<?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>IRCT20220910055927N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-13</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effects of manual therapy and taping in neck pain</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of adding kinesio taping to Mulligan'S mobilization on pain, range of motion, pain pressure thershold, joint proprioception and disability in patients with chronic nonspecific cervical pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After initial assessments, patients are randomly assigned to one of the two groups of intervention and control (method: simple randomization - unit: individual). One envelope containing blue paper and one envelope containing red paper (randomization tool: sealed envelope) are given to the patients, if the patient choose the envelope containing blue paper, will be in the intervention group  and if he chose the envelope containing red paper will be in the control group, Blinding description: Blinding in this study will be single-blind, and in fact, participants will not know which study group they are in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>non specific chronic cervical pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group 1 (n=15) received Mulligan mobilization of the third to seventh cervical vertebrae along with conventional PT (TENS, hot pack, ultrasound and neck isometric exercise), three times a week for two weeks. Intervention 2: Control group: Group 2 (n=15 ) after Mulligan's mobilization of third to seventh neck vertebrae and conventional PT (TENS, hot pack and ultrasound and neck isometric exercise), kinesio tape for neck extensor muscles is attached. The interventions is performed three times a week for two 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 Undecided -This publication schedule is still undetermined</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Dokhaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche- Shemiran, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>f-dokhaei@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Shadmehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Piche- Shemiran, Enghelab Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965111</zip>
        <telephone>+98 21 7752 8468</telephone>
        <email>Shadmehr@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 20 to 55 years with neck pain who have no specific anatomical or pathological cause for their pain
have experienced neck pain for a minimum of 6 months
The severity of patients' pain before intervention should be at least 30 on the visual analog scale.
Their disability level, according to the neck disability index, should be a minimum of 10</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals with a history of trauma, fractures, or spinal and thoracic surgeries
A history of vertebral dislocation or instability
History of malignancy or infection
Patients with osteoporosis
People with rheumatoid arthritis or ankylosing spondylitis
Presence of neck vascular disorders
The radiation of pain from the neck to the arm, forearm, or hand
Bad posture and deformity of Spinal column,
dizziness, headache and vestibular disorders
Individuals who have received any form of manual therapy for neck vertebrae within the past three months
Individuals who are sensitive to kinesio tape</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervical disc disorder, unspecified</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: Group 1 (n=15) received Mulligan mobilization of the third to seventh cervical vertebrae along with conventional PT (TENS, hot pack, ultrasound and neck isometric exercise), three times a week for two weeks.</i_keyword>
      <i_keyword>Control group: Group 2 (n=15 ) after Mulligan's mobilization of third to seventh neck vertebrae and conventional PT (TENS, hot pack and ultrasound and neck isometric exercise), kinesio tape for neck extensor muscles is attached. The interventions is performed three times a week for two weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Before the intervention, immediately after the first intervention session and after 6th intervention session (last session). Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Active range of motion. Timepoint: Before the intervention, immediately after the first intervention session and after 6th intervention session (last session). Method of measurement: Clinometer.</prim_outcome>
      <prim_outcome>Pressure pain threshold. Timepoint: Before the intervention, immediately after the first intervention session and after 6th intervention session (last session). Method of measurement: Algometer.</prim_outcome>
      <prim_outcome>Joint proprioception. Timepoint: Before the intervention, immediately after the first intervention session and after 6th intervention session (last session). Method of measurement: Joint repositioning tests.</prim_outcome>
      <prim_outcome>Disability. Timepoint: Before the intervention, immediately after the first intervention session and after 6th intervention session (last session). Method of measurement: Neck disability 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-13</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
