<?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>IRCT20231107059979N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of strain counterstrain treatment on shoulder pain and range of motion</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of strain counterstrain therapy on shoulder pain and range of motion in People with breast cancer after mastectomy surgery with chronic active trigger point pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73658</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Simple randomization (two patients who are very similar in terms of age, scar area, pain intensity, and body mass index are assigned to one of the control and test groups by tossing a coin.).</study_design>
      <phase>N/A</phase>
      <hc_freetext>unilateral mastectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, in addition to the methods in the control group from the first session the strain counterstrain method will be used for the 5 more active trigger points in people.                       Strain counterstrain method: In this method, the trigger point is identified by touch, and the therapist increases the pressure while still touching it so that the patient reports the onset of pain. Then passively put the muscle in a comfortable (shortened) position to reduce 70% of the pain and maintain a gentle touch on the trigger point, after 90 seconds the release is done and the therapist opens the patient to the resting position. This intervention will be repeated twice for each trigger point. Intervention 2: Control group: In the control group of subjects, after entering the study, people will be taught exercises and people will do the exercises. Start the exercises with 5 minutes of walking, then perform active stretching of the neck and upper trunk, flexion and extension (two repetitions of 20 seconds), perform active movement of the cervical spine for flexion, extension, and rotation (one set and ten repetitions). Performing active movement of the upper limbs for flexion, extension, abduction and adduction of the shoulder (two sets and ten repetitions) and finally performing relaxation exercises with deep breathing for 5 minutes (total duration of the exercises is 25 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 no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Dehghan Sanij</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7 , No 14/2 ,Mohammadi St ,  Ashrafi Esfahani Blv</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461655391</zip>
        <telephone>+98 21 4438 5491</telephone>
        <email>f-dehghans@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>زینب شیروی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enghelab St, corner of Safi Alisha St., Faculty of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>0000000000</zip>
        <telephone>+98 21 7753 3939</telephone>
        <email>Zshiravi@sina.tums.ac.ir</email>
        <affiliation>Tehran 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 range 35-65 years
At least 6 months have passed from adjuvant treatment (chemotherapy and radiation therapy) after mastectomy
Having an active trigger point in at least two muscles from the subscapularis, pectoralis major, infraspinatus and upper trapezius muscles
The presence of pain in the upper limb region according to the diffusion pattern of muscle trigger point pain
Pain score 7-3</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Patients or return of breast cancer
Bilateral mastectomy
People with fibromyalgia
Degenerative diseases of the spine
Taking pain reliever, anti-inflammatory, muscle relaxant medicine in the last week
Signs and symptoms of upper extremity neuropathy
People with depression who receive medication and treatment for this issue
People with lymphedema grade two and above
Not willing to participate in the study or wanting to leave the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z90.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acquired absence of breast and nipple</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: In this group, in addition to the methods in the control group from the first session the strain counterstrain method will be used for the 5 more active trigger points in people.                       Strain counterstrain method: In this method, the trigger point is identified by touch, and the therapist increases the pressure while still touching it so that the patient reports the onset of pain. Then passively put the muscle in a comfortable (shortened) position to reduce 70% of the pain and maintain a gentle touch on the trigger point, after 90 seconds the release is done and the therapist opens the patient to the resting position. This intervention will be repeated twice for each trigger point.</i_keyword>
      <i_keyword>Control group: In the control group of subjects, after entering the study, people will be taught exercises and people will do the exercises. Start the exercises with 5 minutes of walking, then perform active stretching of the neck and upper trunk, flexion and extension (two repetitions of 20 seconds), perform active movement of the cervical spine for flexion, extension, and rotation (one set and ten repetitions). Performing active movement of the upper limbs for flexion, extension, abduction and adduction of the shoulder (two sets and ten repetitions) and finally performing relaxation exercises with deep breathing for 5 minutes (total duration of the exercises is 25 minutes).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity: It is a tool that determines the intensity of pain. Timepoint: The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention). Method of measurement: Visual analog scale: the person places a vertical mark on a continuous 100 mm line segment to indicate the intensity of pain, this line starts with the number 0, which indicates the absence of pain and discomfort, and the number 10, which indicates the worst pain that the person Ever experienced ends. In this study, the person reports the intensity of spontaneous pain, pain during active movement and pain with constant pressure applied by a pressure algometer in the upper limb area.</prim_outcome>
      <prim_outcome>Pressure Pain Threshold: The amount of direct pressure required to elicit a pain response in the target area. Timepoint: The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention). Method of measurement: Pressure pain threshold: after determining the active trigger point in the studied muscles (subscapularis, pectoralis major, infraspinatus and upper trapezius), the pressure algometer device is used to measure the pressure pain threshold of the active trigger point. The study subjects are asked to inform the pain threshold, after measuring 3 times, the average value is recorded as the pressure pain threshold.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Range of motion (ROM): The range of motion that occurs at a joint or set of joints. Timepoint: The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention). Method of measurement: In this study, passive range of motion of the shoulder is measured by a goniometer (standard, Saehan brand, large size).</sec_outcome>
      <sec_outcome>Shoulder Pain and Disability Index (SPDI): shoulder pain and disability index questionnaire, which aims to assess shoulder pain and disability and is filled by the individual. Timepoint: The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention). Method of measurement: This questionnaire has two dimensions, one is pain (5 questions) and the other is functional activities (8 questions) and the scoring of this questionnaire is based on a spectrum of 10 options, the score of each option is the same as the selected number, and finally the individual score is a number between zero and 130 and a larger number indicates greater disability.</sec_outcome>
      <sec_outcome>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): This questionnaire is used to measure the quality of life in cancer patients. Timepoint: The beginning of the study (before the start of the intervention) - the last session (the twelfth session after the intervention). Method of measurement: This questionnaire has 30 questions in 5 functional scales including: physical (5 questions), role playing (2 questions), emotional (2 questions), cognitive (4 questions), social (2 questions) and 9 symptom domains (fatigue, nausea and vomiting, pain, shortness of breath, sleep disorder, loss of appetite, constipation, diarrhea and financial problems) and evaluates the overall quality of life.</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>2023-11-05</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing and Midwifery &amp; Rehabilitation - Tehran University o</contact_name>
        <contact_address>Unit 6 , No 7 ,khojaste pour St ,  Ashrafi Esfahani Blv Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
