<?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>IRCT20210704051785N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-05</date_registration>
      <primary_sponsor>sharif medical and dental college</primary_sponsor>
      <public_title>surgery versus physiotherapy which treatment is better for heel pain.</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effects of Gastrocnemius recession versus physical therapy in chronic plantar fasciitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71384</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: no, Randomization description: The sealed envelope method will be used for random allocation. 40 sealed envelopes (20 for Group A and 20 for Group B) will be prepared. 20 envelopes will contain the letter A, and 20 will include the letter B on a card. The patient will be asked to choose one envelope. Treatment will be given according to treatment group (Group A: control, Group B: experiment), Blinding description: Senior physiotherapists will assess the patient before and after treatment. Senior physiotherapist/assessor will be blinded entirely about patient allocation group (control/intervention).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Plantar fasciitis, heel pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Phonophoresis with ketoprofen gel will reduce pain on alternate days for 4 weeks. Stretching Calf muscle and plantar fascia–specific stretching will be used to relieve pain and improve calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in the home plan. Manual therapy procedures include talocrural joint posterior glide, subtalar joint lateral glide, anterior and posterior glides of the first tarsometatarsal joint, and subtalar joint distraction manipulation, done on alternate days for 4 weeks. Intervention 2: Intervention group: Patients randomized to surgery will be operated with a proximal medial gastrocnemius recession(PMGR) as described by Barouk(17)(Figure 1). No additional procedures will be performed. The operation will be performed with the patients in a prone position under local anesthetic or general anesthesia. A 3-cm transverse skin incision was made in the popliteal fossa, the fascia was opened, and the medial gastrocnemius with its tendon was located. The tendon was then cut while lifting the gastrocnemius with clamps, and care was taken to cut only the white tendon while sparing the underlying muscle. While performing a dorsiflexion movement of the ankle, careful palpation of the muscle was done to ensure that all tendon strands were cut completely. The incision was closed in layers, and only soft dressings were applied. Patients were instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients were allowed to use crutches during the first 2 weeks after surgery. Sutures were removed 2 weeks after surgery.Calf muscle and plantar fascia–specific stretching will be used to relieve pain and improve calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in the home plan.</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>Sarwat Anees</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharif Polyclinic, near Doce Bakers, Railway Road, Raiwind</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 303 4846498</telephone>
        <email>sarwatasifmehmood@gmail.com</email>
        <affiliation>Punjab Social Security Health Management Company Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sarwat Anees</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharif polyclinic, near Muzammil Mart, railway road, raiwind</address>
        <city>Raiwind</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 303 4846498</telephone>
        <email>sarwatasifmehmood@gmail.com</email>
        <affiliation>Sharif medical and dental college</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Heel pain lasting &gt; 3 months
Pain in morning(morning stiffness)
Tenderness over medial plantar fascia insertion
Positive Silfverskiöld test
not recieved physiotherapy session</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Degenerative arthritis of the hindfoot joints
Systemic joint disease
Previous injury or surgery to the foot or ankle
Inoperable due to comorbidity</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>Treatment - Other</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Phonophoresis with ketoprofen gel will reduce pain on alternate days for 4 weeks. Stretching Calf muscle and plantar fascia–specific stretching will be used to relieve pain and improve calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in the home plan. Manual therapy procedures include talocrural joint posterior glide, subtalar joint lateral glide, anterior and posterior glides of the first tarsometatarsal joint, and subtalar joint distraction manipulation, done on alternate days for 4 weeks</i_keyword>
      <i_keyword>Intervention group: Patients randomized to surgery will be operated with a proximal medial gastrocnemius recession(PMGR) as described by Barouk(17)(Figure 1). No additional procedures will be performed. The operation will be performed with the patients in a prone position under local anesthetic or general anesthesia. A 3-cm transverse skin incision was made in the popliteal fossa, the fascia was opened, and the medial gastrocnemius with its tendon was located. The tendon was then cut while lifting the gastrocnemius with clamps, and care was taken to cut only the white tendon while sparing the underlying muscle. While performing a dorsiflexion movement of the ankle, careful palpation of the muscle was done to ensure that all tendon strands were cut completely. The incision was closed in layers, and only soft dressings were applied. Patients were instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients were allowed to use crutches during the first 2 weeks after surgery. Sutures were removed 2 weeks after surgery.Calf muscle and plantar fascia–specific stretching will be used to relieve pain and improve calf muscle flexibility 3 times a day (3 minutes) stretching time, for three months in the home plan</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: numeric pain rating scale will be measured at basline and at 3 months and at 6 months. Method of measurement: measured by numeric pain rating scale.</prim_outcome>
      <prim_outcome>Foot and ankle function involving a range of daily activities. Timepoint: foot and ankle function involving a range of daily activities will be assessed at baseline and at 3 months and at 6 months. Method of measurement: foot and ankle function involving a range of daily activities(FAAM-ADL) scale used.</prim_outcome>
      <prim_outcome>The american orthopedic foot and ankle society ANKLE-HINDFOOT scale. Timepoint: will be assessed at baseline and at 3 months and at 6 months. Method of measurement: AOFAS ankle hindfoot scale used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Health related quality of life. Timepoint: will be assessed at baseline and at 3 months and at 6 months. Method of measurement: the short form SF-36 used.</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>funding</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-10</approval_date>
        <contact_name>the superior university ethics committee</contact_name>
        <contact_address>raiwind road, lahore lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
