<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/NCT03241134</url>
  </required_header>
  <id_info>
    <org_study_id>01N04215</org_study_id>
    <nct_id>NCT03241134</nct_id>
  </id_info>
  <brief_title>Changes in Surface EMG Activity After Dry Needling Compared to Sham Needling</brief_title>
  <official_title>Changes in Surface Electromyographic Activity of the Upper Trapezius After Dry Needling, Compared to Sham Needling, in Office Workers With Work-related Trapezius Myalgia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Ghent</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>
      An experimental study will be conducted to evaluate the effect of a single dry needling&#xD;
      session, compared to a sham needling session, on surface EMG activity (signal amplitude and&#xD;
      frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neck-shoulder pain is a prevalent problem in office workers. These complaints are often&#xD;
      related to myofascial dysfunctions of neck and shoulder muscles, in which the upper trapezius&#xD;
      is a vulnerable victim due to prolonged static postures, repetitive upper limb movements and&#xD;
      stress, often present during office and computer work. Myofascial dysfunction of the upper&#xD;
      trapezius muscle is often referred to as &quot;trapezius myalgia (TM)&quot;. Trapezius myalgia is&#xD;
      clinically diagnosed with the presence of pain, palpable stiffness and tenderness of the&#xD;
      upper part of the trapezius muscle. Several studies show that myofascial trigger points&#xD;
      (MTrPs) play an important role in the development and maintenance of myofascial pain and&#xD;
      trapezius myalgia. Myofascial trigger points are defined as hyperirritable nodules in a&#xD;
      contracture of skeletal muscle fibers, which can cause pain symptoms, motor symptoms as well&#xD;
      as autonomic symptoms.&#xD;
&#xD;
      The pathophysiology of MTrPs is still unclear but several hypotheses exist. The most&#xD;
      plausible explanation is that, due to sustained postures or repetitive low-level tasks, a&#xD;
      sustained irritation of motor end plates with an excessive release of acetylcholine arises.&#xD;
      This may lead to a persistent sarcomere contraction, leading to an impaired local blood&#xD;
      circulation, a reduced tissue oxygenation and energy depletion, the sensitisation of&#xD;
      nociceptors and thus the development of pain.&#xD;
&#xD;
      Dry needling (DN) is a myofascial treatment technique, which has been gaining interest in&#xD;
      recent years. During dry needling, a thin, solid filiform needle is inserted directly into&#xD;
      the MTrP. During this treatment, local twitch responses can be elicited. These are&#xD;
      involuntary contractions of muscle fibers, leading to muscle relaxation, an increased local&#xD;
      blood flow, recovery of the muscle metabolism and thus a reduction of pain and stiffness.&#xD;
&#xD;
      In this experimental study, 60 office workers with trapezius myalgia are recruited from&#xD;
      several work places with predominantly computer based tasks. Participants are required to&#xD;
      perform at least 20 hours of computer work a week, and this since at least one year.&#xD;
      Participants are included based on online questionnaires, a clinical examination of neck and&#xD;
      shoulder, and the identification of a MTrP in the upper trapezius muscle. All participants&#xD;
      will receive information and have to sign an informed consent form.&#xD;
&#xD;
      Participants will be subjected to baseline assessment, which involves measurements of the&#xD;
      surface EMG activity (during rest ) and pain scores. Then, subjects will be required to&#xD;
      perform a computer task during 20 minutes, surface EMG activity will be measured every 5&#xD;
      minutes. After this computer task, surface EMG activity (during rest ) and pain scores will&#xD;
      be measured again. Then, participants will be randomly allocated to either a dry needling&#xD;
      group or a sham needling group. The dry needling group will receive a dry needling treatment&#xD;
      at the identified trigger point location of the upper trapezius, whereas the sham needling&#xD;
      group will receive an intervention in which the needle only penetrates the skin but not the&#xD;
      fascia and muscle tissue. After the treatment, surface EMG activity and pain scores will be&#xD;
      measured again immediately after, 15 minutes and 30 minutes after completion of the&#xD;
      intervention. Thereafter, pain scores will be asked daily, during 7 days after completion of&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">May 9, 2018</completion_date>
  <primary_completion_date type="Actual">May 9, 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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in resting surface EMG activity (amplitude, RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo</measure>
    <time_frame>Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes and 30 minutes after dry or sham needling</time_frame>
    <description>Changes in resting EMG activity (amplitude, Root Mean Square) of the upper trapezius immediately after, 15 minutes and 30 minutes after dry needling, compared to EMG activity after a typing task, will be measured using surface electrodes placed bilaterally at the MTrP location of the upper trapezius. The change in resting surface EMG activity after dry needling will be compared with the change in surface EMG activity after sham needling.&#xD;
Resting surface EMG activity will be expressed as a percentage of a submaximal reference contractions of the upper trapezius (% reference contractions)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in surface EMG activity (amplitude, Root Mean Square) of the upper trapezius during a fatiguing typing task of 20 minutes as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo</measure>
    <time_frame>During the typing task, every five minutes EMG activity will be measured for 30 seconds</time_frame>
    <description>Changes in EMG activity (amplitude, Root Mean Square) of the upper trapezius during a typing task of 20 minutes, will be measured by using surface electrodes placed bilaterally at the MTrP location of the upper trapezius.&#xD;
EMG activity during this typing task will be expressed as a percentage of submaximal reference contractions of the upper trapezius (% reference contractions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain score after dry needling, compared to sham needling, as assessed by the numeric rating scale</measure>
    <time_frame>Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes after dry or sham needling, 30 minutes after dry or sham needling, daily during the seven days following the treatment</time_frame>
    <description>Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) after a typing task, immediately after dry or sham needling, 15 minutes after dry or sham needling and 30 minutes after dry or sham needling. In the 7 days following the treatment, pain scores will be asked daily to the participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pain score after a typing task of 20 minutes as assessed by the numeric rating scale</measure>
    <time_frame>Immediately before and after a typing task of 20 minutes</time_frame>
    <description>Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) before and after a typing task of 20 minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Neck Pain, Posterior</condition>
  <condition>Work-Related Condition</condition>
  <arm_group>
    <arm_group_label>Dry needling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dry needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down in multiple directions. In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham needling</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A single sham needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry needling</intervention_name>
    <description>Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.</description>
    <arm_group_label>Dry needling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham needling</intervention_name>
    <description>During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.</description>
    <arm_group_label>Sham needling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Performing office work since at least one year&#xD;
&#xD;
          -  Performing computer based tasks for at least 20 hours a week&#xD;
&#xD;
          -  NRS &gt; or equal to 3/10&#xD;
&#xD;
          -  Clinical diagnosis of trapezius myalgia&#xD;
&#xD;
          -  Trapezius myalgia is work-related and thus aggravates during working day/ week&#xD;
&#xD;
          -  Presence of a trigger point in the upper trapezius muscle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being in treatment during the study&#xD;
&#xD;
          -  Traumatic injuries/surgery to neck and upper limb region&#xD;
&#xD;
          -  Signs of cervical nerve root impingement&#xD;
&#xD;
          -  Whiplash injury&#xD;
&#xD;
          -  Cardiovascular, neurological, life threatening, systemic and metabolic diseases&#xD;
&#xD;
          -  Diagnosis of fibromyalgia/chronic fatigue syndrome&#xD;
&#xD;
          -  Shoulder pathology&#xD;
&#xD;
          -  Coagulation disorders&#xD;
&#xD;
          -  Pregnancy&#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>Barbara Cagnie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University</name>
      <address>
        <city>Ghent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>June 29, 2018</last_update_submitted>
  <last_update_submitted_qc>June 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Ghent</investigator_affiliation>
    <investigator_full_name>Vakgroeprevaki</investigator_full_name>
    <investigator_title>Prof. Dr. Barbara Cagnie</investigator_title>
  </responsible_party>
  <keyword>Dry needling</keyword>
  <keyword>Sham needling</keyword>
  <keyword>Office workers</keyword>
  <keyword>Myofascial pain</keyword>
  <keyword>Surface electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck 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/NCT03241134
org study id: 01N04215
nct id: NCT03241134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An experimental study will be conducted to evaluate the effect of a single dry needling
      session, compared to a sham needling session, on surface EMG activity (signal amplitude and
      frequency) and pain of the upper trapezius muscle, in office workers with trapezius myalgia.
Neck-shoulder pain is a prevalent problem in office workers. These complaints are often
      related to myofascial dysfunctions of neck and shoulder muscles, in which the upper trapezius
      is a vulnerable victim due to prolonged static postures, repetitive upper limb movements and
      stress, often present during office and computer work. Myofascial dysfunction of the upper
      trapezius muscle is often referred to as "trapezius myalgia (TM)". Trapezius myalgia is
      clinically diagnosed with the presence of pain, palpable stiffness and tenderness of the
      upper part of the trapezius muscle. Several studies show that myofascial trigger points
      (MTrPs) play an important role in the development and maintenance of myofascial pain and
      trapezius myalgia. Myofascial trigger points are defined as hyperirritable nodules in a
      contracture of skeletal muscle fibers, which can cause pain symptoms, motor symptoms as well
      as autonomic symptoms.

      The pathophysiology of MTrPs is still unclear but several hypotheses exist. The most
      plausible explanation is that, due to sustained postures or repetitive low-level tasks, a
      sustained irritation of motor end plates with an excessive release of acetylcholine arises.
      This may lead to a persistent sarcomere contraction, leading to an impaired local blood
      circulation, a reduced tissue oxygenation and energy depletion, the sensitisation of
      nociceptors and thus the development of pain.

      Dry needling (DN) is a myofascial treatment technique, which has been gaining interest in
      recent years. During dry needling, a thin, solid filiform needle is inserted directly into
      the MTrP. During this treatment, local twitch responses can be elicited. These are
      involuntary contractions of muscle fibers, leading to muscle relaxation, an increased local
      blood flow, recovery of the muscle metabolism and thus a reduction of pain and stiffness.

      In this experimental study, 60 office workers with trapezius myalgia are recruited from
      several work places with predominantly computer based tasks. Participants are required to
      perform at least 20 hours of computer work a week, and this since at least one year.
      Participants are included based on online questionnaires, a clinical examination of neck and
      shoulder, and the identification of a MTrP in the upper trapezius muscle. All participants
      will receive information and have to sign an informed consent form.

      Participants will be subjected to baseline assessment, which involves measurements of the
      surface EMG activity (during rest ) and pain scores. Then, subjects will be required to
      perform a computer task during 20 minutes, surface EMG activity will be measured every 5
      minutes. After this computer task, surface EMG activity (during rest ) and pain scores will
      be measured again. Then, participants will be randomly allocated to either a dry needling
      group or a sham needling group. The dry needling group will receive a dry needling treatment
      at the identified trigger point location of the upper trapezius, whereas the sham needling
      group will receive an intervention in which the needle only penetrates the skin but not the
      fascia and muscle tissue. After the treatment, surface EMG activity and pain scores will be
      measured again immediately after, 15 minutes and 30 minutes after completion of the
      intervention. Thereafter, pain scores will be asked daily, during 7 days after completion of
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Changes in resting surface EMG activity (amplitude, RMS) of the upper trapezius after dry needling or sham needling as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo
time frame: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes and 30 minutes after dry or sham needling
description: Changes in resting EMG activity (amplitude, Root Mean Square) of the upper trapezius immediately after, 15 minutes and 30 minutes after dry needling, compared to EMG activity after a typing task, will be measured using surface electrodes placed bilaterally at the MTrP location of the upper trapezius. The change in resting surface EMG activity after dry needling will be compared with the change in surface EMG activity after sham needling.
Resting surface EMG activity will be expressed as a percentage of a submaximal reference contractions of the upper trapezius (% reference contractions)
measure: Changes in surface EMG activity (amplitude, Root Mean Square) of the upper trapezius during a fatiguing typing task of 20 minutes as assessed by the EMG Noraxon 16k Telemyo Device: EMG Noraxon 16k Telemyo
time frame: During the typing task, every five minutes EMG activity will be measured for 30 seconds
description: Changes in EMG activity (amplitude, Root Mean Square) of the upper trapezius during a typing task of 20 minutes, will be measured by using surface electrodes placed bilaterally at the MTrP location of the upper trapezius.
EMG activity during this typing task will be expressed as a percentage of submaximal reference contractions of the upper trapezius (% reference contractions).
measure: Changes in pain score after dry needling, compared to sham needling, as assessed by the numeric rating scale
time frame: Immediately after a typing task of 20 minutes, immediately after dry or sham needling, 15 minutes after dry or sham needling, 30 minutes after dry or sham needling, daily during the seven days following the treatment
description: Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) after a typing task, immediately after dry or sham needling, 15 minutes after dry or sham needling and 30 minutes after dry or sham needling. In the 7 days following the treatment, pain scores will be asked daily to the participants.
measure: Changes in pain score after a typing task of 20 minutes as assessed by the numeric rating scale
time frame: Immediately before and after a typing task of 20 minutes
description: Subjects will have to report their actual pain complaints on a numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain) before and after a typing task of 20 minutes.
arm group label: Dry needling
arm group type: Experimental
description: A single dry needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into skin surface, fascia, into the muscle tissue at the MTrP location, and will move the needle up and down in multiple directions. In case local twitch responses are elicited, this will be repeated until the local twitch responses are extinct.
arm group label: Sham needling
arm group type: Sham Comparator
description: A single sham needling session will be performed with the subject lying on the non painful side. After palpation of a taut band, and detection of a MTrP in the upper trapezius muscle, a trained physiotherapist will penetrate the needle into the skin surface at the MTrP location. The fascia and muscle tissue will not be penetrated.
intervention type: Other
intervention name: Dry needling
description: Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.
arm group label: Dry needling
intervention type: Other
intervention name: Sham needling
description: During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.
arm group label: Sham needling
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Barbara Cagnie, PhD
role: Principal Investigator
affiliation: University Ghent
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Ghent
investigator full name: Vakgroeprevaki
investigator title: Prof. Dr. Barbara Cagnie
mesh term: Neck Pain
sharing ipd: No