<?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>IRCT20240311061253N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-10</date_registration>
      <primary_sponsor>The University of Faisalabad</primary_sponsor>
      <public_title>Effect of plantar massage vs reflexology foot massage on peripheral neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effectiveness of plantar massage and reflexology foot massage on pain, balance and functional reach among patients with peripheral neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76116</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling was used for sample collection. The list of individuals was generated through online randomization generator. According to the list the participants were divided into both groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Peripheral neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: plantar massage. Plantar massage will be given through sensory brush for 3 days per week dor 3 weeks. The brush will be held horizontal to the plantar aspect of the foot. Brushing will be done slowly, never back and forth on the same spot, and with enough pressure to cause the brush's bristles to bend. The goal is to trigger the feet's pressure touch receptors rapidly. Participants will be informed that the therapy might "tickle." Massage will be given for 5 minutes on each foot. Intervention 2: Intervention group: Reflexology foot massage group. Three weeks of foot reflexology will be conducted, with two sessions each week lasting thirty minutes, 15 minutes for each foot. Applying the reflexology method will involve raising the participant's leg level to the practitioner's chest level. Effleurage massage will be given to the dorsal area, plantar region, tibialis anterior, peroneus longus-brevis, and gastro soleus muscles for five minutes. Effleurage will be utilized to stimulate the autonomic nervous system, and also the reflex mechanism of action, capillaries, and lymphatic function. Reflexology massage will be done according to the following application protocol: solar plexus and diaphragm reflexes, adrenal gland reflexes, the arm and shoulder reflexes, the spine reflexes, the hip, thigh and leg reflexes, the sciatic nerve reflexes, solar plexus and diaphragm reflexes. All of these are done for 7*2 on each foot.</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:
Comparative effectiveness of plantar massage and the reflexology foot massage on pain, balance and functional reach among patients with peripheral neuropathy

When:
Starting 6 months after publication and it will remain available for everyone

To whom:
This will be available for everyone

Conditions:
anbreena.rasool@tuf.edu.pk

Where to obtain:
rabeeasaeed@gmail.com
+923030449224

How to obtain:
Any applicant will just need to contact for the data file at rabeeasaeed@gmail.com or at +923030449224

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rabeea Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 313 7709264</telephone>
        <email>2022-ms-pt-032@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rabeea Saeed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 313 7709264</telephone>
        <email>2022-ms-pt-032@tuf.edu.pk</email>
        <affiliation>The University of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 35 and 60 years
Diagnosed patient  of grade II peripheral neuropathy
Ability to stand on both feet
Cooperative patients
Can perform given instructions
Volunteered to participate</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiac problem
upper limb or lower limb amputation at any level
foot or toe ulcer
severe visual impairment
any vestibular disorder
edema, peripheral thrombosis, burn, injury or fracture of lower extremity
ambulation difficulties or using any walking device
neurological disorders, including stroke, parkinson's disease, and dementia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G90.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Idiopathic peripheral autonomic neuropathy</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: plantar massage. Plantar massage will be given through sensory brush for 3 days per week dor 3 weeks. The brush will be held horizontal to the plantar aspect of the foot. Brushing will be done slowly, never back and forth on the same spot, and with enough pressure to cause the brush's bristles to bend. The goal is to trigger the feet's pressure touch receptors rapidly. Participants will be informed that the therapy might "tickle." Massage will be given for 5 minutes on each foot</i_keyword>
      <i_keyword>Intervention group: Reflexology foot massage group. Three weeks of foot reflexology will be conducted, with two sessions each week lasting thirty minutes, 15 minutes for each foot. Applying the reflexology method will involve raising the participant's leg level to the practitioner's chest level. Effleurage massage will be given to the dorsal area, plantar region, tibialis anterior, peroneus longus-brevis, and gastro soleus muscles for five minutes. Effleurage will be utilized to stimulate the autonomic nervous system, and also the reflex mechanism of action, capillaries, and lymphatic function. Reflexology massage will be done according to the following application protocol: solar plexus and diaphragm reflexes, adrenal gland reflexes, the arm and shoulder reflexes, the spine reflexes, the hip, thigh and leg reflexes, the sciatic nerve reflexes, solar plexus and diaphragm reflexes. All of these are done for 7*2 on each foot.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain was measured at 0 weeks before intervention and after the application of the intervention at 3 weeks. Method of measurement: Self-report version of the Leeds assessment of signs and symptoms of neuropathic pain scale (S-LANSS).</prim_outcome>
      <prim_outcome>Balance. Timepoint: Balance was measured at 0 weeks before intervention and after the application of the intervention at 3 weeks. Method of measurement: Balance was measured through Berg Balance Scale (BBS).</prim_outcome>
      <prim_outcome>Functional reach. Timepoint: Functional reach was measured at 0 weeks before intervention and after the application of the intervention at 3 weeks. Method of measurement: Functional reach was measured through functional reach 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>The University of Faisalabad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-15</approval_date>
        <contact_name>Research and Ethics / Technical committee of The University of Faisalabad</contact_name>
        <contact_address>House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
