<?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>IRCT20220530055032N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-27</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of dry needling of scapular and shoulder muscles painful points on pain and function of patients with carpal tunnel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effects of dry needling on painful myofascial points of scapular and shoulder muscles on pain and function of patients with carpal tunnel syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63942</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly divided into two equal groups of routine physical therapy and routine physical therapy plus dry needling via Block randomization method, with a block size of 4 by using of random allocation software, Blinding description: The treatment will be performed by a physiotherapist and the variables will be measured by another physiotherapist who is unaware of the allocated groups, and the data will be analyzed by a statistician who is unaware of the group assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Carpal tunnel syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients will receive 10 sessions of routine physical therapy at the wrist area: therapeutic continuous ultrasound (for 5 min with 3.0 MHz applicator, ERA = 5 cm2, intensity= 1.5 W/cm2); Burst TENS on median nerve (frequency 100Hz, pulse width 80 ms, electrode size 4* 6 for 20 min); hot pack on wrist area; median nerve mobilization technique; Dry needling technique in the muscles around the scapula and shoulder. Intervention 2: Control group: patients will receive 10 sessions of routine physical therapy at the wrist area: therapeutic continuous ultrasound (for 5 min with 3.0 MHz applicator, ERA = 5 cm2, intensity= 1.5 W/cm2); Burst TENS on median nerve (frequency 100Hz, pulse width 80 ms, electrode size 4* 6 for 20 min); hot pack on wrist area; median nerve mobilization 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:
After coordination with the Research Ethics Committee for approval of the ethics committee, participants data file will be provided In complete secrecy and for research purposes only.

When:
6-12 month after acceptance of the article by the journal.

To whom:
In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee.

Conditions:
Preferably it is only used for the subject of my research, but if research is to be done in order to use the statistical population, the main project executor and the student's main collaborator will make a decision with the permission of the ethics committee.

Where to obtain:
Executors of the project can first be referred to through Dr. Zahra Rojhani Shirazi (09171127108), and the main colleague and student collaborator Ms Fatemeh Panahi (09183571646).

How to obtain:
6 months after article publication, referring the request to the executor of the project, an official letter from the ethics committee will be commented on in order to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sedighe Rezaeyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7194733669</zip>
        <telephone>+98 71 3631 7233</telephone>
        <email>sedigherezaeyan73@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Rezaeyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3631 7233</telephone>
        <email>sedigherezaeyan73@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with mild to moderate carpal tunnel syndrome
Aged between 30 and 60 years
Pain and paresthesia in hand (especially thumb, index and middle fingers)
Having symptoms for more than one month
Positive Phalen’s test
Positive Tinel’s test
Painful myofascial points at least in two muscles around scapula (Upper Trapezius, Supraspinatus, Infraspinatus, Subscapularis, Teres minor and major) and at least in one muscle around shoulder (Biceps and Deltoid)
Normal BMI to overweight</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cervical disc protrusion
Cervical radiculopathy
Cervical vertebral degeneration
Double crush syndrome
Upper limb fracture
Sensory or motor defects of the ulnar or radial nerves
History of wrist or cervical spine severe injury
Previous wrist, upper limb or cervical vertebrae surgeries
History of steroid injection into the wrist
History of systemic disease causing carpal tunnel syndrome such as diabetes, rheumatoid arthritis and fibromyalgia
Pregnancy
Thenar muscles atrophy
Use of blood thinner drugs
Tumor
Epilepsy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G56.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Carpal tunnel syndrome</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: patients will receive 10 sessions of routine physical therapy at the wrist area: therapeutic continuous ultrasound (for 5 min with 3.0 MHz applicator, ERA = 5 cm2, intensity= 1.5 W/cm2); Burst TENS on median nerve (frequency 100Hz, pulse width 80 ms, electrode size 4* 6 for 20 min); hot pack on wrist area; median nerve mobilization technique; Dry needling technique in the muscles around the scapula and shoulder.</i_keyword>
      <i_keyword>Control group: patients will receive 10 sessions of routine physical therapy at the wrist area: therapeutic continuous ultrasound (for 5 min with 3.0 MHz applicator, ERA = 5 cm2, intensity= 1.5 W/cm2); Burst TENS on median nerve (frequency 100Hz, pulse width 80 ms, electrode size 4* 6 for 20 min); hot pack on wrist area; median nerve mobilization technique.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Visual analogue scale.</prim_outcome>
      <prim_outcome>Grip power. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Hand-held dynamometer.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: DASH questionnaire.</prim_outcome>
      <prim_outcome>Severity and functional ability. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Boston questioner.</prim_outcome>
      <prim_outcome>Two point discrimination. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Two point discriminator.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-11</approval_date>
        <contact_name>Research Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
