<?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>IRCT20240724062528N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-22</date_registration>
      <primary_sponsor>The University of Lahore</primary_sponsor>
      <public_title>Effects of active and positional release technique in cervicogenic headache patients.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of active and positional release technique on pain, range of motion and functional disability in cervicogenic headache patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: A randomized clinical trail will be  conducted using  purposive samlping technique to collect the data. Participants will be randomly allocated into two groups by lottery method where Group A will receive active release technique and  Group B positional release technique for 4th weeks. Neck disability index , headache disability index and goniometer used to measure outcome variables, Blinding description: This study will be a single blinded study in which assessor will be kept blinded. Outcome assessors are blinded to the treatment assignments of the participants to prevent bias in evaluating the results. This is often done by having assessors work with coded data or by separating the outcome assessment process from the treatment administration and assignment process.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Cervicogenic headache is characterized by persistent unilateral head pain originating from the structures of the neck, including both bony components and soft tissues.It is classified as a secondary headache, with its origins traced back to the upper cervical spine and the atlanto-occipital joint..</hc_freetext>
      <i_freetext>Intervention 1: Experimental Group A: Active release technique(ART) and Routine Physical Therapy:The participants randomly allocated in Group A will be received the Active release technique. Before this technique routine physical therapy consist of heat therapy for 10 minutes will be applied. Tightness in the Sternocleidomastoid is common in patients with Cervical headache. Reduced tightness and trigger point discomfort can be achieved with the aid of the post-isometric relaxation (PIR) approach. To do PIR, first extend the muscle passively. Next, have the patient mildly contract (10–20% of maximum) counter to resistance for 5 seconds passively. Finally, exhale &amp; relax the muscle, and repeat. Five repetitions of PIR exercises will be done. Two sets with a minute rest in between, performed three times per week for four weeks. After this they will receive Active Release Technique. The subjects will be given instructions on how to carry out each exercise properly, including: a. Sitting chair stretch, b. Brugger’s stretch c. Wall angles and doorway stretches will be used to target the pectoralis major, upper trapezius, and levator scapulae, respectively. d. The pushup plus e. Head and neck retractions f. The rhomboids, deep neck flexors, and serratus anterior are strengthened by the Kibler squeeze. Intervention 2: Experimental Group B: Positional release technique and Routine Physical Therapy :The participants randomly allocated in Group B will be received the Positional release technique. Before this technique routine physical therapy consist of heat therapy for 10 minutes will be applied. They will receive positional release technique. And then to perform PIR same process followed in group A will be used. Then patient will be instructed to side-lying position on unaffected side. Create a score of 10 by lightly pinching or squeezing the point. Then, try changing the subject's arm posture by raising it over their heads to relax the Sternocleidomastoid muscle that are tracing, or by bending their necks so they are facing the uncomfortable side while lying on a thick cushion. For 90 seconds, this position will be retained. The subject will be returned to its original position after being released. Additionally, this will be carried out for 4 weeks in 3 sessions per week with 2 repeats.</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:
Demographic data and data related to final outcome will be shared by maintaining the confidentionally

When:
Data will be available after the publication of findings till six months

To whom:
Saira Rasheed

Conditions:
For research purpose

Where to obtain:
To the corresponding author of the study , Saira Rasheed and can contact on 0308-0777993,
sairach171783@gmail.com

How to obtain:
Open access and there is the traditional public data release where anyone can get access to the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saira Rasheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1-km Defence Road , near Bhuptian Chowk, Lahore , Punjab</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 308 0777993</telephone>
        <email>sairach171783@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saira Rasheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>55150</zip>
        <telephone>+92 308 0777993</telephone>
        <email>sairach171783@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 20-50 years
Both Male and females
Individuals diagnosed with neck pain accompanied by cervicogenic headaches
Patients experiencing unilateral pain due to cervicogenic headaches
Individuals suffering from cervicogenic headaches characterized by restricted cervical range of motion</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of tension type headache
History of trauma to the cervical
History of Vertebrobasilar insufficiency
History of Malignancy in the cervical area
History of operative procedure done in the cervical region</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44.86</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervicogenic Headache</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Experimental Group A: Active release technique(ART) and Routine Physical Therapy:The participants randomly allocated in Group A will be received the Active release technique. Before this technique routine physical therapy consist of heat therapy for 10 minutes will be applied. Tightness in the Sternocleidomastoid is common in patients with Cervical headache. Reduced tightness and trigger point discomfort can be achieved with the aid of the post-isometric relaxation (PIR) approach. To do PIR, first extend the muscle passively. Next, have the patient mildly contract (10–20% of maximum) counter to resistance for 5 seconds passively. Finally, exhale &amp; relax the muscle, and repeat. Five repetitions of PIR exercises will be done. Two sets with a minute rest in between, performed three times per week for four weeks. After this they will receive Active Release Technique. The subjects will be given instructions on how to carry out each exercise properly, including: a. Sitting chair stretch, b. Brugger’s stretch c. Wall angles and doorway stretches will be used to target the pectoralis major, upper trapezius, and levator scapulae, respectively. d. The pushup plus e. Head and neck retractions f. The rhomboids, deep neck flexors, and serratus anterior are strengthened by the Kibler squeeze.</i_keyword>
      <i_keyword>Experimental Group B: Positional release technique and Routine Physical Therapy :The participants randomly allocated in Group B will be received the Positional release technique. Before this technique routine physical therapy consist of heat therapy for 10 minutes will be applied. They will receive positional release technique. And then to perform PIR same process followed in group A will be used. Then patient will be instructed to side-lying position on unaffected side. Create a score of 10 by lightly pinching or squeezing the point. Then, try changing the subject's arm posture by raising it over their heads to relax the Sternocleidomastoid muscle that are tracing, or by bending their necks so they are facing the uncomfortable side while lying on a thick cushion. For 90 seconds, this position will be retained. The subject will be returned to its original position after being released. Additionally, this will be carried out for 4 weeks in 3 sessions per week with 2 repeats.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Numeric Pain Rating Scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. It takes &lt;1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity. Timepoint: 4th weeks. Method of measurement: The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. The NPRS takes &lt;1 minute to complete Scores range from 0-10 points, with higher scores indicating greater pain intensity. The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion.</prim_outcome>
      <prim_outcome>The term 'goniometry refers to the measurement of angles, which in rehabilitation settings refers to the measurement of angles in each plane at the joints of the body. The neutral zero method (0 to 180- degree system) is the most widely used method. The range of motion of each joint should be measured in isolation, to avoid trick movement (simultaneous movement of another joint) and muscle insufficiency which may alter the reading. Timepoint: 4th weeks. Method of measurement: The measurement of angles, which in rehabilitation settings refers to the measurement of angles in each plane at the joints of the body. The neutral zero method (0 to 180- degree system) is the most widely used method. The range of motion of each joint should be measured in isolation, to avoid trick movement (simultaneous movement of another joint) and muscle insufficiency which may alter the reading.</prim_outcome>
      <prim_outcome>The Henry Ford Hospital Headache Disability Inventory/Index (HDI) was developed to quantify the impact of headache on daily living. A 25-item headache questionnaire derived from case history responses of subjects with headache, and it sub grouped into functional and emotional subscales to assess the impact of headache, and its treatment on daily living. The Headache Disability Inventory/Index designed by Dr. Jacobson GP, Ramadan NM, et al. (Kılınç et al., 2023). Timepoint: 4th weeks. Method of measurement: A 25-item headache questionnaire with headache, and it sub grouped into functional and emotional subscales to assess the impact of headache, and its treatment on daily living. Using this system, a total score of 10-28 is considered to indicate mild disability; 30-48 is moderate disability; 50-68 is severe disability; 72 or more is complete disability.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neck disability Index(NDI) questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. Timepoint: 4th weeks. Method of measurement: Neck disability Index  consist of 10 sections; Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score where 0 means: no activity limitations, 50 points or 100% means complete activity limitation.</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 Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-22</approval_date>
        <contact_name>Research Ethics Committee of University of Lahore</contact_name>
        <contact_address>University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
