<?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>IRCT20220104053617N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-23</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effects of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non specific neck pain</public_title>
      <acronym>Randomized controlled trial</acronym>
      <scientific_title>Effects of integrated neuromuscular inhibition technique on upper trapezius trigger points in patients with non specific neck pain: a randomized controlled trail</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62539</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sample size was collected and it turned out to be 48. Subjects meeting the inclusion criteria will be randomly allocated into two groups using computer generated randomization method in which computer software will be utilized to allocate 24 subjects in each group. Purposive Random Sampling will be carried out for this purpose. Allocation concealment will be Carried out, Blinding description: Our study will be single blinded. Outcome assessor will be unaware of the treatment given to patient.. He will not be given any information on which treatment is applied on which patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non specific neck pain.</hc_freetext>
      <i_freetext>Intervention 1: Control group:this group will receive training in 30-minute sessions, 5times per week, for 8 weeks. Total duration of treatment in this group will be 30 minutes. Thirty minutes for conventional treatment like low level of the heating at the neck for 5-10 minutes.(2)Posture corrective exercises , alignment and neck-strengthening exercises, Transcutaneous electrical nerve stimulation (TENS). Traction. Short-term immobilization at cervical. Acupuncture. Chiropractic massage. Intervention 2: Intervention group:- In a intervention group Patients will receive conventional physical therapy in 30-minute sessions, 5 times per week, for 8 weeks.that will include low level of the heating at the neck for 5-10 minutes.(2)Posture corrective exercises , alignment and neck-strengthening exercises,  Transcutaneous electrical nerve stimulation (TENS). Traction. Short-term immobilization. Acupuncture. Chiropractic Massage. 2- Along with Conventional Treatment Protocol there will be additional treatment Technique integrated Neuromuscular inhibitionTechnique must be applied to get better outcomes , the duration of thistechnique will be 20-30 minutes data Collection Tools (Proforma/Questionnaire) thirty minutes of integrated neuromuscular inhibition technique.</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:
EFFECTS OF INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE ON
UPPER TRAPEZIUS TRIGGER POINTS IN PATIENTS WITH NON SPECIFIC
NECK PAIN: RANDOMIZED CONTROLLED TRIAL. All collected deidentified IPD

When:
Data will be available from December 2022 for three years.

To whom:
Data will be available for those working in academics or involved in clinical research work

Conditions:
Data can be used for citation purposes

Where to obtain:
Data will be made available through email. Applicants wanted to have access can email on following e mail address and it could take 3 working days to make data available for applicant.
Ema Address: dr.nusratqamar55@gmail.com

How to obtain:
Data will be made available through email. Applicants wanted to have access can email on following e mail address and it could take 3 working days to make data available for applicant.
Ema Address: dr.nusratqamar55@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nusrat Qamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1km.off defence road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>537000</zip>
        <telephone>092 021 111 844 844</telephone>
        <email>dr.nusratqamar55@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nusrat Qamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>1km.off defence road, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>537000</zip>
        <telephone>092 021 111 844 844</telephone>
        <email>dr.nusratqamar55@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Subjects suffering from non-specific neck pain, defined as non-articular or non-systemic as per the referring physician.
Subjects will be required to have neck pain of less than 3 months duration as well as active TrPs inthe upper trapezius muscle, defined as a tender nodule in a taut band that referred pain beyondthe area of contact</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If patiant with neck symptoms will be related to a motor vehicle collision or significant trauma, they will not be included in our study
If patiants will be presenting with signs of serious pathology (e.g. malignancy, infection, inflammatorydisorder, or fracture), then he/she will not be included in the trial
Patients with signs of cervical spinal cord compromise (e.g. diffuse sensory abnormality, diffuse weakness, hyperreflexia, or the presence of clonus), two or more signs of nerve rootinvolvement (e.g. dermatomal sensation changes, myotomal weakness, or diminished/absenttendon jerk reflexes)
A history of neck surgery during the previous 12 months, and a history of cervical degenerativejoint disease as per radiographs, endocrine disorders, and autoimmune conditions (e.g. rheumatoid arthritis, fibromyalgia, etc.)
If pateints had received trigger point injections in the upper trapezius muscle within the past 6 months, they will not be included in our study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.02</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Panniculitis affecting regions of neck and back, cervical region</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>Control group:this group will receive training in 30-minute sessions, 5times per week, for 8 weeks. Total duration of treatment in this group will be 30 minutes. Thirty minutes for conventional treatment like low level of the heating at the neck for 5-10 minutes.(2)Posture corrective exercises , alignment and neck-strengthening exercises, Transcutaneous electrical nerve stimulation (TENS). Traction. Short-term immobilization at cervical. Acupuncture. Chiropractic massage.</i_keyword>
      <i_keyword>Intervention group:- In a intervention group Patients will receive conventional physical therapy in 30-minute sessions, 5 times per week, for 8 weeks.that will include low level of the heating at the neck for 5-10 minutes.(2)Posture corrective exercises , alignment and neck-strengthening exercises,  Transcutaneous electrical nerve stimulation (TENS). Traction. Short-term immobilization. Acupuncture. Chiropractic Massage. 2- Along with Conventional Treatment Protocol there will be additional treatment Technique integrated Neuromuscular inhibitionTechnique must be applied to get better outcomes , the duration of thistechnique will be 20-30 minutes data Collection Tools (Proforma/Questionnaire) thirty minutes of integrated neuromuscular inhibition technique.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain will be assessed at Baseline and after every week for 4 weeks. Method of measurement: Visual Analog Scale will be utilized for the assessment of pain.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Functional Disability will be assessed at Baseline and after every week for 4 weeks. Method of measurement: Neck Disability Index will be utilized for this purpose.</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>2021-12-23</approval_date>
        <contact_name>Ethics committee of University of Lahore</contact_name>
        <contact_address>1km.off defence road, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
