<?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>IRCT20221026056300N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-12</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effects of adding dry needling technique to manual therapy in treatment of  patients with knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The effects of adding dry needling technique to Mulligan’s mobilization with movement technique along with exercise therapy on pain, range of motion, disability and balance in patients with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66612</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is added value study.it means that dry needling technique is added to mulligan's mobilization with movement technique.one group receives Mulligan’s mobilization with movement technique along with exercise therapy with dry needling technique and another group receives Mulligan’s mobilization with movement technique along with exercise with sham dry needling technique, Randomization description: Random allocation method in this study is Permuted Block Randomization. A represents the person who receives mulligan's mobilization with movement technique along with exercise therapy with dry needling technique and B represents the person who receives mulligan's mobilization with movement technique along with exercise therapy with sham dry needling technique. This method runs with considering 4 blocks that the number of all possible 4 permutations equals 6. (4 permutations blocks consist of: ABAB ،ABBA ،BAAB ،BABA ،AABB ،BBAA)
We assign a number to each mode. Using Random Numbers Table, a list with 48 persons will be produced, Blinding description: In this study, main student doing initial assessment based on inclusion and exclusion criteria and treatments in patients. assistant student collecting data from patients and analyzing them. Allocation base on Permuted Block Randomization and for blinding in patients, sham dry needling applied in that way that the patient can't realize that it is not real.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mulligan's mobilization with movement technique along with exercise therapy with dry needling technique. Intervention 2: Intervention group: Mulligan's mobilization with movement technique along with exercise therapy with sham dry needling technique.</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 "No more information".</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Eshghi Vasoukolaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 8, Farhang Avenue, Motahari Street</address>
        <city>Khormouj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7541835981</zip>
        <telephone>+98 77 3532 8595</telephone>
        <email>maryameshghivasoukolaei@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sara Abolahrari Shirazi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiotherapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Chamran Blvd., Abiverdi 1 Ave., Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 77 3627 1552</telephone>
        <email>sahrari@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 45 - 70,
Unilateral or bilateral knee pain and dysfunction, in bilateral knee pain, the knee with more pain will be cured,
Knee osteoarthritis with grade 2 and 3 Kellgren &amp; Lawrence,
At least one active trigger point in muscles around knee that refer pain,
Knee pain more than 3 in VAS scale,
Ability to walk for 6 meters and more,
Disability more than 25 in WOMAC scale,
At least 10 degrees loss in knee flexion range of motion.</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neuropathic pain in lower limb,
Knee replacement surgery,
Surgery in other parts of lower limb in last 6 month.
Radicular pain in knee,
Neurologic diseases,
Rheumatoid Arthritis,
Steroid and analgesic injection in last 3 month in knee,
Fibromyalgia syndrome,
Patellar tendinopathy,
Inflammation or active infection signs in knee,
Pregnancy,
Diabetes,
Epilepsy,
Immune system diseases like AIDS, Cancer, Hepatitis,
Phobia of needle in dry needling technique,
Any treatment for trigger points in considering muscles in last 3 month,
Vascular disease associated with unusual bleeding,
Treatment with Anticoagulants,
Pain in lower limb associated with low back pain,
Fracture or any other orthopedic problem in involved lower limb,
Musculoskeletal disorders in other joints in lower limb (except osteoarthritis)
Physiotherapy sessions in last 3 month for knee joint.</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: Mulligan's mobilization with movement technique along with exercise therapy with dry needling technique</i_keyword>
      <i_keyword>Intervention group: Mulligan's mobilization with movement technique along with exercise therapy with sham dry needling technique</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Knee Range of Motion. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index questionnaire.</prim_outcome>
      <prim_outcome>Number of active trigger points in muscles around knee. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Counting active trigger points.</prim_outcome>
      <prim_outcome>Local pain of trigger points in muscles around knee. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional mobility. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Timed Up and Go test.</sec_outcome>
      <sec_outcome>Balance. Timepoint: Before treatment, After treatment, 4 weeks after treatment. Method of measurement: Modified STAR Excursion Balance Test (mSEBT).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-19</approval_date>
        <contact_name>Ethics committee of shiraz university of medical sciences</contact_name>
        <contact_address>Seventh floor, Central building of Shiraz university of medical sciences, Zand ave., Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
