<?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>IRCT20250629066291N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-25</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Added Value of Diaphragm Myofascial Release in Improving Pain, Function and Balance in Females With Patellofemoral Pain</public_title>
      <acronym></acronym>
      <scientific_title>Added Value of Diaphragm Myofascial Release in Improving Pain, Function and Balance in Females With Patellofemoral Pain A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88926</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned into two groups using block randomization with a block size of six, Blinding description: It is important to note that the examiners will be blinded to the randomization process, which will be carried out by an independent individual. Moreover, evaluation and intervention procedures will be conducted by two separate physiotherapists to minimize bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellofemoral pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Diaphragmatic Myofascial Release and Exercise Therapy. Participants in the intervention group received diaphragmatic myofascial release combined with therapeutic exercises. For diaphragmatic release, the patient was positioned in supine. The therapist stood at the head of the table and placed bilateral manual contact beneath the lower costal cartilages (ribs 5–10) using the hypothenar eminence and the last three fingers of both hands. During inspiration, gentle traction was applied in a cephalad and slightly lateral direction while simultaneously facilitating rib elevation. During expiration, the therapist gradually deepened the manual contact toward the inner costal margins, following tissue relaxation. Each session of diaphragmatic release lasted approximately 5 minutes. Intervention 2: Control Group: Therapeutic Exercise. Participants in the control group received therapeutic exercises only.</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:
Information collection form including primary and secondary outcomes, informed consent form and SPSS file

When:
After publication the results of the study

To whom:
Researchers working in academic and scientific institutions

Conditions:
Only for recording information in scientific databases

Where to obtain:
Correspondence with the project manager by email. Haghighat_fa@yahoo.com

How to obtain:
Maximum one month after sending the request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194815644</zip>
        <telephone>+98 71 3624 0101</telephone>
        <email>haghighat_fa@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Haghighat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194815644</zip>
        <telephone>+98 71 3624 0101</telephone>
        <email>haghighat_fa@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of unilateral PFP by a qualified physician or physiotherapist
Females between ۱۸ and ۳۵ years
Presence of anterior or retro patellar knee pain during at least two of the following activities: squatting, kneeling, ascending/descending stairs, prolonged sitting with flexed knee, running, jumping
pain on palpation of the medial or lateral patellar facet, or the anterior aspect of the medial or lateral femoral condyle.
Duration of symptoms for more than ۸ weeks
Pain intensity of ≥۳ on the NRS (numerical rating scale) during the week before assessment
scoring less than ۸۵ out of ۱۰۰ on the Kujala anterior knee pain scale (AKPS)
positive patellar apprehension test (sensitivity: ۸۶.۷%, specificity: ۸۶.۷%)
Willingness to participate and provide informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of knee surgery, trauma, or patellar dislocation
Evidence of other knee pathologies (e.g., meniscal tear, ligament injury, or osteoarthritis)
Active inflammatory conditions affecting the lower limb
Neurological, systemic musculoskeletal and metabolic disorders (e.g., multiple sclerosis, rheumatoid arthritis and diabetes respectively)
History of fracture, dislocation or surgery of lower limb or any condition affecting gait
Marked structural deformity and known pathological condition of back, hip, and ankle
Respiratory disorders that could influence diaphragm function (e.g., COPD, asthma)
Cardiovascular disorders
metabolic disorders
Professional athlete (an individual who regularly participates in a specific sport at least three times per week for a minimum of two hours)
Participation in other physiotherapy treatments or structured exercise programs in the past ۶ months
Pregnancy
the patient should not be in the menstrual phase at the time of assessment
Body Mass Index (BMI) &gt; ۳۰</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Diaphragmatic Myofascial Release and Exercise Therapy. Participants in the intervention group received diaphragmatic myofascial release combined with therapeutic exercises. For diaphragmatic release, the patient was positioned in supine. The therapist stood at the head of the table and placed bilateral manual contact beneath the lower costal cartilages (ribs 5–10) using the hypothenar eminence and the last three fingers of both hands. During inspiration, gentle traction was applied in a cephalad and slightly lateral direction while simultaneously facilitating rib elevation. During expiration, the therapist gradually deepened the manual contact toward the inner costal margins, following tissue relaxation. Each session of diaphragmatic release lasted approximately 5 minutes.</i_keyword>
      <i_keyword>Control Group: Therapeutic Exercise. Participants in the control group received therapeutic exercises only.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Before intervention; One day after intervention period. Method of measurement: Numerical pain rating scale.</prim_outcome>
      <prim_outcome>Physical function. Timepoint: Before intervention; One day after intervention period. Method of measurement: The Kujala Anterior Knee Pain Scale (KANPS).</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before intervention; One day after intervention period. Method of measurement: Modified star excursion test.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-17</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Ethics committee, Research and Technology Vice-Chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
