<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20170715035097N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-13</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of dry needling and ischemic pressure on trigger points in knee osteoarthritis patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of dry needling and ischemic compression on the trigger points of the lower half muscles behind the knee on pain and disability and muscle and joint stiffness in knee osteoarthritis patients: randomized clinical trial single-blind</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69497</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization is done using the block balanced randomization method. Considering that the current study has 3 groups, therefore, blocks of 6 letters are used, which is done by a site called Randomization.com. This site produces a list that is numbered from 1 to 60 according to the sample size of the study and one of the letters A, B or C is randomly written in front of each number. Then 60 envelopes are prepared, which are numbered from 1 to 60, According to the list produced by the site, the letter A, B or C in front of each number is written on a piece of paper and placed in the corresponding envelope, and the envelope is sealed, and before starting the treatment, the first patient is given envelope number 1 and to the second patient envelope number 2 and so on. Therefore, after opening each envelope, it is determined which group each patient belongs to, Blinding description: In this study, the outcome assessor is blinded to the  groups allocation and other parts of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: 3 sessions of dry needling twice a week on trigger points plus10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles). Intervention 2: Second intervention group: 3 sessions of ischemic compression (pressure) twice a week on trigger points plus 10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles). Intervention 3: Control group: 10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohsen Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Blind Alley, Daneshjoo Boulevard, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7736 4525</telephone>
        <email>mohsenshams48@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Blind Alley, Daneshjoo Boulevard, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 21 7739 4525</telephone>
        <email>mohsenshams48@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mild to moderate severity of osteoarthritis (grade I-III in the Kellgren-Lawrence scale)
The presence of at least one trigger point (latent or active) in the gastrocnemius and popliteus muscles based on the criteria of Travell and Simons, which can be detected by touch.
Age between 50-70 years
The pain level of knee osteoarthritis patients should be higher than 30 mm and less than 80 mm on the VAS scale and at least 3 months have passed since its onset.
Morning joint stiffness less than 30 minutes</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe inflammation/swelling of the knee
Any previous fracture or surgery of the lower limb
Systemic disease (such as rheumatoid arthritis or diabetes)
Contraindications to using dry needling, including pregnancy, malignancy, fear of needles, bleeding disorders (such as hemophilia or thalassemia), taking antiplatelet and anticoagulant drugs
Complete replacement of the knee joint on the affected side
Injection of opioid analgesics or corticosteroids in the last 30 days
Fibromyalgia syndrome
Physical therapy or dry needling in the last 3 months
Radiculopathy/myopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bilateral primary osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: 3 sessions of dry needling twice a week on trigger points plus10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles)</i_keyword>
      <i_keyword>Second intervention group: 3 sessions of ischemic compression (pressure) twice a week on trigger points plus 10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles)</i_keyword>
      <i_keyword>Control group: 10 daily routine physiotherapy sessions (Includes 20 minutes of conventional TENS with a frequency of 100 Hz and 50 microsecond duration as much as the patient feels with a hot pack on the back of the knee, quadriceps strengthening exercises, hip abductors and calf muscles)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Before the intervention - immediately after the end of the intervention. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: Before the intervention - immediately after the end of the intervention. Method of measurement: Knee injury and Osteoartritis Outcome Score questionnaire.</sec_outcome>
      <sec_outcome>Muscle stiffness. Timepoint: Before the intervention - immediately after the end of the intervention. Method of measurement: Shear wave elastosonography.</sec_outcome>
      <sec_outcome>Joint stiffness. Timepoint: Before the intervention - immediately after the end of the intervention. Method of measurement: Electrogoniometer and pendulum test.</sec_outcome>
      <sec_outcome>Pressure pain threshold. Timepoint: Before the intervention - immediately after the end of the intervention. Method of measurement: Algometer.</sec_outcome>
      <sec_outcome>Rang Of Motion. Timepoint: Before the intervention - immediately after the end of the intervention. Method of measurement: Standard goniometer.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-15</approval_date>
        <contact_name>University of social welfare and rehabilitation sciences</contact_name>
        <contact_address>Koodakyar Blind Alley , Daneshjoo Boulevard , Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
