<?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>IRCT20151123025202N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-17</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Treatment of forward head posture</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the efficacy of therapeutic exercises and trigger points dry needling in patients with forward head posture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57460</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We made 60 cards and write letter V on 30 for Intervention and on the other 30 letter D for the control group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and will be opened, based on selected letter V or D patients will be assigned to exercises therapy or dry needling  group.The sampling process will be continues until all the cards are selected, Blinding description: In this study, the person evaluating the angle of head, neck and shoulders in the image taken by digital camera and analyzed computer software, pain score of patients with visual analog scale  and quality of life of patients with SF-12 scale will be blinded regarding to intervention groups .</study_design>
      <phase>3</phase>
      <hc_freetext>forward head posture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The duration of treatment in this study will be 3 months (12 weeks). Exercise therapy sessions will be performed twice a week for 20 minutes under the supervision of a therapist. The exercise therapy protocol will include three stretching exercises and four strength exercises aimed at correcting the condition of the neck and shoulders position. Strength training is designed for rotator cuff activity, minor fear, infra-spinatus, scapular stabilizing muscles (upper and lower trapezius), rhomboids, and deep neck flexors. Stretching exercises are designed to stretch the shortened pectoralis minor muscles and the SCM neck muscles and the scapula lift. The exercise program is performed under the direct supervision of the therapist to ensure the correctness of the exercises. To increase patients' resistance, all exercises are started lightly, including 2 sets of 15, and gradually increase the intensity, number of sets and repetition of movements. The average duration of exercise will be 20 minutes and the exercise sequence is random. Intervention 2: Intervention group: For patients in the Dry Needling group of trigger points  (TrPs), the neck and shoulder girdle muscles, including the trapezius, SCM, sub-occipital, scapula, scale, pectoralis major, and infra-spinatus muscles, will first be evaluated by a experienced specialist to finding TrPs. . The identified TrPs are marked for each patient in an anatomical shape. For Dry Needling, patients will be asked to lie in a comfortable bed in a quiet room for 10 minutes. Dry Needling is then performed by inserting an acupuncture needle 0.3 mm in diameter and 50 mm in length into the identified TrPs. The needle is raised and lowered for 3-5 times and then removed. As in the exercise therapy group, treatment sessions in this group will be twice a week for 12 weeks.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abbas Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan shahid fahmideh street medicine school</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0097</telephone>
        <email>a.moradi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Loabat Majidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat Hospital, Shahid Beheshti Blv, Hamedan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6514845411</zip>
        <telephone>+98 81 3264 0030</telephone>
        <email>lobat.majidi@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of forward head posture  abnormalities according to clinical criteria
Age 65-14 years</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidity of other musculoskeletal diseases, spinal diseases, neurological and motor diseases
History of shoulder surgery
Vascular diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M95.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acquired deformity of musculoskeletal system, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The duration of treatment in this study will be 3 months (12 weeks). Exercise therapy sessions will be performed twice a week for 20 minutes under the supervision of a therapist. The exercise therapy protocol will include three stretching exercises and four strength exercises aimed at correcting the condition of the neck and shoulders position. Strength training is designed for rotator cuff activity, minor fear, infra-spinatus, scapular stabilizing muscles (upper and lower trapezius), rhomboids, and deep neck flexors. Stretching exercises are designed to stretch the shortened pectoralis minor muscles and the SCM neck muscles and the scapula lift. The exercise program is performed under the direct supervision of the therapist to ensure the correctness of the exercises. To increase patients' resistance, all exercises are started lightly, including 2 sets of 15, and gradually increase the intensity, number of sets and repetition of movements. The average duration of exercise will be 20 minutes and the exercise sequence is random.</i_keyword>
      <i_keyword>Intervention group: For patients in the Dry Needling group of trigger points  (TrPs), the neck and shoulder girdle muscles, including the trapezius, SCM, sub-occipital, scapula, scale, pectoralis major, and infra-spinatus muscles, will first be evaluated by a experienced specialist to finding TrPs. . The identified TrPs are marked for each patient in an anatomical shape. For Dry Needling, patients will be asked to lie in a comfortable bed in a quiet room for 10 minutes. Dry Needling is then performed by inserting an acupuncture needle 0.3 mm in diameter and 50 mm in length into the identified TrPs. The needle is raised and lowered for 3-5 times and then removed. As in the exercise therapy group, treatment sessions in this group will be twice a week for 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes neck and shoulder angle. Timepoint: Before the intervention and at the end of week 12 of the intervention. Method of measurement: Taking a photo of the profile of the body, analysis with a computer.</prim_outcome>
      <prim_outcome>Pain severity. Timepoint: Before the intervention and at the end of week 12 of the intervention. Method of measurement: Visual Analogues Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life associated with forward head posture. Timepoint: Before and 12 weeks after the intervention. Method of measurement: Questionnaire SF-12.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-30</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Science</contact_name>
        <contact_address>ُShahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
