<?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>IRCT20190707044128N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-30</date_registration>
      <primary_sponsor>khyber medical university</primary_sponsor>
      <public_title>Hold Relax Technique and Ischemic Compression followed by a sustained stretch in treating Myofacial Trigger Points of Upper Trapezius</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Analysis on the effectiveness of Hold Relax Technique and Ischemic Compression followed by a sustained stretch in treating Myofacial Trigger Points of Upper Trapezius:  A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40865</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be recruited in three groups i.e. Group A (Hold-Relax technique), Group B (Ischemic Compression followed by sustained stretch) and Group C (Both techniques) by randomization through Chit-box method.  
Chit-Box Method: For random allocation of 60 cases into three groups equally, prepare 60 chits writing “A” (for Group-A) on 20 chits, “B” (for Group-B) on 20 chits and “C” (for Group-C) on 20 chits. After folding the chits and putting in a box and well mixing, draw a chit, note the letter written on it, and then draw the second chit without replacing the first, note it and proceed similarly until the last i.e. 60th chit is drawn. The generated random allocation sequence may be one as appears in Table below. According to this sequence the first case registered will go to the Group-A, second case again to the Group-A, third to the Group-C and so on to the last case to Group-B. 

Table: Chit-Box Method for Randomization
Draw	                                  1st 	                   2nd 	          3rd 	                --	        15th 
Result (Letters on chit)	A	A	C	B	C	B	B	A	A	A	B	C	-	C	A	B	B
Registered Case No. 	1	2	3	4	5	6	7	8	9	10	11	12	--	57	58	59	60
(No. Allocation), Blinding description: The outcome assessor will be kept blind about the treatment protocols and randomization process during the whole trial.</study_design>
      <phase>3</phase>
      <hc_freetext>The Myofascial Pain Syndrome (MPS).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group-A of 20 patients (Experimental group) will be treated with a Hold-Relax technique that will be applied on the upper Trapezius muscle of the affected side for 1 set of 5 repetitions with 10 seconds hold. It involves a stretch of the muscle up to a point of a resistance barrier. The patient then contracts the muscle to about 25% of their own muscle force against the practitioner’s resistance. The body part remains in a static position resulting in an isometric contraction. The patient holds this contraction for 10 seconds. After this the patient is asked to relax for the next 10 seconds. This is then followed by a further 10 seconds stretch in order to find a new barrier position. Intervention 2: Control group: Group-B of 20 patients (Control group) will be treated with Ischemic compression followed by a sustained stretch technique. Firstly, the trapezius muscle is stretched to the point of discomfort then a digital pressure is applied for 20 seconds with the examiners thumb or finger which temporarily occludes the blood supply to the area. It is then followed by a sustained stretch of 15 seconds on the same muscle. This procedure will be repeated for five times in one session. Intervention 3: Control group: Group-C of 20 patients will be treated with a combined therapy containing Hold relax technique plus Ischemic compression followed by a sustained stretch technique for 1 set of 5 repetitions.</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 there is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ishaq Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Soan Garden, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 42 111 865 865</telephone>
        <email>ishaqpt786@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ishaq Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Soan Garden, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>75500</zip>
        <telephone>+92 42 111 865 865</telephone>
        <email>ishaqpt786@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group between 20- 45 years,, ,
Both Male and Female patients
Chronic cases of Upper trapezius myofacial pain
Patients with at least 15-24 points (30-48%) score in Neck Disability Index</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients receiving treatment by other methods like vapocoolants, dry needling, acupuncture injections etc.
Neck or shoulder surgery within the past year
Neurological or rheumatic disorders
Clinical evidence of radiculopathy, myelopathy or joint disorders
Whiplash in the previous 6 months
Recent fracture of the cervical spine
Cervical instability
Cervical spondylosis
Ankylosing spondylitis
Disc prolapsed
Osteoporosis
Mental disorders</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group-A of 20 patients (Experimental group) will be treated with a Hold-Relax technique that will be applied on the upper Trapezius muscle of the affected side for 1 set of 5 repetitions with 10 seconds hold. It involves a stretch of the muscle up to a point of a resistance barrier. The patient then contracts the muscle to about 25% of their own muscle force against the practitioner’s resistance. The body part remains in a static position resulting in an isometric contraction. The patient holds this contraction for 10 seconds. After this the patient is asked to relax for the next 10 seconds. This is then followed by a further 10 seconds stretch in order to find a new barrier position.</i_keyword>
      <i_keyword>Control group: Group-B of 20 patients (Control group) will be treated with Ischemic compression followed by a sustained stretch technique. Firstly, the trapezius muscle is stretched to the point of discomfort then a digital pressure is applied for 20 seconds with the examiners thumb or finger which temporarily occludes the blood supply to the area. It is then followed by a sustained stretch of 15 seconds on the same muscle. This procedure will be repeated for five times in one session.</i_keyword>
      <i_keyword>Control group: Group-C of 20 patients will be treated with a combined therapy containing Hold relax technique plus Ischemic compression followed by a sustained stretch technique for 1 set of 5 repetitions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: At the start of intervention and then after one month (12sessions) of treatment administration. Method of measurement: VAS (Visual Analogue Scale) for measuring the Pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Disability. Timepoint: At the start of intervention and then after one month (12sessions) of treatment administration. Method of measurement: NDI (Neck Disability Index) for measuring the Disability.</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>khyber medical university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-09-29</approval_date>
        <contact_name>Advanced Studies &amp; Research Board of Khyber Medical University</contact_name>
        <contact_address>Block-IV PDA building, Phase-V Hayatabad Islamabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
