<?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>IRCT20210314050704N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-23</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of dry needling on knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of physiotherapy and physiotherapy with dry needling on pain, Range of motion, physical function, functional performance and the effectiveness of treatment in patients with primary knee osteoarthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55667</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization using closed envelopes so that the number of samples, gender and unilateral or bilateral osteoarthritis are equal in two groups. The 4-volume random block allocation method will be used. All possible 4 permutations will be listed in two groups (permutations 1 to 6 are as follows) A is the intervention group and B is the control group:
 1-AABB 2-ABAB 3-BAAB 4-BABA 5-BBAA 6-ABBA 
Then, from a random number table with a random starting point, 6 numbers between 1 and 6 will be randomly selected (either using software or randomaize.com). For example, if the 6 random numbers obtained are 3 5 4 3 4 6 , It will mean that the first four people similar to block 3, the second four people similar to block 5 and ... will be allocated, Blinding description: This study will be performed in a double-blind manner and the blinding includes a physiotherapist who performs the pre- and post-treatment evaluation in addition to the person who analyzes the data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Physiotherapy with dry needling. Participants in this group receive 12 sessions (3 times a week) of routine physiotherapy (Electrotherapy, manual therapy and exercise therapy) with dry needling at the trigger points of the muscles around the knee and hip. Intervention 2: Control group: Routine physiotherapy. Participants in this group receive 12 sessions (3 times a week) of routine physiotherapy (Electrotherapy, manual therapy and exercise therapy).</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>Mahdie Morshedlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 862, Manzari Ave., West Farjam Blvd., Narmak., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1681984111</zip>
        <telephone>+98 51 4326 3656</telephone>
        <email>MorshedlouM981@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Asghar Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Science, Vakilabad Blvd., Mashhad Town</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9185763788</zip>
        <telephone>+98 51 3882 7029</telephone>
        <email>Hosseiniha@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants aged 40 years or older with knee pain and uni- or bilateral dysfunction
Diagnosis of primary knee osteoarthritis based on clinical and radiographic findings (Kellgren-Lawrence 1-3)
At least one active or one latent myofascial trigger point elicited by palpation ipsilateral to the painful knee(s)
Pain of at least 2 on the NRS scale for more than 3 months</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from other conditions that could cause myofascial or neuropathic pain in the lower limb, such as lumbar radiculopathy, saphenous nerve entrapment, or paresthetica meralgia
Previous total replacement of the same knee or both knees
Any other surgical procedure of the lower limbs in the previous six months
Medical record for myopathy or lumbo-sacral neuropathy
physical therapy, acupuncture or other treatments for the painful knee in the last 6 months
Inflammatory joint disease such as rheumatoid arthritis
Serious trauma or systematic disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Physiotherapy with dry needling. Participants in this group receive 12 sessions (3 times a week) of routine physiotherapy (Electrotherapy, manual therapy and exercise therapy) with dry needling at the trigger points of the muscles around the knee and hip.</i_keyword>
      <i_keyword>Control group: Routine physiotherapy. Participants in this group receive 12 sessions (3 times a week) of routine physiotherapy (Electrotherapy, manual therapy and exercise therapy).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity in Numeric Rating Scale index. Timepoint: Before and after the intervention. Method of measurement: Numeric Rating Scale index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Knee joint range of motion. Timepoint: Before and after the intervention. Method of measurement: Goniometer.</sec_outcome>
      <sec_outcome>Physical function. Timepoint: Before and after the intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index questionnaire.</sec_outcome>
      <sec_outcome>Functional performance. Timepoint: Before and after the intervention. Method of measurement: Timed Up and Go test.</sec_outcome>
      <sec_outcome>The effectiveness of treatment. Timepoint: After the intervention. Method of measurement: Global Rating of Change scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-05</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Faculty of Paramedical Sciences, Mashhad University of Medical Sciences, Azadi Sq Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
