<?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>IRCT20090301001722N28</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Mulligan SNAGS versus Muscle Energy Techniques in Chronic Cervical Spondylosis</public_title>
      <acronym></acronym>
      <scientific_title>COMPARISON OF THE EFFECTS OF MULLIGAN SUSTAINED NATURAL APOPHYSEAL GLIDES VERSUS MUSCLE ENERGY TECHNIQUE ON PAIN, DISABILITY AND FUNCTION IN PATIENTS WITH CHRONIC CERVICAL SPONDYLOSIS.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70571</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before the process of randomization, we will screen all the participants and assign them a unique number from 1 to 60. Then the process of randomization will be carried out using Random Allocation software version 1.0 (developed by the Department of Anaesthesia, Isfahan University of Medical Sciences, Isfahan, Iran). It is a randomization software for parallel group trials. It requires the total sample size and the total number of groups. We will add a total sample size of 52 participants and 2 groups into the software with only one block. The software generates an output file that can be opened with internet explorer. The output file contains a list of numbers along with assigned groups. In our case, the groups will be A and G with 26 participants in each group. Then this sequence will be used for participant allocation in the study groups, Blinding description: The care provider will be blinded to the groups of the study which means they will not know which group is the treatment group and which group is the control group. While the outcome assessors will be blinded to the treatment protocols and study hypothesis. They will not be aware of the treatment protocols used for each group and what are the study hypothesis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CERVICAL SPONDYLOSIS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: (Group A) will receive conventional physical therapy with Mulligan Sustained Natural Apophyseal Glides. The patient will take the sitting position, this position is sustained for 8 –10 seconds, while maintaining that position as the subject inhales a breath deeply and when the subject exhaled his breath, the therapist moves to the next barrier after sustaining 8 to 10 seconds then took 2 to 3 seconds of relaxation, then repeated the same regime for 3 to7 times 3 sessions per week and single session per day for 4 weeks. Sustained natural apophyseal glides (SNAGs) were repeated 7 to 10 times in a session with a hold of 10 seconds and repeated 3 times a week for four consecutive weeks. Intervention 2: Intervention group: (Group B) will receive conventional physical therapy with Muscle Energy Techniques. For example, in C3-C4, the patient was taken in a supine position with the neck slightly flexed passively by the therapist The right middle finger will be placed over the right pillars of C3-C4 and the neck will be taken to the maximum position of side-bending rotation to the right, engaging the barrier. The left hand was placed over the patient's left parietal and temporal areas. With this hand offering counterforce, the patient will be invited to side-bend and rotated to the left, for 5 seconds. Post-isometric relaxation of these muscles following the 5-7-second mild contraction, after which the neck will be taken to its new barrier, and the same procedure will be repeated 2 or 3 times in one session, the patients will be treated 3 days per week for 4 consecutive 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 Currently we are working on streamlining the project and data collection. After recruiting the participants we may be able to deidentify individual data sets.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Hadian Rassanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enqelab Avenue Pech Shemiraan, School of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 7753 6134</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Hadian Rassanani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Enqelab Avenue Pech Shemiraan, School of Rehabilitation</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1148965141</zip>
        <telephone>+98 21 7753 6134</telephone>
        <email>hadianrs@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both genders.
Patients diagnosed with cervical spondylosis.
Age between 45 to 65 years.
Cervical spondylosis ≥ 6 months.
Degenerative spondylosis on X-rays.
Positive Spurling test.
Positive cervical distraction test.
Pain intensity ≥ 3 on the Numeric pain rating scale.
Patient without cervicogenic headache.
No cervical myelopathy.
No whiplash-associated disorders.
No previous cervical spine surgeries.
No cervical arterial dysfunction patients.
No deformity (e.g. Torticollis, springe’s deformity, scoliosis).</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are not carrying out the study for any reason.
The patient will complain of difficulty or signs and symptoms.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M47.812</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spondylosis without myelopathy or radiculopathy, cervical region</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 A) will receive conventional physical therapy with Mulligan Sustained Natural Apophyseal Glides. The patient will take the sitting position, this position is sustained for 8 –10 seconds, while maintaining that position as the subject inhales a breath deeply and when the subject exhaled his breath, the therapist moves to the next barrier after sustaining 8 to 10 seconds then took 2 to 3 seconds of relaxation, then repeated the same regime for 3 to7 times 3 sessions per week and single session per day for 4 weeks. Sustained natural apophyseal glides (SNAGs) were repeated 7 to 10 times in a session with a hold of 10 seconds and repeated 3 times a week for four consecutive weeks.</i_keyword>
      <i_keyword>Intervention group: (Group B) will receive conventional physical therapy with Muscle Energy Techniques. For example, in C3-C4, the patient was taken in a supine position with the neck slightly flexed passively by the therapist The right middle finger will be placed over the right pillars of C3-C4 and the neck will be taken to the maximum position of side-bending rotation to the right, engaging the barrier. The left hand was placed over the patient's left parietal and temporal areas. With this hand offering counterforce, the patient will be invited to side-bend and rotated to the left, for 5 seconds. Post-isometric relaxation of these muscles following the 5-7-second mild contraction, after which the neck will be taken to its new barrier, and the same procedure will be repeated 2 or 3 times in one session, the patients will be treated 3 days per week for 4 consecutive weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Numeric Pain Rating Scale. Timepoint: Before the first session and at the end of the last (12th) session. Method of measurement: Numeric Pain Rating Scale.</prim_outcome>
      <prim_outcome>Bubble Inclniometry. Timepoint: Before the first session and at the end of the last (12th) session. Method of measurement: Bubble Inclinometer.</prim_outcome>
      <prim_outcome>Hand Grip Strength. Timepoint: Before the first session and at the end of the last (12th) session. Method of measurement: Digital Hand Held Dynamometer.</prim_outcome>
      <prim_outcome>Craniovertebral Angle (Forward Head Posture). Timepoint: Before the first session and at the end of the last (12th) session. Method of measurement: Kinovea Software.</prim_outcome>
      <prim_outcome>Cervical Proprioception. Timepoint: Before the first session and at the end of the last (12th) session. Method of measurement: Laser Tracker.</prim_outcome>
      <prim_outcome>Neck Disability. Timepoint: Before the first session and at the end of the last (12th) 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>2023-06-07</approval_date>
        <contact_name>Faculty of Nursing and Midwifery and the Faculty of Rehabilitation - Tehran University of Medical Sc</contact_name>
        <contact_address>School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
