<?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>IRCT20211130053231N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-18</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effect of Muscle energy technique in treatment of  cervical radiculopathy</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Phonophoresis With And Without Muscle Energy Technique On Pain, Cervical Range of Motion And Functional Disability In Patients With Degenerative Cervical Radiculopathy: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60365</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: lottery-based randomization procedure:
All the recruited subjects' names and ids were written on individual small paper/chits. All these papers were folded and put into a box. The box was shaken to mix all the papers. Then one by one each slip was drawn from the box. The group of the first drawn slip patient was sorted into group A and later with each draw of the paper all subjects were placed alternatively in the group B and group A, Blinding description: both assessor of outcomes (fellow physiotherapist) and statistician ( data analyzer) will be blinded. They both will have no knowledge of the patient's group and treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Degenerative cervical radiculopathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A (n=25) was treated with ketoprofen gel phonophoresis along with post isometric relaxation technique of muscle energy technique 3 times/week on alternate days (total 12 sessions) for 4 weeks. Conservative physical therapy treatment was also delivered which included cervical traction, Active range of motions, and thermotherapy. For phonophoresis, Fastum gel (2.5% w/w ketoprofen gel) was mixed with aqua sonic gel as a coupling medium. The US machine was adjusted in continuous mode at 1 MHz frequency while an intensity of 1.5W/cm₂ will be applied for 10 mins on a circular basis. For MET each patient received 4 repetitions of post-isometric relaxation. each contraction required 20%of submaximal effort and was sustained for 8 secs. Then the muscle to be stretched for 20 seconds, which was followed by a rest period of 5 seconds. Intervention 2: Control group: Group B (n =25) received ketoprofen phonophoresis only 3 times/week on alternate days (total 12 sessions) for 4 weeks. Conservative physical therapy treatment was also delivered which included cervical traction, Active range of motions, and thermotherapy.  For phonophoresis, Fastum gel (2.5% w/w ketoprofen gel) was mixed with aqua sonic gel as a coupling medium. The US machine was adjusted in continuous mode at 1 MHz frequency while an intensity of 1.5W/cm₂ will be applied for 10 mins on a circular basis.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there is no further justification</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maheen Ashraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shadman town house p82 Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 0071665</telephone>
        <email>msptn02191027@student.uol.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maheen Ashraf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shadman town house p82 Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>+92 334 0071665</telephone>
        <email>msptn02191027@student.uol.edu.pk</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>CR diagnosis with sub-acute history and physical examination findings
Diagnosed CR patients referred from a physician.
Patients were diagnosed based on the prediction rule. i.e. (a) unilateral upper limb sensory and motor function dysfunction was observed (including muscle weakness, paresthesia, and sharp pain. (b)when positive results were found in three of these four tests (Spurling's test, The ipsilateral cervical spinal rotation less than 60 degrees, Distraction test, Upper Limb Neurodynamic Test 1)
age between 30 to 65
both male and female</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetes mellitus
Peripheral and central nervous system disease
Polyneuropathy
Malignancy
History of surgical intervention on the neck area
Certain surgical indications (e.g., progressive neurological deficit)
“Red flags” (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
Cervical spine injections (steroidal) in the past 2 week
Current use of steroidal medication prescribed for radiculopathy symptoms
Bilateral upper limb sensory and motor dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M50.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cervical disc disorder with radiculopathy, unspecified cervical region</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A (n=25) was treated with ketoprofen gel phonophoresis along with post isometric relaxation technique of muscle energy technique 3 times/week on alternate days (total 12 sessions) for 4 weeks. Conservative physical therapy treatment was also delivered which included cervical traction, Active range of motions, and thermotherapy. For phonophoresis, Fastum gel (2.5% w/w ketoprofen gel) was mixed with aqua sonic gel as a coupling medium. The US machine was adjusted in continuous mode at 1 MHz frequency while an intensity of 1.5W/cm₂ will be applied for 10 mins on a circular basis. For MET each patient received 4 repetitions of post-isometric relaxation. each contraction required 20%of submaximal effort and was sustained for 8 secs. Then the muscle to be stretched for 20 seconds, which was followed by a rest period of 5 seconds.</i_keyword>
      <i_keyword>Control group: Group B (n =25) received ketoprofen phonophoresis only 3 times/week on alternate days (total 12 sessions) for 4 weeks. Conservative physical therapy treatment was also delivered which included cervical traction, Active range of motions, and thermotherapy.  For phonophoresis, Fastum gel (2.5% w/w ketoprofen gel) was mixed with aqua sonic gel as a coupling medium. The US machine was adjusted in continuous mode at 1 MHz frequency while an intensity of 1.5W/cm₂ will be applied for 10 mins on a circular basis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before intervention, after 2 weeks and after 4 weeks of intervention. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Cervical range of motion. Timepoint: Before intervention, after 2 weeks and after 4 weeks of intervention. Method of measurement: goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional disability. Timepoint: Before intervention, after 2 weeks and after 4 weeks of intervention. Method of measurement: Neck disability index (NDI).</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>2021-07-15</approval_date>
        <contact_name>University of Lahore</contact_name>
        <contact_address>1-Km Defense Road, near Bhuptian Chowk Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
