<?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>IRCT20241119063780N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-29</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>A Comprehensive corrective exercise program with and without soft tissue massage therapy on pain, functional mobility and quality of life among office syndrome patients</public_title>
      <acronym></acronym>
      <scientific_title>A Comprehensive corrective exercise program with and without soft tissue massage therapy on pain, functional mobility and quality of life among office syndrome patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80298</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This is simple , individual randomization study. Non probability sampling technique will be used to select participants in which sealed envelops will be used in randomization and  allocation concealment will be carried out, Blinding description: This is single blinded study in which assessor will be kept blind who will unaware of the treatment being studied to which group's participants.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Myalgia in office syndrome refers to muscle pain caused by prolonged sitting, poor posture, and repetitive movements. It commonly affects the neck, shoulders, and back, leading to discomfort and stiffness..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The study involves participants randomly assigned to Group A, who will be received the Comprehensive corrective exercise program. This massage regimen will be  complemented by routine physical therapy, consisting of a 15-minute application of heat therapy. The Corrective comprehensive exercises will be designed in three phases, including initial, improvement, and maintenance. Exercises were progressed in frequency and intensity during these phases, as long as the movements will be performed in a good quality. The exercises in the initial phase will be  characterized with a cognitive focus on scapular muscles (i.e., the internal focus of attention). Subjects will be  instructed to contract underactive muscles isometric ally and relax overactive muscles for normalization of scapular position and motion, after restoring the muscle balance in the static conditions, participants added upper extremity movements in various training positions . Once the participants could contract appropriate muscles in correct alignment during the movement pattern, the protocol will be focused on improving sustained postures. This goal will be addressed in the improvement phase when necessary tissue adaptations occurred by increasing the load of exercise. In the maintenance phase, the participant continued to do the exercises and maintain the training adaptations for two weeks". The exercises will be  the same as the improvement phase without any progression in intensity and frequency three phases (concentric, isometric, and eccentric) lasting for 3s each. They had already been trained to achieved the reliable reproduction of the movement at the required velocity.  They performed the movement five times, and the rest time lasted 3s in-betweens. Intervention 2: Intervention group: The participants randomly allocated in Group B will be received passive Soft tissue therapy. Before Passive Soft Tissue Therapy routine physical therapy consist of electrical stimulation with heat therapy for 15 minutes will be applied. Participants will be encouraged to relax as much as possible before the pressure will be applied. After identifying and marking the most sensitive latent Trigger point(TP) in the area, the patient will be asked to lie in a supine or sitting position and the therapist stood over her at the end of the bed, putting her thumb on the area and applying pressure to the extent that the participant felt the pain; the contact with the TP will be maintained all through the treatment. Then the therapist will be passively moved in a position of comfort (5-8 degrees) so that participants will be report 75% reduction in pain. This condition will be maintained for 90 seconds and performed 3 times per session, with a 15-second rest interval.</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 confidentially

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

To whom:
For people working in academic institutions as well as people working in clinic can alsoapply to receive it

Conditions:
For research purpose

Where to obtain:
To the corresponding aithor of the study , Hafsa Chandio and can contact on +92 302 3159237, Hafsaphysiotherapist0@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>Hafsa Chandio</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>+92 302 3159237</telephone>
        <email>Hafsaphysiotherapist0@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hafsa Chandio</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>+92 302 3159237</telephone>
        <email>Hafsaphysiotherapist0@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 18-55 years
Both male and female
Participants diagnosed with having atleast one myofacial trigger point on trapezius muscle
Participants who reported using a laptop for more than three hours daily
Participants who have worked in an office setting or on a laptop for more than 1 year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy
Patients with history of motor vehicle accident
Patients with Cervical &amp; lumbar radiculopathies with or without neurological deficits
Patients with degeneration of spine
Patients with history of myofascial pain therapy within the mouth
Patients with recent fracture/dislocation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Myalgia</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: The study involves participants randomly assigned to Group A, who will be received the Comprehensive corrective exercise program. This massage regimen will be  complemented by routine physical therapy, consisting of a 15-minute application of heat therapy. The Corrective comprehensive exercises will be designed in three phases, including initial, improvement, and maintenance. Exercises were progressed in frequency and intensity during these phases, as long as the movements will be performed in a good quality. The exercises in the initial phase will be  characterized with a cognitive focus on scapular muscles (i.e., the internal focus of attention). Subjects will be  instructed to contract underactive muscles isometric ally and relax overactive muscles for normalization of scapular position and motion, after restoring the muscle balance in the static conditions, participants added upper extremity movements in various training positions . Once the participants could contract appropriate muscles in correct alignment during the movement pattern, the protocol will be focused on improving sustained postures. This goal will be addressed in the improvement phase when necessary tissue adaptations occurred by increasing the load of exercise. In the maintenance phase, the participant continued to do the exercises and maintain the training adaptations for two weeks". The exercises will be  the same as the improvement phase without any progression in intensity and frequency three phases (concentric, isometric, and eccentric) lasting for 3s each. They had already been trained to achieved the reliable reproduction of the movement at the required velocity.  They performed the movement five times, and the rest time lasted 3s in-betweens.</i_keyword>
      <i_keyword>Intervention group: The participants randomly allocated in Group B will be received passive Soft tissue therapy. Before Passive Soft Tissue Therapy routine physical therapy consist of electrical stimulation with heat therapy for 15 minutes will be applied. Participants will be encouraged to relax as much as possible before the pressure will be applied. After identifying and marking the most sensitive latent Trigger point(TP) in the area, the patient will be asked to lie in a supine or sitting position and the therapist stood over her at the end of the bed, putting her thumb on the area and applying pressure to the extent that the participant felt the pain; the contact with the TP will be maintained all through the treatment. Then the therapist will be passively moved in a position of comfort (5-8 degrees) so that participants will be report 75% reduction in pain. This condition will be maintained for 90 seconds and performed 3 times per session, with a 15-second rest interval</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Numerical Pain Rating Scale (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. Timepoint: 8th week. Method of measurement: 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 BPI-sf is a modification of the Brief Pain Inventory - Long Form, which includes additional questions on demographics (date of birth, marital status, education, employment), pain history, aggravating and easing factors, treatment and medication, pain quality, and response to treatment. Timepoint: 8th week. Method of measurement: The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale.</prim_outcome>
      <prim_outcome>The WHOQOL-BREF is a shorter version of the WHOQOL. Both were developed by the World Health Organization (WHO) and published in 1995. It has been tested for reliability and validity. The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Timepoint: 8th week. Method of measurement: Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". The WHOQOL-BREF covers four domains each with specific facets. These domains are Physical health, psychological, social relationships and environment.</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>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>
