<?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>IRCT20231118060102N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-26</date_registration>
      <primary_sponsor>kharazmi University</primary_sponsor>
      <public_title>"Effect of adding pain neuroscience education to high-load strengthening exercises on clinical and functional outcomes of participants with hyper mobility spectrum disorder"</public_title>
      <acronym>Pain Neuroscience Education (PNE) ,Hyper mobility spectrum disorder (HSD)</acronym>
      <scientific_title>Comparison of the effect of adding pain neuroscience education to high-load strengthening exercises on clinical and functional outcomes of participants with hyper mobility spectrum disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-11-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>47</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79146</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: The sample size is divided using G-POWER software - randomization method by choosing numbers from 1 to 45 (prepared by the trainer in advance and placed in sealed envelopes in the box) - research The present semi-experimental study was conducted in three groups - one blind strain - with a pre-test-post-test research design with two intervention groups and one control group, Randomization description: The method of randomly selecting participants involves choosing numbers from 1 to 45, which are prepared in advance by the instructor and placed in sealed envelopes in a box. The randomization sequence remains concealed until the completion of the baseline assessments of the patients, Blinding description: The evaluator (Outcome Assessor) is blinded to the allocation of groups so that the results are unbiased and accurate.The three groups in the study are supervised by a corrective movement instructor.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Shoulder hypermobility disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: high-threshold strengthening exercises with pain neuroscience training. Three familiarization sessions (two weeks) with training approaches to deal with pain and how to implement exercises will be held in approximately three months. The first session is a group session for a duration of 30 minutes to an hour with a maximum of six participants in each group using a PowerPoint. The second session, which includes three explanatory videos (online). The third session includes a 30-minute one-on-one conversation that relates the personal needs of the participants and the content to the pain neuroscience education. The contents of this group are about the physiology of pain and the nerve endings of pain. Intervention 2: Control group: Control group: The subjects of this group receive information on anatomy, physiology, the importance of self-care and ergonomic recommendations of Pasture. Intervention 3: Intervention group: High-threshold strength training: weight training for 16 weeks, training twice a week (individually supervised) in a fitness center, consisting of 60 minutes of training for the first session, 30 minutes for subsequent sessions, and once a week (unsupervised) is done in one's own home. Their training program includes five exercises for shoulder muscles. The exercise intensity model is progressive with decreasing patterns between increasing periods.</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>Pardis Garouee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iman Junubi St, 19 Alley, No. 158</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7185994343</zip>
        <telephone>+98 938 413 4786</telephone>
        <email>pgarouee@gmail.com</email>
        <affiliation>kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pardis Garouee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iman Junubi St,19 Alley, No. 158</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7185994343</zip>
        <telephone>+98 71 3632 7162</telephone>
        <email>pgarouee@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women aged 18 - 65
Generalized HSD (G-HSD) defined with Beighton score cut-off ≥ 5 for women up to the age of 50 years and ≥ 4 for those above 50 years and all men, if the Beighton score was 1 point below the age and sex-specific cut-off AND the five-part questionnaire (5PQ) was positive (= at least two positive items).
Present with one or more secondary symptomatic musculoskeletal manifestations, defined as either    musculoskeletal pain in minimum one shoulder for at least three months    and/or    recurrent joint dislocations or joint instability without a reported history of trauma defined as either a) minimum three atraumatic dislocations in same shoulder, b) minimum two atraumatic dislocations in two different joints (minimum one in the shoulder) occurring at different times, or c) medical confirmation of joint instability in minimum two joints (minimum one in the shoulder) not related to trauma.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Clinically suspected referred pain from the cervical spine
Systemic inflammatory rheumatic diseases
Connective tissue diseases (e.g. Marfans, Stickler's or Loeys Dietz syndromes, Ehlers-Danlos Syndromes except hypermobile type)
Neurological diseases
Pregnancy or childbirth within the past year or planning to get pregnant during the study period
Shoulder surgery within the past year
Steroid injection in the affected shoulder within three months
Inability to speak
Unable to comply with protocol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Other diso</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>XIII Diseases of the musculoskeletal system and connective tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: high-threshold strengthening exercises with pain neuroscience training. Three familiarization sessions (two weeks) with training approaches to deal with pain and how to implement exercises will be held in approximately three months. The first session is a group session for a duration of 30 minutes to an hour with a maximum of six participants in each group using a PowerPoint. The second session, which includes three explanatory videos (online). The third session includes a 30-minute one-on-one conversation that relates the personal needs of the participants and the content to the pain neuroscience education. The contents of this group are about the physiology of pain and the nerve endings of pain.</i_keyword>
      <i_keyword>Control group: Control group: The subjects of this group receive information on anatomy, physiology, the importance of self-care and ergonomic recommendations of Pasture.</i_keyword>
      <i_keyword>Intervention group: High-threshold strength training: weight training for 16 weeks, training twice a week (individually supervised) in a fitness center, consisting of 60 minutes of training for the first session, 30 minutes for subsequent sessions, and once a week (unsupervised) is done in one's own home. Their training program includes five exercises for shoulder muscles. The exercise intensity model is progressive with decreasing patterns between increasing periods.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Adding pain neuroscience education to high-load strengthening exercises - clinical and functional variables (pain, strength, range of motion, fear of movement, shoulder function) in shoulder hyper mobility spectrum disorder. Timepoint: It is measured before the start and after 16 weeks. Method of measurement: Western Ontario Questionnaire to assess the individual's self-report of joint laxity and instability - Hand-held dynamometer to measure muscle strength - Numerical pain rating scale to assess pain intensity - Goniometer to measure range of motion - Fear of movement questionnaire to assess fear of movement.</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>Pardis Garouee</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-28</approval_date>
        <contact_name>Ethics Committee of Iran Sports Science Research Institute</contact_name>
        <contact_address>Iman Junubi Street - 19 Alley - No. 158 Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
