<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/NCT03025412</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1931</org_study_id>
    <nct_id>NCT03025412</nct_id>
  </id_info>
  <brief_title>A Comparison of Endoscopic Surgery and Exercise Therapy in Patients With Longstanding Achilles Tendinopathy</brief_title>
  <official_title>A Comparison of Endoscopic Surgery and Conservative Treatment in Patients With Longstanding Mid-portion Achilles Tendinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norwegian University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite&#xD;
      this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment.&#xD;
&#xD;
      Surgery for midportion achilles tendinopathy has for many years been done as an open&#xD;
      procedure. New knowledge resulted in a variety of minimally invasive procedures and the&#xD;
      development of endoscopic surgery.&#xD;
&#xD;
      In this study, the effect of non-open surgery and conservative treatment (physiotherapy and&#xD;
      exercises) will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment difficulties due to recently introduced new surgical procedure&#xD;
  </why_stopped>
  <start_date type="Actual">April 19, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <phase>N/A</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain using The Victorian Institute of Sports Assessment - Achilles</measure>
    <time_frame>3 months (immediately following 12 week exercising)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain using a numeric rating scale (NRS)</measure>
    <time_frame>3 months (immediately following 12 week exercising</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain using a numeric rating scale (NRS)</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HAD)</measure>
    <time_frame>3 months (immediately following 12 week exercising)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HAD)</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale of Kinesiophobia [TSK]</measure>
    <time_frame>3 months (immediately following 12 week exercising)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale of Kinesiophobia [TSK]</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-clinician therapeutic relationship</measure>
    <time_frame>3 months (immediately following 12 week exercising)</time_frame>
    <description>assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-clinician therapeutic relationship</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
    <description>assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal strength (one repetition maximum, 1RM)</measure>
    <time_frame>3 months (immediately following 12 week exercising)</time_frame>
    <description>Measures of maximal strength will be conducted in the following manner; participants do a warm up routine where they perform 8-15 repetitions with a comfortable load. This is performed in a leg-press machine. The load is gradually increased, and the participant performs the exercise once per attempt. 3 minutes break are given in between each attempt. The heaviest load the participants manages to lift is their 1RM, and is planned to be achieved within 3-6 attempts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal strength (one repetition maximum, 1RM)</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
    <description>Measures of maximal strength will be conducted in the following manner; participants do a warm up routine where they perform 8-15 repetitions with a comfortable load. This is performed in a leg-press machine. The load is gradually increased, and the participant performs the exercise once per attempt. 3 minutes break are given in between each attempt. The heaviest load the participants manages to lift is their 1RM, and is planned to be achieved within 3-6 attempts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-exhaustion</measure>
    <time_frame>3 months (immediately following 12 week exercising)</time_frame>
    <description>A time-to-exhaustion test will be performed by the participants, with the same movement as described for the 1RM-test. If there is bilateral pain, the most painful side will be tested. The plantar flexion movement will be performed with a frequency of 0.5 Hz, starting with a load of 5 kg. Each minute additional 5 kg will be added until exhaustion is achieved or pain exceeds 5 on a VAS-scale. This is a common test in studies where one wish to assess aerobic endurance capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-exhaustion</measure>
    <time_frame>6 months after 12 week exercising</time_frame>
    <description>A time-to-exhaustion test will be performed by the participants, with the same movement as described for the 1RM-test. If there is bilateral pain, the most painful side will be tested. The plantar flexion movement will be performed with a frequency of 0.5 Hz, starting with a load of 5 kg. Each minute additional 5 kg will be added until exhaustion is achieved or pain exceeds 5 on a VAS-scale. This is a common test in studies where one wish to assess aerobic endurance capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>6 months follow-up after rehabilitation</time_frame>
    <description>measured by accelerometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Endoscopic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic surgery</intervention_name>
    <description>Ambulatory surgery. Same surgeon for all patients. General anesthesia. Full debridement of the paratenon and crural fascia. Also the plantaris longus tendon is debrided, but no additional tenotomy executed. Postoperative rehabilitation. Oral nonsteroidal anti-inflammatory drugs 7 days postoperatively. Active ankle dorsiflexion and plantar flexion from day 1 postoperative. Partly weight bearing (30 kg) from day 1 postoperative. Full weight bearing allowed from week 3 postoperative. Gradually increased load, both in activity of daily living, stationary bike and stretching, with individually and pragmatic progression due to pain response. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.</description>
    <arm_group_label>Endoscopic surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>physiotherapy and exercise</intervention_name>
    <description>Exercise schedule: Weeks 1-6, Eccentric unilateral loading while standing on the step of a staircase performed in two exercises; with straight knee and with bent knee. Weeks 7-9, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions x 3 performed with straight knee, and 15 repetitions x 3 performed with bent knee. 3 - 4 times a week. Weeks 10-12, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions maximum (15RM) x 3 performed with straight knee, and 15 RM x 3 performed with bent knee. 3 - 4 times a week. One leg performance or hand hold weight for extra load is used to obtain the exact number of RM.</description>
    <arm_group_label>Conservative treatment</arm_group_label>
    <arm_group_label>Endoscopic surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of mid-portion achilles tendinopathy&#xD;
&#xD;
          -  pain during at least 3 months&#xD;
&#xD;
          -  decreased function (a score less than 80 on VISA-A)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physiotherapy during previous three months&#xD;
&#xD;
          -  history of major achilles trauma&#xD;
&#xD;
          -  cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise&#xD;
             tolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorunn Helbostad, prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 11, 2019</last_update_submitted>
  <last_update_submitted_qc>April 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Achilles Tendon</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Minimally Invasive Surgical Procedures</keyword>
  <keyword>Exercise therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
  </condition_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/NCT03025412
org study id: 2016/1931
nct id: NCT03025412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Exercise is a preferred treatment modality for mid-portion achilles tendinopathy. Despite
      this, as many as 44 % of achilles tendinopathy patients do not respond to exercise treatment.

      Surgery for midportion achilles tendinopathy has for many years been done as an open
      procedure. New knowledge resulted in a variety of minimally invasive procedures and the
      development of endoscopic surgery.

      In this study, the effect of non-open surgery and conservative treatment (physiotherapy and
      exercises) will be compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: pain using The Victorian Institute of Sports Assessment - Achilles
time frame: 3 months (immediately following 12 week exercising)
measure: pain using The Victorian Institute of Sports Assessment - Achilles questionnaire (VISA-A)
time frame: 6 months after 12 week exercising
measure: pain using a numeric rating scale (NRS)
time frame: 3 months (immediately following 12 week exercising
measure: pain using a numeric rating scale (NRS)
time frame: 6 months after 12 week exercising
measure: Hospital Anxiety and Depression Scale (HAD)
time frame: 3 months (immediately following 12 week exercising)
measure: Hospital Anxiety and Depression Scale (HAD)
time frame: 6 months after 12 week exercising
measure: Tampa Scale of Kinesiophobia [TSK]
time frame: 3 months (immediately following 12 week exercising)
measure: Tampa Scale of Kinesiophobia [TSK]
time frame: 6 months after 12 week exercising
measure: Patient-clinician therapeutic relationship
time frame: 3 months (immediately following 12 week exercising)
description: assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
measure: Patient-clinician therapeutic relationship
time frame: 6 months after 12 week exercising
description: assessed by Scale To Assess Therapeutic Relationships in Community Mental Health Care (STAR)
measure: Maximal strength (one repetition maximum, 1RM)
time frame: 3 months (immediately following 12 week exercising)
description: Measures of maximal strength will be conducted in the following manner; participants do a warm up routine where they perform 8-15 repetitions with a comfortable load. This is performed in a leg-press machine. The load is gradually increased, and the participant performs the exercise once per attempt. 3 minutes break are given in between each attempt. The heaviest load the participants manages to lift is their 1RM, and is planned to be achieved within 3-6 attempts.
measure: Maximal strength (one repetition maximum, 1RM)
time frame: 6 months after 12 week exercising
description: Measures of maximal strength will be conducted in the following manner; participants do a warm up routine where they perform 8-15 repetitions with a comfortable load. This is performed in a leg-press machine. The load is gradually increased, and the participant performs the exercise once per attempt. 3 minutes break are given in between each attempt. The heaviest load the participants manages to lift is their 1RM, and is planned to be achieved within 3-6 attempts.
measure: Time-to-exhaustion
time frame: 3 months (immediately following 12 week exercising)
description: A time-to-exhaustion test will be performed by the participants, with the same movement as described for the 1RM-test. If there is bilateral pain, the most painful side will be tested. The plantar flexion movement will be performed with a frequency of 0.5 Hz, starting with a load of 5 kg. Each minute additional 5 kg will be added until exhaustion is achieved or pain exceeds 5 on a VAS-scale. This is a common test in studies where one wish to assess aerobic endurance capacity.
measure: Time-to-exhaustion
time frame: 6 months after 12 week exercising
description: A time-to-exhaustion test will be performed by the participants, with the same movement as described for the 1RM-test. If there is bilateral pain, the most painful side will be tested. The plantar flexion movement will be performed with a frequency of 0.5 Hz, starting with a load of 5 kg. Each minute additional 5 kg will be added until exhaustion is achieved or pain exceeds 5 on a VAS-scale. This is a common test in studies where one wish to assess aerobic endurance capacity.
measure: Physical activity level
time frame: 6 months follow-up after rehabilitation
description: measured by accelerometer
arm group label: Endoscopic surgery
arm group type: Experimental
description: Ambulatory surgery. Postoperative rehabilitation. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
arm group label: Conservative treatment
arm group type: Active Comparator
description: Physiotherapy and exercise. First physiotherapy consultation: Information, advice, instructions. Exercise regime during 12 weeks in three phases.
intervention type: Procedure
intervention name: endoscopic surgery
description: Ambulatory surgery. Same surgeon for all patients. General anesthesia. Full debridement of the paratenon and crural fascia. Also the plantaris longus tendon is debrided, but no additional tenotomy executed. Postoperative rehabilitation. Oral nonsteroidal anti-inflammatory drugs 7 days postoperatively. Active ankle dorsiflexion and plantar flexion from day 1 postoperative. Partly weight bearing (30 kg) from day 1 postoperative. Full weight bearing allowed from week 3 postoperative. Gradually increased load, both in activity of daily living, stationary bike and stretching, with individually and pragmatic progression due to pain response. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
arm group label: Endoscopic surgery
intervention type: Behavioral
intervention name: physiotherapy and exercise
description: Exercise schedule: Weeks 1-6, Eccentric unilateral loading while standing on the step of a staircase performed in two exercises; with straight knee and with bent knee. Weeks 7-9, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions x 3 performed with straight knee, and 15 repetitions x 3 performed with bent knee. 3 - 4 times a week. Weeks 10-12, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions maximum (15RM) x 3 performed with straight knee, and 15 RM x 3 performed with bent knee. 3 - 4 times a week. One leg performance or hand hold weight for extra load is used to obtain the exact number of RM.
arm group label: Conservative treatment
arm group label: Endoscopic surgery
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jorunn Helbostad, prof
role: Study Director
affiliation: Norwegian University of Science and Technology
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Tendinopathy
sharing ipd: Undecided