<?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>IRCT20250519065806N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-01</date_registration>
      <primary_sponsor>Sports Sciences Research Institute</primary_sponsor>
      <public_title>Combined myofascial release and fascia stretching therapy for chronic heel pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Combined Myofascial Release and Fascia Stretching Therapy Versus Myofascial Release Alone on Pain and Function in Chronic Plantar Fasciopathy: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89728</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After completion of baseline assessments, participants were randomly allocated to one of three groups: Myofascial Release, Myofascial Release and Fascia Stretching Therapy, or control. Randomization was performed using a simple random allocation procedure with a 1:1:1 ratio to ensure equal group sizes.
The randomization sequence was generated using a computer-based random number generator by a researcher who was not involved in participant recruitment, intervention delivery, or outcome assessment. Allocation assignments were placed in sequentially numbered opaque sealed envelopes, which were opened only after completion of baseline measurements.
To reduce assessment bias, the outcome assessor remained blinded to group allocation throughout the study. Participants were instructed not to disclose their assigned intervention during post-intervention testing, Blinding description: Outcome assessor and data and statistical analyzer will
be blinded from knowing intervention groups. This
individual, a physiotherapist, is blinded to group
allocation and is unaware of which participants belong to
the intervention group and which belong to the control
group.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic Plantar Fasciopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After obtaining ethics approval, individuals with chronic plantar fasciopathy who met the inclusion criteria were invited to participate in the study. Participants were identified through structured interviews and questionnaires that included demographic and medical history information, conducted by the researcher. The inclusion criteria were: age between 25 and 40 years, clinical diagnosis of chronic plantar fasciopathy (symptoms lasting more than 3 months), localized tenderness at the medial calcaneal tuberosity, pain during the first steps after rest (especially morning pain), no structured physiotherapy within the past 3 months, ability to complete the intervention period, and written informed consent. Exclusion criteria included: history of corticosteroid injection in the affected foot within the previous 6 months, previous foot or ankle surgery, systemic inflammatory or rheumatologic diseases (e.g., rheumatoid arthritis or lupus), neurological disorders affecting lower limb function (e.g., neuropathy or radiculopathy), structural foot deformities (e.g., severe pes planus, pes cavus, or congenital deformities), acute musculoskeletal injury of the lower limb during the study period, concurrent participation in other rehabilitation or physiotherapy programs, use of analgesic or anti-inflammatory medications that could affect outcomes (unless on a stable dose), and pregnancy (if applicable).All participants provided written informed consent after receiving a full explanation of the study objectives, procedures, and their responsibilities. Demographic and clinical data, including age, height, weight, physical activity history, and pain intensity, were collected through questionnaires and face-to-face interviews. A total of 90 eligible participants were randomly allocated with equal probability into three groups: myofascial release (MFR) (n = 30), combined myofascial release and fascia stretching therapy (MFR+FST) (n = 30), and control (n = 30). The two intervention groups participated in an 8-week supervised training program, consisting of three 45-minute sessions per week. Each session included 10 minutes of warm-up, 30 minutes of the main intervention, and 5 minutes of cool-down. Exercise intensity and difficulty were progressively increased based on participant tolerance and adaptation. In both intervention groups, standardized myofascial release (MFR) was applied. Participants were positioned supine with the lower limb supported in an extended position and the ankle maintained in a neutral position by the therapist. The therapist applied sustained ischemic pressure using the thumb at three anatomical sites: the medial calcaneal tuberosity, the distal first metatarsal, and the distal fifth metatarsal. Each point received 90 seconds of pressure, repeated three times, with a total treatment duration of approximately 15 minutes per session.In the combined intervention group, fascia stretching therapy (FST) was additionally performed. Participants stood in a forward lunge position facing a wall, with the contralateral limb placed anteriorly and in contact with the wall. The therapist stood behind the participant, holding the affected ankle and tibia while applying controlled posterior traction toward the therapist’s trunk. Stretching was performed in two variations: with the knee extended to target the gastrocnemius muscle and with the knee flexed to target the soleus muscle. All participants were evaluated before and after the intervention period. Outcome measures included pain intensity assessed using the Visual Analogue Scale (VAS) and functional ability assessed using the Foot Function Index (FFI). Intervention 2: Control group: No intervention was performed before ethics approval and trial registration. After obtaining ethical approval, eligible individuals were invited to participate in the study. For participant recruitment, the researcher visited the physician’s clinic and reviewed medical records of patients diagnosed with chronic plantar fasciopathy. Potential participants were screened according to the predefined inclusion and exclusion criteria. Eligibility was assessed for each individual through direct contact and clinical screening based on the study criteria. Based on the required sample size, eligible individuals who initially agreed to participate were selected. The objectives of the study, as well as potential benefits and possible risks of participation, were fully explained to all participants. Participants were informed that their participation was voluntary and that they could withdraw from the study at any stage without any consequences. Written informed consent was obtained from all participants who agreed to participate. Demographic information, including age, weight, and height, was collected through face-to-face interviews. All participants underwent baseline (pre-intervention) assessment before the start of the intervention. Outcome measures included pain intensity assessed using the Visual Analogue Scale (VAS) and functional ability assessed using the Foot Function Index (FFI). The order of assessment was identical for all participants. A pre-test was also conducted for the control group before the intervention period. The control group did not receive any intervention for 8 weeks and continued their usual daily activities throughout the study period. All participants were reassessed after the 8 weeks using the same outcome measures.</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 pulication

To whom:
Everyone

Conditions:
For research and rehabilitation

Where to obtain:
Email

How to obtain:
One week time to gather the needed data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Seyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 32, Miremad Avenue, Motahari Street. Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1416935840</zip>
        <telephone>+98 21 6652 3147</telephone>
        <email>seyedi@ssrc.ac.ir</email>
        <affiliation>Sports Sciences Research Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mostafa Jalili Bafrouei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>17th North Kargar street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1423654123</zip>
        <telephone>+98 21 9109 9511</telephone>
        <email>m.jalili.b@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults aged 25–40 years
Clinical diagnosis of chronic plantar fasciopathy (symptom duration &gt;3 months) by doctor of medicine
Presence of localized tenderness at the medial calcaneal tuberosity
Pain during the first steps after a period of rest
Willingness to participate and provide written informed consent
absence of specific spinal pathology or musculoskeletal disoredrs lower limbs
No prior structured physiotherapy for the condition in the last 3 months
Ability to participate in the full intervention period</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of corticosteroid injection in the affected foot within the previous 6 months
Previous foot or ankle surgery
Systemic inflammatory or rheumatologic diseases (e.g., rheumatoid arthritis, lupus)
Neurological disorders affecting lower limb function (e.g., neuropathy, radiculopathy)
Structural foot deformities (e.g., severe pes planus, pes cavus, or congenital deformities)
Acute musculoskeletal injuries of the lower extremity during the study period
Participation in other physical therapy or rehabilitation programs during the study
Use of analgesic or anti-inflammatory medication that could affect pain outcomes without a stable dosage
Failure to attend more than 20% of treatment sessions or poor adherence to protocol
Pregnancy (for females)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M72.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Plantar fascial fibromatosis</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: After obtaining ethics approval, individuals with chronic plantar fasciopathy who met the inclusion criteria were invited to participate in the study. Participants were identified through structured interviews and questionnaires that included demographic and medical history information, conducted by the researcher. The inclusion criteria were: age between 25 and 40 years, clinical diagnosis of chronic plantar fasciopathy (symptoms lasting more than 3 months), localized tenderness at the medial calcaneal tuberosity, pain during the first steps after rest (especially morning pain), no structured physiotherapy within the past 3 months, ability to complete the intervention period, and written informed consent. Exclusion criteria included: history of corticosteroid injection in the affected foot within the previous 6 months, previous foot or ankle surgery, systemic inflammatory or rheumatologic diseases (e.g., rheumatoid arthritis or lupus), neurological disorders affecting lower limb function (e.g., neuropathy or radiculopathy), structural foot deformities (e.g., severe pes planus, pes cavus, or congenital deformities), acute musculoskeletal injury of the lower limb during the study period, concurrent participation in other rehabilitation or physiotherapy programs, use of analgesic or anti-inflammatory medications that could affect outcomes (unless on a stable dose), and pregnancy (if applicable).All participants provided written informed consent after receiving a full explanation of the study objectives, procedures, and their responsibilities. Demographic and clinical data, including age, height, weight, physical activity history, and pain intensity, were collected through questionnaires and face-to-face interviews. A total of 90 eligible participants were randomly allocated with equal probability into three groups: myofascial release (MFR) (n = 30), combined myofascial release and fascia stretching therapy (MFR+FST) (n = 30), and control (n = 30). The two intervention groups participated in an 8-week supervised training program, consisting of three 45-minute sessions per week. Each session included 10 minutes of warm-up, 30 minutes of the main intervention, and 5 minutes of cool-down. Exercise intensity and difficulty were progressively increased based on participant tolerance and adaptation. In both intervention groups, standardized myofascial release (MFR) was applied. Participants were positioned supine with the lower limb supported in an extended position and the ankle maintained in a neutral position by the therapist. The therapist applied sustained ischemic pressure using the thumb at three anatomical sites: the medial calcaneal tuberosity, the distal first metatarsal, and the distal fifth metatarsal. Each point received 90 seconds of pressure, repeated three times, with a total treatment duration of approximately 15 minutes per session.In the combined intervention group, fascia stretching therapy (FST) was additionally performed. Participants stood in a forward lunge position facing a wall, with the contralateral limb placed anteriorly and in contact with the wall. The therapist stood behind the participant, holding the affected ankle and tibia while applying controlled posterior traction toward the therapist’s trunk. Stretching was performed in two variations: with the knee extended to target the gastrocnemius muscle and with the knee flexed to target the soleus muscle. All participants were evaluated before and after the intervention period. Outcome measures included pain intensity assessed using the Visual Analogue Scale (VAS) and functional ability assessed using the Foot Function Index (FFI).</i_keyword>
      <i_keyword>Control group: No intervention was performed before ethics approval and trial registration. After obtaining ethical approval, eligible individuals were invited to participate in the study. For participant recruitment, the researcher visited the physician’s clinic and reviewed medical records of patients diagnosed with chronic plantar fasciopathy. Potential participants were screened according to the predefined inclusion and exclusion criteria. Eligibility was assessed for each individual through direct contact and clinical screening based on the study criteria. Based on the required sample size, eligible individuals who initially agreed to participate were selected. The objectives of the study, as well as potential benefits and possible risks of participation, were fully explained to all participants. Participants were informed that their participation was voluntary and that they could withdraw from the study at any stage without any consequences. Written informed consent was obtained from all participants who agreed to participate. Demographic information, including age, weight, and height, was collected through face-to-face interviews. All participants underwent baseline (pre-intervention) assessment before the start of the intervention. Outcome measures included pain intensity assessed using the Visual Analogue Scale (VAS) and functional ability assessed using the Foot Function Index (FFI). The order of assessment was identical for all participants. A pre-test was also conducted for the control group before the intervention period. The control group did not receive any intervention for 8 weeks and continued their usual daily activities throughout the study period. All participants were reassessed after the 8 weeks using the same outcome measures</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity and functional capacity. Timepoint: First week and 8 weeks. Method of measurement: Visual Analog Scale (VAS) and Foot Functional Index.</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>Sports Sciences Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-11</approval_date>
        <contact_name>Sports Sciences Research Institute</contact_name>
        <contact_address>No 32 , Miremad Avenue, Motahary street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
