<?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>IRCT20240201060879N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of diaphragm myofascial release on pain, disability, range of motion, kinesiophobia and quality of life in patients with chronic shoulder pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of diaphragm myofascial release on pain, disability, range of motion, kinesiophobia and quality of life in patients with chronic shoulder pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using random allocation software and based on the random block method with a block size of 4 and with an allocation ratio of 1:1, and patients will be divided into intervention and control groups, Blinding description: Patients in each group do not know about the other group. (Patients are blinded  to study groups)
The evaluator of variables before and after treatment is another physiotherapist who is blinded to the type of treatment and patients. (Assessor is blinded to study groups).</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic shoulder pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diaphragm myofascial release. In this group, in addition to routine physiotherapy, which includes the use of low-frequency TENS, IR (infrared) and therapeutic exercises at home and in the clinic, a type of manual therapy called myofascial release is also used for the diaphragm muscle. This manual therapy is considered as  an effective technique to reduce pain and disability, which aims to restore the optimal length of fascial tissue. The treatment in this group lasts six sessions requiting the patient to be visited every other day. The diaphragm myofascial release technique is performed in two ways. In the first method, the patient is lying in supine postion and the therapist is placed on top of the patient's head, and the hypothenar area of both hands is located under the lower ribs, and the patient is asked to inhale and exhale. During inhalation, a force is applied in the direction of raising and pulling out the lower ribs, and during exhalation, manual resistance is applied. This technique is done in two sets with ten repetitions. In the next method, the patient lies prone. one hand of the therapist is placed on the popliteal area and the other hand is placed on the edge of the lower ribs on the same side. The patient performs inhalation and exhalation and both hands move away from each other during exhalation. After ten repetitions, this treatment is repeated for the other side as well. Intervention 2: Control group: Sham myofascial diaphragm release treatment. In this group, patients receive routine physical therapy that includes the use of low-frequency TENS, IR (infrared) and therapeutic exercises at home and in the clinic. The treatment in this group lasts six sessions requiting the patient to be visited every other day. Diaphragm myofascial release treatment in this group is sham. In this way, the hands are similar to the intervention group, but no effective force is applied to the person's body.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is After analyzing the data, raw data are published in general.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Ghaderi Varkani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>69 number, Khayat Basre alley, Nabard St., Piroozi St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1766915878</zip>
        <telephone>+98 21 3317 6833</telephone>
        <email>fateme1ghaderi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Ghaderi Varkani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nabard St, Khayat Basre alley, 69</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1766915878</zip>
        <telephone>+98 21 3317 6833</telephone>
        <email>fateme1ghaderi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patients suffering from chronic shoulder pain(More than three months have passed since the onset of symptoms) and with a referral from the specialist doctor
Age range from 25 to 45 years
both genders
Has not received physiotherapy treatment in the last two months.
Pain during activity or rest should be between 3 and 7 on the VAS scale.
Having informed consent</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Neurological problems (such as multiple sclerosis, stroke, etc.)
Systemic diseases (such as rheumatism, fibromyalgia, etc.)
History of previous surgery, fracture, shoulder dislocation
A professional athlete who has intense upper limb activity during exercise.
If, according to clinical examinations and joint play, it is determined that the pain is of capsular origin (such as a frozen shoulder)
If clinical tests show that the pain has a neck origin (cervical radiculopathy).
Osteoporosis, cancer
Reluctance to continue treatment
If it is found in the MRI image that the patient has a complete tendon rupture of even one of the rotator cuff muscles, or in clinical tests such as the drop arm test, it is found that one of the tendons of the shoulder is torn.
BMI above 30 (obese people)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25-9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>M25-5</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: Diaphragm myofascial release. In this group, in addition to routine physiotherapy, which includes the use of low-frequency TENS, IR (infrared) and therapeutic exercises at home and in the clinic, a type of manual therapy called myofascial release is also used for the diaphragm muscle. This manual therapy is considered as  an effective technique to reduce pain and disability, which aims to restore the optimal length of fascial tissue. The treatment in this group lasts six sessions requiting the patient to be visited every other day. The diaphragm myofascial release technique is performed in two ways. In the first method, the patient is lying in supine postion and the therapist is placed on top of the patient's head, and the hypothenar area of both hands is located under the lower ribs, and the patient is asked to inhale and exhale. During inhalation, a force is applied in the direction of raising and pulling out the lower ribs, and during exhalation, manual resistance is applied. This technique is done in two sets with ten repetitions. In the next method, the patient lies prone. one hand of the therapist is placed on the popliteal area and the other hand is placed on the edge of the lower ribs on the same side. The patient performs inhalation and exhalation and both hands move away from each other during exhalation. After ten repetitions, this treatment is repeated for the other side as well.</i_keyword>
      <i_keyword>Control group: Sham myofascial diaphragm release treatment. In this group, patients receive routine physical therapy that includes the use of low-frequency TENS, IR (infrared) and therapeutic exercises at home and in the clinic. The treatment in this group lasts six sessions requiting the patient to be visited every other day. Diaphragm myofascial release treatment in this group is sham. In this way, the hands are similar to the intervention group, but no effective force is applied to the person's body.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before starting the intervention and after completing 6 sessions of physiotherapy. Method of measurement: using VAS scale.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before starting the intervention and after completing 6 sessions of physiotherapy. Method of measurement: Using the SPADI questionnaire.</prim_outcome>
      <prim_outcome>Chest expansion. Timepoint: Before starting the intervention and after completing 6 sessions of physiotherapy. Method of measurement: Using a tape measure.</prim_outcome>
      <prim_outcome>Shoulder range of motion( flexion, abduction, external rotation). Timepoint: Before starting the intervention and after completing 6 sessions of physiotherapy. Method of measurement: using a goniometer.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: before the intervention and one month after the completion of 6 physiotherapy sessions. Method of measurement: Using the SF-12 questionnaire.</prim_outcome>
      <prim_outcome>Kinesiophobia. Timepoint: Before starting the intervention and after completing 6 sessions of physiotherapy. Method of measurement: Using the tampa questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-09</approval_date>
        <contact_name>Ethics committee of Tehran university of medical science</contact_name>
        <contact_address>Tehran University of Medical Sciences Central Building, Qods St. intersection, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
