<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/NCT02996409</url>
  </required_header>
  <id_info>
    <org_study_id>51623</org_study_id>
    <nct_id>NCT02996409</nct_id>
  </id_info>
  <brief_title>High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy</brief_title>
  <acronym>HAT</acronym>
  <official_title>The Value of a High-Volume Image-Guided Injection in Chronic Midportion Achilles Tendinopathy: a Double-blind, Randomized, Placebo-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Arthritis Association</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Anna Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual&#xD;
      treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In&#xD;
      most cases this gives satisfactory results, however there is a significant group of patients&#xD;
      in which the exercise program is not sufficient. Prior to our study, three United Kingdom&#xD;
      based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's)&#xD;
      in chronic midportion Achilles tendinopathy. They all showed promising results. However none&#xD;
      of these studies had an adequate control group. This double-blind, placebo-controlled,&#xD;
      randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection&#xD;
      in chronic midportion Achilles tendinopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background of the study - Overuse injury of the Achilles tendon is a common entity in&#xD;
      athletes. Especially middle aged athletes are at risk. Elite running athletes have a lifetime&#xD;
      risk of sustaining an Achilles tendon injury of 52%. At the moment the usual treatment for&#xD;
      chronic midportion Achilles tendinopathy is an excentric exercise program. In most cases this&#xD;
      gives great results, however there is a significant group of patients in which the exercise&#xD;
      program is not sufficient. Three United Kingdom-based case series evaluated the efficacy of&#xD;
      High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy.&#xD;
      They all showed promising results. However none of these studies used a comparative group.&#xD;
      There is consequently a lack of high-quality studies in this field and therefore the&#xD;
      investigators cannot recommend this treatment yet for this indication.&#xD;
&#xD;
      Objective of the study - To investigate the efficacy of a high-volume image guided injection&#xD;
      (HVIGI) in chronic midportion Achilles tendinopathy.&#xD;
&#xD;
      Hypothesis - The average VISA-A score is higher in the patient group treated with a&#xD;
      progressive exercise program in combination with a high volume image guided injection in&#xD;
      comparison with the group treated with low volume injection as a control group in combination&#xD;
      with a progressive exercise program.&#xD;
&#xD;
      Study design - A double-blind, randomized, placebo-controlled clinical trial. Randomization&#xD;
      and stratification (based on activity level using the Ankle Activity Score) will be performed&#xD;
      using a computer-generated model. Measurements will be performed at baseline, 2, 6, 12 and 24&#xD;
      weeks post injection. At every time point both the primary and secondary outcome measurements&#xD;
      will be collected. The painDETECT and the Pain Coping Inventory questionnaires will be&#xD;
      derived at baseline and 24 week post injection.&#xD;
&#xD;
      Study population - In total, 80 patients with clinically diagnosed chronic midportion&#xD;
      Achilles tendinopathy will be included in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)</measure>
    <time_frame>Change in VISA-A score at 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain detect questionnaire (PD-Q)</measure>
    <time_frame>Change in pain detect score at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Pain Coping Inventory (PCI)</measure>
    <time_frame>Change in PCI score at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>10 hop test</measure>
    <time_frame>Change in visual analogue scale score following a 10 hop test at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility m. gastrocnemius using a goniometer</measure>
    <time_frame>Change in flexibility of the gastrocnemius muscle at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Flexibility m. soleus using a goniometer</measure>
    <time_frame>Change in flexibility of the soleus muscle at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Power m. gastrocnemius using a hand-held dynamometer</measure>
    <time_frame>Change in power of the gastrocnemius muscle at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Power m. soleus using a hand-held dynamometer</measure>
    <time_frame>Change in power of the soleus muscle at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination)</measure>
    <time_frame>Change in degree of neovascularization at 24 weeks</time_frame>
    <description>Ultrasonography examination before and after eccentric/isotonic calf exercises or rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to sports using a standardized weekly questionnaire</measure>
    <time_frame>Change in return to sport at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to the exercise program and return to sports activity program using a standardized weekly questionnaire assessing the percentage of exercises that is performed</measure>
    <time_frame>Change in compliance at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with treatment results</measure>
    <time_frame>Change at 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Acceptable Symptom Scale (PASS)</measure>
    <time_frame>Change at 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Tendinopathy</condition>
  <condition>Achilles Tendon Pain</condition>
  <condition>Injection Site Fibrosis</condition>
  <arm_group>
    <arm_group_label>High-Volume Image-Guided Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HVIGI: Injection of 50 cc ( 40 cc 0,9% sodium chloride solution + 10 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Volume Image-Guided Injection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>LVIGI: Injection of 2 cc (1.6 cc 0.9% Sodium chloride solution + 0.4 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HVIGI</intervention_name>
    <description>High Volume Image-Guided Injection with a saline/lidocain solution</description>
    <arm_group_label>High-Volume Image-Guided Injection</arm_group_label>
    <other_name>Saline 0.9% 40 ml</other_name>
    <other_name>Lidocain 1.0% 10 ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LVIGI</intervention_name>
    <description>Placebo control with injection of a saline/lidocain solution (low volume)</description>
    <arm_group_label>Low-Volume Image-Guided Injection</arm_group_label>
    <other_name>Saline 0.9% 1.6 ml</other_name>
    <other_name>Lidocain 1.0% 0.4 ml</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Progressive exercise program</intervention_name>
    <description>A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.</description>
    <arm_group_label>High-Volume Image-Guided Injection</arm_group_label>
    <arm_group_label>Low-Volume Image-Guided Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-70 years.&#xD;
&#xD;
          2. Clinical diagnosis of chronic midportion Achilles tendinopathy: Painful swelling of&#xD;
             the Achilles tendon, 2-7 cm proximal to it's calcaneal insertion.&#xD;
&#xD;
          3. Non-response to exercise program for 6 weeks.&#xD;
&#xD;
          4. Painful Achilles tendon for more than 2 months.&#xD;
&#xD;
          5. Neovascularisation is present on Power Doppler Ultrasonography examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinical suspicion of insertional disorders (pain at the site of the insertion of the&#xD;
             Achilles tendon on the calcaneum)&#xD;
&#xD;
          2. Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpable&#xD;
             &quot;gap&quot;)&#xD;
&#xD;
          3. Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes&#xD;
             are plantar flexed against resistance)&#xD;
&#xD;
          4. Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural&#xD;
             nerve)&#xD;
&#xD;
          5. Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peronea spot&#xD;
             in combination with localized pain)&#xD;
&#xD;
          6. Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid&#xD;
             Arthritis and sarcoidosis.&#xD;
&#xD;
          7. Condition that prevents the patients from executing an active exercise program&#xD;
&#xD;
          8. Recently prescribed drugs (within 2 years) with a putative effect on symptoms and&#xD;
             tendon healing (quinolone antibiotics, corticosteroids).&#xD;
&#xD;
          9. Previous Achilles tendon rupture.&#xD;
&#xD;
         10. Patient has received surgical intervention for his injury.&#xD;
&#xD;
         11. Patient does not wish, for whatever reason, to undergo one of the two treatments&#xD;
&#xD;
         12. A medical condition that would affect safety of injection (e.g. peripheral vascular&#xD;
             disease, use of anticoagulant medication)&#xD;
&#xD;
         13. Known presence of a pregnancy&#xD;
&#xD;
         14. Condition of the Achilles tendon caused by medications (arising in relation to moment&#xD;
             of intake), such as quinolones and statins&#xD;
&#xD;
         15. Inability to give informed consent.&#xD;
&#xD;
         16. Participation in other concomitant treatment programs.&#xD;
&#xD;
         17. Patient has already one side included in this study.&#xD;
&#xD;
         18. Allergy for lidocain.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R.J. de Vos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus MC University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasmus MC University Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>A.C. van der Vlist</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT02996409/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02996409
org study id: 51623
nct id: NCT02996409
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Overuse injury of the Achilles tendon is a common entity in athletes. Currently, the usual
      treatment for chronic midportion Achilles tendinopathy is an eccentric exercise program. In
      most cases this gives satisfactory results, however there is a significant group of patients
      in which the exercise program is not sufficient. Prior to our study, three United Kingdom
      based studies have investigated the efficacy of High-Volume Image-Guided Injections (HVIGI's)
      in chronic midportion Achilles tendinopathy. They all showed promising results. However none
      of these studies had an adequate control group. This double-blind, placebo-controlled,
      randomized clinical trial will investigate the value of a High-Volume Image-Guided Injection
      in chronic midportion Achilles tendinopathy.
Background of the study - Overuse injury of the Achilles tendon is a common entity in
      athletes. Especially middle aged athletes are at risk. Elite running athletes have a lifetime
      risk of sustaining an Achilles tendon injury of 52%. At the moment the usual treatment for
      chronic midportion Achilles tendinopathy is an excentric exercise program. In most cases this
      gives great results, however there is a significant group of patients in which the exercise
      program is not sufficient. Three United Kingdom-based case series evaluated the efficacy of
      High-Volume Image-Guided Injections (HVIGI's) in chronic midportion Achilles tendinopathy.
      They all showed promising results. However none of these studies used a comparative group.
      There is consequently a lack of high-quality studies in this field and therefore the
      investigators cannot recommend this treatment yet for this indication.

      Objective of the study - To investigate the efficacy of a high-volume image guided injection
      (HVIGI) in chronic midportion Achilles tendinopathy.

      Hypothesis - The average VISA-A score is higher in the patient group treated with a
      progressive exercise program in combination with a high volume image guided injection in
      comparison with the group treated with low volume injection as a control group in combination
      with a progressive exercise program.

      Study design - A double-blind, randomized, placebo-controlled clinical trial. Randomization
      and stratification (based on activity level using the Ankle Activity Score) will be performed
      using a computer-generated model. Measurements will be performed at baseline, 2, 6, 12 and 24
      weeks post injection. At every time point both the primary and secondary outcome measurements
      will be collected. The painDETECT and the Pain Coping Inventory questionnaires will be
      derived at baseline and 24 week post injection.

      Study population - In total, 80 patients with clinically diagnosed chronic midportion
      Achilles tendinopathy will be included in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)
time frame: Change in VISA-A score at 24 weeks
measure: Pain detect questionnaire (PD-Q)
time frame: Change in pain detect score at 24 weeks
measure: The Pain Coping Inventory (PCI)
time frame: Change in PCI score at 24 weeks
measure: 10 hop test
time frame: Change in visual analogue scale score following a 10 hop test at 24 weeks
measure: Flexibility m. gastrocnemius using a goniometer
time frame: Change in flexibility of the gastrocnemius muscle at 24 weeks
measure: Flexibility m. soleus using a goniometer
time frame: Change in flexibility of the soleus muscle at 24 weeks
measure: Power m. gastrocnemius using a hand-held dynamometer
time frame: Change in power of the gastrocnemius muscle at 24 weeks
measure: Power m. soleus using a hand-held dynamometer
time frame: Change in power of the soleus muscle at 24 weeks
measure: Degree of neovascularisation (determined with standardized Power Doppler Ultrasonography examination)
time frame: Change in degree of neovascularization at 24 weeks
description: Ultrasonography examination before and after eccentric/isotonic calf exercises or rest
measure: Return to sports using a standardized weekly questionnaire
time frame: Change in return to sport at 24 weeks
measure: Compliance to the exercise program and return to sports activity program using a standardized weekly questionnaire assessing the percentage of exercises that is performed
time frame: Change in compliance at 24 weeks
measure: Patient satisfaction with treatment results
time frame: Change at 24 weeks
measure: Patient Acceptable Symptom Scale (PASS)
time frame: Change at 24 weeks
arm group label: High-Volume Image-Guided Injection
arm group type: Experimental
description: HVIGI: Injection of 50 cc ( 40 cc 0,9% sodium chloride solution + 10 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities.
arm group label: Low-Volume Image-Guided Injection
arm group type: Placebo Comparator
description: LVIGI: Injection of 2 cc (1.6 cc 0.9% Sodium chloride solution + 0.4 cc 1% lidocain) in combination with a progressive exercise program and gradual return to sports activities.
intervention type: Drug
intervention name: HVIGI
description: High Volume Image-Guided Injection with a saline/lidocain solution
arm group label: High-Volume Image-Guided Injection
other name: Saline 0.9% 40 ml
other name: Lidocain 1.0% 10 ml
intervention type: Drug
intervention name: LVIGI
description: Placebo control with injection of a saline/lidocain solution (low volume)
arm group label: Low-Volume Image-Guided Injection
other name: Saline 0.9% 1.6 ml
other name: Lidocain 1.0% 0.4 ml
intervention type: Other
intervention name: Progressive exercise program
description: A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.
arm group label: High-Volume Image-Guided Injection
arm group label: Low-Volume Image-Guided Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: R.J. de Vos, PhD
role: Principal Investigator
affiliation: Erasmus MC University Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: A.C. van der Vlist
investigator title: Principal investigator
mesh term: Tendinopathy
mesh term: Lidocaine
sharing ipd: Undecided
provided document: 