<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/NCT03774251</url>
  </required_header>
  <id_info>
    <org_study_id>47910</org_study_id>
    <nct_id>NCT03774251</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy</brief_title>
  <official_title>A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich&#xD;
      plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory&#xD;
      Greater Trochanteric Pain Syndrome (GTPS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich&#xD;
      plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory&#xD;
      Greater Trochanteric Pain Syndrome (GTPS).&#xD;
&#xD;
      GTPS is a common cause of extra-articular lateral hip pain which occurs in up to 10- 25% of&#xD;
      the population, and is a common presenting complaint to primary care and Sports Medicine&#xD;
      clinics. Previously, most cases of GTPS were diagnosed as trochanteric bursitis, for which&#xD;
      the standard treatment focused on relieving inflammation with non-steroidal anti-inflammatory&#xD;
      medications and corticosteroid injections. However, corticosteroid injections typically only&#xD;
      provide short term pain relief, likely secondary to the fact that the underlying pathology is&#xD;
      likely not from an isolated bursal inflammation. Recent studies suggest that in fact the most&#xD;
      common cause of GTPS is gluteus medius or minimus tendinopathy or tear. Platelet rich plasma&#xD;
      (PRP) has been used in treating tendinopathies and tendon tears throughout the body to&#xD;
      promote healing through the concentrated growth factors released from platelets.&#xD;
      Extracorporeal shock wave therapy (ESWT) is another treatment which has been used&#xD;
      increasingly in the treatment of tendinopathies. The purpose of this randomized prospective&#xD;
      study is to compare the efficacy of PRP injection to ESWT in treating patients with a&#xD;
      clinical diagnosis of GTPS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding not secured&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>
    <intervention_model_description>Randomized prospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Pain: VAS</measure>
    <time_frame>4 weeks, 3 months, 6 months, 12 months</time_frame>
    <description>Visual Analog Scale (VAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Function as measured by the International Hip Outcome Tool (iHot)</measure>
    <time_frame>4 weeks, 3 months, 6 months, 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in Function as measured by the Lower extremity functional scale (LEFS)</measure>
    <time_frame>4 weeks, 3 months, 6 months, 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Greater Trochanter Pain Syndrome - PRP Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to undergo platelet rich plasma injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Greater Trochanter Pain Syndrome - ESWT Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to extracorporeal shock wave therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet-Rich Plasma Injection</intervention_name>
    <description>The patient will undergo a single platelet-rich plasma peritendinous injection</description>
    <arm_group_label>Greater Trochanter Pain Syndrome - PRP Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extracorporeal Shock Wave Therapy</intervention_name>
    <description>The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip</description>
    <arm_group_label>Greater Trochanter Pain Syndrome - ESWT Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Individuals with documented diagnosis of greater trochanter pain syndrome, with MRI&#xD;
        evidence of gluteus minimus or medius tendinopathy, whose lateral hip pain has been&#xD;
        refractory to conservative management with non-steroid anti-inflammatory medications and at&#xD;
        least 6 weeks of Physical Therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 or &gt; 65 years&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular&#xD;
             structures.&#xD;
&#xD;
          4. Evidence of concomitant injury to the involved lower extremity, including&#xD;
             radiculopathy or radiculitis, piriformis syndrome, ischial tuberosity avulsion&#xD;
&#xD;
          5. History of prior steroid injection and Orthobiologic injection or surgery to the&#xD;
             involved lower extremity f. Any inflammatory or neoplastic disorder&#xD;
&#xD;
        g. Blood coagulation disorders or use of antiplatelet or anticoagulant drugs h. Severe knee&#xD;
        or hip osteoarthritis i. Patients with symptoms of more than 6 months' duration were not&#xD;
        considered as patients in the chronic stages of this condition and may require a different&#xD;
        therapeutic approach including surgical treatment.&#xD;
&#xD;
        j. Severe Diabetes Mellitus who need insulin injection k. Severe active lumbar&#xD;
        radiculopathy with pain, numbness, or weakness in a dermatomal distribution l. Implanted&#xD;
        pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Fredericson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Medicine Outpatient Center</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16.</citation>
    <PMID>27610386</PMID>
  </reference>
  <reference>
    <citation>Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N. Home training, local corticosteroid injection, or radial shock wave therapy for greater trochanter pain syndrome. Am J Sports Med. 2009 Oct;37(10):1981-90. doi: 10.1177/0363546509334374. Epub 2009 May 13.</citation>
    <PMID>19439758</PMID>
  </reference>
  <reference>
    <citation>Ribeiro AG, Ricioli W Junior, Silva AR, Polesello GC, Guimaraes RP. PRP IN THE TREATMENT OF TROCHANTERIC SYNDROME: A PILOT STUDY. Acta Ortop Bras. 2016 Jul-Aug;24(4):208-212. doi: 10.1590/1413-785220162404159837.</citation>
    <PMID>28243176</PMID>
  </reference>
  <reference>
    <citation>Redmond JM, Chen AW, Domb BG. Greater Trochanteric Pain Syndrome. J Am Acad Orthop Surg. 2016 Apr;24(4):231-40. doi: 10.5435/JAAOS-D-14-00406.</citation>
    <PMID>26990713</PMID>
  </reference>
  <reference>
    <citation>Mani-Babu S, Morrissey D, Waugh C, Screen H, Barton C. The effectiveness of extracorporeal shock wave therapy in lower limb tendinopathy: a systematic review. Am J Sports Med. 2015 Mar;43(3):752-61. doi: 10.1177/0363546514531911. Epub 2014 May 9.</citation>
    <PMID>24817008</PMID>
  </reference>
  <reference>
    <citation>Jacobson JA, Yablon CM, Henning PT, Kazmers IS, Urquhart A, Hallstrom B, Bedi A, Parameswaran A. Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis. J Ultrasound Med. 2016 Nov;35(11):2413-2420. doi: 10.7863/ultra.15.11046. Epub 2016 Sep 23.</citation>
    <PMID>27663654</PMID>
  </reference>
  <reference>
    <citation>Seo KH, Lee JY, Yoon K, Do JG, Park HJ, Lee SY, Park YS, Lee YT. Long-term outcome of low-energy extracorporeal shockwave therapy on gluteal tendinopathy documented by magnetic resonance imaging. PLoS One. 2018 Jul 17;13(7):e0197460. doi: 10.1371/journal.pone.0197460. eCollection 2018.</citation>
    <PMID>30016333</PMID>
  </reference>
  <reference>
    <citation>Furia JP, Rompe JD, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for greater trochanteric pain syndrome. Am J Sports Med. 2009 Sep;37(9):1806-13. doi: 10.1177/0363546509333014. Epub 2009 May 13.</citation>
    <PMID>19439756</PMID>
  </reference>
  <reference>
    <citation>Fitzpatrick J, Bulsara MK, O'Donnell J, McCrory PR, Zheng MH. The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendinopathy: A Randomized, Double-Blind Controlled Trial Comparing a Single Platelet-Rich Plasma Injection With a Single Corticosteroid Injection. Am J Sports Med. 2018 Mar;46(4):933-939. doi: 10.1177/0363546517745525. Epub 2018 Jan 2.</citation>
    <PMID>29293361</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>September 15, 2021</last_update_submitted>
  <last_update_submitted_qc>September 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Michael Fredericson, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT03774251
org study id: 47910
nct id: NCT03774251
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich
      plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory
      Greater Trochanteric Pain Syndrome (GTPS).
The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich
      plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory
      Greater Trochanteric Pain Syndrome (GTPS).

      GTPS is a common cause of extra-articular lateral hip pain which occurs in up to 10- 25% of
      the population, and is a common presenting complaint to primary care and Sports Medicine
      clinics. Previously, most cases of GTPS were diagnosed as trochanteric bursitis, for which
      the standard treatment focused on relieving inflammation with non-steroidal anti-inflammatory
      medications and corticosteroid injections. However, corticosteroid injections typically only
      provide short term pain relief, likely secondary to the fact that the underlying pathology is
      likely not from an isolated bursal inflammation. Recent studies suggest that in fact the most
      common cause of GTPS is gluteus medius or minimus tendinopathy or tear. Platelet rich plasma
      (PRP) has been used in treating tendinopathies and tendon tears throughout the body to
      promote healing through the concentrated growth factors released from platelets.
      Extracorporeal shock wave therapy (ESWT) is another treatment which has been used
      increasingly in the treatment of tendinopathies. The purpose of this randomized prospective
      study is to compare the efficacy of PRP injection to ESWT in treating patients with a
      clinical diagnosis of GTPS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized prospective study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Improvement in Pain: VAS
time frame: 4 weeks, 3 months, 6 months, 12 months
description: Visual Analog Scale (VAS)
measure: Improvement in Function as measured by the International Hip Outcome Tool (iHot)
time frame: 4 weeks, 3 months, 6 months, 12 months
measure: Improvement in Function as measured by the Lower extremity functional scale (LEFS)
time frame: 4 weeks, 3 months, 6 months, 12 months
arm group label: Greater Trochanter Pain Syndrome - PRP Arm
arm group type: Active Comparator
description: Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to undergo platelet rich plasma injection
arm group label: Greater Trochanter Pain Syndrome - ESWT Arm
arm group type: Active Comparator
description: Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to extracorporeal shock wave therapy
intervention type: Biological
intervention name: Platelet-Rich Plasma Injection
description: The patient will undergo a single platelet-rich plasma peritendinous injection
arm group label: Greater Trochanter Pain Syndrome - PRP Arm
intervention type: Device
intervention name: Extracorporeal Shock Wave Therapy
description: The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip
arm group label: Greater Trochanter Pain Syndrome - ESWT Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Fredericson, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
citation: Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16.
PMID: 27610386
citation: Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N. Home training, local corticosteroid injection, or radial shock wave therapy for greater trochanter pain syndrome. Am J Sports Med. 2009 Oct;37(10):1981-90. doi: 10.1177/0363546509334374. Epub 2009 May 13.
PMID: 19439758
citation: Ribeiro AG, Ricioli W Junior, Silva AR, Polesello GC, Guimaraes RP. PRP IN THE TREATMENT OF TROCHANTERIC SYNDROME: A PILOT STUDY. Acta Ortop Bras. 2016 Jul-Aug;24(4):208-212. doi: 10.1590/1413-785220162404159837.
PMID: 28243176
citation: Redmond JM, Chen AW, Domb BG. Greater Trochanteric Pain Syndrome. J Am Acad Orthop Surg. 2016 Apr;24(4):231-40. doi: 10.5435/JAAOS-D-14-00406.
PMID: 26990713
citation: Mani-Babu S, Morrissey D, Waugh C, Screen H, Barton C. The effectiveness of extracorporeal shock wave therapy in lower limb tendinopathy: a systematic review. Am J Sports Med. 2015 Mar;43(3):752-61. doi: 10.1177/0363546514531911. Epub 2014 May 9.
PMID: 24817008
citation: Jacobson JA, Yablon CM, Henning PT, Kazmers IS, Urquhart A, Hallstrom B, Bedi A, Parameswaran A. Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis. J Ultrasound Med. 2016 Nov;35(11):2413-2420. doi: 10.7863/ultra.15.11046. Epub 2016 Sep 23.
PMID: 27663654
citation: Seo KH, Lee JY, Yoon K, Do JG, Park HJ, Lee SY, Park YS, Lee YT. Long-term outcome of low-energy extracorporeal shockwave therapy on gluteal tendinopathy documented by magnetic resonance imaging. PLoS One. 2018 Jul 17;13(7):e0197460. doi: 10.1371/journal.pone.0197460. eCollection 2018.
PMID: 30016333
citation: Furia JP, Rompe JD, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for greater trochanteric pain syndrome. Am J Sports Med. 2009 Sep;37(9):1806-13. doi: 10.1177/0363546509333014. Epub 2009 May 13.
PMID: 19439756
citation: Fitzpatrick J, Bulsara MK, O'Donnell J, McCrory PR, Zheng MH. The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendinopathy: A Randomized, Double-Blind Controlled Trial Comparing a Single Platelet-Rich Plasma Injection With a Single Corticosteroid Injection. Am J Sports Med. 2018 Mar;46(4):933-939. doi: 10.1177/0363546517745525. Epub 2018 Jan 2.
PMID: 29293361
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Michael Fredericson, MD
investigator title: Professor
mesh term: Tendinopathy
mesh term: Syndrome
mesh term: Somatoform Disorders
sharing ipd: No