<?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>IRCT20191023045212N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-02</date_registration>
      <primary_sponsor>RIMS,Multan</primary_sponsor>
      <public_title>Effect OF Sustained Natural Apophyseal Glide Versus Cervical Manipulation In Treatment Of Mechanical Neck Pain</public_title>
      <acronym>RCT</acronym>
      <scientific_title>Effect Of Sustained Natural Apophyseal Glide Versus Cervical Manipulation In Treatment Of Mechanical Neck  Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2640-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/43499</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomly allocated into 2 groups to receive either the cervical manipulation or  sustained natural Apophyseal glide  .the randomization was done using lottery method, Blinding description: patients were blinded as they do not know there  respected group,therapist who gave treatment and assess the outcome was blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mechanical neck pain can be define as it is most common musculoskeletal irritation that originates from posterior side of skull bone and radiates towards lower region of cervical vertebra of backbone and sometimes it also migrate into  shoulders and arms as well.Cervical region pain  is a most general  problem, having a point occurrence of almost 13% and  prevalence for lifetime is about 50 %.Mechanical neck pain infers that the there are many  sources of neck pain that pain may be  the result of  supporting structures of spine like muscles and ligaments.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Subjects will be treated with Sustained Natural Apophyseal Glide (SNAG) which included two sessions per week. Patients in this group will receive a baseline treatment that is heating pad for 15 minutes before the treatment. Procedure will be repeat in sets of 5 to 10 for 6 weeks. Intervention 2: Intervention group: Subjects will be treated with Cervical Manipulation after baseline treatment that is heating pad for 15 minutes which included two sessions per week for 6 weeks.</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>Sana altaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>GULGASHT ,Tehsile chowk ,multan</address>
        <city>multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 42 32591427</telephone>
        <email>rims.multan@yahoo.com</email>
        <affiliation>RIMS,Multan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana altaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>TEhsile chowk ,gulgasht ,multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 42 32591427</telephone>
        <email>rims.multan@yahoo.com</email>
        <affiliation>RIMS,multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	44 patients both males and females with mechanical neck pain aged between 20 to 65 will be included
•	hypo-mobility of the cervical range of motion
•	Non -discogenic neck pain, stiffness, muscle tension, headache and migraine
•	Comparable signs (pain associated with movement, or pain associated with specific functional activities.
•	Painful cervical extension, local tenderness, and restricted inter-segmental motion.</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>•	Any contraindication to systemic manifestation (e.g. inflammation, infection, advanced degeneration, congenital malformation, trauma, cerebrovascular abnormalities).
Positive neurological examination e.g. presence of positive motor reflex, or sensory abnormalities indicating spinal root compression
•	cervical spine surgery or stenosis ,metabolic or systemic disorders or cancer
•	Any associated pathology of the upper cervical region or upper limb that may cause overlapping with the clinical finding as referred pain from costotransverse joint, rotator cuff tendonitis, and cervical rib syndrome.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Subjects will be treated with Sustained Natural Apophyseal Glide (SNAG) which included two sessions per week. Patients in this group will receive a baseline treatment that is heating pad for 15 minutes before the treatment. Procedure will be repeat in sets of 5 to 10 for 6 weeks</i_keyword>
      <i_keyword>Intervention group: Subjects will be treated with Cervical Manipulation after baseline treatment that is heating pad for 15 minutes which included two sessions per week for 6 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain will be primary outcome variable that will be measure by NPRS. Timepoint: outcome will be measured before the application of intervention and after  6 weeks of intervention application. Method of measurement: pain will be measure using NPRS,for cervical range of motion goniometer will be used,NDI for disability.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cervical range of motion and function in patient with mechanical neck pain. Timepoint: cervical range of motion and function. Method of measurement: inclinometer and NDI questionnaire will be use to measure cervical range of motion and function.</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>Self</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2641-03-02</approval_date>
        <contact_name>Ethics committee of Riphah college of Rehabilitation and Allied Health Sciences</contact_name>
        <contact_address>Quaid-e-Azam campus 28-M, Quaid-e-Azam ,Industrial Estate ,Kot Lakhpat ,Lahore. Lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
