<?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>IRCT20191208045652N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-04</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of electroacupuncture and exercise therapy on pelvic surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of exercise therapy with electroacupuncture with exercise therapy with electrical percutaneous nerve motility on pain, physical function and gait in people with complete hip arthroplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59637</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, for the first time, electroacupuncture for people who have had hip arthroplasty is examined to measure its effects, Blinding description: Participants, the therapist, and the person evaluating the participants go blind. Of course, participants are given enough information about how to enter the study first and they are explained. For physiotherapist, which also uses electroacupuncture or exercise therapy, it is blinded to prevent bias for interventions. Outcome assessment is also done for the person who does not know which group the participant is in and wants to score based on guesswork.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Total Hip Arthroplasty (THA).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  the intervention group, the first session of treatment will use electroacupuncture along with exercise therapy.DZ-II NERVE AND MUSCLE STIMILATOR made in China in 2016 will be used.Sterile disposable needles with a diameter of 0.25 mm and a length of 50 mm will be used by the SMS company South Korea, produced in 2019. Electroacupuncture device settings include 2 Hz frequency, conventional mode, duration 20 minutes. The needles are attached to the device and attach to 10 points on the body. Intervention 2: Control group: In the control group, the first session will use TENS. In this group, 10 sessions of exercise therapy with electrical stimulation through the skin with the help of the SDZ-II NERVE AND MUSCLE STIMILATOR device Made in China, it is used in the area of ​​pain. While the supine patient is lying on the bed, the 4 electrodes of the device are closed diagonally in the patient's pain range, electrical stimulation with a frequency of 100 Hz is applied for 20 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>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 not much information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzia Yassin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattar Khan Street. Nyayesh Street. Rasoul Akram Hospitalو Physiotherapy department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 2222 8052</telephone>
        <email>m.yassin.pt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzia Yassin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sattar Khan Street. Nyayesh Street. Rasoul Akram Hospitalو Physiotherapy department</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 2222 8052</telephone>
        <email>m.yassin.pt@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing hip arthroplasty surgery one to two days after surgery
People aged 60 and over
The surgical incision is anterior-external and the head of the hip bone and acetabulum have been replaced
Patients' pain at the time of initial evaluation after surgery should be at least 3 cm based on a numerical pain rating scale
Ability to read and write in cycles
Ability to walk at least 50 meters
History of neurological diseases that cause patients to be unable to function</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Re-hip surgery
Existence of infection after hip replacement surgery
Partial loss of hip or acetabulum during study due to interventions
History of using painkillers that are outside the treatment regimen of a specialist physician while studying or are different from other painkillers used by other patients
Patients with diabetes, etc. who use painkillers to reduce joint pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of hip</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:  the intervention group, the first session of treatment will use electroacupuncture along with exercise therapy.DZ-II NERVE AND MUSCLE STIMILATOR made in China in 2016 will be used.Sterile disposable needles with a diameter of 0.25 mm and a length of 50 mm will be used by the SMS company South Korea, produced in 2019. Electroacupuncture device settings include 2 Hz frequency, conventional mode, duration 20 minutes. The needles are attached to the device and attach to 10 points on the body.</i_keyword>
      <i_keyword>Control group: In the control group, the first session will use TENS. In this group, 10 sessions of exercise therapy with electrical stimulation through the skin with the help of the SDZ-II NERVE AND MUSCLE STIMILATOR device Made in China, it is used in the area of ​​pain. While the supine patient is lying on the bed, the 4 electrodes of the device are closed diagonally in the patient's pain range, electrical stimulation with a frequency of 100 Hz is applied for 20 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>In this study, the amount of pain is the primary outcome variable because the sample size and inclusion criteria are determined based on this variable. Timepoint: Days 1, 5, 15 and 30 of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical function. Timepoint: Days 1, 5, 15 and 30 of the intervention. Method of measurement: Hip Disability and Osteoarthritis Outcome Score (HOOS), Three tests of maximum walking speed, 3-minute walking test and sitting and standing up test.</sec_outcome>
      <sec_outcome>Edema of the entire lower limb. Timepoint: Days 1, 5, 15 and 30 of the intervention. Method of measurement: Using a tape measure, the edema of the entire lower limb is measured in areas 10 cm above the knee joint, the middle part of the leg as well as the middle area of ​​the foot.</sec_outcome>
      <sec_outcome>Hip Range of motion. Timepoint: Days 1, 5, 15 and 30 of the intervention. Method of measurement: A goniometer is used to measure the range of motion of the hip joint.</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>2021-10-16</approval_date>
        <contact_name>Research Ethics Committees of Iran University of Medical Sciences</contact_name>
        <contact_address>Sattar Khan Street. Nyayesh Street. Rasoul Akram Hospital. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
