<?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>IRCT20220804055615N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-29</date_registration>
      <primary_sponsor>Memon College of Physical and Rehasbilitaive Medicine</primary_sponsor>
      <public_title>Effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) on trigger points versus manual Exercises</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Instrument-Assisted Soft Tissue Mobilization (IASTM) on trigger points of the cervical and lumbar region among sedentary individuals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68956</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used in this study. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group assignments, which keeps the number of participants in each group similar at all times. The block size is determined with 2 treatment groups, a block size of 4. After block size has been determined, all possible balanced combinations of assignment within the block (ie, an equal number for all groups within the block) will be calculated. Blocks are then randomly chosen to determine the participants' assignment into the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>To treat the myofascial trigger points in cervical and lumbar region.</hc_freetext>
      <i_freetext>Intervention 1: Twenty five  participants will be received instrument-assisted soft tissue mobilization treatment technique using ergon tool. The position of patients will be in prone lying. With the help of ergon tool, we give strokes (sweeping motion) proximal to distal or distal to proximal in both ways over the myofascial restrictions for 10 minutes. Along with ergon technique conventional treatment including hot pack 15 minutes, strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles 3-6 repetition with 10 seconds hold. Every patient undergoes 45 minutes’ treatment session, 3 sessions/ week for 6 weeks. Assessment will be performed at baseline and at the end of 6th week treatment protocol. Intervention 2: Twenty five participants will be received only conventional treatment including hot pack therapy for 15 minutes. Strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles, 3-6 repetitions with 10 seconds hold. Every patient undergoes 45 minutes’ treatment session, 3 sessions/ week for 6 weeks. Assessment will be performed at baseline and at the end of 6th week treatment protocol.</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 analytical data will be avail in published article or can be request by email to get the data</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohabbat Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safoora goth</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>75270</zip>
        <telephone>+92 21 99261810</telephone>
        <email>ramal_209@yahoo.com</email>
        <affiliation>Memon Medical Institute Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohabbat Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safoora</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>75270</zip>
        <telephone>+92 21 99261810</telephone>
        <email>ramal_209@yahoo.com</email>
        <affiliation>Memon Medical Institute Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 40 years are included
Who having cervical and lumbar pain more than 6 months
Patients diagnosed with at least active trigger points in cervical &amp; lumbar region
Patients having pain intensity of at least 3 in the numeric pain scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the pain is related to any trauma  or fracture
Patients with tuberculosis of spine
Patients with any types of wounds
History of infections or any other cause of back pain not due to muscles  spasm or trigger point
If the patients have a history of whiplash injury
If the patients have history of head, neck and cervical spinal surgery
If the patients have a history of cervical radiculopathy
If the patients  have diagnosed with fibromyalgia and myopathy
If the patients have history of cancer at relevant area of body
If the patients get the myofascial physical therapy treatment within the past one month
If the patients are taking any anti-psychotic medicine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Twenty five  participants will be received instrument-assisted soft tissue mobilization treatment technique using ergon tool. The position of patients will be in prone lying. With the help of ergon tool, we give strokes (sweeping motion) proximal to distal or distal to proximal in both ways over the myofascial restrictions for 10 minutes. Along with ergon technique conventional treatment including hot pack 15 minutes, strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles 3-6 repetition with 10 seconds hold. Every patient undergoes 45 minutes’ treatment session, 3 sessions/ week for 6 weeks. Assessment will be performed at baseline and at the end of 6th week treatment protocol.</i_keyword>
      <i_keyword>Twenty five participants will be received only conventional treatment including hot pack therapy for 15 minutes. Strengthening exercises of all weak cervical and lumbar muscles with 10-12 repetitions of each muscle would be performed. Stretching exercises of all tight cervical and lumbar muscles, 3-6 repetitions with 10 seconds hold. Every patient undergoes 45 minutes’ treatment session, 3 sessions/ week for 6 weeks. Assessment will be performed at baseline and at the end of 6th week treatment protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Instrumental versus manual exercises for trigger point release. Timepoint: The outcomes will be measured at the baseline and re-measured after the 18 sessions. The intervention protocol is based on three sessions per week for six weeks. Method of measurement: Outcome will measure by numeric pain rating scale, neck disability index, pain sensitivity questionnaire and modified somatic perception questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Muscle power. Timepoint: Before and after 18 session of treatment. Method of measurement: Manual muscle power test.</sec_outcome>
      <sec_outcome>To check range of motion before and after intervention. Timepoint: Before and after 18 session of treatment. Method of measurement: Range of motion will be check by inclinometer.</sec_outcome>
      <sec_outcome>To check pain scale before an after the interventions. Timepoint: Before and after 18 session of treatment. Method of measurement: Pain will be check by numeric pain scale.</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>Memon College of Physical and Rehasbilitaive Medicine</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-14</approval_date>
        <contact_name>Institutional Review Board Memon Medical Institute Hospital</contact_name>
        <contact_address>Safoora Goth Scheme 33 Karachi Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
