<?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>IRCT20221117056531N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-20</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison between acupuncture with Laser and acupuncture with acupressure on pain and function of patients with knee arthrosis.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between acupuncture with Laser and acupuncture with acupressure on pain and function of patients with knee osteoarthritis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, the researcher who conducts the intervention is blinded, and the allocation of people into three groups and the registration of their characteristics will be done by another person.</study_design>
      <phase>N/A</phase>
      <hc_freetext>knee mosteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: Acupuncture - In this group, during six treatment sessions, first 15 minutes of IR rays and then 5 points of acupuncture XI YAN-SP9-GB34-ST35-ST36 are performed for twenty minutes. Eco needle is used in size 2.5 cm long and 0.25 mm in diameter. Intervention 2: Intervention group 2: Acupuncture and laser acupuncture points - In this group, during six treatment sessions, first 15 minutes of IR rays are received. Then, for 20 minutes, acupuncture points XI YAN-SP9-GB34-ST35-ST36 are subjected to acupuncture with echo needles of 25 mm size and 0.25 mm diameter. Then laser the same points for 5 minutes with MODE parameters; PULSED- PEAK POWER; 150 mW- AVERAGE POWER: 100 mW- DOSE 6 J PER POINT- NUMBER OF POINT 5 is performed with 870M laser of Novin company. Intervention 3: Intervention group 3: Acupuncture and acupressure - in this group, during six treatment sessions, first 15 minutes of IR rays are received. Then, for 20 minutes, acupuncture points XI YAN-SP9-GB34-ST35-ST36 are subjected to acupuncture with echo needles of size 25 mm and 0.25 mm in diameter. Then, for 7 minutes, acupressure on the same points with thumb pressure Therapist's hand is performed for 80 seconds to create a sensation. Then the patient performs active knee movements for 5 minutes.</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:
Part of primary and secondary outcome data

When:
The access period starts 6 months after the results are published

To whom:
Industrial and academic researchers

Conditions:
Personal use of documents is not allowed

Where to obtain:
aidazolghadr.pt@gmail.com
email

How to obtain:
Send a request to an email address and receive an initial response. Then sending the information by the researcher until one week later

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>aida zolghadr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>rajaei</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1373885693</zip>
        <telephone>+98 21 6632 5502</telephone>
        <email>aidazolghadr.pt@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aida zolghadr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>rajaei</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1373885693</zip>
        <telephone>+98 21 6632 5502</telephone>
        <email>aidazolghadr.pt@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 40 to 75 years
Chronic one-sided knee pain that has been going on for more than 6 months (33)
Diagnosis of grade 2 or 3 osteoarthritis with radiology according to the Kellgren-Lawrence scale (33) diagnosed by the evaluating therapist
BMI: 18.5-29.9
The amount of pain as much as 40 to 90% of the total VAS score6.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having contraindications for acupuncture (including infection and open wound or cancer) (20)
Suffering from other chronic diseases in the critical phase
3. Intra-articular injection, use of knee support, surgery or use of drugs that affect treatment and evaluation.
history of joint injections to reduce pain in the past 30 days or the intention to do so during the study (20),
attendance during pregnancy and breastfeeding (30)
history of performing single or combined treatments or physiotherapy in the last 6 months (17)
Having a pacemaker and taking anticoagulant drugs (17) and uncontrolled blood pressure
history of surgery in the considered knee (20)
radiographic evidence of severe osteoarthritis in the patellofemoral joint</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M00-M99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>اختلال ماهیچه ای استخوانی= آرتروز زانو</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: Acupuncture - In this group, during six treatment sessions, first 15 minutes of IR rays and then 5 points of acupuncture XI YAN-SP9-GB34-ST35-ST36 are performed for twenty minutes. Eco needle is used in size 2.5 cm long and 0.25 mm in diameter.</i_keyword>
      <i_keyword>Intervention group 2: Acupuncture and laser acupuncture points - In this group, during six treatment sessions, first 15 minutes of IR rays are received. Then, for 20 minutes, acupuncture points XI YAN-SP9-GB34-ST35-ST36 are subjected to acupuncture with echo needles of 25 mm size and 0.25 mm diameter. Then laser the same points for 5 minutes with MODE parameters; PULSED- PEAK POWER; 150 mW- AVERAGE POWER: 100 mW- DOSE 6 J PER POINT- NUMBER OF POINT 5 is performed with 870M laser of Novin company</i_keyword>
      <i_keyword>Intervention group 3: Acupuncture and acupressure - in this group, during six treatment sessions, first 15 minutes of IR rays are received. Then, for 20 minutes, acupuncture points XI YAN-SP9-GB34-ST35-ST36 are subjected to acupuncture with echo needles of size 25 mm and 0.25 mm in diameter. Then, for 7 minutes, acupressure on the same points with thumb pressure Therapist's hand is performed for 80 seconds to create a sensation. Then the patient performs active knee movements for 5 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity according to VAS. Timepoint: Baseline - first session - sixth session - after three weeks. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Performance change. Timepoint: Baseline - session one - session six - three weeks later. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index Total score.</sec_outcome>
      <sec_outcome>Changing the range of motion of Aktiochum and opening the knee. Timepoint: Baseline - session one - session six - three weeks later. Method of measurement: By 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-16</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Rajaee St تهران Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
