<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/NCT02995083</url>
  </required_header>
  <id_info>
    <org_study_id>16090902</org_study_id>
    <nct_id>NCT02995083</nct_id>
  </id_info>
  <brief_title>Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial</brief_title>
  <official_title>Corticosteriods vs. Saline vs. Air Placebo Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the clinical benefit of intra-articular injections of saline in patients with&#xD;
      symptomatic osteoarthritis of the knee and compare the clinical response of saline to the&#xD;
      current standard treatment with corticosteroids and an air injection placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As non-surgical treatments of OA are essential, multiple trials have been done to compare&#xD;
      standard of care IA injection therapies to more novel injection treatments, with many of&#xD;
      these trials using saline as the control arm. The purpose of using a control arm is to&#xD;
      attempt to eliminate placebo effect and help distinguish the true effectiveness of a therapy.&#xD;
      There has been controversy over the clinical effect of saline in treating OA with some&#xD;
      arguing that saline may have some clinical benefit. If this is true, it could allow for the&#xD;
      true effect of standard of care therapies to appear diminished when compared to saline as a&#xD;
      placebo. A recent meta analysis looked at the use of saline as a placebo in 38 randomized&#xD;
      control trials to determine if intra-articular saline injections for knee OA had a clinical&#xD;
      effect. The study found that IA injections of saline significantly improved short-term knee&#xD;
      pain in 32 of the studies which involved 1705 patients, p &lt;0.001, and long-term pain was&#xD;
      significantly decreased in 19 of the studies involving 1445 patients, p &lt;0.001. It is&#xD;
      essential to empirically determine if saline has a clinical effect due to the role it plays&#xD;
      as a placebo in many clinical studies of the management of OA with intra-articular&#xD;
      injections.&#xD;
&#xD;
      Objective: To investigate the clinical benefit of intra-articular injections of saline in&#xD;
      patients with symptomatic osteoarthritis of the knee and compare the clinical response of&#xD;
      saline to the current standard treatment with corticosteroids and an air injection placebo.&#xD;
&#xD;
      Study Design: Prospective, single-blinded, randomized, clinical study. Patients will be&#xD;
      randomized into three treatment arms in a 1:1:1 fashion with approximately 50 patients in the&#xD;
      saline arm, 50 patients in the corticosteroid arm, and 50 patients in the placebo arm.&#xD;
&#xD;
      Null Hypothesis: Clinical knee outcomes of subjects following one intra-articular knee&#xD;
      injection of air will be similar to one intra-articular knee injection of saline or&#xD;
      corticosteroid for symptomatic patients diagnosed with knee OA.&#xD;
&#xD;
      Statistical Assumptions: Power Analysis&#xD;
&#xD;
      Investigational Arm: 10 ml Saline (Normal Saline)&#xD;
&#xD;
      Control Arm: 1 ml of 40 mg corticosteroid in 9 ml 1% lidocaine (Depo-medrol, Pfizer, New&#xD;
      York, New York), 10 ml air (placebo)&#xD;
&#xD;
      Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in the WOMAC&#xD;
      Index score 12 weeks after first injection with regards to baseline score.&#xD;
&#xD;
      Secondary Efficacy Secondary efficacy endpoints include the change in the full Endpoints:&#xD;
      WOMAC Index, KOOS, Lysholm, IKDC, VAS, SF-12 and use of rescue medication (steroid at 12&#xD;
      weeks).&#xD;
&#xD;
      Enrollment: Prospective, randomized, clinical study designed to evaluate 150 subjects. All&#xD;
      enrolled subjects will have a pre-procedure visit, one treatment visit, and follow-up visits&#xD;
      at week 6 and week 12 if they require a rescue injection and will fill out patient reported&#xD;
      outcome measures at 1, 6, 12, and 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study deemed not feasible&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Early Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC)</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Mean change in the WOMAC Index score from baseline score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in Knee injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Mean change in the KOOS from baseline score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Mean change in IKDC from baseline score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Visual Analogue Scale (VAS)</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Mean change in VAS from baseline score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Short Form 12 (SF-12) score</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Mean change in SF-12 from baseline score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in The Lysholm Knee score</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Mean change in The Lysholm Knee score from baseline score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in use of rescue medication</measure>
    <time_frame>12 weeks after injection</time_frame>
    <description>Use of anti-inflammatory, analgesics, and rescue corticosteroid injection. Number of pills taken each day. This will be collected via survey. If the medical examiner feels that the patient is continuing to do poorly and they did not receive the steroid injection intervention, then they will be offered a rescue corticosteroid injection at 12 weeks. The number of patients who do not initially receive a corticosteroid injection and require a rescue corticosteroid injection at 12 weeks will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Symptomatic Osteoarthritis of the Knee</condition>
  <arm_group>
    <arm_group_label>Knee injection with corticosteroids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using clinically accepted methods, subjects will undergo a palpation guided injection of corticosteroids into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee injection with saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Using clinically accepted methods, subjects will undergo a palpation guided injection of saline into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee injection with air</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Using clinically accepted methods, subjects will undergo a palpation guided injection of air into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine</intervention_name>
    <description>Patients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine</description>
    <arm_group_label>Knee injection with corticosteroids</arm_group_label>
    <other_name>Corticosteroid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline 10 ml</intervention_name>
    <description>Patients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml</description>
    <arm_group_label>Knee injection with saline</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Air 10 ml</intervention_name>
    <description>Patients will receive an ultrasound guided intra-articular injection of Air 10 ml</description>
    <arm_group_label>Knee injection with air</arm_group_label>
    <other_name>Air</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient must be between the ages of 18 and 80&#xD;
&#xD;
          2. Informed consent has been obtained from the patient&#xD;
&#xD;
          3. The patient must have diagnosed symptomatic osteoarthritis of the tibio-femoral or&#xD;
             patello-femoral compartment of the target knee for at least 1 month&#xD;
&#xD;
          4. The patient has moderate-to-severe knee pain reflected by an average visual analogue&#xD;
             scale (VAS) score of 4 or greater (out of a possible 10) over the previous 7 days.&#xD;
&#xD;
          5. Radiographic imaging must show grade II-III osteoarthritis on the Kellgren &amp; Lawrence&#xD;
             Scale.&#xD;
&#xD;
          6. Patients may have bilateral osteoarthritis but only patients with unilateral symptoms&#xD;
             may be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Knee instability&#xD;
&#xD;
          2. A score less than 4 (out of a possible 10) on their intake VAS&#xD;
&#xD;
          3. Major axial deviation (&gt;5º valgus or varus deviation as evidenced on a standard of&#xD;
             care x-ray.&#xD;
&#xD;
          4. Previous surgery at the target knee &lt; 6 months.&#xD;
&#xD;
          5. Symptomatic osteoarthritis of the contralateral knee or any other joint.&#xD;
&#xD;
          6. Systemic or intra articular injection to any joint with corticosteroids within 6&#xD;
             months prior to screening&#xD;
&#xD;
          7. Previous joint injection of any type in the past 6 months&#xD;
&#xD;
          8. Systemic conditions that could interfere with outcome such as Rheumatoid arthritis,&#xD;
             coagulopathy, and anemia.&#xD;
&#xD;
          9. Allergy to any of the injected substances.&#xD;
&#xD;
         10. Any patient unable to cease NSAID usage (other than low dose aspirin) due to unrelated&#xD;
             condition.&#xD;
&#xD;
         11. Cognitive impairment or unable to provide informed consent&#xD;
&#xD;
         12. Recent knee trauma with violation of the intra-articular bone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikhil N Verma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Midwest Orthopaedics at Rush University</affiliation>
  </overall_official>
  <reference>
    <citation>Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.</citation>
    <PMID>18759314</PMID>
  </reference>
  <reference>
    <citation>Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.</citation>
    <PMID>27238876</PMID>
  </reference>
  <reference>
    <citation>Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther. 2012 Aug;42(8):716-23. doi: 10.2519/jospt.2012.4038. Epub 2012 Mar 8.</citation>
    <PMID>22402677</PMID>
  </reference>
  <reference>
    <citation>Kim J, Seo BS. How to calculate sample size and why. Clin Orthop Surg. 2013 Sep;5(3):235-42. doi: 10.4055/cios.2013.5.3.235. Epub 2013 Aug 20.</citation>
    <PMID>24009911</PMID>
  </reference>
  <reference>
    <citation>Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008 Dec;67(12):1716-23. doi: 10.1136/ard.2008.092015. Epub 2008 Jun 9.</citation>
    <PMID>18541604</PMID>
  </reference>
  <reference>
    <citation>Eker HE, Cok OY, Aribogan A, Arslan G. The efficacy of intra-articular lidocaine administration in chronic knee pain due to osteoarthritis: A randomized, double-blind, controlled study. Anaesth Crit Care Pain Med. 2017 Apr;36(2):109-114. doi: 10.1016/j.accpm.2016.05.003. Epub 2016 Jul 30.</citation>
    <PMID>27485803</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Mukesh Ahuja</investigator_full_name>
    <investigator_title>Certified Principal Investigator, Research Administrator</investigator_title>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02995083
org study id: 16090902
nct id: NCT02995083
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To investigate the clinical benefit of intra-articular injections of saline in patients with
      symptomatic osteoarthritis of the knee and compare the clinical response of saline to the
      current standard treatment with corticosteroids and an air injection placebo.
As non-surgical treatments of OA are essential, multiple trials have been done to compare
      standard of care IA injection therapies to more novel injection treatments, with many of
      these trials using saline as the control arm. The purpose of using a control arm is to
      attempt to eliminate placebo effect and help distinguish the true effectiveness of a therapy.
      There has been controversy over the clinical effect of saline in treating OA with some
      arguing that saline may have some clinical benefit. If this is true, it could allow for the
      true effect of standard of care therapies to appear diminished when compared to saline as a
      placebo. A recent meta analysis looked at the use of saline as a placebo in 38 randomized
      control trials to determine if intra-articular saline injections for knee OA had a clinical
      effect. The study found that IA injections of saline significantly improved short-term knee
      pain in 32 of the studies which involved 1705 patients, p <0.001, and long-term pain was
      significantly decreased in 19 of the studies involving 1445 patients, p <0.001. It is
      essential to empirically determine if saline has a clinical effect due to the role it plays
      as a placebo in many clinical studies of the management of OA with intra-articular
      injections.

      Objective: To investigate the clinical benefit of intra-articular injections of saline in
      patients with symptomatic osteoarthritis of the knee and compare the clinical response of
      saline to the current standard treatment with corticosteroids and an air injection placebo.

      Study Design: Prospective, single-blinded, randomized, clinical study. Patients will be
      randomized into three treatment arms in a 1:1:1 fashion with approximately 50 patients in the
      saline arm, 50 patients in the corticosteroid arm, and 50 patients in the placebo arm.

      Null Hypothesis: Clinical knee outcomes of subjects following one intra-articular knee
      injection of air will be similar to one intra-articular knee injection of saline or
      corticosteroid for symptomatic patients diagnosed with knee OA.

      Statistical Assumptions: Power Analysis

      Investigational Arm: 10 ml Saline (Normal Saline)

      Control Arm: 1 ml of 40 mg corticosteroid in 9 ml 1% lidocaine (Depo-medrol, Pfizer, New
      York, New York), 10 ml air (placebo)

      Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in the WOMAC
      Index score 12 weeks after first injection with regards to baseline score.

      Secondary Efficacy Secondary efficacy endpoints include the change in the full Endpoints:
      WOMAC Index, KOOS, Lysholm, IKDC, VAS, SF-12 and use of rescue medication (steroid at 12
      weeks).

      Enrollment: Prospective, randomized, clinical study designed to evaluate 150 subjects. All
      enrolled subjects will have a pre-procedure visit, one treatment visit, and follow-up visits
      at week 6 and week 12 if they require a rescue injection and will fill out patient reported
      outcome measures at 1, 6, 12, and 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC)
time frame: 12 weeks after injection
description: Mean change in the WOMAC Index score from baseline score
measure: Mean change in Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 12 weeks after injection
description: Mean change in the KOOS from baseline score
measure: Mean change in International Knee Documentation Committee (IKDC) score
time frame: 12 weeks after injection
description: Mean change in IKDC from baseline score
measure: Mean change in Visual Analogue Scale (VAS)
time frame: 12 weeks after injection
description: Mean change in VAS from baseline score
measure: Mean change in Short Form 12 (SF-12) score
time frame: 12 weeks after injection
description: Mean change in SF-12 from baseline score
measure: Mean change in The Lysholm Knee score
time frame: 12 weeks after injection
description: Mean change in The Lysholm Knee score from baseline score
measure: Mean change in use of rescue medication
time frame: 12 weeks after injection
description: Use of anti-inflammatory, analgesics, and rescue corticosteroid injection. Number of pills taken each day. This will be collected via survey. If the medical examiner feels that the patient is continuing to do poorly and they did not receive the steroid injection intervention, then they will be offered a rescue corticosteroid injection at 12 weeks. The number of patients who do not initially receive a corticosteroid injection and require a rescue corticosteroid injection at 12 weeks will be recorded.
arm group label: Knee injection with corticosteroids
arm group type: Active Comparator
description: Using clinically accepted methods, subjects will undergo a palpation guided injection of corticosteroids into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.
arm group label: Knee injection with saline
arm group type: Placebo Comparator
description: Using clinically accepted methods, subjects will undergo a palpation guided injection of saline into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.
arm group label: Knee injection with air
arm group type: Sham Comparator
description: Using clinically accepted methods, subjects will undergo a palpation guided injection of air into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.
intervention type: Drug
intervention name: 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine
description: Patients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine
arm group label: Knee injection with corticosteroids
other name: Corticosteroid
intervention type: Drug
intervention name: Normal Saline 10 ml
description: Patients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml
arm group label: Knee injection with saline
other name: Saline
intervention type: Drug
intervention name: Air 10 ml
description: Patients will receive an ultrasound guided intra-articular injection of Air 10 ml
arm group label: Knee injection with air
other name: Air
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nikhil N Verma, MD
role: Principal Investigator
affiliation: Midwest Orthopaedics at Rush University
citation: Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.
PMID: 18759314
citation: Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.
PMID: 27238876
citation: Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther. 2012 Aug;42(8):716-23. doi: 10.2519/jospt.2012.4038. Epub 2012 Mar 8.
PMID: 22402677
citation: Kim J, Seo BS. How to calculate sample size and why. Clin Orthop Surg. 2013 Sep;5(3):235-42. doi: 10.4055/cios.2013.5.3.235. Epub 2013 Aug 20.
PMID: 24009911
citation: Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008 Dec;67(12):1716-23. doi: 10.1136/ard.2008.092015. Epub 2008 Jun 9.
PMID: 18541604
citation: Eker HE, Cok OY, Aribogan A, Arslan G. The efficacy of intra-articular lidocaine administration in chronic knee pain due to osteoarthritis: A randomized, double-blind, controlled study. Anaesth Crit Care Pain Med. 2017 Apr;36(2):109-114. doi: 10.1016/j.accpm.2016.05.003. Epub 2016 Jul 30.
PMID: 27485803
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Mukesh Ahuja
investigator title: Certified Principal Investigator, Research Administrator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Lidocaine
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
sharing ipd: No