<?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>IRCT20210321050752N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-20</date_registration>
      <primary_sponsor>Self Supported</primary_sponsor>
      <public_title>Myofascial release technique on pain and quality of life in patient of fibromyalgia</public_title>
      <acronym></acronym>
      <scientific_title>Effects of myofascial release technique on pain and quality of life in patient of fibromyalgia: a randomised controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomized by using the computer-generated method and further concealed envelop method is used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group, Blinding description: Assessor will only assess the patient at baseline and after follow-up for treatment outcomes.  Assessor safe the data for follow-up and will not share it with any therapist or patient.  At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fibromyalgia.</hc_freetext>
      <i_freetext>Intervention 1: Group B: Myofascial mobilization with routine physical therapy:  The participants executed a 12-week supervised myofascial mobilization program of 40-minute sessions performed twice a week. Intervention 2: Group A: Routine physical therapy:  The routine physical therapy group underwent a 12-week supervised exercise program of 40- minute sessions performed thrice a week. Stretching and strengthening exercises. TENS units, ultrasound are applied on participant. The targeted muscles for stretching were: gluteus, iliopsoas, ischiotibials, paravertebralis, latissimus dorsi, hip adductor muscles, trapezium and pectoralis. At early stages of the program, participants performed three repetitions; from the fifth week, four repetitions; and from the ninth week, five. The stretch intensity were increased gradually to the point of moderate discomfort and the position was held for 30 seconds. Myofascial mobilization release will be given before every session of stretching exercise. Readings will be taken at baseline, 6th or 12th week of interventionThe participants executed a 12-week supervised strengthening exercise program of 40-minute sessions performed twice a week, with progressive overload. In the first two sessions, no load was used. Subsequently, 0.5kg was added each week if the patient identified the effort as slightly intense on the Borg scale (score = 13)22.The patients were instructed to do a series of eight repetitions of strengthening exercises for the following muscles23: triceps surae, hip adductors and abductors, hip flexor, shoulder flexor and extensor, anterior and posterior deltoids, pectoralis major and rhomboids.</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:
Numeric pain rating scale will be used for the assessment of pain.
WHO Quality of life questionnaire will be used to assess the quality of life.

When:
6 months after publication.

To whom:
academic and clinical research writers.

Conditions:
Never without permission.

Where to obtain:
From Muhammad Waqas through mail id.
drwaqasfayyaz@gmail.com
or through a Researchgate account. 
https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf

How to obtain:
From Muhammad Waqas through mail id.
drwaqasfayyaz@gmail.com
or through a Researchgate account. 
https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54920</zip>
        <telephone>+92 323 5043603</telephone>
        <email>muhammad.waqas@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Akram</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54920</zip>
        <telephone>0092347474815‬</telephone>
        <email>sana.akram@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both gender
Age between 20-40 years
Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology
History of widespread chronic pain for more than 3 months
The patient must exhibit more than 11 of 18 tender point</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cognitive deficit that does not allow the understanding of the evaluation instruments
Physical activity started or changed in the last three months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fibromyalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group B: Myofascial mobilization with routine physical therapy:  The participants executed a 12-week supervised myofascial mobilization program of 40-minute sessions performed twice a week.</i_keyword>
      <i_keyword>Group A: Routine physical therapy:  The routine physical therapy group underwent a 12-week supervised exercise program of 40- minute sessions performed thrice a week. Stretching and strengthening exercises. TENS units, ultrasound are applied on participant. The targeted muscles for stretching were: gluteus, iliopsoas, ischiotibials, paravertebralis, latissimus dorsi, hip adductor muscles, trapezium and pectoralis. At early stages of the program, participants performed three repetitions; from the fifth week, four repetitions; and from the ninth week, five. The stretch intensity were increased gradually to the point of moderate discomfort and the position was held for 30 seconds. Myofascial mobilization release will be given before every session of stretching exercise. Readings will be taken at baseline, 6th or 12th week of interventionThe participants executed a 12-week supervised strengthening exercise program of 40-minute sessions performed twice a week, with progressive overload. In the first two sessions, no load was used. Subsequently, 0.5kg was added each week if the patient identified the effort as slightly intense on the Borg scale (score = 13)22.The patients were instructed to do a series of eight repetitions of strengthening exercises for the following muscles23: triceps surae, hip adductors and abductors, hip flexor, shoulder flexor and extensor, anterior and posterior deltoids, pectoralis major and rhomboids</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Data will be calculated at baseline, 1st follow up at 8th week and 2nd follow up at 16th week. Method of measurement: ●	Numeric pain rating scale to measure pain.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Data will be calculated at baseline, 1st follow up at 8th week and 2nd follow up at 16th week. Method of measurement: WHO Quality of life questionnaire used to assess quality of life.</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>Self Supported</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-01</approval_date>
        <contact_name>The rules and regulations set by the ethical committee of The University of Lahore wIll be followed </contact_name>
        <contact_address>RAIWIND ROAD CAMPUS: 1-Km, Raiwind Road, Near Thokar Niaz Big, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
