<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/NCT04442321</url>
  </required_header>
  <id_info>
    <org_study_id>19/043</org_study_id>
    <nct_id>NCT04442321</nct_id>
  </id_info>
  <brief_title>Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve in Patients With Lateral Epicondylalgia</brief_title>
  <official_title>Effectiveness of Ultrasound-Guided Percutaneous Electrical Stimulation on Radial Nerve With Exercises in Patients With Lateral Epicondylalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</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>
      Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3%&#xD;
      of the general population. Several authors have found greater mechanical pain sensitivity in&#xD;
      the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a&#xD;
      similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation&#xD;
      has shown reduce pain in several conditions. Percutaneous electrical stimulation on the&#xD;
      radial nerve could cause an important relief in lateral epicondylalgia.&#xD;
&#xD;
      Hypothesis: Percutaneous electrical stimulation on radial nerve plus exercise therapy in&#xD;
      patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation&#xD;
      plus exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical&#xD;
      Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve&#xD;
      stimulation current throughout needling filaments place close to the nerve.&#xD;
&#xD;
      Study Aims:&#xD;
&#xD;
      Aim #1: The primary aim of the study is to compare the effect of the short, mid and long-term&#xD;
      of PENS on intensity of pain as measured by numeric pain rating scale and disability as&#xD;
      measured by Patient Rated Tennis Elbow Evaluation (PRTEE) in patients with lateral&#xD;
      epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham&#xD;
      PENS plus exercise program.&#xD;
&#xD;
      Aim #2: The secondary aim of the study is to compare the effect of the short, medium and&#xD;
      long-term of PENS on disability as measured by DASH questionnaire, and psychological factors&#xD;
      (fear and avoidance and catastrophism) and Global Rating of Change (GRoC) in patients with&#xD;
      lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program&#xD;
      or Sham PENS plus exercise program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Elbow Pain Intensity between baseline and follow-up periods</measure>
    <time_frame>Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Elbow Related-Disability between baseline and follow-up periods</measure>
    <time_frame>Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Measured with Patient Rated Tennis Elbow Evaluation (PRTEE). It is a 15-item questionnaire designed to measure forearm pain and disability in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Upper Extremity Related-Disability between baseline and follow-up period</measure>
    <time_frame>Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Measured with Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. It includes 30 items assessing (1) degree of difficulty during the preceding week in performing several physical activities because of problems in a upper extremity (21 items), (2) severity of each of the symptoms of pain, activity related pain, tingling, weakness, and stiffness (5 items), and (3) the problem's effect on social activities, work, and sleep and its psychological impact (4 items). Each item is answered on a 5-point scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact). The responses to the 30 items are summed to form a raw score that is then converted to a scale from 0 to 100 with a formula. A higher score reflects greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Kinesiophobia between baseline and follow-up periods</measure>
    <time_frame>Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pain Catastrophizing between baseline and follow-up periods</measure>
    <time_frame>Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Pain Catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Self-perceived Improvement between baseline and follow-up periods</measure>
    <time_frame>Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention</time_frame>
    <description>Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Tennis Elbow</condition>
  <arm_group>
    <arm_group_label>PENS plus exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Experimental: PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently . It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham PENS plus exercise group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Comparator: Sham PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently. It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PENS plus exercise</intervention_name>
    <description>The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:&#xD;
Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle&#xD;
Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe&#xD;
The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:&#xD;
TENS Frequency 2 Hz&#xD;
TENS Pulse width - 250 microseconds&#xD;
Duration - 30 minutes.&#xD;
TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.&#xD;
Administration - One per week&#xD;
Self-management loaded exercises prescribed by a physical therapist, two times per week.</description>
    <arm_group_label>PENS plus exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham PENS plus exercise</intervention_name>
    <description>The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:&#xD;
Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle&#xD;
Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe&#xD;
The electrical current will not be working, and the needles will be placed during 30 minutes:&#xD;
- Administration - One per week&#xD;
Self-management loaded exercises prescribed by a physical therapist, two times per week.</description>
    <arm_group_label>Sham PENS plus exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test:&#xD;
&#xD;
               1. pain during palpation of lateral epicondyle&#xD;
&#xD;
               2. pain on resisted wrist extension&#xD;
&#xD;
               3. pain on resisted middle finger extension&#xD;
&#xD;
               4. pain during hand-grip.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of fractures, luxations, surgery and/or musculoskeletal disorders in upper&#xD;
             limb.&#xD;
&#xD;
               -  Neurological disorders, inflammatory and/or degenerative diseases.&#xD;
&#xD;
               -  Having received as treatment techniques that involve needles on the previous 6&#xD;
                  months to study enrollment, or having received percutaneous electrical&#xD;
                  stimulation as a treatment before.&#xD;
&#xD;
               -  Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant&#xD;
                  women or under suspect of pregnancy.&#xD;
&#xD;
               -  Contraindications of needle's insertions: anticoagulant therapy, needle phobia,&#xD;
                  diabetes, hypothyroidism, lymphoedema, muscular diseases).&#xD;
&#xD;
               -  Contraindications of electrical current application.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gustavo Plaza, PT, PhD</last_name>
    <phone>609578380</phone>
    <phone_ext>+34</phone_ext>
    <email>gusplaza@ucm.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad Complutense de Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gustavo Plaza, PT, PhD</last_name>
      <phone>609578380</phone>
      <phone_ext>+34</phone_ext>
      <email>gusplaza@ucm.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lateral Epicondylalgia</keyword>
  <keyword>Lateral Epicondylitis</keyword>
  <keyword>Lateral Elbow Tendinopathy</keyword>
  <keyword>Lateral Elbow Pain</keyword>
  <keyword>Percutaneous Electrical Nerve Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tennis Elbow</mesh_term>
  </condition_browse>
  <!-- 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/NCT04442321
org study id: 19/043
nct id: NCT04442321
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3%
      of the general population. Several authors have found greater mechanical pain sensitivity in
      the radial nerve when compared with healthy subjects. Radial tunnel syndrome exhibits a
      similar clinical presentation to lateral epicondylalgia. Percutaneous electrical stimulation
      has shown reduce pain in several conditions. Percutaneous electrical stimulation on the
      radial nerve could cause an important relief in lateral epicondylalgia.

      Hypothesis: Percutaneous electrical stimulation on radial nerve plus exercise therapy in
      patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation
      plus exercise.
Randomized, double-blind, placebo controlled clinical trial, using Percutaneous Electrical
      Nerve Stimulation (PENS). PENS is technique to provide a transcutaneous electrical nerve
      stimulation current throughout needling filaments place close to the nerve.

      Study Aims:

      Aim #1: The primary aim of the study is to compare the effect of the short, mid and long-term
      of PENS on intensity of pain as measured by numeric pain rating scale and disability as
      measured by Patient Rated Tennis Elbow Evaluation (PRTEE) in patients with lateral
      epicondylalgia with random assignment to two treatments: PENS plus exercise program or Sham
      PENS plus exercise program.

      Aim #2: The secondary aim of the study is to compare the effect of the short, medium and
      long-term of PENS on disability as measured by DASH questionnaire, and psychological factors
      (fear and avoidance and catastrophism) and Global Rating of Change (GRoC) in patients with
      lateral epicondylalgia with random assignment to two treatments: PENS plus exercise program
      or Sham PENS plus exercise program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in Elbow Pain Intensity between baseline and follow-up periods
time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
description: Pain intensity measured with a 10 (0 - No pain - 10 The worst pain) numeric rating scale
measure: Changes in Elbow Related-Disability between baseline and follow-up periods
time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
description: Measured with Patient Rated Tennis Elbow Evaluation (PRTEE). It is a 15-item questionnaire designed to measure forearm pain and disability in patients
measure: Changes in Upper Extremity Related-Disability between baseline and follow-up period
time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
description: Measured with Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. It includes 30 items assessing (1) degree of difficulty during the preceding week in performing several physical activities because of problems in a upper extremity (21 items), (2) severity of each of the symptoms of pain, activity related pain, tingling, weakness, and stiffness (5 items), and (3) the problem's effect on social activities, work, and sleep and its psychological impact (4 items). Each item is answered on a 5-point scale ranging from 1 (no difficulty to perform, no symptom, or no impact) to 5 (unable to do, very severe symptom, or high impact). The responses to the 30 items are summed to form a raw score that is then converted to a scale from 0 to 100 with a formula. A higher score reflects greater disability.
measure: Changes in Kinesiophobia between baseline and follow-up periods
time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
description: Tampa Scale for Kinesiophobia. To assess the fear of movement and pain-related fear. The 11 items are scored 1-4, with total scores ranging from 11 to 44. The addition of all the points obtained from each of the items results in the level of kinesiophobia, with higher scores indicating greater perceived kinesiophobia
measure: Changes in Pain Catastrophizing between baseline and follow-up periods
time frame: Baseline, 1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
description: Pain Catastrophizing Scale (PCS). This tool is a 13-item questionnaire designed to measure the three components of pain-related catastrophizing: rumination, magnification, and helplessness, resulting in a unique score. Each item is responded to on a 5-point scale (0 not at all, 4 all the time) relating the degree to which the individual experiences a thought or feeling of a painful situation.
measure: Changes in Self-perceived Improvement between baseline and follow-up periods
time frame: Baseline,1 week post-intervention, and 1, 3, 6 and 12 months after the intervention
description: Global ratings on changes in regards to their level of elbow well-being since the treatment on a 15-point self-report scale (from -7, very much worse, to 7, completely recover)
arm group label: PENS plus exercise group
arm group type: Active Comparator
description: Experimental: PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently . It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
arm group label: Sham PENS plus exercise group
arm group type: Sham Comparator
description: Sham Comparator: Sham PENS plus exercise group 4-week intervention program with 1 weekly treatment session, one of percutaneous electrical stimulation. In addition, self-management loaded exercise, prescribed by the physical therapist but completed by the patient independently. It involved isometric exercises, eccentric exercise, eccentric-concentric with weight or resistive therapeutic band.
intervention type: Other
intervention name: PENS plus exercise
description: The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle
Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe
The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:
TENS Frequency 2 Hz
TENS Pulse width - 250 microseconds
Duration - 30 minutes.
TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.
Administration - One per week
Self-management loaded exercises prescribed by a physical therapist, two times per week.
arm group label: PENS plus exercise group
intervention type: Other
intervention name: Sham PENS plus exercise
description: The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle
Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe
The electrical current will not be working, and the needles will be placed during 30 minutes:
- Administration - One per week
Self-management loaded exercises prescribed by a physical therapist, two times per week.
arm group label: Sham PENS plus exercise group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gustavo Plaza, PT, PhD
phone: 609578380
phone ext: +34
email: gusplaza@ucm.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
mesh term: Tennis Elbow