<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/NCT03298854</url>
  </required_header>
  <id_info>
    <org_study_id>SPECT/CTinlowbackpain</org_study_id>
    <nct_id>NCT03298854</nct_id>
  </id_info>
  <brief_title>The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients With Low Back Pain</brief_title>
  <official_title>The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients With Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohamed Fathy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive&#xD;
      predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology&#xD;
      of low back pain in adolescent and adult patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain(LBP) is extremely common. Though estimates vary widely, studies in developed&#xD;
      countries report one year prevalence of 22-65% and lifetime prevalence up to 84%. (Walker,&#xD;
      2000) (1) The differential diagnosis for back pain is broad and includes degenerative&#xD;
      disease, infection, inflammation, tumors and trauma(Zukotynski, Curtis et al. 2010) (2). The&#xD;
      etiology of low back pain in young athletes differs from that seen in adults, with bony&#xD;
      etiology being more common than disc-related disease(Matesan, Behnia et al. 2016) (3).&#xD;
&#xD;
      The American College of Physicians and the American Pain Society classify LBP into the&#xD;
      following broad categories: nonspecific LBP, back pain potentially associated with&#xD;
      radiculopathy or spinal stenosis, and back pain potentially associated with another specific&#xD;
      spinal cause. Additionally, guidelines emphasize a focused history and physical examination,&#xD;
      reassurance, initial pain management medications if necessary, and consideration of physical&#xD;
      therapies without imaging in patients with nonspecific LBP. Duration of symptoms also helps&#xD;
      guide treatment algorithms in patients with acute, sub-acute, or chronic LBP.(Chou, Qaseem et&#xD;
      al. 2011) (4).&#xD;
&#xD;
      Many imaging modalities are available to the clinician and radiologist for evaluating LBP.&#xD;
      Application of these modalities depends on the working diagnosis, the urgency of the clinical&#xD;
      problem, and comorbidities of the patient. Radiographs of the lumbar spine are not routinely&#xD;
      recommended in acute nonspecific LBP because they are of limited diagnostic value.&#xD;
      Radiography is the initial imaging study of choice for assessing LBP in patients with a&#xD;
      history of trauma and patients suspected of possible vertebral compression fracture.In&#xD;
      addition, radiographs are recommended to evaluate a young patient for ankylosing&#xD;
      spondylitis.(Jarvik, Gold et al. 2015) (5)&#xD;
&#xD;
      Patients with LBP lasting for &gt;6 weeks having completed conservative management with&#xD;
      persistent radiculopathic symptoms, may seek magnetic resonance imaging (MRI). Patients with&#xD;
      severe or progressive neurologic deficit on presentation and red flags should be evaluated&#xD;
      with MRI. Computed tomography (CT) scans provide superior bone detail but are not as useful&#xD;
      in depicting soft tissue pathologies such as disc disease when compared with MRI. CT is&#xD;
      useful for revealing bone structural problems such as spondylolysis, pseudarthrosis,&#xD;
      fracture, scoliosis, and stenosis and for postsurgical evaluation of bone graft integrity,&#xD;
      surgical fusion, and instrumentation (Brinjikji, Luetmer et al. 2015) (6)&#xD;
&#xD;
      Tc-99m methylene diphosphonates bone scan is a highly sensitive technique for detection of&#xD;
      bone diseases and can allow the detection of the pathophysiology of trauma at a very early&#xD;
      stage. Due its excellent sensitivity it is often used as a screening tool, however limited&#xD;
      anatomical details result in poor specificity, It can be performed as limited or whole body&#xD;
      bone scintigraphy (Van der Wall, Lee et al. 2010) (7). Dynamic and blood pool phases can&#xD;
      increase specificity in the diagnosis of inflammatory pathology, but they are not routinely&#xD;
      used in cases of facet joint disease (Shur, Corrigan et al. 2015) (8)&#xD;
&#xD;
      Bone scan is a useful clinical tool to explore the etiology of low back pain like&#xD;
      spondylolysis and other less common etiologies in young athletes. It is also particularly&#xD;
      important to detect the active source of pain when more than one bony abnormality is seen in&#xD;
      anatomical imaging. The addition of three dimensional data acquisition SPECT (single photon&#xD;
      emission computed tomography) increases the clinical accuracy due to increased contrast&#xD;
      resolution and anatomical localization.(Matesan, Behnia et al. 2016) (3)&#xD;
&#xD;
      Radionuclide bone scintigraphy with (SPECT) provides functional imaging and is used to detect&#xD;
      microcalcification due to increased osteoblastic activity. In the absence of other pathology&#xD;
      the foci of increased osteoblastic activity reflect areas of mechanical stress and&#xD;
      degenerative change in the skeleton. SPECT has been widely used to evaluate patients with&#xD;
      spinal pain and facet joint arthropathy. For the detection of clinically significant facet&#xD;
      arthropathy, The SPECT/CT images have an incremental diagnostic value that can influence&#xD;
      clinical management by selecting only SPECT positive facet joint targets. (Matar,&#xD;
      Navalkissoor et al. 2013) (9)&#xD;
&#xD;
      For some aspects, SPECT/ CT can be helpful even in a trauma setting. In particular, the&#xD;
      combination of highly sensitive but nonspecific scintigraphy with non-sensitive but highly&#xD;
      specific computed tomography makes it particularly useful in anatomically complex regions&#xD;
      such as the pelvis and spine. From a trauma surgeon's point of view, the four main&#xD;
      indications for nuclear medicine imaging are the detection of (occult) fractures, and the&#xD;
      imaging of inflammatory bone and joint diseases, chronic diseases and postoperative&#xD;
      complications such as instability of instrumentation or implants. which can consistently be&#xD;
      found in a substantial number of patients (Scheyerer, Pietsch et al. 2014) (10), However its&#xD;
      use as an appropriate imaging modality should be considered carefully given the increased&#xD;
      radiation dose in young individuals with benign disease and low dose CT protocols should be&#xD;
      used (Shur, Corrigan et al. 2015) (8)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients with Low Back Pain</measure>
    <time_frame>2years</time_frame>
    <description>evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the assessment of low back pain in adolescent and adult patients</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Low Back Pain, Mechanical</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>99mTc-MDP SPECT/CT</intervention_name>
    <description>Delayed whole body images, using Symbia-T-Siemens dual headed gamma camera, will be obtained 2-3 hours after injection of 15-25 mCi of Tc-99m MDP (Methylene diphosphonate) followed by SPECT images of the lumbar spine and pelvis.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients more than 18 years old&#xD;
&#xD;
          -  Suffering from mechanical low back pain, either acute (less than 4 weeks), sub-acute&#xD;
             (4 weeks up to 3 months) or chronic (more than 3 months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known history of malignant disease&#xD;
&#xD;
          -  Patients with previous history of lumbar spine surgery&#xD;
&#xD;
          -  Patients with severe pain who cannot withstand the long duration of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed AH Mekkawy, professor</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marwa F Abd ElHay</last_name>
    <phone>01022291658</phone>
    <email>mohamedfathy1911995@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hemat AS Mahmoud, MD</last_name>
    <phone>01007532268</phone>
    <email>hemat.ahmed2012@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Fathy</investigator_full_name>
    <investigator_title>Resident of Nuclear Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium Tc 99m Medronate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03298854
org study id: SPECT/CTinlowbackpain
nct id: NCT03298854
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the diagnostic performance (sensitivity, specificity, Negative and positive
      predictive value) of skeletal co-registered SPECT/CT imaging in the detection of the etiology
      of low back pain in adolescent and adult patients
Low back pain(LBP) is extremely common. Though estimates vary widely, studies in developed
      countries report one year prevalence of 22-65% and lifetime prevalence up to 84%. (Walker,
      2000) (1) The differential diagnosis for back pain is broad and includes degenerative
      disease, infection, inflammation, tumors and trauma(Zukotynski, Curtis et al. 2010) (2). The
      etiology of low back pain in young athletes differs from that seen in adults, with bony
      etiology being more common than disc-related disease(Matesan, Behnia et al. 2016) (3).

      The American College of Physicians and the American Pain Society classify LBP into the
      following broad categories: nonspecific LBP, back pain potentially associated with
      radiculopathy or spinal stenosis, and back pain potentially associated with another specific
      spinal cause. Additionally, guidelines emphasize a focused history and physical examination,
      reassurance, initial pain management medications if necessary, and consideration of physical
      therapies without imaging in patients with nonspecific LBP. Duration of symptoms also helps
      guide treatment algorithms in patients with acute, sub-acute, or chronic LBP.(Chou, Qaseem et
      al. 2011) (4).

      Many imaging modalities are available to the clinician and radiologist for evaluating LBP.
      Application of these modalities depends on the working diagnosis, the urgency of the clinical
      problem, and comorbidities of the patient. Radiographs of the lumbar spine are not routinely
      recommended in acute nonspecific LBP because they are of limited diagnostic value.
      Radiography is the initial imaging study of choice for assessing LBP in patients with a
      history of trauma and patients suspected of possible vertebral compression fracture.In
      addition, radiographs are recommended to evaluate a young patient for ankylosing
      spondylitis.(Jarvik, Gold et al. 2015) (5)

      Patients with LBP lasting for >6 weeks having completed conservative management with
      persistent radiculopathic symptoms, may seek magnetic resonance imaging (MRI). Patients with
      severe or progressive neurologic deficit on presentation and red flags should be evaluated
      with MRI. Computed tomography (CT) scans provide superior bone detail but are not as useful
      in depicting soft tissue pathologies such as disc disease when compared with MRI. CT is
      useful for revealing bone structural problems such as spondylolysis, pseudarthrosis,
      fracture, scoliosis, and stenosis and for postsurgical evaluation of bone graft integrity,
      surgical fusion, and instrumentation (Brinjikji, Luetmer et al. 2015) (6)

      Tc-99m methylene diphosphonates bone scan is a highly sensitive technique for detection of
      bone diseases and can allow the detection of the pathophysiology of trauma at a very early
      stage. Due its excellent sensitivity it is often used as a screening tool, however limited
      anatomical details result in poor specificity, It can be performed as limited or whole body
      bone scintigraphy (Van der Wall, Lee et al. 2010) (7). Dynamic and blood pool phases can
      increase specificity in the diagnosis of inflammatory pathology, but they are not routinely
      used in cases of facet joint disease (Shur, Corrigan et al. 2015) (8)

      Bone scan is a useful clinical tool to explore the etiology of low back pain like
      spondylolysis and other less common etiologies in young athletes. It is also particularly
      important to detect the active source of pain when more than one bony abnormality is seen in
      anatomical imaging. The addition of three dimensional data acquisition SPECT (single photon
      emission computed tomography) increases the clinical accuracy due to increased contrast
      resolution and anatomical localization.(Matesan, Behnia et al. 2016) (3)

      Radionuclide bone scintigraphy with (SPECT) provides functional imaging and is used to detect
      microcalcification due to increased osteoblastic activity. In the absence of other pathology
      the foci of increased osteoblastic activity reflect areas of mechanical stress and
      degenerative change in the skeleton. SPECT has been widely used to evaluate patients with
      spinal pain and facet joint arthropathy. For the detection of clinically significant facet
      arthropathy, The SPECT/CT images have an incremental diagnostic value that can influence
      clinical management by selecting only SPECT positive facet joint targets. (Matar,
      Navalkissoor et al. 2013) (9)

      For some aspects, SPECT/ CT can be helpful even in a trauma setting. In particular, the
      combination of highly sensitive but nonspecific scintigraphy with non-sensitive but highly
      specific computed tomography makes it particularly useful in anatomically complex regions
      such as the pelvis and spine. From a trauma surgeon's point of view, the four main
      indications for nuclear medicine imaging are the detection of (occult) fractures, and the
      imaging of inflammatory bone and joint diseases, chronic diseases and postoperative
      complications such as instability of instrumentation or implants. which can consistently be
      found in a substantial number of patients (Scheyerer, Pietsch et al. 2014) (10), However its
      use as an appropriate imaging modality should be considered carefully given the increased
      radiation dose in young individuals with benign disease and low dose CT protocols should be
      used (Shur, Corrigan et al. 2015) (8)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The Diagnostic Performance of Skeletal 99mTc-MDP SPECT/CT in Patients with Low Back Pain
time frame: 2years
description: evaluate the diagnostic performance (sensitivity, specificity, Negative and positive predictive value) of skeletal co-registered SPECT/CT imaging in the assessment of low back pain in adolescent and adult patients
intervention type: Device
intervention name: 99mTc-MDP SPECT/CT
description: Delayed whole body images, using Symbia-T-Siemens dual headed gamma camera, will be obtained 2-3 hours after injection of 15-25 mCi of Tc-99m MDP (Methylene diphosphonate) followed by SPECT images of the lumbar spine and pelvis.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mohamed AH Mekkawy, professor
role: Study Director
affiliation: Assiut University
last name: Marwa F Abd ElHay
phone: 01022291658
email: mohamedfathy1911995@gmail.com
last name: Hemat AS Mahmoud, MD
phone: 01007532268
email: hemat.ahmed2012@yahoo.com
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Fathy
investigator title: Resident of Nuclear Medicine
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Technetium Tc 99m Medronate