<?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>IRCT20260813070635N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Sex-Based Comparison of the Effects of a Combined Program of Myofascial Release, Codman and Elastic Band Exercises, on Pain, Range of Motion, and Function in Patients with Frozen Shoulder</public_title>
      <acronym></acronym>
      <scientific_title>Sex-Based Comparison of the Effects of a Combined Program of Myofascial Release, Codman and Elastic Band Exercises, on Pain, Range of Motion, and Function in Patients with Frozen Shoulder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/92485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: We reviewed the records of patients who had visited the clinic with shoulder pain—confirmed by an orthopedist—and classified them by gender. Within each gender category, the participants' records were assigned—using a completely random process and in equal numbers—to female control, female intervention, male control, and male intervention groups, Blinding description: “Outcome assessments were performed by an assessor who was blinded to group allocation. Due to the nature of the intervention, the participants and intervention provider could not be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Idiopathic frozen shoulder (adhesive capsulitis), characterized by shoulder pain, stiffness, restricted range of motion, and functional impairment..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Female intervention group underwent an 8-week supervised combined rehabilitation program, consisting of three sessions per week, each lasting 45 to 55 minutes. The program included 7 minutes of myofascial release (MFR) targeting the shoulder complex using gentle stretching, sustained manual pressure, and slow, multi-directional strokes; Codman’s pendulum exercises performed with minimal active shoulder muscle engagement and progressive advancement; and elastic band exercises involving shoulder flexion, extension, abduction, adduction, and internal/external rotation. Resistance, repetitions, and exercise progression were adjusted based on the Borg RPE scale and individual therapeutic response. Intervention 2: Intervention group: The men in the intervention group underwent an 8-week supervised combined rehabilitation program, consisting of three sessions per week, with each session lasting 45 to 55 minutes. The program comprised 7 minutes of myofascial release (MFR) targeting the shoulder complex using gentle stretching, sustained manual pressure, and slow, multi-directional strokes; Codman’s pendulum exercises performed with minimal active shoulder muscle engagement and progressive advancement; and elastic band exercises involving shoulder flexion, extension, abduction, adduction, and internal/external rotation. Resistance, repetitions, and exercise progression were adjusted based on the Borg RPE scale and individual therapeutic response. Intervention 3: Control group: Control Group: Following the initial assessments, the men and women in the control group were informed that they would be contacted after eight weeks to begin therapeutic interventions. Additionally, they were contacted weekly throughout this eight-week period to monitor their well-being and provide psychological support.</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:
There is no further information

When:
3 month after publish

To whom:
Everyone

Conditions:
For research and rehabilitation

Where to obtain:
Email: siadatneli@gmail.com

How to obtain:
One week is required to gather the necessary data and provide it to the requester.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Kashani Siadat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 1st Baharestan Alley, Kimasi Street, East Hafez Street, Kazem-Abad Neighborhood, Pasdaran Street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1665683872</zip>
        <telephone>+98 21 2232 9237</telephone>
        <email>siadatneli@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Kashani Siadat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 1st Baharestan Alley, Kimasi Street, East Hafez Street, Kazem-Abad Neighborhood, Pasdaran Street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1665683872</zip>
        <telephone>+98 21 2232 9237</telephone>
        <email>siadatneli@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 35 and 60 years.
Idiopathic FS diagnosed by a specialist, a non athletic lifestyle.
Chronic shoulder pain for ≥3 months
Pain severity ≥3 on the VAS.
Motion limitation (abduction &lt;135°, external rotation &lt;40°, flexion &lt;120°).</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Use of corticosteroids or anti inflammatory drugs.
History of secondary shoulder pathology.
Absence from ≥3 consecutive or ≥2 non consecutive intervention sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.0</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>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Female intervention group underwent an 8-week supervised combined rehabilitation program, consisting of three sessions per week, each lasting 45 to 55 minutes. The program included 7 minutes of myofascial release (MFR) targeting the shoulder complex using gentle stretching, sustained manual pressure, and slow, multi-directional strokes; Codman’s pendulum exercises performed with minimal active shoulder muscle engagement and progressive advancement; and elastic band exercises involving shoulder flexion, extension, abduction, adduction, and internal/external rotation. Resistance, repetitions, and exercise progression were adjusted based on the Borg RPE scale and individual therapeutic response.</i_keyword>
      <i_keyword>Intervention group: The men in the intervention group underwent an 8-week supervised combined rehabilitation program, consisting of three sessions per week, with each session lasting 45 to 55 minutes. The program comprised 7 minutes of myofascial release (MFR) targeting the shoulder complex using gentle stretching, sustained manual pressure, and slow, multi-directional strokes; Codman’s pendulum exercises performed with minimal active shoulder muscle engagement and progressive advancement; and elastic band exercises involving shoulder flexion, extension, abduction, adduction, and internal/external rotation. Resistance, repetitions, and exercise progression were adjusted based on the Borg RPE scale and individual therapeutic response.</i_keyword>
      <i_keyword>Control group: Control Group: Following the initial assessments, the men and women in the control group were informed that they would be contacted after eight weeks to begin therapeutic interventions. Additionally, they were contacted weekly throughout this eight-week period to monitor their well-being and provide psychological support.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Baseline and immediately after the 8-week intervention. Method of measurement: Visual Analog Scale (VAS).</prim_outcome>
      <prim_outcome>Shoulder range of motion (ROM). Timepoint: Baseline and immediately after the 8-week intervention. Method of measurement: Universal goniometer, measuring shoulder flexion, abduction, and external rotation.</prim_outcome>
      <prim_outcome>Shoulder functional disability. Timepoint: Baseline and immediately after the 8-week intervention. Method of measurement: Disabilities of the Arm, Shoulder and Hand (DASH) and Shoulder Pain and Disability Index (SPADI) questionnaires.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-31</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Science and Research Branch</contact_name>
        <contact_address>University Square, Shohadaye Hesarak Boulevard, End of Shahid Sattari Expressway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
