<?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>IRCT20241220064105N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-19</date_registration>
      <primary_sponsor>Muhammad Instituite of Rehabilitation Sciences, Multan</primary_sponsor>
      <public_title>Effectiveness of  Clove Oil Massage</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of  Clove Oil Massage with and without Mulligan Traction and mobilization techniques in Cervical Radiculopathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>370</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81787</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This randomization will be done by Lottery method to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator, Blinding description: "The statistical analyst and outcome assessor will be blinded to treatment allocation by using securely stored randomization codes, accessible only to an independent party. Data will be analyzed using anonymous identifiers, and group allocation will be revealed only after data collection and analysis are complete. This ensures minimization of bias.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Cervical Radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients will receive Mulligan traction and mobilization with clove oil and menthol via massage. Manual traction will last 10 minutes, with 10-second pulls and 5-second rests. Treatment will occur 3 times a week for 4 weeks, totaling 12 sessions. Mulligan SMWAM will be performed with 10-30 repetitions, and SNAG mobilizations will be applied. Clove oil and menthol will be topically applied daily for 4 weeks, with each session lasting 5-6 minutes. Intervention 2: Control group: Patients will receive 12 treatment sessions over 4 weeks, with 3 sessions per week (10-20 minutes each). Mulligan manual traction will be applied for 10 minutes, with 10-second pulls and 5-second rests. Mulligan SMWAM will start with 10 repetitions in the first session, increasing to 30 repetitions in subsequent sessions. Mulligan SNAG mobilizations will also be provided.</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 N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maliha Khalid Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bosan Road</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 312 6862130</telephone>
        <email>malihatareen1997@gmail.com</email>
        <affiliation>Muhammad Instituite of Rehabilitation Sciences, Multan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Komal Ammar Bukhari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bosan Road</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 314 6361728</telephone>
        <email>komalbukhari608@gmail.com</email>
        <affiliation>Muhammad Instituite of Rehabilitation Sciences, Multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18–70y  paresthesia,
Uni-lateral upper-extremity pain or numbness Loss of reflexes in the affected nerve root distribution
Motor or sensory dysfunction (optional)
Pain radiating to the arm cervical rotation range of motion less than 60 degrees
Positive distraction test
Positive Spurling's</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Fractures
Open wounds
Patients with spinal cord compression
Traumatic injuries
Cancer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M50.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervical disc disorder with radiculopathy</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: Patients will receive Mulligan traction and mobilization with clove oil and menthol via massage. Manual traction will last 10 minutes, with 10-second pulls and 5-second rests. Treatment will occur 3 times a week for 4 weeks, totaling 12 sessions. Mulligan SMWAM will be performed with 10-30 repetitions, and SNAG mobilizations will be applied. Clove oil and menthol will be topically applied daily for 4 weeks, with each session lasting 5-6 minutes.</i_keyword>
      <i_keyword>Control group: Patients will receive 12 treatment sessions over 4 weeks, with 3 sessions per week (10-20 minutes each). Mulligan manual traction will be applied for 10 minutes, with 10-second pulls and 5-second rests. Mulligan SMWAM will start with 10 repetitions in the first session, increasing to 30 repetitions in subsequent sessions. Mulligan SNAG mobilizations will also be provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 4weeks. Method of measurement: NPRS.</prim_outcome>
      <prim_outcome>Cervical Radiculopathy disorder. Timepoint: 4weeks. Method of measurement: NDI.</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>Muhammad Instituite of Rehabilitation Sciences, Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-22</approval_date>
        <contact_name>The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences</contact_name>
        <contact_address>Bosan Road Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
