<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/NCT02982460</url>
  </required_header>
  <id_info>
    <org_study_id>UOMalaga</org_study_id>
    <nct_id>NCT02982460</nct_id>
  </id_info>
  <brief_title>Effects of Isoinertial Training on Rotator Cuff Tendinopathy</brief_title>
  <official_title>The Effects of Isoinertial Training on Rotator Cuff Tendinopathy. A Randomized Controlled Double-blind Follow-up Trail. A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaga</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder&#xD;
      pain with prevalence estimated to be as high as 14% in general working-age population. RCT is&#xD;
      a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome,&#xD;
      RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised&#xD;
      by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease&#xD;
      function, lower health-related quality of life, poor sleep quality, work absenteeism, as well&#xD;
      as patient's suffering. Previous studies support exercise as an adequate treatment in RCT.&#xD;
      Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial&#xD;
      training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to&#xD;
      conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric&#xD;
      training versus eccentric training alone on improving pain and function in RCT. The&#xD;
      objectives were to evaluate: (i) The process of recruitment and retention rates; (ii)&#xD;
      Willingness of participants to be randomised; (iii) The extent of contamination between&#xD;
      groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the&#xD;
      effects of isoinertial training plus eccentric training versus eccentric training alone on&#xD;
      rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with&#xD;
      RCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and setting The design of the present study will be a randomized controlled&#xD;
      single-blind trial with 2 follow-ups (one week and one month after intervention) that will be&#xD;
      performed between January 2017 and March 2017 in one private physiotherapy clinic in Malaga,&#xD;
      Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and&#xD;
      one month after intervention (t3). Written informed consent will be acquired for all&#xD;
      participants prior to their participation. The study will be implemented and reported in line&#xD;
      with the CONSORT statement.&#xD;
&#xD;
      Recruitment Eligible participants who will be interested in the study will be asked to&#xD;
      provide written informed consent to participate. Subsequently the patient-reported outcome&#xD;
      measures will be completed to establish baseline pain, function, rotator cuff strength,&#xD;
      scapular muscle activity, scapular muscle endurance and level of self-efficacy. After&#xD;
      completion of the baseline measures, the participants will be randomly allocated to the&#xD;
      isoinertial training plus eccentric or eccentric training groups. The measures of pain,&#xD;
      function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and&#xD;
      self-efficacy will be repeated one week and one month after intervention. Anonymized age and&#xD;
      gender will be collected for those participants who decline to take part in the study to&#xD;
      assess the external validity of the recruited sample of participants. Participant data files&#xD;
      will be stored in numerical order and in a secure and accessible place and manner.&#xD;
      Participant files will be maintained in storage for a period of 3 years after completion of&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>&quot;Change from Baseline function at 1 month&quot;</measure>
    <time_frame>1 month</time_frame>
    <description>This outcome will be measured with the shoulder pain and disability index (SPADI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>&quot;Change from Baseline pain at 1 month&quot;</measure>
    <time_frame>1 month</time_frame>
    <description>This outcome will be measured with the shoulder pain and disability index (SPADI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>&quot;Change from Baseline rotator cuff strength at 1 months&quot;</measure>
    <time_frame>1 month</time_frame>
    <description>The handheld dynamometer (HHD) (MicroFET 2, Hoggan Health Industries Inc., Biometrics, The Netherlands) was used to measure the following shoulder muscles strength: supraspinous, infraspinatus, subscapular, and teres minor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Change from Baseline scapular muscle activity at 1 months&quot;</measure>
    <time_frame>1 month</time_frame>
    <description>Surface electromyography (EMG; BTS FREEEMG 300, BTS S. p. A., Milan, Italy) was used to measure muscle activity. We attached an electrode to the supraspinous, infraspinatus, subscapular, and teres minor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Change from Baseline scapular muscle endurance at 1 months&quot;</measure>
    <time_frame>1 month</time_frame>
    <description>Endurance of the trapezius and serratus anterior muscles was assessed using the scapular muscle endurance (SME) test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Change from Baseline self-efficacy at 1 months&quot;</measure>
    <time_frame>1 month</time_frame>
    <description>Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Rotator Cuff Tendinopathy</condition>
  <arm_group>
    <arm_group_label>Isoinertial + eccentric exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The isoinertial training will be based on 4 sets of 8 maximal repetitions using a YoYo-Squat (YoYo Technology AB, Stockholm, Sweden). This exercise device use the inertia of a spinning flywheel (moment inertia = 0.11 kg m-2), offering resistance during coupled concentric and eccentric actions, and allows for high demanding to rotator cuff exercises while offering the possibility to perform with an eccentric overload.Two initial repetitions in any set were aimed at accelerating the flywheel, before executing the subsequent 8 actions at maximal effort. Eccentric exercise will based on a set of 4 exercise implicating abduction, lateral rotation, extension and flexion of the shoulder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eccentric exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eccentric exercise will based on a set of 4 exercise implicating abduction, lateral rotation, extension and flexion of the shoulder. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isoinertial + eccentric exercise</intervention_name>
    <description>A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.</description>
    <arm_group_label>Isoinertial + eccentric exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eccentric exercise</intervention_name>
    <description>A session of eccentric exercise covers the strength of scapular muscles.</description>
    <arm_group_label>Eccentric exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-35 years&#xD;
&#xD;
          -  Willing and able to participate&#xD;
&#xD;
          -  Primary complaint of shoulder pain&#xD;
&#xD;
          -  No/minimal resting for shoulder pain&#xD;
&#xD;
          -  Range of shoulder movement largely preserved&#xD;
&#xD;
          -  Two out of three positive impingement tests: empty-can test, Hawkins-Kennedy test,&#xD;
             modified Neer test&#xD;
&#xD;
          -  Pain on isometric rotator cuff testing, usually abduction or lateral rotation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjective feeling of instability and positive apprehension sign&#xD;
&#xD;
          -  Positive scapular assistance and/or resistance test&#xD;
&#xD;
          -  Partial or full ruptures of the rotator cuff&#xD;
&#xD;
          -  Calcifications greater than 4 mm&#xD;
&#xD;
          -  (Acromion type III (per Bigliani criteria)&#xD;
&#xD;
          -  Bursitis&#xD;
&#xD;
          -  History of shoulder fracture and/or shoulder surgery&#xD;
&#xD;
          -  Glenohumeral disorders (inflammatory arthritis, osteoarthritis, osteonecrosis, cuff&#xD;
             arthropathy, septic arthritis, adhesive capsulitis, glenohumeral instability); (viii)&#xD;
             Regional disorders (cervical radiculopathy, brachial neuritis, nerve entrapment&#xD;
             syndrome, sternoclavicular arthritis, reflex sympathetic dystrophy, and neoplasms)&#xD;
&#xD;
          -  Systemic diseases&#xD;
&#xD;
          -  Corticosteroid injection 3 months prior to the study treatment and within 1 months&#xD;
             prior to the study treatment on other body parts.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alejandro Luque Suarez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Javier Martinez Calderon, PhD student</last_name>
    <phone>655570595</phone>
    <phone_ext>+34</phone_ext>
    <email>javier_martinez_calderon@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alejandro Luque Suarez, PhD</last_name>
    <phone>606939920</phone>
    <phone_ext>+34</phone_ext>
    <email>aluques@uma.es</email>
  </overall_contact_backup>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Alejandro Luque-Suarez</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Rotator cuff tendinopathy</keyword>
  <keyword>Eccentric exercise</keyword>
  <keyword>Isoinertial training</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>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/NCT02982460
org study id: UOMalaga
nct id: NCT02982460
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rotator cuff tendinopathy (RCT) is regarded as a common and burdensome source of shoulder
      pain with prevalence estimated to be as high as 14% in general working-age population. RCT is
      a broad entity, including a vast variety of diagnosis such as shoulder impingement syndrome,
      RC tendinitis/tendinosis, as well as subacromial bursitis. The course of RCT is characterised
      by persistent pain and/or disability and/or recurrent episodes. It often leads to decrease
      function, lower health-related quality of life, poor sleep quality, work absenteeism, as well
      as patient's suffering. Previous studies support exercise as an adequate treatment in RCT.
      Nevertheless, our knowledge, there is no studies evaluating the effects of isoinertial
      training in RCT. Therefore, the aim of this study will be to pilot the methods proposed to
      conduct a substantive study to evaluate the efficacy of isoinertial training plus eccentric
      training versus eccentric training alone on improving pain and function in RCT. The
      objectives were to evaluate: (i) The process of recruitment and retention rates; (ii)
      Willingness of participants to be randomised; (iii) The extent of contamination between
      groups; (iv) Participant adherence with treatment. The secondary aim will be to analyse the
      effects of isoinertial training plus eccentric training versus eccentric training alone on
      rotator cuff strength, scapular muscle activity, and scapular muscle endurance in people with
      RCT.
Study design and setting The design of the present study will be a randomized controlled
      single-blind trial with 2 follow-ups (one week and one month after intervention) that will be
      performed between January 2017 and March 2017 in one private physiotherapy clinic in Malaga,
      Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and
      one month after intervention (t3). Written informed consent will be acquired for all
      participants prior to their participation. The study will be implemented and reported in line
      with the CONSORT statement.

      Recruitment Eligible participants who will be interested in the study will be asked to
      provide written informed consent to participate. Subsequently the patient-reported outcome
      measures will be completed to establish baseline pain, function, rotator cuff strength,
      scapular muscle activity, scapular muscle endurance and level of self-efficacy. After
      completion of the baseline measures, the participants will be randomly allocated to the
      isoinertial training plus eccentric or eccentric training groups. The measures of pain,
      function, rotator cuff strength, scapular muscle activity, scapular muscle endurance and
      self-efficacy will be repeated one week and one month after intervention. Anonymized age and
      gender will be collected for those participants who decline to take part in the study to
      assess the external validity of the recruited sample of participants. Participant data files
      will be stored in numerical order and in a secure and accessible place and manner.
      Participant files will be maintained in storage for a period of 3 years after completion of
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: "Change from Baseline function at 1 month"
time frame: 1 month
description: This outcome will be measured with the shoulder pain and disability index (SPADI)
measure: "Change from Baseline pain at 1 month"
time frame: 1 month
description: This outcome will be measured with the shoulder pain and disability index (SPADI)
measure: "Change from Baseline rotator cuff strength at 1 months"
time frame: 1 month
description: The handheld dynamometer (HHD) (MicroFET 2, Hoggan Health Industries Inc., Biometrics, The Netherlands) was used to measure the following shoulder muscles strength: supraspinous, infraspinatus, subscapular, and teres minor.
measure: "Change from Baseline scapular muscle activity at 1 months"
time frame: 1 month
description: Surface electromyography (EMG; BTS FREEEMG 300, BTS S. p. A., Milan, Italy) was used to measure muscle activity. We attached an electrode to the supraspinous, infraspinatus, subscapular, and teres minor.
measure: "Change from Baseline scapular muscle endurance at 1 months"
time frame: 1 month
description: Endurance of the trapezius and serratus anterior muscles was assessed using the scapular muscle endurance (SME) test.
measure: "Change from Baseline self-efficacy at 1 months"
time frame: 1 month
description: Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
arm group label: Isoinertial + eccentric exercise
arm group type: Experimental
description: The isoinertial training will be based on 4 sets of 8 maximal repetitions using a YoYo-Squat (YoYo Technology AB, Stockholm, Sweden). This exercise device use the inertia of a spinning flywheel (moment inertia = 0.11 kg m-2), offering resistance during coupled concentric and eccentric actions, and allows for high demanding to rotator cuff exercises while offering the possibility to perform with an eccentric overload.Two initial repetitions in any set were aimed at accelerating the flywheel, before executing the subsequent 8 actions at maximal effort. Eccentric exercise will based on a set of 4 exercise implicating abduction, lateral rotation, extension and flexion of the shoulder.
arm group label: Eccentric exercise
arm group type: Active Comparator
description: Eccentric exercise will based on a set of 4 exercise implicating abduction, lateral rotation, extension and flexion of the shoulder. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment.
intervention type: Other
intervention name: Isoinertial + eccentric exercise
description: A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.
arm group label: Isoinertial + eccentric exercise
intervention type: Other
intervention name: Eccentric exercise
description: A session of eccentric exercise covers the strength of scapular muscles.
arm group label: Eccentric exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Alejandro Luque Suarez, PhD
role: Principal Investigator
affiliation: University of Malaga
last name: Javier Martinez Calderon, PhD student
phone: 655570595
phone ext: +34
email: javier_martinez_calderon@hotmail.com
last name: Alejandro Luque Suarez, PhD
phone: 606939920
phone ext: +34
email: aluques@uma.es
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Alejandro Luque-Suarez
investigator title: PhD
mesh term: Tendinopathy
sharing ipd: No