the lumbar region, each session consisting of TENS (50-100 Hz stimulation frequency, 200 µs pulse duration, intensity is increased as much as the patient could tolerate, 20 minutes in total), hotpack (to be placed on the painful area, 20 minutes), US (1 mHz frequency, 10 minutes, 1.5 watt/cm2 intensity).
  arm group label: physical therapy
  intervention type: Other
  intervention name: physical therapy + espb
  description: the same physical therapy program, in addition Ultrasound-guided lumbar ESPB is performed using an in-line cephalic approach, and after contacting the corner of the L3 transverse process, a small dose of saline is injected into the fascial space between the L3 transverse process and the erector spinae muscles to "lift off" the fascia. After verification, a mixture of 20 mL of 1% lidocaine and 3 mg betamethasone is administered for unilateral injection. The procedure is performed bilaterally.
  arm group label: physical therapy + espb
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ozge Gulsum Illeez
  role: Study Director
  affiliation: Fatih Sultan Mehmet Taining and Research Hospital
  last name: Ozge Gulsum Illeez
  phone: +905326255684
  email: ozgeilleez@hotmail.com
  last name: Yunus Emre Doğan
  phone: +905060512500
  email: ynsemredogan91@gmail.com
  citation: Graham RB, Sugrue PA, Koski TR. Adult Degenerative Scoliosis. Clin Spine Surg. 2016 Apr;29(3):95-107. doi: 10.1097/BSD.0000000000000367.
  PMID: 26945131
  citation: Ploumis A, Transfledt EE, Denis F. Degenerative lumbar scoliosis associated with spinal stenosis. Spine J. 2007 Jul-Aug;7(4):428-36. doi: 10.1016/j.spinee.2006.07.015. Epub 2007 Feb 28.
  PMID: 17630141
  citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
  PMID: 27501016
  citation: Ahiskalioglu A, Alici HA, Ciftci B, Celik M, Karaca O. Continuous ultrasound guided erector spinae plane block for the management of chronic pain. Anaesth Crit Care Pain Med. 2019 Aug;38(4):395-396. doi: 10.1016/j.accpm.2017.11.014. Epub 2017 Dec 15. No abstract available.
  PMID: 29253539
  citation: Akyuz ME, Firidin MN. Bilateral ultrasound-guided erector spinae plane block for postoperative persistent low back pain in lumbar disc surgery. Eur Spine J. 2022 Jul;31(7):1873-1878. doi: 10.1007/s00586-022-07212-z. Epub 2022 Apr 14.
  PMID: 35420380
  citation: Durmus IE, Surucu S, Muz A, Takmaz SA. The effectiveness of erector spinae plane block in patients with chronic low back pain. Eur Rev Med Pharmacol Sci. 2023 Jan;27(1):138-143. doi: 10.26355/eurrev_202301_30864.
  PMID: 36647861
  responsible party type: Principal Investigator
  investigator affiliation: Fatih Sultan Mehmet Training and Research Hospital
  investigator full name: Ozge Illeez, MD
  investigator title: Principal Investigator
  mesh term: Scoliosis
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No