<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/NCT04475965</url>
  </required_header>
  <id_info>
    <org_study_id>EIH UCM</org_study_id>
    <nct_id>NCT04475965</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain</brief_title>
  <official_title>The Influence of the Intensity of Isometric Exercise on Pain Intensity, Muscle Pain Sensitivity and Function in Patients With Chronic Shoulder Pain: A Parallel Single-blind Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jorge Fuentes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Católica del Maule</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the influence of the intensity of Isometric Contraction&#xD;
      of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary&#xD;
      isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary&#xD;
      isometric contraction) on pain intensity, pain thresholds, and function in chronic pain&#xD;
      shoulder patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic&#xD;
      musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41)&#xD;
      received a five-series Isometric Contraction of shoulder external rotators at 20% maximal&#xD;
      voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol&#xD;
      but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In&#xD;
      both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes.&#xD;
      Patients received five sessions of treatment during a two-week period. Outcome measures&#xD;
      included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain&#xD;
      intensity numerical rating score), and shoulder function (Constant Score).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">October 5, 2019</completion_date>
  <primary_completion_date type="Actual">August 27, 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>
    <intervention_model_description>Participants were randomly assigned to groups by using a random number table. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity Numerical Rating Scale</measure>
    <time_frame>Baseline through the end of the intervention (2 week period)</time_frame>
    <description>The Pain intensity Numerical Rating Scale is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a number on a horizontally depicted 11-point scale from 0 (no pain) to 10 (worst possible pain). Based on its several advantages (i.e. more responsive, sensitive and easy to administer) over other pain measuring scales, the PI-NRS has been recommended as a core outcome measure in clinical trials of chronic pain treatments. The minimal clinically important change for this scale has been reported to range from 1.5 to 3.2 points. Other authors have determined a meaningful clinical change of 2 points from baseline pain scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>Baseline through the end of the intervention (2 week period)</time_frame>
    <description>The shoulder function was assessed by the Constant Score scale. This is a multi-item functional scale assessing pain, activities of daily living, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function respectively.&#xD;
Pain and activities of daily living (subjective aspects receiving 35 points) are answered by the patient ; and range of motion and strength (objective aspects receiving 65 points) require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle pain sensitivity</measure>
    <time_frame>Baseline through the end of the intervention (2 week period)</time_frame>
    <description>Muscle pain sensitivity was evaluated through the pressure pain threshold, or the minimum pressure that induces pain or discomfort. Pressure pain thresholds measurements have been shown to have good or excellent inter-rater intraclass correlation coeficient values ranging from 0.74 to 0.90, and intra-rater reliability interclass correlation coefficient values ranging from 0.75 to 0.99. The minimal clinically important change calculated for this outcome has been reported to be ≥ 1.10 Kg/cm2/s</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Chronic Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Group 1 20% maximal voluntary isometric contraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in group 1 received a five-series Isometric Contraction of shoulder external rotators at 20% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 80% maximal voluntary isometric contraction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in group 2 received a five-series Isometric Contraction of shoulder external rotators at 80% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isometric exercise for shoulder external rotators</intervention_name>
    <description>The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).</description>
    <arm_group_label>Group 1 20% maximal voluntary isometric contraction</arm_group_label>
    <arm_group_label>Group 2 80% maximal voluntary isometric contraction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female having a chronic shoulder soft-tissue injury of at least 3 month&#xD;
             duration resulting in a mild to moderate level of disability (Constant score scale),&#xD;
             pain intensity score between 3 and 8 points (pain intensity numerical rating scale),&#xD;
             and age between 18 and 65 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants were excluded if they had any contraindications related to the&#xD;
             application of isometric exercise, neurological problems (central or peripheral),&#xD;
             concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic&#xD;
             disease conditions, had participated in any moderate or vigorous physical activity in&#xD;
             the las 72 hours previous the outcome assessment.&#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>Hans Neira, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Concepcion University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Traumatológico</name>
      <address>
        <city>Concepción</city>
        <state>Bio Bio</state>
        <zip>4030000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Católica del Maule</investigator_affiliation>
    <investigator_full_name>Jorge Fuentes</investigator_full_name>
    <investigator_title>Clinical professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</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/NCT04475965
org study id: EIH UCM
nct id: NCT04475965
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate the influence of the intensity of Isometric Contraction
      of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary
      isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary
      isometric contraction) on pain intensity, pain thresholds, and function in chronic pain
      shoulder patients.
This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic
      musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41)
      received a five-series Isometric Contraction of shoulder external rotators at 20% maximal
      voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol
      but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In
      both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes.
      Patients received five sessions of treatment during a two-week period. Outcome measures
      included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain
      intensity numerical rating score), and shoulder function (Constant Score).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomly assigned to groups by using a random number table. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.
measure: Pain intensity Numerical Rating Scale
time frame: Baseline through the end of the intervention (2 week period)
description: The Pain intensity Numerical Rating Scale is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a number on a horizontally depicted 11-point scale from 0 (no pain) to 10 (worst possible pain). Based on its several advantages (i.e. more responsive, sensitive and easy to administer) over other pain measuring scales, the PI-NRS has been recommended as a core outcome measure in clinical trials of chronic pain treatments. The minimal clinically important change for this scale has been reported to range from 1.5 to 3.2 points. Other authors have determined a meaningful clinical change of 2 points from baseline pain scores.
measure: Shoulder function
time frame: Baseline through the end of the intervention (2 week period)
description: The shoulder function was assessed by the Constant Score scale. This is a multi-item functional scale assessing pain, activities of daily living, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function respectively.
Pain and activities of daily living (subjective aspects receiving 35 points) are answered by the patient ; and range of motion and strength (objective aspects receiving 65 points) require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.
measure: Muscle pain sensitivity
time frame: Baseline through the end of the intervention (2 week period)
description: Muscle pain sensitivity was evaluated through the pressure pain threshold, or the minimum pressure that induces pain or discomfort. Pressure pain thresholds measurements have been shown to have good or excellent inter-rater intraclass correlation coeficient values ranging from 0.74 to 0.90, and intra-rater reliability interclass correlation coefficient values ranging from 0.75 to 0.99. The minimal clinically important change calculated for this outcome has been reported to be ≥ 1.10 Kg/cm2/s
arm group label: Group 1 20% maximal voluntary isometric contraction
arm group type: Experimental
description: Patients in group 1 received a five-series Isometric Contraction of shoulder external rotators at 20% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.
arm group label: Group 2 80% maximal voluntary isometric contraction
arm group type: Active Comparator
description: Patients in group 2 received a five-series Isometric Contraction of shoulder external rotators at 80% of maximal voluntary isometric contraction. Each series of Isometric Contraction was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period.
intervention type: Other
intervention name: Isometric exercise for shoulder external rotators
description: The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).
arm group label: Group 1 20% maximal voluntary isometric contraction
arm group label: Group 2 80% maximal voluntary isometric contraction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hans Neira, BSc
role: Principal Investigator
affiliation: Concepcion University
facility: 
country: Chile
responsible party type: Sponsor-Investigator
investigator affiliation: Universidad Católica del Maule
investigator full name: Jorge Fuentes
investigator title: Clinical professor
mesh term: Shoulder Pain
sharing ipd: No