<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/NCT03240783</url>
  </required_header>
  <id_info>
    <org_study_id>StGeorgeH</org_study_id>
    <nct_id>NCT03240783</nct_id>
  </id_info>
  <brief_title>A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain</brief_title>
  <acronym>SCIATICA</acronym>
  <official_title>A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain: Evaluate Route Versus Pharmacology of Intervention, and Feasibility in Public Hospital and Community Practice Settings.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St George Hospital, Australia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St George &amp; Sutherland Medical Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St George Hospital, Australia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: In subjects with acute sciatica (≤ 4 weeks duration), this is a pilot comparative&#xD;
      effectiveness study to evaluate feasibility and to determine final sample size for a future&#xD;
      adequately powered randomised controlled trial of (i) CT-guided transforaminal lumbosacral&#xD;
      epidural steroid injection, and (ii) oral dexamethasone, in a masked (blinded), randomised,&#xD;
      sham injection and oral placebo controlled trial.&#xD;
&#xD;
      Study Design: 60 patients with acute sciatica will randomised 1:1:1:1 to receive either (i)&#xD;
      epidural steroid injection &amp; oral placebo, (ii) epidural normal saline injection &amp; oral&#xD;
      placebo, (iii) oral dexamethasone &amp; IM sham-injection, (iv) IM sham-injection &amp; oral placebo.&#xD;
&#xD;
      Outcomes: The primary outcome is reduction of disability at 3 weeks using the Oswestry&#xD;
      Disability Index. Secondary outcomes include reduction of disability at 6 and 48 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute sciatica, a major cause of pain and disability, is a common presentation to medical&#xD;
      practices and hospitals. Up to 25% of patients do not recover after 12 months. Sciatica&#xD;
      refers to radicular pain and radiculopathy from lumbosacral nerve root pathology caused by&#xD;
      lumbosacral disc herniation and degenerative lumbosacral spondylosis involving the L2/3 to&#xD;
      L5/S1 intervertebral discs and foramina. Selective transforaminal epidural steroid injection&#xD;
      and systemic steroids are therapeutic options in patients who do not improve with&#xD;
      conservative management. However, there is limited evidence of effectiveness of these&#xD;
      treatments in acute sciatica.&#xD;
&#xD;
      This pilot study is designed to evaluate the following feasibility and study conduct issues:&#xD;
      type and standardization of interventions and associated sham and placebo control,&#xD;
      appropriateness of inclusion and exclusion criteria, rate of recruitment, study conduct&#xD;
      including randomisation allocation concealment, successful masking, wait time for delivery of&#xD;
      services (allied health, diagnostic imaging, and procedures), and ensuring efficient,&#xD;
      appropriate and safe study conduct for recruitment from emergency departments, hospital&#xD;
      inpatients, general practitioners and specialists in the community, and radiology departments&#xD;
      in hospital and community practices. Study logistics will differ across these settings, and&#xD;
      processes to ensure standardization will be evaluated. Other issues explored include&#xD;
      co-therapy with analgesics, NSAIDS, pregabalin, physical and manual therapies, and the timing&#xD;
      of rescue therapy, including neurosurgery. It is our experience with previous RCTs that&#xD;
      piloting all facets and procedures is essential for the successful conduct of a RCT.&#xD;
&#xD;
      Furthermore, results of the categorical and continuous primary and secondary outcomes from&#xD;
      this pilot RCT will be used to calculate the sample size of an adequately powered RCT to&#xD;
      determine which treatments currently used in the management of acute sciatica/lumbosacral&#xD;
      radiculopathy of less than 4 weeks duration, is the most effective in reducing pain and&#xD;
      disability in the short-term and prevent progression to persistent or recurrent&#xD;
      sciatica/lumbosacral radiculopathy in the long term.&#xD;
&#xD;
      Study Design: 60 patients with acute sciatica will randomised 1:1:1:1&#xD;
&#xD;
      Arm 1: CT - fluoroscopic guided transforaminal lumbar epidural steroid (1 ml) mixed with&#xD;
      local anaesthetic (1 ml) (Active Intervention) AND oral placebo taper (Placebo Control) Note:&#xD;
      The injectable steroid and local anaesthetic preparation is standardized to replicate current&#xD;
      practice: EITHER (i) betamethasone injectable 5.7 (1ml), a particulate corticosteroid with&#xD;
      the local anaesthetic bupivacaine 0.5% (1ml) OR (ii) dexamethasone injectable 4mg (1ml) a&#xD;
      non-particulate corticosteroid with local anaesthetic lignocaine 1% (1ml).&#xD;
&#xD;
      Arm 2: CT - fluoroscopic guided transforaminal lumbar epidural normal saline (1 ml) mixed&#xD;
      with local anaesthetic (1ml) (Active Intervention controlling for pharmacology) AND oral&#xD;
      placebo taper (Placebo Control) Note: The Normal Saline is a Normal Saline flush 0.9%&#xD;
      injectable solution. The local anaesthetic preparation is standardized to replicate current&#xD;
      practice: EITHER (i) bupivacaine 0.5% (1ml) OR (ii) lignocaine 1% (1ml).&#xD;
&#xD;
      Arm 3: Oral dexamethasone taper (Active Intervention) AND sham injection (Sham Control) Oral&#xD;
      dexamethasone taper is a 15 day tapered dosing: (i) days 1-5, dexamethasone 4 mg morning and&#xD;
      evening, (ii) days 6-10, dexamethasone 2 mg morning and evening, and (iii) days 11-15,&#xD;
      dexamethasone 1mg morning and evening. The dexamethasone gelatine capsule is identical to the&#xD;
      placebo capsule in appearance. The sham injection is CT/fluoroscopic guided (with parameters&#xD;
      set to zero) lumbar sham injection. The needle placement is down to muscle layer but NOT into&#xD;
      the epidural space, and there is no injection of any fluid.&#xD;
&#xD;
      Arm 4: Sham injection (Sham Control) AND oral placebo taper (Placebo Control) The sham&#xD;
      injection is CT/fluoroscopic guided (with parameters set to zero) lumbar sham injection. The&#xD;
      needle placement is down to muscle layer but NOT into the epidural space, and there is no&#xD;
      injection of any fluid. The oral placebo is a gelatine capsule with filler. It is identical&#xD;
      to the dexamethasone capsule in appearance.&#xD;
&#xD;
      Participants: If eligibility criteria are met then participants will be invited to&#xD;
      participate in the RCT. If the participant agrees, then the participant proceeds down study&#xD;
      pathway. A log of all potential participants who are referred and screened and who either&#xD;
      decline to participate in the RCT or deemed ineligible by the eligibility criteria will be&#xD;
      kept. This will ascertain the representativeness of those who consent to be randomized,&#xD;
      consistent with CONSORT guidelines. Data collected in the refusal/reject log will include&#xD;
      age, gender, reason(s) for ineligibility or refusal, and, if available, pain/disability score&#xD;
      and treatment.&#xD;
&#xD;
      Outcomes: The primary outcome is reduction of disability at 3 weeks using the&#xD;
      condition-specific Oswestry Disability Index (ODI). Secondary outcomes include reduction of&#xD;
      disability at 6 and 48 weeks on (ODI), Numerical Rating Scale (NRS) for leg pain and for back&#xD;
      pain respectively, measures of generic function/disability and quality of life (SF-36,&#xD;
      EQ-5D), length of hospital stay, medication co-therapy use (simple analgesics, opiate&#xD;
      analgesics, pregabalin, and NSAIDs), need for rescue procedures or surgery, time to return to&#xD;
      work (if applicable), compliance with treatment, masking success, measures of study conduct&#xD;
      and efficiency, and adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2</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 1:1:1:1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participant, care-provider (general-practitioner and/or specialist), investigator, and outcomes assessor are masked to the treatment arms. All personnel except the radiologist delivering the procedure and the investigator responsible for randomisation will be masked to the randomisation arm. The participant, study personnel, other investigators, participant's treating physician and study analyst will be blind to the results.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oswestry Disability Index (ODI) version 2.0</measure>
    <time_frame>3 weeks</time_frame>
    <description>ODI is a functional status measure specifically developed for disorders of the spine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI) version 2.0</measure>
    <time_frame>6 weeks</time_frame>
    <description>ODI is a functional status measure specifically developed for disorders of the spine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI) version 2.0</measure>
    <time_frame>12 weeks</time_frame>
    <description>ODI is a functional status measure specifically developed for disorders of the spine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI) version 2.0</measure>
    <time_frame>48 weeks</time_frame>
    <description>ODI is a functional status measure specifically developed for disorders of the spine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale (NRS) for leg pain</measure>
    <time_frame>3 weeks</time_frame>
    <description>The NRS is a validated 11 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale (NRS) for leg pain</measure>
    <time_frame>6 weeks</time_frame>
    <description>The NRS is a validated 11 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale (NRS) for leg pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>The NRS is a validated 11 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale (NRS) for leg pain</measure>
    <time_frame>48 weeks</time_frame>
    <description>The NRS is a validated 11 point scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Short-Form 36 (SF-36) questionnaire</measure>
    <time_frame>1, 3, 6, 12, and 48 weeks</time_frame>
    <description>health related quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroQol 5D</measure>
    <time_frame>1, 3, 6, 12, and 48 weeks</time_frame>
    <description>quality-adjusted-life-year using QALYs</description>
  </other_outcome>
  <other_outcome>
    <measure>Work and health utilisation</measure>
    <time_frame>1, 3, 6, 12, and 48 weeks</time_frame>
    <description>days missed from paid employment (if applicable) because of sciatica, use of health services such as doctor, other health-care provider related visits (acupuncture, chiropractic), repeat epidurals and surgical procedures</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>1, 3, 6, 12, and 48 weeks</time_frame>
    <description>These will include steroid adverse effects (blood pressure, blood glucose, changes in mood and sleep) and procedural adverse effects (headaches, bleeding) and information about additional procedures, surgery and hospitalisations.</description>
  </other_outcome>
  <other_outcome>
    <measure>Masking success</measure>
    <time_frame>Day 0, Day 1, Weeks 1, 3, 6 and 12</time_frame>
    <description>Whether participants, outcome assessors and investigators were successfully masked to study randomised arms</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Sciatica</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Betamethasone OR Dexamethasone Injectable CT - fluoroscopic guided transforaminal lumbar epidural steroid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal Saline Flush, 0.9% Injectable Solution CT - fluoroscopic guided transforaminal lumbar epidural normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexamethasone Oral Tablet:&#xD;
Oral dexamethasone 15 day tapered dosing is as follows: (i) days 1-5, 4 mg morning and evening, (ii) days 6-10, 2 mg morning and evening, and (iii) days 11-15, 1mg morning and evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sham Injection and/or oral placebo: CT/fluoroscopic guided (parameters set to zero) transforaminal lumbar sham (needle placement down to muscle and no injection of any fluid) AND placebo oral tablets taper.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethasone OR Dexamethasone Injectable</intervention_name>
    <description>Procedural agents. The steroid and local anaesthetic preparation will be standardized to replicate current radiology interventional practices that use either particulate or non-particulate steroids. Betamethasone Sodium Phosphate/Acetate 5.7 mg/ml Injectable is a particulate corticosteroid and is used with the local anaesthetic bupivacaine 0.5% (1ml). Dexamethasone 4mg (1ml) is a non-particulate corticosteroid and is used with the local anaesthetic lignocaine 1% (1ml).</description>
    <arm_group_label>Arm 1</arm_group_label>
    <other_name>celestone chondrase 5.7 mg/ml injectable suspension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline Flush, 0.9% Injectable Solution</intervention_name>
    <description>Procedural agents. The local anaesthetic preparation used with the Normal Saline Flush, 0.9% Injectable Solution, will be standardized to replicate current radiology interventional practices: either local anaesthetic bupivacaine 0.5% (1ml) or local anaesthetic lignocaine 1% (1ml).</description>
    <arm_group_label>Arm 2</arm_group_label>
    <other_name>There is no other name.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone Oral Tablet</intervention_name>
    <description>Dexamethasone Oral Tablet: 15 day taper dosing is: days 1-5 8mg (4mg bd) , days 6-10 4 mg (2mg bd), and days 11-15 2 mg (1mg bd). The dexamethasone is over-encapsulated in a gelatine capsule that is identical to the placebo capsule in appearance.</description>
    <arm_group_label>Arm 3</arm_group_label>
    <other_name>Dexmethsone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Injection and/or oral placebo</intervention_name>
    <description>The sham Injection procedure is needle placement down to muscle at the designated spinal level and no injection of any fluid. The oral placebo is a gelatine capsule packed with filler.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_label>Arm 4</arm_group_label>
    <other_name>There is no other name</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Leg pain of any description with clinical findings consistent with single level&#xD;
             radiculopathy&#xD;
&#xD;
          -  Minimum symptom duration &gt; 72hrs&#xD;
&#xD;
          -  Maximum symptom duration &lt; 3 weeks to ensure symptom duration at randomisation is ≤ 4&#xD;
             weeks&#xD;
&#xD;
          -  No previous episode of same level radicular pain in the previous 6 months&#xD;
&#xD;
          -  Pain intensity at &gt;30 on the Oswestry Disability Index (ODI)&#xD;
&#xD;
          -  Imaging (MRI and/or CT) indicating herniated disc or foraminal stenosis or both,&#xD;
             concordant with the level indicated by history and physical examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous transforaminal epidural steroids at any level in the last 12 months&#xD;
&#xD;
          -  Previous oral steroids in the last 12 months&#xD;
&#xD;
          -  Any lumbar surgery at same level, or above or below the level at any time&#xD;
&#xD;
          -  Previous lumbar surgery at any other level to that in (iii) within the last 12 months&#xD;
&#xD;
          -  Pregnancy, or lactation/breastfeeding&#xD;
&#xD;
          -  Direct indication for neurosurgery (e.g. cauda equina syndrome, or progressive motor&#xD;
             loss i.e. less than or equal to 3/5 power)&#xD;
&#xD;
          -  Inability to read or understand English&#xD;
&#xD;
          -  Any serious medical or psychiatric condition that may interfere with participation or&#xD;
             outcome assessment such as: need for uninterrupted anti-coagulation, spinal fracture,&#xD;
             active infection or metastatic disease suspected, active cancer, poorly controlled&#xD;
             diabetes, or patients with diabetes on any insulin, uncontrolled hypertension&#xD;
             (systolic blood pressure &gt;180 or diastolic blood pressure &gt;110 within 30 days of&#xD;
             randomization date), active peptic ulcer disease, history of intolerance to steroid&#xD;
             therapy, previous or current psychiatric history of bipolar disease, or secondary gain&#xD;
             such as anticipated or ongoing legal proceedings, history of substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marissa Lassere, MBBS PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St George Hospital SESLHD</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marissa N Lassere, MBBS PhD</last_name>
    <phone>+61291131111</phone>
    <phone_ext>2139</phone_ext>
    <email>m.lassere@unsw.edu.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sue Baker, BSc</last_name>
    <phone>+61291132705</phone>
    <email>Sue.Baker@health.nsw.gov.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St George Hospital</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marissa ND Lassere, MBBS PhD</last_name>
      <phone>+61 2 91132139</phone>
      <email>m.lassere@unsw.edu.au</email>
    </contact>
    <contact_backup>
      <last_name>Sue Baker, BSc</last_name>
      <phone>+61 2 91132705</phone>
      <email>sue.baker@health.nsw.gov.au</email>
    </contact_backup>
    <investigator>
      <last_name>Marissa N Lassere, MBBS PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Smerdely, MBBS PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Grant Pickard, MBChB FRACP</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Derek Glenn, MBBS FRANZCR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carl Bryant, MBBS FRANZCR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeanette Thom, BSc PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kent Johnson, MA MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St George Hospital, Australia</investigator_affiliation>
    <investigator_full_name>Marissa Lassere</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>CT-Fluoroscopic Selective Transforaminal Epidural Steroid</keyword>
  <keyword>Oral Dexamethasone</keyword>
  <keyword>Acute Lumbar Radiculopathy</keyword>
  <keyword>Sciatic Neuropathy</keyword>
  <keyword>Betamethasone injectable</keyword>
  <keyword>Dexamethasone injectable</keyword>
  <keyword>Acute Lumbar radicular pain</keyword>
  <keyword>Randomized Controlled Trial (RCT)</keyword>
  <keyword>Comparative Effectiveness Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sciatica</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03240783
org study id: StGeorgeH
nct id: NCT03240783
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Aim: In subjects with acute sciatica (≤ 4 weeks duration), this is a pilot comparative
      effectiveness study to evaluate feasibility and to determine final sample size for a future
      adequately powered randomised controlled trial of (i) CT-guided transforaminal lumbosacral
      epidural steroid injection, and (ii) oral dexamethasone, in a masked (blinded), randomised,
      sham injection and oral placebo controlled trial.

      Study Design: 60 patients with acute sciatica will randomised 1:1:1:1 to receive either (i)
      epidural steroid injection & oral placebo, (ii) epidural normal saline injection & oral
      placebo, (iii) oral dexamethasone & IM sham-injection, (iv) IM sham-injection & oral placebo.

      Outcomes: The primary outcome is reduction of disability at 3 weeks using the Oswestry
      Disability Index. Secondary outcomes include reduction of disability at 6 and 48 weeks.
Acute sciatica, a major cause of pain and disability, is a common presentation to medical
      practices and hospitals. Up to 25% of patients do not recover after 12 months. Sciatica
      refers to radicular pain and radiculopathy from lumbosacral nerve root pathology caused by
      lumbosacral disc herniation and degenerative lumbosacral spondylosis involving the L2/3 to
      L5/S1 intervertebral discs and foramina. Selective transforaminal epidural steroid injection
      and systemic steroids are therapeutic options in patients who do not improve with
      conservative management. However, there is limited evidence of effectiveness of these
      treatments in acute sciatica.

      This pilot study is designed to evaluate the following feasibility and study conduct issues:
      type and standardization of interventions and associated sham and placebo control,
      appropriateness of inclusion and exclusion criteria, rate of recruitment, study conduct
      including randomisation allocation concealment, successful masking, wait time for delivery of
      services (allied health, diagnostic imaging, and procedures), and ensuring efficient,
      appropriate and safe study conduct for recruitment from emergency departments, hospital
      inpatients, general practitioners and specialists in the community, and radiology departments
      in hospital and community practices. Study logistics will differ across these settings, and
      processes to ensure standardization will be evaluated. Other issues explored include
      co-therapy with analgesics, NSAIDS, pregabalin, physical and manual therapies, and the timing
      of rescue therapy, including neurosurgery. It is our experience with previous RCTs that
      piloting all facets and procedures is essential for the successful conduct of a RCT.

      Furthermore, results of the categorical and continuous primary and secondary outcomes from
      this pilot RCT will be used to calculate the sample size of an adequately powered RCT to
      determine which treatments currently used in the management of acute sciatica/lumbosacral
      radiculopathy of less than 4 weeks duration, is the most effective in reducing pain and
      disability in the short-term and prevent progression to persistent or recurrent
      sciatica/lumbosacral radiculopathy in the long term.

      Study Design: 60 patients with acute sciatica will randomised 1:1:1:1

      Arm 1: CT - fluoroscopic guided transforaminal lumbar epidural steroid (1 ml) mixed with
      local anaesthetic (1 ml) (Active Intervention) AND oral placebo taper (Placebo Control) Note:
      The injectable steroid and local anaesthetic preparation is standardized to replicate current
      practice: EITHER (i) betamethasone injectable 5.7 (1ml), a particulate corticosteroid with
      the local anaesthetic bupivacaine 0.5% (1ml) OR (ii) dexamethasone injectable 4mg (1ml) a
      non-particulate corticosteroid with local anaesthetic lignocaine 1% (1ml).

      Arm 2: CT - fluoroscopic guided transforaminal lumbar epidural normal saline (1 ml) mixed
      with local anaesthetic (1ml) (Active Intervention controlling for pharmacology) AND oral
      placebo taper (Placebo Control) Note: The Normal Saline is a Normal Saline flush 0.9%
      injectable solution. The local anaesthetic preparation is standardized to replicate current
      practice: EITHER (i) bupivacaine 0.5% (1ml) OR (ii) lignocaine 1% (1ml).

      Arm 3: Oral dexamethasone taper (Active Intervention) AND sham injection (Sham Control) Oral
      dexamethasone taper is a 15 day tapered dosing: (i) days 1-5, dexamethasone 4 mg morning and
      evening, (ii) days 6-10, dexamethasone 2 mg morning and evening, and (iii) days 11-15,
      dexamethasone 1mg morning and evening. The dexamethasone gelatine capsule is identical to the
      placebo capsule in appearance. The sham injection is CT/fluoroscopic guided (with parameters
      set to zero) lumbar sham injection. The needle placement is down to muscle layer but NOT into
      the epidural space, and there is no injection of any fluid.

      Arm 4: Sham injection (Sham Control) AND oral placebo taper (Placebo Control) The sham
      injection is CT/fluoroscopic guided (with parameters set to zero) lumbar sham injection. The
      needle placement is down to muscle layer but NOT into the epidural space, and there is no
      injection of any fluid. The oral placebo is a gelatine capsule with filler. It is identical
      to the dexamethasone capsule in appearance.

      Participants: If eligibility criteria are met then participants will be invited to
      participate in the RCT. If the participant agrees, then the participant proceeds down study
      pathway. A log of all potential participants who are referred and screened and who either
      decline to participate in the RCT or deemed ineligible by the eligibility criteria will be
      kept. This will ascertain the representativeness of those who consent to be randomized,
      consistent with CONSORT guidelines. Data collected in the refusal/reject log will include
      age, gender, reason(s) for ineligibility or refusal, and, if available, pain/disability score
      and treatment.

      Outcomes: The primary outcome is reduction of disability at 3 weeks using the
      condition-specific Oswestry Disability Index (ODI). Secondary outcomes include reduction of
      disability at 6 and 48 weeks on (ODI), Numerical Rating Scale (NRS) for leg pain and for back
      pain respectively, measures of generic function/disability and quality of life (SF-36,
      EQ-5D), length of hospital stay, medication co-therapy use (simple analgesics, opiate
      analgesics, pregabalin, and NSAIDs), need for rescue procedures or surgery, time to return to
      work (if applicable), compliance with treatment, masking success, measures of study conduct
      and efficiency, and adverse events.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised 1:1:1:1
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participant, care-provider (general-practitioner and/or specialist), investigator, and outcomes assessor are masked to the treatment arms. All personnel except the radiologist delivering the procedure and the investigator responsible for randomisation will be masked to the randomisation arm. The participant, study personnel, other investigators, participant's treating physician and study analyst will be blind to the results.
measure: Oswestry Disability Index (ODI) version 2.0
time frame: 3 weeks
description: ODI is a functional status measure specifically developed for disorders of the spine
measure: Oswestry Disability Index (ODI) version 2.0
time frame: 6 weeks
description: ODI is a functional status measure specifically developed for disorders of the spine
measure: Oswestry Disability Index (ODI) version 2.0
time frame: 12 weeks
description: ODI is a functional status measure specifically developed for disorders of the spine
measure: Oswestry Disability Index (ODI) version 2.0
time frame: 48 weeks
description: ODI is a functional status measure specifically developed for disorders of the spine
measure: Numerical Rating Scale (NRS) for leg pain
time frame: 3 weeks
description: The NRS is a validated 11 point scale
measure: Numerical Rating Scale (NRS) for leg pain
time frame: 6 weeks
description: The NRS is a validated 11 point scale
measure: Numerical Rating Scale (NRS) for leg pain
time frame: 12 weeks
description: The NRS is a validated 11 point scale
measure: Numerical Rating Scale (NRS) for leg pain
time frame: 48 weeks
description: The NRS is a validated 11 point scale
measure: Short-Form 36 (SF-36) questionnaire
time frame: 1, 3, 6, 12, and 48 weeks
description: health related quality of life
measure: EuroQol 5D
time frame: 1, 3, 6, 12, and 48 weeks
description: quality-adjusted-life-year using QALYs
measure: Work and health utilisation
time frame: 1, 3, 6, 12, and 48 weeks
description: days missed from paid employment (if applicable) because of sciatica, use of health services such as doctor, other health-care provider related visits (acupuncture, chiropractic), repeat epidurals and surgical procedures
measure: Adverse events
time frame: 1, 3, 6, 12, and 48 weeks
description: These will include steroid adverse effects (blood pressure, blood glucose, changes in mood and sleep) and procedural adverse effects (headaches, bleeding) and information about additional procedures, surgery and hospitalisations.
measure: Masking success
time frame: Day 0, Day 1, Weeks 1, 3, 6 and 12
description: Whether participants, outcome assessors and investigators were successfully masked to study randomised arms
arm group label: Arm 1
arm group type: Experimental
description: Betamethasone OR Dexamethasone Injectable CT - fluoroscopic guided transforaminal lumbar epidural steroid
arm group label: Arm 2
arm group type: Experimental
description: Normal Saline Flush, 0.9% Injectable Solution CT - fluoroscopic guided transforaminal lumbar epidural normal saline
arm group label: Arm 3
arm group type: Experimental
description: Dexamethasone Oral Tablet:
Oral dexamethasone 15 day tapered dosing is as follows: (i) days 1-5, 4 mg morning and evening, (ii) days 6-10, 2 mg morning and evening, and (iii) days 11-15, 1mg morning and evening.
arm group label: Arm 4
arm group type: Other
description: Sham Injection and/or oral placebo: CT/fluoroscopic guided (parameters set to zero) transforaminal lumbar sham (needle placement down to muscle and no injection of any fluid) AND placebo oral tablets taper.
intervention type: Drug
intervention name: Betamethasone OR Dexamethasone Injectable
description: Procedural agents. The steroid and local anaesthetic preparation will be standardized to replicate current radiology interventional practices that use either particulate or non-particulate steroids. Betamethasone Sodium Phosphate/Acetate 5.7 mg/ml Injectable is a particulate corticosteroid and is used with the local anaesthetic bupivacaine 0.5% (1ml). Dexamethasone 4mg (1ml) is a non-particulate corticosteroid and is used with the local anaesthetic lignocaine 1% (1ml).
arm group label: Arm 1
other name: celestone chondrase 5.7 mg/ml injectable suspension
intervention type: Drug
intervention name: Normal Saline Flush, 0.9% Injectable Solution
description: Procedural agents. The local anaesthetic preparation used with the Normal Saline Flush, 0.9% Injectable Solution, will be standardized to replicate current radiology interventional practices: either local anaesthetic bupivacaine 0.5% (1ml) or local anaesthetic lignocaine 1% (1ml).
arm group label: Arm 2
other name: There is no other name.
intervention type: Drug
intervention name: Dexamethasone Oral Tablet
description: Dexamethasone Oral Tablet: 15 day taper dosing is: days 1-5 8mg (4mg bd) , days 6-10 4 mg (2mg bd), and days 11-15 2 mg (1mg bd). The dexamethasone is over-encapsulated in a gelatine capsule that is identical to the placebo capsule in appearance.
arm group label: Arm 3
other name: Dexmethsone
intervention type: Other
intervention name: Sham Injection and/or oral placebo
description: The sham Injection procedure is needle placement down to muscle at the designated spinal level and no injection of any fluid. The oral placebo is a gelatine capsule packed with filler.
arm group label: Arm 1
arm group label: Arm 2
arm group label: Arm 3
arm group label: Arm 4
other name: There is no other name
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Marissa Lassere, MBBS PhD
role: Principal Investigator
affiliation: St George Hospital SESLHD
last name: Marissa N Lassere, MBBS PhD
phone: +61291131111
phone ext: 2139
email: m.lassere@unsw.edu.au
last name: Sue Baker, BSc
phone: +61291132705
email: Sue.Baker@health.nsw.gov.au
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: St George Hospital, Australia
investigator full name: Marissa Lassere
investigator title: Principal Investigator
mesh term: Sciatica
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Betamethasone
mesh term: BB 1101
sharing ipd: Undecided