<?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>IRCT20200215046499N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-25</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of dry needling and physiotherapy in patients with frozen shoulder</public_title>
      <acronym></acronym>
      <scientific_title>Effects of dry needling on subscapularis and conventional physiotherapy on clinical symptom improvement in people with frozen shoulder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67031</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with a sealed envelope: Two envelopes are prepared with the first and second group titles. Each participant randomly selects one envelope and the envelope number is recorded for the participant. The envelopes are then merged and the next participant selects another envelope from the two envelopes as the previous procedure to complete the randomization process in both groups, Blinding description: evaluator is blind to the type of intervention in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>frozen shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to receiving the subscapularis dry needling during 3 sessions (in the 3rd, 6th, and 9th sessions of treatment) with a sterile dong bang needle with a size of 30*50 mm, the patient receives conventional physiotherapy treatment provided by the physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with a speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day. Intervention 2: Control group: People in this group only will receive conventional physiotherapy treatment provided by a physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.</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 Its release schedule is not yet decided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hakimeh adigozali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Adigozalih@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hakimeh adigozali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd</address>
        <city>tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3337 5359</telephone>
        <email>Adigozalih@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Those who have been diagnosed with frozen shoulder by a doctor and have symptoms such as pain and reduced range of motion in the capsular pattern in the shoulder joint for 3 months or more
age between 35 and 65 years old
the presence of active trigger points in the subscapularis muscle on the involved side
Pain intensity of at least 3 out of 10 in the VAS</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>skin problems in the neck and shoulder area
Antiplatelet therapy has been used in the three days before the start of the study
In the six months before starting the study, they had a history of cancer and related pain in the shoulder and pectoral region
In the three months before the start of the study, they used corticosteroid injections in the shoulder area
needle fobia
Non-cooperation during treatment
Shoulder arthroscopy surgery
cervical radiculopathy or any neurological injury in upper limb
Patients with rheumatoid or neurological diseases
Patients who use pace makers
Patients with positive  subacromial entrapment tests</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of unspecified shoulder</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: In addition to receiving the subscapularis dry needling during 3 sessions (in the 3rd, 6th, and 9th sessions of treatment) with a sterile dong bang needle with a size of 30*50 mm, the patient receives conventional physiotherapy treatment provided by the physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with a speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.</i_keyword>
      <i_keyword>Control group: People in this group only will receive conventional physiotherapy treatment provided by a physiotherapist. Conventional treatment includes the use of continuous ultrasound with a frequency of 3 MHz for 6 minutes around the joint capsule, the use of high intensity electric current with a frequency of 80 Hz and diversion for 20 minutes, and the use of a hot pack simultaneously with the application of the current. For the involved shoulder, postero-anterior, antero-posterior and caudal glides can be used with speed of 2 to 3 glides per second and for a total of 30 seconds for each set. The number of sets for each movement is 5 and the rest time between sets is 30 seconds. We ask the patient to stretch the shoulder muscles as well. The duration of each stretch is 30 seconds and the interval between them is 15 seconds and it is done during 3 sets. We ask the patient to do active-assistive exercises using a towel for 5 minutes a day. The number of conventional treatment sessions is 10 sessions, every other day.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Range of motion of shoulder joint. Timepoint: before and after intervention. Method of measurement: goniometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain intensity of trigger point. Timepoint: before and after intervention. Method of measurement: Visual analog scale.</sec_outcome>
      <sec_outcome>Pain intensity of shoulder joint. Timepoint: before and after intervention. Method of measurement: visual analog scale (VAS).</sec_outcome>
      <sec_outcome>Pain pressure threshold of trigger points. Timepoint: before and after intervention. Method of measurement: algometer.</sec_outcome>
      <sec_outcome>Upper limb functional disability. Timepoint: at first, fifth and tenth of treatment sessions. Method of measurement: disability of arm, shoulder and hand (DASH).</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>Tabriz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-06</approval_date>
        <contact_name>Ethics committee of Tabriz University of medical sciences</contact_name>
        <contact_address>Faculty of Rehabilitation Sciences, Tabriz University of medical sciences, 29 Bahman Blvd, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
