<?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>IRCT20210806052089N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-07</date_registration>
      <primary_sponsor>Yasmin physiotherapy centre</primary_sponsor>
      <public_title>Effectiveness of acupressure in patients with perceived stress related sub-acute neck pain.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Acupressure with Stretching and Acupressure Technique alone in Patients with Perceived Stress Related Sub-Acute Neck Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple random sampling technique (probability sampling) where each participant has equal chance of getting enrolled into the study, was used for the sampling and after which the participants were enrolled into 2 equal treatment groups, Group A (acupressure with stretching group) and Group B (acupressure alone group) by lottery method where the selection of participants into groups depends upon the card drawn and the specific number assigned to participants, Blinding description: Participants will be aware of the description of treatments being performed in both groups but will not be aware which treatment will be performed on them.
The participants of both groups will not be aware of the study groups.
All the participants will be masked in the study.
This will be carried out by keeping the anonymous by study period.</study_design>
      <phase>3</phase>
      <hc_freetext>neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (acupressure with stretching). The group received warm-up session of hot-pack and neck isometric exercises with 10s hold at 20% of the isometric strength repeated for 8 repetitions in 4 all 4 directions Participants in group A received acupressure at 21 acupressure points, Each of the acupoint was pressed for 10 seconds and repeated for 5 times. This acupressure treatment took almost 20 minutes of session and then group A participants received addition of stretching. Stretching techniques were performed in such order: towards lateral flexion (upper part of trapezius), ipsilateral flexion and rotation (scalene) and towards flexion (extensor muscles) each for 30 sec and repeated 2–3 times. This complete session took 30 minutes total. Intervention 2: Intervention group: Group B  (Acupressure alone group). The participants of group B received warm-up of hot-pack and isometric exercise and then the acupressure therapy on all points for treatment time of 20 minutes only was performed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is As we have signed and assured the participants that there data will not be shared anywhere else other than this study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatima Naseem Bhatti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House#p-119 Muhammad bibi colony , Faisalabad road jaranwala</address>
        <city>Jaranwala</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 4312868</telephone>
        <email>Fatimabhatti1765@yahoo.com</email>
        <affiliation>The university of Faisalabad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatima Naseem Bhatti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House#p-119 Muhammad bibi colony, Faisalabad road, Jaranwala</address>
        <city>Jaranwala</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 41 4312868</telephone>
        <email>Fatimabhatti1765@yahoo.com</email>
        <affiliation>The university of Faisalabad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Middle aged male and female participants between minimum age of 30 and maximum of 50 years
Effectiveness of Acupressure with Stretching and Acupressure Technique alone in Patients with Perceived Stress Related Sub-Acute Neck Pain moderate score perceived stress scale score (14 or greater)
Willing to participate by signing the consent form
With neck pain history of &gt;30 days (sub-acute)
Complain of neck pain &gt; 30mm on VAS, (moderate)
Non-radiating neck pain
Not undergoing psychiatry treatment or psychotropic medication were included into study</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participants with any diagnosed musculoskeletal disorder (spondylolisthesis, spondylitis, Rheumatoid arthritis etc.)
Pregnant females,
Participants suffering from cancer,
Undergone surgery in past 3 months
With neck pain history of &gt;90 days (chronic)
HIV disorders, swelling, skin issues
High blood pressure
Any wound or contagious disease at the acupressure points
Any neurological disorder (Parkinson’s, dementia, stroke etc.)
Any vascular disorders (phlebitis, vertebral or carotid artery disorders,atherosclerosis etc.)
Any infectious disease (T.B, Hepatitis etc.) were excluded from study</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A (acupressure with stretching). The group received warm-up session of hot-pack and neck isometric exercises with 10s hold at 20% of the isometric strength repeated for 8 repetitions in 4 all 4 directions Participants in group A received acupressure at 21 acupressure points, Each of the acupoint was pressed for 10 seconds and repeated for 5 times. This acupressure treatment took almost 20 minutes of session and then group A participants received addition of stretching. Stretching techniques were performed in such order: towards lateral flexion (upper part of trapezius), ipsilateral flexion and rotation (scalene) and towards flexion (extensor muscles) each for 30 sec and repeated 2–3 times. This complete session took 30 minutes total.</i_keyword>
      <i_keyword>Intervention group: Group B  (Acupressure alone group). The participants of group B received warm-up of hot-pack and isometric exercise and then the acupressure therapy on all points for treatment time of 20 minutes only was performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual Analogous Scale. Timepoint: Baseline, after 2weeks(6th session), after 4weeks(12th session). Method of measurement: This involves pain range from no pain to max unbearable pain. Here, the VAS is considered as a horizontal line that measures 100mm in length. The patient marks the line at the point they think the severity of their perception of pain can represent.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Neck Disability Index. Timepoint: Baseline and after 4th week (12th session). Method of measurement: Neck disability index (NDI) is a questionnaire used to assess the disability caused by the neck pain in everyday life. It involves 10 questions related to the activities of daily livings, that gives 6 possible options and point ranging 0-5, the least one is marked gives 0 score and last option being marked gives the 5 points, total points are 50 and the scoring is done by, dividing the patient score by 50 and multiplying by 100 gives a score in percent. If certain question (e.g. x) is missed because the patient doesn’t do it, then total score will be divided by (50-x) points.The interpretation of NDI is given as: 0-4points (0-8%) no disability,5-14points (10 – 28%) mild disability,15-24points (30-48%) moderate disability,25-34points (50- 64%) severe disability,35-50points (70-100%) complete disability.</sec_outcome>
      <sec_outcome>Perceived stress scale. Timepoint: Baseline and after 4th week (12th session). Method of measurement: The perceived stress scale (PSS) is most commonly used psychometric scale for the measurement of perception of stress.This is simple questionnaire with simple and related to nature questions. It descripts the feeling of patient regarding certain aspects in last month.The scores of PSS are obtained by simply reversing the patient’s responses of positive sensed questions “4, 5, 7 and 8”. i.e. (0=4, 1=3, 2=2, 3=2, 4=0) and then summing up all responses. The score can range from 0-40 where the higher scores represent higher level of stress by patient. The scoring is interpreted as: 0-13= low perceived stress,14-26= moderate perceived stress and 27-40= high perceived stress.</sec_outcome>
      <sec_outcome>Cervical range of motion. Timepoint: Baseline and after 4th week (12th session). Method of measurement: The cervical ranges of motion (flexion, extension, side bending and rotation) was measured by using Goniometer.</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>Yasmin physiotherapy centre</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-21</approval_date>
        <contact_name>Ethics and technical committee of university of Faisalabad</contact_name>
        <contact_address>The university of Faisalabad,university town, Sargodha road ,Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-21</approval_date>
        <contact_name>Ethics and technical committee of university of Faisalabad</contact_name>
        <contact_address>The university of Faisalabad,university town, Sargodha road ,Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
