<?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>IRCT20150519022320N33</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-12</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Effect of Swedish Massage and Hip Strengthening Exercises on Pain, Range of Motion and Daily Life Function in The Elderly with Knee Osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Effect of Swedish Massage and Hip Strengthening Exercises on Pain, Range of Motion and Daily Life Function in The Elderly with Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71869</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After determining the samples, the data will be divided into 3 groups A, B, and C according to age and sex, in such a way that the first data in one of the 3 groups will be divided by a simple random method and using the "Random allocation software" are selected and and in the next 2 groups, the data is allocated in the same way based on the software. After allocating the data equally to 3 groups, treatment methods were written on 3 separate sheets and a method will be assigned to each group by lottery, and the intervention groups of Swedish massage and Hip Strengthening Exercises and the Control group will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Swedish massage intervention group participates in two face-to-face educational sessions with one of their family members, and the massage protocol is taught by the researcher using a training booklet and pictures, and at the end of the sessions, all the elderly are taught one by one. They are evaluated in terms of performing the massage correctly around their knee joint. Then, for 8 weeks, 3 sessions a week and each session for 30 minutes at home, according to the training method, they apply Swedish massage on their knee joint. They are also provided with educational booklets and pictures. During the study, all participants are monitored through telephone follow-ups and can raise their questions and problems, and they are also reminded to perform massage in each session. Intervention 2: Intervention group: The intervention group of hip strengthening exercises together with one of their family members participates in two face-to-face training sessions and the protocol of doing the exercises is taught by the researcher using training booklets and pictures, and at the end of the sessions, all the elderly are taught one by one. They are evaluated in terms of doing the exercises correctly. Then, for 8 weeks, 3 sessions per week and each session for 30 minutes, they perform hip strengthening exercises at home according to the training method. They are also provided with educational booklets and pictures. During the study, all participants are monitored through telephone follow-ups and can raise their questions and problems, and are also reminded to do the exercises of each session. Intervention 3: Control group: The control group receives routine treatment, which includes conventional drugs and treatments under the supervision of a rheumatology specialist, and the researcher does not intervene on 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>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 Due to the lack of intervention</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse Blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 60 to 70 years
People who are mentally alert and able to answer the questions of the questionnaires
Patients with osteoarthritis of the knee according to the diagnosis of a rheumatologist, the presence of pain along with at least 3 of the 6 clinical criteria of the American Rheumatology Association and suffering from this disease for a minimum of 6 months and a maximum of 5 years
Having pain for more than three months (chronic pain)
Have a basic score of 40-70 (out of 100) for knee pain on the VAS scale.
Absence of local skin infections or open skin in massage areas
No history of other autoimmune diseases such as lupus erythematosus, rheumatoid arthritis and chronic neuropathic diseases such as diabetes
No intra-articular injection during the last three months
No history of knee surgery and severe injury to the knee</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having health problems that affect Swedish massage and exercises, such as heart and brain disorders
chronic use of knee braces, crutches, and walkers
having a regular exercise program in the previous 6 months</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Swedish massage intervention group participates in two face-to-face educational sessions with one of their family members, and the massage protocol is taught by the researcher using a training booklet and pictures, and at the end of the sessions, all the elderly are taught one by one. They are evaluated in terms of performing the massage correctly around their knee joint. Then, for 8 weeks, 3 sessions a week and each session for 30 minutes at home, according to the training method, they apply Swedish massage on their knee joint. They are also provided with educational booklets and pictures. During the study, all participants are monitored through telephone follow-ups and can raise their questions and problems, and they are also reminded to perform massage in each session.</i_keyword>
      <i_keyword>Intervention group: The intervention group of hip strengthening exercises together with one of their family members participates in two face-to-face training sessions and the protocol of doing the exercises is taught by the researcher using training booklets and pictures, and at the end of the sessions, all the elderly are taught one by one. They are evaluated in terms of doing the exercises correctly. Then, for 8 weeks, 3 sessions per week and each session for 30 minutes, they perform hip strengthening exercises at home according to the training method. They are also provided with educational booklets and pictures. During the study, all participants are monitored through telephone follow-ups and can raise their questions and problems, and are also reminded to do the exercises of each session.</i_keyword>
      <i_keyword>Control group: The control group receives routine treatment, which includes conventional drugs and treatments under the supervision of a rheumatology specialist, and the researcher does not intervene on them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: All participants will complete the visual analog scale before the intervention and immediately after the end of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: The range of motion of all participants will be measured by a goniometer before the intervention and immediately after the end of the intervention. Method of measurement: goniometer.</prim_outcome>
      <prim_outcome>Daily life function. Timepoint: All participants will complete the sub-scale of daily life function from Knee Injuries and Osteoarthritis Outcome Questionnaire (KOOS) before the intervention and immediately after the end of the intervention. Method of measurement: sub-scale of daily life function knee Injury and Osteoarthritis Outcome Score (KOOS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-08-08</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse avenue, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
