<?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>IRCT20160531028186N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-05</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sahrman exercise on headache and balance in patients with cervical headache</public_title>
      <acronym></acronym>
      <scientific_title>The effect of sahrman approach on headache and balance indices in patients with  chronic cervicogenic headache:  single blinded randomize clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64764</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering that age, gender, obesity and thinness can be confounding variables based on past studies, it is necessary to match the two control and intervention groups with respect to these variables. Based on gender, age (less than or equal to 40 and more than 40 years) and obesity (thin, normal, overweight and obese) will be placed in an age-sex-obesity subgroup. Then in each subgroup of a random sequence that The permutation block method based on the table of random numbers will be used to place people in one of the control or intervention groups. The size of each block will be considered 2, Blinding description: The outcomes is assessed by another physiotherapist who is blind to the type of treatment being given to the patient.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cervicogenic headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Sohrman's exercises:In the Sohrman exercise group, in addition to receiving TENS, hot packs and ultrasound(under the same conditions as in the routine treatment group), the patient will be taught exercises and functional training during daily activities to improve movement. Each exercise is repeated in 3 series and each series 10 times. According to the type of movement syndrome and including rest time, exercises will be done for 35 to 50 minutes in each session. The number of treatment sessions will be 12 sessions, three days a week for four weeks. Intervention 2: Participants in the routine treatment group will be treated with hot packs, TENS with a frequency of 100 Hz and 50 microseconds duration, and ultrasound with a frequency of 1 megahertz and an intensity of 1 w/cm2. The electrodes will be placed in the occipital and paravertebral areas on both sides, and the intensity of the current used for each patient will be adjusted to the level of pain-free paresthesia. Ultrasound will be applied in the areas of the paravertebral muscles and the upper and outer edge of the upper trapezius muscle, unilaterally and for 5 minutes. The duration of each session will be 30 minutes.</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:
All the main outcome data can be shared.

When:
6 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers and experts in this field must ensure that data is not misused

Where to obtain:
afsanehsamiei72@yahoo.com

How to obtain:
The applicant must be fully and transparently identified and express his intention at his request. About 2 to 4 weeks after verification, the data will reach him.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Hosseinifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmojomoghadam Laboratory, Ayatollah Kafami St.</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6485598136</zip>
        <telephone>+98 54 3342 4675</telephone>
        <email>fardash_s@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Hosseinifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Physiotherapy, Faculty of Rehabilitation Sciences, Razmjomoghadam Laboratory, Ayatollah Kafami St.</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6485598136</zip>
        <telephone>+98 54 3342 4675</telephone>
        <email>fardash_s@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women between the ages of 18-65
Having a history of headache for at least three months
Having at least 5 of the CHISG diagnostic criteria.
Having most (more than half) of Sohrman's diagnostic criteria for extension and extension rotation syndrome.
Absence of: degenerative symptoms, radiculopathy, severe pastural disorders, progressive rheumatological and neurological diseases, history of accidents and whiplash injuries, malignancy.
No history of neck surgery and no blood pressure disorders, vision problems, and dizziness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>disinclination to continue treatment
Aggravation of symptoms during treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other headache syndromes</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: Sohrman's exercises:In the Sohrman exercise group, in addition to receiving TENS, hot packs and ultrasound(under the same conditions as in the routine treatment group), the patient will be taught exercises and functional training during daily activities to improve movement. Each exercise is repeated in 3 series and each series 10 times. According to the type of movement syndrome and including rest time, exercises will be done for 35 to 50 minutes in each session. The number of treatment sessions will be 12 sessions, three days a week for four weeks.</i_keyword>
      <i_keyword>Participants in the routine treatment group will be treated with hot packs, TENS with a frequency of 100 Hz and 50 microseconds duration, and ultrasound with a frequency of 1 megahertz and an intensity of 1 w/cm2. The electrodes will be placed in the occipital and paravertebral areas on both sides, and the intensity of the current used for each patient will be adjusted to the level of pain-free paresthesia. Ultrasound will be applied in the areas of the paravertebral muscles and the upper and outer edge of the upper trapezius muscle, unilaterally and for 5 minutes. The duration of each session will be 30 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance. Timepoint: Before and after treatment and one month after treatment. Method of measurement: Biodex SD device.</prim_outcome>
      <prim_outcome>Headache intensity. Timepoint: Before and after treatment and one month after treatment. Method of measurement: visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Headache disability. Timepoint: Before and after treatment and one month after treatment. Method of measurement: Headache Disability Questionnaire.</sec_outcome>
      <sec_outcome>Neck disability. Timepoint: Before and after treatment and one month after treatment. Method of measurement: Neck disability index.</sec_outcome>
      <sec_outcome>Duration of headache. Timepoint: Before and after treatment and one month after treatment. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Frequency of headache. Timepoint: Before and after treatment and one month after treatment. Method of measurement: questionnaire.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-24</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
