<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/NCT03236779</url>
  </required_header>
  <id_info>
    <org_study_id>ALBOLOUSHI</org_study_id>
    <nct_id>NCT03236779</nct_id>
  </id_info>
  <brief_title>A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain</brief_title>
  <official_title>A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad San Jorge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Kuwait</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Zaragoza</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>
      This is a clinical trial that will be done in the state of Kuwait, at the physical&#xD;
      rehabilitation medicine hospital. the participants will be recruited from all over Kuwait,&#xD;
      there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of&#xD;
      health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Physical therapy approaches continue evolving. During the last years, minimally invasive&#xD;
      techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining&#xD;
      promising results for tendon pathology. PNE technique is a minimally invasive treatment that&#xD;
      consists of an application of a galvanic electrolytic current that causes a controlled local&#xD;
      inflammatory process in the target tissue. This allows for phagocytosis and the subsequent&#xD;
      regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to&#xD;
      manage MTrP, but there are no studies supporting that they have an additional beneficial&#xD;
      effect over DN.&#xD;
&#xD;
      From a biological point of view, it seems reasonable to ascertain that a patient will obtain&#xD;
      benefits thanks to the mechanical effects provided by the needle and that patients may&#xD;
      benefit more if the electrolysis effect is added to the mechanical stimuli provided by the&#xD;
      needle. Therefore, the aim of this randomized controlled study is to compare the&#xD;
      effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2018</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 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>This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Foot Health Status Questioner (FHSQ) PAIN</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks</time_frame>
    <description>Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS Maximum</measure>
    <time_frame>1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)</time_frame>
    <description>Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)</measure>
    <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks&quot;</time_frame>
    <description>The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Plantar Fascitis</condition>
  <condition>Myofacial Pain Syndromes</condition>
  <condition>Trigger Point Pain, Myofascial</condition>
  <arm_group>
    <arm_group_label>Dry needling (DN) arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous needle electrolysis (PNE) arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dry needling</intervention_name>
    <description>The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
    <arm_group_label>Dry needling (DN) arm</arm_group_label>
    <arm_group_label>Percutaneous needle electrolysis (PNE) arm</arm_group_label>
    <other_name>Percutaneous needle electrolysis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the&#xD;
             International Classification of Function, Disability, and Health from the Orthopedic&#xD;
             Section of the American Physical Therapy Association&#xD;
&#xD;
          -  Age greater than 21 years according to the Kuwaiti law.&#xD;
&#xD;
          -  History of plantar heel pain for greater than one month.&#xD;
&#xD;
          -  Walking 50 meters without any support&#xD;
&#xD;
          -  Having MTPs on initial physical examination on plantar and calf muscles&#xD;
&#xD;
          -  Accepting to be treated by a male physiotherapist.&#xD;
&#xD;
          -  Capacity to understand the study and the informed consent, as well as having signed&#xD;
             the document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Needle phobia&#xD;
&#xD;
          -  Allergy from needles or hypersensitivity to metals&#xD;
&#xD;
          -  Presence of coagulopathy or use of anticoagulants&#xD;
&#xD;
          -  Presence of peripheral arterial vascular disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Dermatological disease with the dry needling area&#xD;
&#xD;
          -  The presence of a chronic medical condition that might preclude participation in the&#xD;
             study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis,&#xD;
             ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy,&#xD;
             mononeuropathy.&#xD;
&#xD;
          -  Treatment of plantar heel pain with needling or acupuncture during last 4 weeks.&#xD;
&#xD;
          -  A history of injection therapy in the heel in the previous three months.&#xD;
&#xD;
          -  Previous history of foot surgery or fracture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Physical Medicine and rehabilitation Kuwait</name>
      <address>
        <city>Kuwait</city>
        <country>Kuwait</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kuwait</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <results_first_submitted>July 30, 2020</results_first_submitted>
  <results_first_submitted_qc>January 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2021</results_first_posted>
  <last_update_submitted>January 23, 2021</last_update_submitted>
  <last_update_submitted_qc>January 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>ZAID AL BOLOUSHI</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Plantar</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Facial Neuralgia</mesh_term>
    <mesh_term>Facial Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>ACCORDING TO THE LAW AND REGULATIONS FROM THE ETHICAL COMMITTEE IN KUWAIT. I CAN'T SHARE THE NAME OF THE PATIENTS, THEIR CONTACT OR ID. OTHER DATA WHICH ARE RELATED TO THE STUDY I CAN SHARE.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03236779/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03236779/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dry Needling (DN) Arm</title>
          <description>Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
        </group>
        <group group_id="P2">
          <title>Percutaneous Needle Electrolysis (PNE) Arm</title>
          <description>The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dry Needling (DN) Arm</title>
          <description>Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
        </group>
        <group group_id="B2">
          <title>Percutaneous Needle Electrolysis (PNE) Arm</title>
          <description>The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.5" spread="8.9"/>
                    <measurement group_id="B2" value="48.1" spread="8.8"/>
                    <measurement group_id="B3" value="48.8" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Kuwait</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Foot Health Status Questioner (FHSQ) PAIN</title>
        <description>Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dry Needling (DN) Arm</title>
            <description>Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
          </group>
          <group group_id="O2">
            <title>Percutaneous Needle Electrolysis (PNE) Arm</title>
            <description>The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Foot Health Status Questioner (FHSQ) PAIN</title>
          <description>Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8" spread="18.8"/>
                    <measurement group_id="O2" value="40.4" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.4" spread="27.7"/>
                    <measurement group_id="O2" value="71.9" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.1" spread="28.4"/>
                    <measurement group_id="O2" value="67.4" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.8" spread="24.8"/>
                    <measurement group_id="O2" value="63.6" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>26 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8" spread="25.3"/>
                    <measurement group_id="O2" value="67.1" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>52 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4" spread="25.1"/>
                    <measurement group_id="O2" value="73.1" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS Maximum</title>
        <description>Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable</description>
        <time_frame>1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VAS DN</title>
            <description>the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain</description>
          </group>
          <group group_id="O2">
            <title>VAS PNE</title>
            <description>the average and maximum level of pain over the past 48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain</description>
          </group>
        </group_list>
        <measure>
          <title>VAS Maximum</title>
          <description>Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline 1st session</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.0"/>
                    <measurement group_id="O2" value="7.5" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2nd session</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="2.3"/>
                    <measurement group_id="O2" value="5.5" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3rd session</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="2.6"/>
                    <measurement group_id="O2" value="5.3" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4th session</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.9"/>
                    <measurement group_id="O2" value="4.5" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)</title>
        <description>The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks&quot;</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dry Needling (DN) Arm</title>
            <description>Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
          </group>
          <group group_id="O2">
            <title>Percutaneous Needle Electrolysis (PNE) Arm</title>
            <description>The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
          </group>
        </group_list>
        <measure>
          <title>The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)</title>
          <description>The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.23"/>
                    <measurement group_id="O2" value="0.67" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78" spread="0.22"/>
                    <measurement group_id="O2" value="0.76" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.72" spread="0.23"/>
                    <measurement group_id="O2" value="0.74" spread="0.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.30"/>
                    <measurement group_id="O2" value="0.70" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>26 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="0.29"/>
                    <measurement group_id="O2" value="0.73" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>52 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.27"/>
                    <measurement group_id="O2" value="0.77" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Foot Health Status Questioner (FHSQ) PAIN</title>
        <description>Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain</description>
        <time_frame>Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dry Needling (DN) Arm</title>
            <description>Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
          </group>
          <group group_id="O2">
            <title>Percutaneous Needle Electrolysis (PNE) Arm</title>
            <description>The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.&#xD;
dry needling: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.</description>
          </group>
        </group_list>
        <measure>
          <title>Foot Health Status Questioner (FHSQ) PAIN</title>
          <description>Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8" spread="18.8"/>
                    <measurement group_id="O2" value="40.4" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.4" spread="27.7"/>
                    <measurement group_id="O2" value="71.9" spread="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.1" spread="28.4"/>
                    <measurement group_id="O2" value="67.4" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.8" spread="24.8"/>
                    <measurement group_id="O2" value="63.6" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>26 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8" spread="25.3"/>
                    <measurement group_id="O2" value="67.1" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>52 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.4" spread="25.1"/>
                    <measurement group_id="O2" value="73.1" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year follow up</time_frame>
      <desc>Unable to tolerate pain of the treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>Dry Needling</title>
          <description>Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle entry was performed. The chosen technique for manipulating the needle was the technique described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 1Hz/sec (5 entries).</description>
        </group>
        <group group_id="E2">
          <title>Percutaneous Needle Electrolysis</title>
          <description>The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once the needle reached the relevant treatment area, this was needled in exactly the same manner as in the dry needling group, with the only difference being that the needle was transmitting an electrical current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to their pain tolerance).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>drop out</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>unable to tolerate pain</sub_title>
                <description>Unable to tolerate pain of the treatment</description>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="51"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Pablo Herrero Gallego. PT, PhD.</name_or_title>
      <organization>Head of iPhysio Research Group. Editor-in-Chief Journal of Invasive Techniques in Physical Therapy</organization>
      <phone>(+34) 646168248</phone>
      <email>pherrero@usj.es</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03236779
org study id: ALBOLOUSHI
nct id: NCT03236779
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a clinical trial that will be done in the state of Kuwait, at the physical
      rehabilitation medicine hospital. the participants will be recruited from all over Kuwait,
      there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of
      health.
Physical therapy approaches continue evolving. During the last years, minimally invasive
      techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining
      promising results for tendon pathology. PNE technique is a minimally invasive treatment that
      consists of an application of a galvanic electrolytic current that causes a controlled local
      inflammatory process in the target tissue. This allows for phagocytosis and the subsequent
      regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to
      manage MTrP, but there are no studies supporting that they have an additional beneficial
      effect over DN.

      From a biological point of view, it seems reasonable to ascertain that a patient will obtain
      benefits thanks to the mechanical effects provided by the needle and that patients may
      benefit more if the electrolysis effect is added to the mechanical stimuli provided by the
      needle. Therefore, the aim of this randomized controlled study is to compare the
      effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.
measure: Foot Health Status Questioner (FHSQ) PAIN
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
description: Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
measure: VAS Maximum
time frame: 1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4)
description: Participants will complete the visual analogue scale (VAS) before each treatment session, considering the level of pain they have just before start the treatment session and the highest level of pain they have had during the last 48 hours. The exact words of the questions will be: 1) what is the level of pain, as average, you have feel during last 48 hours?; and 2) what is the maximum level of pain you have feel during last 48 hours? Participants will be explained that a score of 0 indicates the absence of pain whereas a score of 10 represents the maximum tolerable pain. The VAS is widely used and is valid and reliable
measure: The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks"
description: The EQ-5D-5L self-report questionnaire is a descriptive system with five questions, each representing one dimension of health-related QoL, that is, mobility, self-care, daily activities, pain/discomfort and depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Scoring is based on a 0 to 100% scale, where 100% represent the best QoL.
arm group label: Dry needling (DN) arm
arm group type: Experimental
description: Once the clinician locates the MTrP, he will insert the needle over it and he will do a quick entry of the needle. The chosen technique to manipulate the needle will be Hong technique, which consist of quick entry and exit of the needle (fast in/fast out) to get local twitch response (LTR), it will be repeated 5 times with a rhythmic movement of 1Hz/sec. LTRs will be counted and registered.
arm group label: Percutaneous needle electrolysis (PNE) arm
arm group type: Active Comparator
description: The electrotherapy equipment used (Enraf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3, 1.5 mA for 5 seconds conveyed to the muscle will be applied. It will be done exactly the same way as in the DN group with the only difference that the needle will be transmitting the electrical current.
intervention type: Other
intervention name: dry needling
description: The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
arm group label: Dry needling (DN) arm
arm group label: Percutaneous needle electrolysis (PNE) arm
other name: Percutaneous needle electrolysis
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Kuwait
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: ZAID AL BOLOUSHI
investigator title: PhD student
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
mesh term: Myofascial Pain Syndromes
mesh term: Facial Neuralgia
mesh term: Facial Pain
sharing ipd: No
ipd description: ACCORDING TO THE LAW AND REGULATIONS FROM THE ETHICAL COMMITTEE IN KUWAIT. I CAN'T SHARE THE NAME OF THE PATIENTS, THEIR CONTACT OR ID. OTHER DATA WHICH ARE RELATED TO THE STUDY I CAN SHARE.
provided document: 
provided document: 
participant flow: 
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outcome list: 
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certain agreements: 
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