<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/NCT03304730</url>
  </required_header>
  <id_info>
    <org_study_id>65291417.0.0000.0071</org_study_id>
    <nct_id>NCT03304730</nct_id>
  </id_info>
  <brief_title>Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study</brief_title>
  <official_title>Prognostic Factors of Efficacy in Corticoid and Anesthetic Joint Infiltration for the Treatment of Patients With Low Back Pain Secondary to Zygapophyseal Osteoarthritis: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Israelita Albert Einstein</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>
      Magnet Resonance Image findings of facet osteoarthritis and patient characteristics are&#xD;
      prognostic factors for improving or worsening the clinical outcome after treatment with facet&#xD;
      infiltration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction: Low back pain is one of the significant health problems; studies have&#xD;
           shown that it can affect 80-85% of people throughout life; consisting of the second&#xD;
           major cause of work withdrawal. In the investigation by lumbar spine imaging methods,&#xD;
           facet osteoarthritis (FO) is one of the most prevalent diagnoses, in 59.6% for men and&#xD;
           66.7% for women. The process of osteoarthritis begins early in the spine; more than half&#xD;
           of adults are under 30 years old, presenting degenerative changes in the facets, being&#xD;
           more commonly affected by the L4-L5 level. It is estimated that the pain of facet origin&#xD;
           corresponds to 30% of cases of low back pain. The treatment of low back pain, which&#xD;
           presents questionable results, has a substantial economic impact on the health system&#xD;
           and represents a growing concern for public and medical policymakers. The lack of&#xD;
           diagnostic accuracy and the various types of treatment without evidence of appropriate&#xD;
           effectiveness are considered the leading causes of the increasing costs of the health&#xD;
           system. Biomechanical, neuroanatomical, and neurophysiological studies demonstrated free&#xD;
           and encapsulated nerve endings in the lumbar facet joints and nerves containing&#xD;
           substance P and peptides related to the calcitonin gene. Chemical or mechanical stimuli&#xD;
           can cause pain. The pathophysiology of facet pain is not fully understood, but it is&#xD;
           believed that facet osteoarthritis is due to repetitive mechanical stress, with&#xD;
           subsequent inflammation and elongation of the joint capsule, generating pain.&#xD;
&#xD;
           Several treatments are used in low back pain secondary to FO. The most used are&#xD;
           non-hormonal anti-inflammatory drugs and physiotherapy as a conservative measure.&#xD;
           Interventional procedures such as facet intraarticular or periarticular infiltration of&#xD;
           corticoid for neural blockade and denervation by radiofrequency are considered minimally&#xD;
           invasive options, indicated for cases in which conservative treatment fails. Surgical&#xD;
           treatment of arthrodesis is also part of the therapeutic options. A systemic&#xD;
           corticosteroid is within the available therapeutic arsenal but has undesirable side&#xD;
           effects, and its use is restricted in a short period. In order to increase drug&#xD;
           concentration at the symptom site, without the undesirable side effects of the systemic&#xD;
           corticosteroid, facet intraarticular infiltration (FI) has been used as a complementary&#xD;
           treatment. The therapeutic value of FI is not consensus, with widely divergent results&#xD;
           in the literature. Nevertheless, it is one of the most used treatments, observing a&#xD;
           growing demand for this procedure in the last decades. The selection of the appropriate&#xD;
           patient, who would benefit from the treatment, is a determining factor in the outcome of&#xD;
           the FI since, in the thesis, only the subgroup of patients with the active inflammatory&#xD;
           process in the facet joint would have a positive result corticosteroid infiltration.&#xD;
           Identifying this subgroup of patients is a challenge because the diagnosis of facet&#xD;
           origin pain is often imprecise. With proper and accurate diagnosis, FI is expected to&#xD;
           achieve better results. Magnetic resonance imaging (MRI) can identify the morphological&#xD;
           characteristics of facet osteoarthritis, generating a classification in degrees mild,&#xD;
           moderate, or severe. It also allows diagnosing the presence or absence of an&#xD;
           inflammatory process in the facet joint, usually manifested by indirect signs such as&#xD;
           bone edema, periarticular soft-tissue edema, joint effusion, and synovitis. However,&#xD;
           morphological characteristics and inflammatory markers of MR imaging have not been&#xD;
           tested as prognostic factors of FI efficacy. Patients' characteristics such as gender,&#xD;
           age, schooling, family income, smoking, body mass index, professional activity may&#xD;
           affect the expected results, but they have not been tested as prognostic factors of FI&#xD;
           efficacy.&#xD;
&#xD;
           1.1 Rationale: The relationship between MRI findings of facet osteoarthritis and the&#xD;
           effect on FI of corticoid and anesthetic has not been studied. The relationship between&#xD;
           the characteristics of age, sex, education, family income, smoking, body mass index,&#xD;
           professional activity, and the effect on FI of steroids and anesthetics has not been&#xD;
           studied.&#xD;
&#xD;
           Determining the prognostic factors may impact the clinical routine of physicians and&#xD;
           patients, guiding the treatment, and selecting those with chances of better results with&#xD;
           the FI.&#xD;
&#xD;
           1.2 Hypotheses: MRI findings of facet osteoarthritis and patient characteristics are&#xD;
           prognostic factors for improving or worsening the clinical outcome after treatment with&#xD;
           FI.&#xD;
&#xD;
        2. Purpose: To determine the prognostic factors of corticoid and anesthetic infiltration in&#xD;
           treating facet osteoarthritis in the lumbar spine. To determine the association between&#xD;
           MRI imaging findings and pain, functional disability, and patient's quality of life. To&#xD;
           determine the association between age, sex, schooling, family income, smoking, body mass&#xD;
           index, professional activity in pain, functional disability, and patient's quality of&#xD;
           life.&#xD;
&#xD;
        3. Method: This prospective cohort study will include all patients with clinical suspicion&#xD;
           of facet pain who have undergone MRI and have been referred to the intervention center&#xD;
           of the image department of a tertiary hospital to perform FI with corticoid and&#xD;
           anesthetic. On the day of the procedure, patients will be invited to participate in the&#xD;
           study. Before performing the facet infiltration, patients will respond to an informed&#xD;
           consent form (ICF) and five questionnaires: 1. data collection form; 2. the visual&#xD;
           analogue pain scale (VAS); 3. Roland-Morris questionnaire on functional disability; 4.&#xD;
           Oswestry questionnaire on functional disability; 5. EuroQol questionnaire (EQ-5D) on&#xD;
           quality of life. All patients will be followed for one year, responding by telephone&#xD;
           VAS, Roland-Morris, Oswestry, and EQ-5D questionnaires at 1, 3, 6, and 12 months after&#xD;
           the FI to measure the effectiveness of the proposed treatment. The systemic use of&#xD;
           corticosteroids, the performance of another infiltration or surgery, and the number of&#xD;
           analgesics ingested per day will also be evaluated in the follow-up. Researchers will&#xD;
           only apply the specific questionnaires of the project, not influence the indication,&#xD;
           accomplishment, and treatment of FI complications or the clinical routine of the&#xD;
           intervention center. The following variables will be collected to characterize the&#xD;
           sample: age (years), sex (male or female), schooling (years of study), smoking (number&#xD;
           of cigarettes per day), family income, professional activity (type of occupation, number&#xD;
           of hours sitting or standing, carrying weight or not) and oral analgesic use (number of&#xD;
           tablets taken per day). The FI procedure will be guided by computed tomography. The&#xD;
           radiation dose used will be the minimum possible to obtain images with sufficient&#xD;
           quality to guide the location and progression of the needle, being within limits&#xD;
           established in the institutional protocols and already practiced in the department.&#xD;
           After imaging confirmation of the correct intraarticular positioning of the needle, a&#xD;
           solution containing triamcinolone 20 mg/ml and hydrochloride of naropin in a ratio of 1:&#xD;
           1, in the volume of 1.5 to 2.0 ml, will be injected. After the procedure, the patient&#xD;
           will be discharged and advised to do home rest for 24 hours. The study design proposes&#xD;
           to determine the correlation between the clinical outcome measured by the results of the&#xD;
           VAS, Roland-Morris, Oswestry, and EQ-5D questionnaires, and the variables identified by&#xD;
           MRI and also the correlation between the clinical outcome and the variables: age, sex,&#xD;
           educational level, smoking, family income, body mass index (BMI), professional activity&#xD;
           and amount of analgesics ingested per day. All patients will be followed for one year,&#xD;
           responding by telephone VAS, Roland-Morris, Oswestry, and EQ-5D questionnaires at 1, 3,&#xD;
           6, and 12 months after the IF to measure the effectiveness of the proposed treatment.&#xD;
           The systemic use of corticosteroids, the performance of another infiltration or surgery,&#xD;
           and the number of analgesics ingested per day will also be evaluated.&#xD;
&#xD;
      3.1 Image exams and evaluator: All the lumbar spine MRI scans performed by the patients will&#xD;
      be analyzed. Two radiologists will read MRI exams without knowledge of clinical, laboratory,&#xD;
      or patient evaluation and questionnaire results. The variables degree of facet&#xD;
      osteoarthritis, bone edema, periarticular edema, synovitis, effusion, osteophytes,&#xD;
      subchondral sclerosis, subchondral cysts, sliding, sagittal or horizontal orientation,&#xD;
      identified by MRI, will be tabulated.&#xD;
&#xD;
      3.2 Rating: MRI studies will be evaluated respecting patients' anonymity. Patients'&#xD;
      characteristics, MRI imaging findings, and VAS, Roland-Morris, Oswestry, and EQ-5D&#xD;
      questionnaires will be tabulated according to the following characteristics: age, sex,&#xD;
      schooling, family income, smoking, weight, height, body mass index (BMI), occupational&#xD;
      activity, analgesic ingestion, laterality, location, degree of facet arthritis, bone edema,&#xD;
      periarticular edema, synovitis, effusion, osteophytes, subchondral sclerosis, subchondral&#xD;
      cysts, orientation sagittal or horizontal, facet sliding, VAS, Roland-Morris, EQ-5D, and&#xD;
      Oswestry.&#xD;
&#xD;
      3.3 Sample size estimation: Taking into account the primary variable of the study as the&#xD;
      presence of inflammatory process in the facet joint, identified at MRI, with an expected&#xD;
      prevalence of 30% in the sample and as the primary outcome the functional disability, as&#xD;
      measured by the Roland-Morris questionnaire, when checking the sample size needed to detect a&#xD;
      difference between the groups, with and without inflammatory process, before and after the FI&#xD;
      procedure, it will require 117 patients in total, with a difference in the mean of the groups&#xD;
      of 4.0 points. This calculation considered that the standard deviation of the difference of&#xD;
      averages between the groups would be homogeneous and 7.0 points, as observed in the&#xD;
      literature. Therefore, this study will include 147 patients considering a loss of follow-up&#xD;
      in 20%. The sample size needed to compare the groups will be recalculated once the study has&#xD;
      a three-month follow-up of 70 patients based on the SD and the proportion of facet&#xD;
      inflammation observed. The calculations were made considering 80% test power and a&#xD;
      significance level of 5%.&#xD;
&#xD;
      3.4 Statistical analysis: Patient characteristics, MRI findings and pain (VAS), disability&#xD;
      (Roland Morris and Oswestry), quality of life (EQ-5D) scores will be described using absolute&#xD;
      frequencies and percentages in categorical variables, or through means, standard deviations&#xD;
      or medians and quartiles, in addition to minimum and maximum values, in quantitative&#xD;
      variables. The MRI characteristics analyzed by two observers will be evaluated for agreement&#xD;
      using correlation coefficients appropriate to the observed distribution of cases, such as the&#xD;
      Kappa coefficient. To evaluate MRI findings and patient characteristics (age, sex, smoking,&#xD;
      family income, BMI, education, occupation, and analgesic intake) in the evolution of pain&#xD;
      (VAS), disability (Roland Morris and Oswestry), and quality of life (EuroQol) during twelve&#xD;
      months after infiltration, will be used mixed linear models or generalized linear models, in&#xD;
      multiple approaches, being such models appropriate for measurements obtained from the same&#xD;
      patient at different times. The results of the models will be presented by effect estimates&#xD;
      (change in mean pain or means of functional disability and quality of life) and 95%&#xD;
      confidence intervals.&#xD;
&#xD;
      We plan to carry out the analysis with the statistical package R and consider the&#xD;
      significance level 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Roland Moris Questionnaire</measure>
    <time_frame>Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months</time_frame>
    <description>functional disability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analogue Pain Scale (VAS)</measure>
    <time_frame>Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months</time_frame>
    <description>pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Oswestry Back Pain Disability</measure>
    <time_frame>Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months</time_frame>
    <description>functional disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EuroQol questionnaire (EQ-5D)</measure>
    <time_frame>Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months</time_frame>
    <description>quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in pain medication usage</measure>
    <time_frame>Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months</time_frame>
    <description>indirect sign of improvement or worsening of pain</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">147</enrollment>
  <condition>Degenerative Arthropathy of Lumbar Spinal Facet Joint</condition>
  <arm_group>
    <arm_group_label>facet inflammatory signs</arm_group_label>
    <description>patients with facet inflammatory signs identified on MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no facet inflammatory signs</arm_group_label>
    <description>patients without facet inflammatory signs identified on MRI</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients seen at the spine outpatient clinic of a tertiary hospital with clinical&#xD;
        diagnosis of low back pain of facet origin will be eligible to participate in the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
        The following are inclusion criteria for participants:&#xD;
&#xD;
          -  Older than 18 years;&#xD;
&#xD;
          -  Fluent or native Portuguese language speaker;&#xD;
&#xD;
          -  Continuous or intermittent low back pain for at least three months;&#xD;
&#xD;
          -  Low back pain with or without irradiation to the gluteal region indicating facet&#xD;
             syndrome (pain is aggravated by spine extension or bending toward the affected side;&#xD;
             pain is exacerbated by prolonged sitting or walking up steps, as well as retaining one&#xD;
             position for a prolonged time);&#xD;
&#xD;
          -  Failure of traditional treatment includes, but is not limited to, physical or drug&#xD;
             therapy;&#xD;
&#xD;
          -  Understand the purpose of the study;&#xD;
&#xD;
          -  Voluntarily provide a free and informed consent form, by themselves or through their&#xD;
             partners, and complete the questionnaires, before undergoing infiltration, over the&#xD;
             telephone or online during the follow-up.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        The following are exclusion criteria for participants:&#xD;
&#xD;
          -  Younger than 18 years old,&#xD;
&#xD;
          -  Symptomatic lumbar spinal stenosis with claudication or radiculopathy;&#xD;
&#xD;
          -  Evidence of radiculopathy;&#xD;
&#xD;
          -  Active rheumatologic diseases;&#xD;
&#xD;
          -  Congenital or acquired deformities of the lumbar spine;&#xD;
&#xD;
          -  Fracture or sequel of lumbar spine fracture of traumatic, pathological or osteoporotic&#xD;
             origin;&#xD;
&#xD;
          -  Surgical manipulation of the lumbar spine;&#xD;
&#xD;
          -  MRI scans of limited quality and incomplete sequences;&#xD;
&#xD;
          -  Treated with systemic steroids less than one month before the IFI;&#xD;
&#xD;
          -  Treated with IFI with steroids within the last six months;&#xD;
&#xD;
          -  Diagnosed with uncontrolled diabetes mellitus;&#xD;
&#xD;
          -  History of allergy to anesthetics or adverse reaction to steroids;&#xD;
&#xD;
          -  Pregnant women or women who breastfed;&#xD;
&#xD;
          -  Who could not be contacted over the phone during follow-up.&#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>Joao C Rodrigues, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joao C Rodrigues, MD</last_name>
    <phone>551121512452</phone>
    <email>joao.rodrigues@einstein.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mario Lenza, PhD</last_name>
    <phone>551121511444</phone>
    <email>mario.lenza@einstein.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Israelista Albert Einstein</name>
      <address>
        <city>São Paulo</city>
        <zip>05652-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joao C Rodrigues, MD</last_name>
      <phone>551121512452</phone>
      <email>joao.rodrigues@einstein.br</email>
    </contact>
    <contact_backup>
      <last_name>Mario Lenza, PhD</last_name>
      <phone>551121511444</phone>
      <email>mario.lenza@einstein.br</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Freyhardt P, Hartwig T, De Bucourt M, Maurer M, Renz D, Gebauer B, Hamm B, Teichgraber UK, Streitparth F. MR-guided facet joint injection therapy using an open 1.0-T MRI system: an outcome study. Eur Radiol. 2013 Dec;23(12):3296-303. doi: 10.1007/s00330-013-2940-9. Epub 2013 Jun 28.</citation>
    <PMID>23812244</PMID>
  </reference>
  <reference>
    <citation>Manchikanti L, Hirsch JA, Falco FJ, Boswell MV. Management of lumbar zygapophysial (facet) joint pain. World J Orthop. 2016 May 18;7(5):315-37. doi: 10.5312/wjo.v7.i5.315. eCollection 2016 May 18.</citation>
    <PMID>27190760</PMID>
  </reference>
  <reference>
    <citation>Friedly J, Chan L, Deyo R. Increases in lumbosacral injections in the Medicare population: 1994 to 2001. Spine (Phila Pa 1976). 2007 Jul 15;32(16):1754-60. doi: 10.1097/BRS.0b013e3180b9f96e.</citation>
    <PMID>17632396</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Israelita Albert Einstein</investigator_affiliation>
    <investigator_full_name>Joao Carlos Rodrigues</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Zygapophyseal Joint</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Spine Osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03304730
org study id: 65291417.0.0000.0071
nct id: NCT03304730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Magnet Resonance Image findings of facet osteoarthritis and patient characteristics are
      prognostic factors for improving or worsening the clinical outcome after treatment with facet
      infiltration.
1. Introduction: Low back pain is one of the significant health problems; studies have
           shown that it can affect 80-85% of people throughout life; consisting of the second
           major cause of work withdrawal. In the investigation by lumbar spine imaging methods,
           facet osteoarthritis (FO) is one of the most prevalent diagnoses, in 59.6% for men and
           66.7% for women. The process of osteoarthritis begins early in the spine; more than half
           of adults are under 30 years old, presenting degenerative changes in the facets, being
           more commonly affected by the L4-L5 level. It is estimated that the pain of facet origin
           corresponds to 30% of cases of low back pain. The treatment of low back pain, which
           presents questionable results, has a substantial economic impact on the health system
           and represents a growing concern for public and medical policymakers. The lack of
           diagnostic accuracy and the various types of treatment without evidence of appropriate
           effectiveness are considered the leading causes of the increasing costs of the health
           system. Biomechanical, neuroanatomical, and neurophysiological studies demonstrated free
           and encapsulated nerve endings in the lumbar facet joints and nerves containing
           substance P and peptides related to the calcitonin gene. Chemical or mechanical stimuli
           can cause pain. The pathophysiology of facet pain is not fully understood, but it is
           believed that facet osteoarthritis is due to repetitive mechanical stress, with
           subsequent inflammation and elongation of the joint capsule, generating pain.

           Several treatments are used in low back pain secondary to FO. The most used are
           non-hormonal anti-inflammatory drugs and physiotherapy as a conservative measure.
           Interventional procedures such as facet intraarticular or periarticular infiltration of
           corticoid for neural blockade and denervation by radiofrequency are considered minimally
           invasive options, indicated for cases in which conservative treatment fails. Surgical
           treatment of arthrodesis is also part of the therapeutic options. A systemic
           corticosteroid is within the available therapeutic arsenal but has undesirable side
           effects, and its use is restricted in a short period. In order to increase drug
           concentration at the symptom site, without the undesirable side effects of the systemic
           corticosteroid, facet intraarticular infiltration (FI) has been used as a complementary
           treatment. The therapeutic value of FI is not consensus, with widely divergent results
           in the literature. Nevertheless, it is one of the most used treatments, observing a
           growing demand for this procedure in the last decades. The selection of the appropriate
           patient, who would benefit from the treatment, is a determining factor in the outcome of
           the FI since, in the thesis, only the subgroup of patients with the active inflammatory
           process in the facet joint would have a positive result corticosteroid infiltration.
           Identifying this subgroup of patients is a challenge because the diagnosis of facet
           origin pain is often imprecise. With proper and accurate diagnosis, FI is expected to
           achieve better results. Magnetic resonance imaging (MRI) can identify the morphological
           characteristics of facet osteoarthritis, generating a classification in degrees mild,
           moderate, or severe. It also allows diagnosing the presence or absence of an
           inflammatory process in the facet joint, usually manifested by indirect signs such as
           bone edema, periarticular soft-tissue edema, joint effusion, and synovitis. However,
           morphological characteristics and inflammatory markers of MR imaging have not been
           tested as prognostic factors of FI efficacy. Patients' characteristics such as gender,
           age, schooling, family income, smoking, body mass index, professional activity may
           affect the expected results, but they have not been tested as prognostic factors of FI
           efficacy.

           1.1 Rationale: The relationship between MRI findings of facet osteoarthritis and the
           effect on FI of corticoid and anesthetic has not been studied. The relationship between
           the characteristics of age, sex, education, family income, smoking, body mass index,
           professional activity, and the effect on FI of steroids and anesthetics has not been
           studied.

           Determining the prognostic factors may impact the clinical routine of physicians and
           patients, guiding the treatment, and selecting those with chances of better results with
           the FI.

           1.2 Hypotheses: MRI findings of facet osteoarthritis and patient characteristics are
           prognostic factors for improving or worsening the clinical outcome after treatment with
           FI.

        2. Purpose: To determine the prognostic factors of corticoid and anesthetic infiltration in
           treating facet osteoarthritis in the lumbar spine. To determine the association between
           MRI imaging findings and pain, functional disability, and patient's quality of life. To
           determine the association between age, sex, schooling, family income, smoking, body mass
           index, professional activity in pain, functional disability, and patient's quality of
           life.

        3. Method: This prospective cohort study will include all patients with clinical suspicion
           of facet pain who have undergone MRI and have been referred to the intervention center
           of the image department of a tertiary hospital to perform FI with corticoid and
           anesthetic. On the day of the procedure, patients will be invited to participate in the
           study. Before performing the facet infiltration, patients will respond to an informed
           consent form (ICF) and five questionnaires: 1. data collection form; 2. the visual
           analogue pain scale (VAS); 3. Roland-Morris questionnaire on functional disability; 4.
           Oswestry questionnaire on functional disability; 5. EuroQol questionnaire (EQ-5D) on
           quality of life. All patients will be followed for one year, responding by telephone
           VAS, Roland-Morris, Oswestry, and EQ-5D questionnaires at 1, 3, 6, and 12 months after
           the FI to measure the effectiveness of the proposed treatment. The systemic use of
           corticosteroids, the performance of another infiltration or surgery, and the number of
           analgesics ingested per day will also be evaluated in the follow-up. Researchers will
           only apply the specific questionnaires of the project, not influence the indication,
           accomplishment, and treatment of FI complications or the clinical routine of the
           intervention center. The following variables will be collected to characterize the
           sample: age (years), sex (male or female), schooling (years of study), smoking (number
           of cigarettes per day), family income, professional activity (type of occupation, number
           of hours sitting or standing, carrying weight or not) and oral analgesic use (number of
           tablets taken per day). The FI procedure will be guided by computed tomography. The
           radiation dose used will be the minimum possible to obtain images with sufficient
           quality to guide the location and progression of the needle, being within limits
           established in the institutional protocols and already practiced in the department.
           After imaging confirmation of the correct intraarticular positioning of the needle, a
           solution containing triamcinolone 20 mg/ml and hydrochloride of naropin in a ratio of 1:
           1, in the volume of 1.5 to 2.0 ml, will be injected. After the procedure, the patient
           will be discharged and advised to do home rest for 24 hours. The study design proposes
           to determine the correlation between the clinical outcome measured by the results of the
           VAS, Roland-Morris, Oswestry, and EQ-5D questionnaires, and the variables identified by
           MRI and also the correlation between the clinical outcome and the variables: age, sex,
           educational level, smoking, family income, body mass index (BMI), professional activity
           and amount of analgesics ingested per day. All patients will be followed for one year,
           responding by telephone VAS, Roland-Morris, Oswestry, and EQ-5D questionnaires at 1, 3,
           6, and 12 months after the IF to measure the effectiveness of the proposed treatment.
           The systemic use of corticosteroids, the performance of another infiltration or surgery,
           and the number of analgesics ingested per day will also be evaluated.

      3.1 Image exams and evaluator: All the lumbar spine MRI scans performed by the patients will
      be analyzed. Two radiologists will read MRI exams without knowledge of clinical, laboratory,
      or patient evaluation and questionnaire results. The variables degree of facet
      osteoarthritis, bone edema, periarticular edema, synovitis, effusion, osteophytes,
      subchondral sclerosis, subchondral cysts, sliding, sagittal or horizontal orientation,
      identified by MRI, will be tabulated.

      3.2 Rating: MRI studies will be evaluated respecting patients' anonymity. Patients'
      characteristics, MRI imaging findings, and VAS, Roland-Morris, Oswestry, and EQ-5D
      questionnaires will be tabulated according to the following characteristics: age, sex,
      schooling, family income, smoking, weight, height, body mass index (BMI), occupational
      activity, analgesic ingestion, laterality, location, degree of facet arthritis, bone edema,
      periarticular edema, synovitis, effusion, osteophytes, subchondral sclerosis, subchondral
      cysts, orientation sagittal or horizontal, facet sliding, VAS, Roland-Morris, EQ-5D, and
      Oswestry.

      3.3 Sample size estimation: Taking into account the primary variable of the study as the
      presence of inflammatory process in the facet joint, identified at MRI, with an expected
      prevalence of 30% in the sample and as the primary outcome the functional disability, as
      measured by the Roland-Morris questionnaire, when checking the sample size needed to detect a
      difference between the groups, with and without inflammatory process, before and after the FI
      procedure, it will require 117 patients in total, with a difference in the mean of the groups
      of 4.0 points. This calculation considered that the standard deviation of the difference of
      averages between the groups would be homogeneous and 7.0 points, as observed in the
      literature. Therefore, this study will include 147 patients considering a loss of follow-up
      in 20%. The sample size needed to compare the groups will be recalculated once the study has
      a three-month follow-up of 70 patients based on the SD and the proportion of facet
      inflammation observed. The calculations were made considering 80% test power and a
      significance level of 5%.

      3.4 Statistical analysis: Patient characteristics, MRI findings and pain (VAS), disability
      (Roland Morris and Oswestry), quality of life (EQ-5D) scores will be described using absolute
      frequencies and percentages in categorical variables, or through means, standard deviations
      or medians and quartiles, in addition to minimum and maximum values, in quantitative
      variables. The MRI characteristics analyzed by two observers will be evaluated for agreement
      using correlation coefficients appropriate to the observed distribution of cases, such as the
      Kappa coefficient. To evaluate MRI findings and patient characteristics (age, sex, smoking,
      family income, BMI, education, occupation, and analgesic intake) in the evolution of pain
      (VAS), disability (Roland Morris and Oswestry), and quality of life (EuroQol) during twelve
      months after infiltration, will be used mixed linear models or generalized linear models, in
      multiple approaches, being such models appropriate for measurements obtained from the same
      patient at different times. The results of the models will be presented by effect estimates
      (change in mean pain or means of functional disability and quality of life) and 95%
      confidence intervals.

      We plan to carry out the analysis with the statistical package R and consider the
      significance level 5%.
observational model: Cohort
time perspective: Prospective
measure: Change in Roland Moris Questionnaire
time frame: Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months
description: functional disability
measure: Change in Visual Analogue Pain Scale (VAS)
time frame: Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months
description: pain
measure: Change in Oswestry Back Pain Disability
time frame: Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months
description: functional disability
measure: Change in EuroQol questionnaire (EQ-5D)
time frame: Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months
description: quality of life
measure: Reduction in pain medication usage
time frame: Change from baseline to 1 month, to 3 months, to 6 months, and to 12 months
description: indirect sign of improvement or worsening of pain
arm group label: facet inflammatory signs
description: patients with facet inflammatory signs identified on MRI
arm group label: no facet inflammatory signs
description: patients without facet inflammatory signs identified on MRI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joao C Rodrigues, MD
role: Principal Investigator
affiliation: Hospital Israelita Albert Einstein
last name: Joao C Rodrigues, MD
phone: 551121512452
email: joao.rodrigues@einstein.br
last name: Mario Lenza, PhD
phone: 551121511444
email: mario.lenza@einstein.br
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
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PMID: 17762805
citation: DePalma MJ, Ketchum JM, Saullo T. What is the source of chronic low back pain and does age play a role? Pain Med. 2011 Feb;12(2):224-33. doi: 10.1111/j.1526-4637.2010.01045.x. Epub 2011 Jan 25.
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citation: Manchikanti L, Pampati V, Falco FJ, Hirsch JA. An updated assessment of utilization of interventional pain management techniques in the Medicare population: 2000 - 2013. Pain Physician. 2015 Mar-Apr;18(2):E115-27.
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PMID: 22230900
citation: Freyhardt P, Hartwig T, De Bucourt M, Maurer M, Renz D, Gebauer B, Hamm B, Teichgraber UK, Streitparth F. MR-guided facet joint injection therapy using an open 1.0-T MRI system: an outcome study. Eur Radiol. 2013 Dec;23(12):3296-303. doi: 10.1007/s00330-013-2940-9. Epub 2013 Jun 28.
PMID: 23812244
citation: Manchikanti L, Hirsch JA, Falco FJ, Boswell MV. Management of lumbar zygapophysial (facet) joint pain. World J Orthop. 2016 May 18;7(5):315-37. doi: 10.5312/wjo.v7.i5.315. eCollection 2016 May 18.
PMID: 27190760
citation: Friedly J, Chan L, Deyo R. Increases in lumbosacral injections in the Medicare population: 1994 to 2001. Spine (Phila Pa 1976). 2007 Jul 15;32(16):1754-60. doi: 10.1097/BRS.0b013e3180b9f96e.
PMID: 17632396
responsible party type: Principal Investigator
investigator affiliation: Hospital Israelita Albert Einstein
investigator full name: Joao Carlos Rodrigues
investigator title: Physician
mesh term: Osteoarthritis
sharing ipd: No