<?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>IRCT20141216020330N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of dry needling in knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of hamstring muscle dry needling with routine physiotherapy on pain , flexibility and function of patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72328</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trail, blocked randomization process will be used. there will be blocks of 4 in which the number of participants in each treatment group will be equal in blocks. The website"www.randomizer.org" will be used to create the blocks, blocks would be 6 series of 4 including the A and B letters. Letter A for the dry needling group and letter B standing for the control group. according to the calculated sample size, for selection of the blocks we will roll the dice and this randomized selection will repeat for 10 times, Blinding description: In this study assessor blinding method will be used, then the study will be single-blinded in the way that the assessor will not have any information about grouping of the participant.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: including 10 sessions of treatment ,3 sessions per week, patients will recieve routine physiotherapy as electrical stimulation and mobilization manual therapy and therapeutic exercise and in 5 session as every other day the participants will have dry needling on 6 specific points of Hamstring muscle. Intervention 2: Control group: including 10 sessions of treatment ,3 sessions per week, patients will receive routine physiotherapy as electrical stimulation and mobilization manual therapy and therapeutic exercise.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying participants

When:
The access period starts 3 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
Everyone who conducts research on clinical studies can request access to documents and non-identifiable data for any type of statistical analysis related to the studies.

Where to obtain:
In order to access the documents, the applicants can visit the Faculty of Rehabilitation Sciences of the University of Iran, located in Tehran, Mirdamad Square, Mader Square, Shahid Shah Nazari Street, or contact them via email at amiri.a@iums.ac.ir.

How to obtain:
After requesting documents, the applicant can receive the information within a week by coordinating through communication channels.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, University of Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>amiri.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Rehabilitation Sciences, University of Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>amiri.a@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>mild to moderate knee osteoarthritis diagnosis, grade 2-3 of KL(Kellgren-Lawrence) scale
Reduced flexibility of Hamstring muscle
Pain score of Min 2 units and Max 7 units of NPRS</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acute inflammation and swelling in knee joint
History of fracture in vertebral column or lower extremity in past 3 months
History of surgery in any of lower extremities in past 3 months
History of previous surgery in painful and osteoarthritic knee
History of physiotherapy, acupuncture or intra-articular injection treatment through past 3 months
Uncontrolled systemic or background disease like Diabetic or Rhumatoid Aethritis limiting activities of daily living
Immune deficiency disease
bleeding disorder ex: Hemophilia or Thalassemia
Fear of dry needles
Having at least 2 neurological signs
Cancer
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee, Hamstring, Flexibility and Dry needling</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: including 10 sessions of treatment ,3 sessions per week, patients will recieve routine physiotherapy as electrical stimulation and mobilization manual therapy and therapeutic exercise and in 5 session as every other day the participants will have dry needling on 6 specific points of Hamstring muscle</i_keyword>
      <i_keyword>Control group: including 10 sessions of treatment ,3 sessions per week, patients will receive routine physiotherapy as electrical stimulation and mobilization manual therapy and therapeutic exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention and after 10 sessions of intervention. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Flexibility. Timepoint: Before intervention and after 10 sessions of intervention. Method of measurement: Measuring range of motion using goniometry by Straight Leg Raising Test and Active/Passive Knee Extension Test.</sec_outcome>
      <sec_outcome>Function. Timepoint: Before intervention and after 10 sessions of intervention. Method of measurement: Timed Up and Go Test, Knee Injury and Osteoarthritis Outcome Score questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-23</approval_date>
        <contact_name>Ethics committee of Iran university of medical sciences</contact_name>
        <contact_address>Hemmat highway next to Milad tower Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
