<?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>IRCT20181210041914N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-09</date_registration>
      <primary_sponsor>Shahid Bahonar university of Kerman</primary_sponsor>
      <public_title>The Effect of Four Weeks of Swedish Massage on Knee Joint Biomechanical Parameters During Walking in Adult Women With Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Four Weeks of Swedish Massage on Knee Joint Biomechanical Parameters During Walking in Adult Women With Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the restricted randomization method of block randomization has been used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups. The size of all blocks was equal and in this two-group experiment, we had 6 blocks (including 3 participants in the massage intervention group and 3 participants in the control group). The randomization tool was one of the software for random sequence generation (software allocation Random) that in addition to simple randomization is able to generate a random sequence by blocking method. Concealment allocation was also used for concealment, which is the method used to execute a random sequence on study participants; So that before the individual is assigned, the assigned group is not known. Also, sequentially numbered, opaque sealed envelopes (SNOSE) were used in which each of the random sequences created on a registration card and the cards inside the envelopes were placed, respectively. In order to maintain a random sequence, the envelopes were numbered in the same way on the outer surface. Finally, the envelopes were glued and placed in a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes was opened and the assigned group of the participant was revealed, Blinding description: In this study, both participants and researchers were unaware of the allocation of study groups. The participants in the experimental group thought that everyone had received the intervention and the participants in the control group were unaware of the intervention for the experimental group. The researchers also did not know which group received the intervention while evaluating the information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group received 12 standard sessions of Swedish massage (three interval sessions a week, within 4 weeks, about 20-30 minutes per session) by a professional and licensed massage therapist. The therapist used a standard protocol, involving the petrissage (compression or manipulation of soft tissue between the fingers and thumb), effleurage (gliding of hands over the skin or soft tissues), and tapotement (percussion-based massage where hands strike soft tissue in a repetitive, rhythmic fashion) techniques. These techniques were applied to the quadriceps muscle group of the affected leg by thumb-kneading the rectus femoris, vastus medialis, vastus lateralis, as well as the iliotibial band and the patellar tendon. Intervention 2: Control group: The control group received only their usual treatment during this period and no training protocol was adopted for them.</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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
Since 1397

To whom:
Researchers working in academia and people in industry

Conditions:
There is no other condition

Where to obtain:
Irandoc

How to obtain:
Search in Irandoc

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariborz Mohammadipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, Imam Khomeini Highway, Shahid Bahonar University Research Square, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913439</zip>
        <telephone>+98 34 3325 7141</telephone>
        <email>fariborz.mpour@yahoo.com</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Sabet</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kerman, Imam Khomeini Highway, Shahid Bahonar University Research Square, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913439</zip>
        <telephone>+98 34 3325 7141</telephone>
        <email>fereshteh_sabet@yahoo.com</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women in the age range of 45 to 65 years
Having radiological symptoms of osteoarthritis in one knee
Chronic knee pain for 1 month or more
Morning stiffness less than 30 minutes
Crepitus</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Any pain or lesion in the lower limb (except osteoarthritis of the knee)
Use of energy drinks, drugs and alcohol
The presence of wounds, warts, cracks and inflamed acnes in the area of ​​the extensor muscles of the affected knee
History of neurological and muscular diseases
Existence of any systemic diseases such as rheumatism, diabetes or a history of cardiovascular and pulmonary diseases
History of any surgery on the affected knee
Intra-articular injection (PRP) during the last six months
History of fractures and dislocations in the lower extremities during the past year
Have a regular exercise program for the past six months
Having knee pain less than one day a month
Inability to walk without help</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: The intervention group received 12 standard sessions of Swedish massage (three interval sessions a week, within 4 weeks, about 20-30 minutes per session) by a professional and licensed massage therapist. The therapist used a standard protocol, involving the petrissage (compression or manipulation of soft tissue between the fingers and thumb), effleurage (gliding of hands over the skin or soft tissues), and tapotement (percussion-based massage where hands strike soft tissue in a repetitive, rhythmic fashion) techniques. These techniques were applied to the quadriceps muscle group of the affected leg by thumb-kneading the rectus femoris, vastus medialis, vastus lateralis, as well as the iliotibial band and the patellar tendon.</i_keyword>
      <i_keyword>Control group: The control group received only their usual treatment during this period and no training protocol was adopted for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kinematics parameters of walking gait. Timepoint: The mentioned variable was measured at the baseline (before the intervention) and 4 weeks after the start of the massage intervention. Method of measurement: Motion Analysis System.</prim_outcome>
      <prim_outcome>Muscle activity of quadriceps. Timepoint: The mentioned variable was measured at the baseline (before the intervention) and 4 weeks after the start of the massage intervention. Method of measurement: Bio electronica muscle electrical activity recorder made in Italy, Usb2 + model with 16 channels.</prim_outcome>
      <prim_outcome>Voluntary isometric strength of quadriceps muscles. Timepoint: The mentioned variable was measured at the baseline (before the intervention) and 4 weeks after the start of the massage intervention. Method of measurement: Hand Held Dynamometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Symptoms Of Knee Osteoarthritis. Timepoint: The mentioned variable was measured at the baseline (before the intervention) and 4 weeks after the start of the massage intervention. Method of measurement: The Western Ontario and McMaster Universities Osteoarthritis Index.</sec_outcome>
      <sec_outcome>Knee Joint Proprioception. Timepoint: The mentioned variable was measured at the baseline (before the intervention) and 4 weeks after the start of the massage intervention. Method of measurement: In order to evaluate the knee joint proprioception, a system consisting of skin marking, digital imaging with Canon camera (20 megapixel resolution made in Japan) and AutoCAD software (made by Autodesk USA) was used.</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 Bahonar university of Kerman</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-11</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman, Haft Bagh Alavi axis, campus of University of Medical Sciences Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
