<?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>IRCT20201216049730N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The impacts of releasing the stiffness of hip adductor muscles on sacroiliac joint pain</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the impacts of releasing the stiffness of hip adductor muscles on sacroiliac joint pain: a randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53557</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study subjects are divided into two groups in a simple randomization with a ratio of one to one. In group A the stiffness of hip adductor muscles will be released in addition to the standard treatment of sacroiliac joint pain but group B will only receive the  standard treatment of sacroiliac joint pain.
The grouping will be written on pieces of paper, sealed in envelopes, and then given to the secretary. The secretary will randomly give one of the envelopes to the patient. The therapist will assign each patient to group A or B depending on the group written in the patient's envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sacroiliac joint pain and dysfunction: Painful touching of the sacroiliac joint and the positive test of 3 or more of the 6 tests diagnoses sacroiliac joint pain and dysfunction. Condition 2: Hip adductor muscles: include Adductor Longus, Adductor Brevis, and  Adductor Magnus. In this study, Adductor longus muscle is examined. Diagnosis of hip adductor disorder can be made by two imaging techniques, including ultrasound or MRI or clinical examination.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A, in addition to the standard treatment of sacroiliac joint pain, hip adductor muscles will be released. Duration of treatment: 4 sessions by the therapist (2 sessions per week) with daily exercises at home. Treatment of sacroiliac joint pain includes heat therapy for 5 minutes (daily), needling painful areas (2 sessions per week), sacroiliac joint mobilization exercises, each exercise 3 sets of 10 repetition, daily. Release of hip adductors including heat therapy for 5 minutes (daily), manual therapy (using friction massage and ischemic pressure) for 5 minutes (2 sessions per week), use of vibrator for 5 minutes (2 sessions per week), adductor stretching 30 seconds to the maximum range of motion whit out Pain, 3 repetitions, daily. Intervention 2: Control group: Intervention group: Group B who will receive standard treatment for sacroiliac joint pain. Duration of treatment: 4 sessions by the therapist (2 sessions per week) with daily exercises at home. Treatment of sacroiliac joint pain includes heat therapy for 5 minutes (daily), needling painful areas (2 sessions per week), sacroiliac joint mobilization exercises, each exercise 3 sets of 10 repetition, daily.</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 potential data is shared in the form of an article after unidentifiable individuals

When:
Accessed since 2022

To whom:
Researchers working in academic and scientific institutions

Conditions:
No analysis is allowed on the data

Where to obtain:
sarashams@gmail.com

How to obtain:
To access the data, individuals must send a request to the inserted email and after receiving the necessary checks and if they are eligible, they will receive the requested data within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Sara Shams</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Taleghani Hospital, Arabi Ave., Yemen Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>sarashams6990@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hassabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Taleghani Hospital, Arabi Ave., Yemen Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2243 2560</telephone>
        <email>hassabi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with low back pain less than 3 months
Diagnosis of sacroiliac joint disorder (3 or more positive test)
Equal true and functional length of lower limb (functional length: distance between umbilicus to distal of medial ankle, true length: distance between anterior superior iliac spine to distal of medial ankle)
No history of severe trauma to the spine, pelvis, lower limbs, abdomen and chest during the last 12 months
No history of spine, pelvic, lower limb, abdomen and chest surgery during the last 12 months
Absence of localized lesion of the spine including tumor, infection and fracture
Absence of known congenital pelvic and spinal disorders that restrict movement or impair examination
Absence of known systemic arthropathy
Absence of neuropathy
Absence of metabolic disorders
Absence of symptoms or evidence of radiculopathy
Absence of pregnancy
No history of receiving any  treatment for sacroiliac joint pain in the last 3 months
Women should not be in the first six months after delivery
Women should not be post menopausal</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any musculoskeletal disorder of the lower extremities that interferes with movement or examination</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A, in addition to the standard treatment of sacroiliac joint pain, hip adductor muscles will be released. Duration of treatment: 4 sessions by the therapist (2 sessions per week) with daily exercises at home. Treatment of sacroiliac joint pain includes heat therapy for 5 minutes (daily), needling painful areas (2 sessions per week), sacroiliac joint mobilization exercises, each exercise 3 sets of 10 repetition, daily. Release of hip adductors including heat therapy for 5 minutes (daily), manual therapy (using friction massage and ischemic pressure) for 5 minutes (2 sessions per week), use of vibrator for 5 minutes (2 sessions per week), adductor stretching 30 seconds to the maximum range of motion whit out Pain, 3 repetitions, daily</i_keyword>
      <i_keyword>Control group: Intervention group: Group B who will receive standard treatment for sacroiliac joint pain. Duration of treatment: 4 sessions by the therapist (2 sessions per week) with daily exercises at home. Treatment of sacroiliac joint pain includes heat therapy for 5 minutes (daily), needling painful areas (2 sessions per week), sacroiliac joint mobilization exercises, each exercise 3 sets of 10 repetition, daily.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sacroiliac joint pain. Timepoint: Before starting treatment, at the beginning of each treatment session, at the end of 4 treatment sessions. Method of measurement: The patient is asked and recorded as 0 (painless) to 10 (worst possible pain) by the visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Sacroiliac joint tenderness. Timepoint: Before starting treatment, at the beginning of each treatment session, at the end of 4 treatment sessions. Method of measurement: Touch the sacroiliac joint to check for tenderness. Recording of tenderness information by a specialist doctor is done as follows: 1- No pain 2- Mild tenderness (causing pain with deep touch) 3- Moderate tenderness (causing pain with superficial touch) 4- Severe tenderness (severe reaction of the patient with superficial touch).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before starting treatment, at the end of 4 sessions of treatment. Method of measurement: Oswestry questionnaire.</sec_outcome>
      <sec_outcome>Adductor muscle tenderness. Timepoint: Before starting treatment, at the beginning of each treatment session, at the end of 4 treatment sessions. Method of measurement: Touch the junction of the adductor longus muscle to check for tenderness. Tenderness is recorded by a sports medicine specialist as 1- painless 2- mild tenderness (causing pain with deep touch) 3- moderate tenderness (causing pain with superficial touch) 4- severe tenderness (severe reaction of the patient with superficial touch).</sec_outcome>
      <sec_outcome>Stiffness of adductor muscles. Timepoint: Before starting treatment, at the beginning of each treatment session, at the end of 4 treatment sessions. Method of measurement: Touch the length of the adductor longus muscle to check muscle stiffness. Stiffness is recorded by a sports medicine specialist in the form of 1- usual consistency 2- touch of stiffness 3- clear protrusion.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-12</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences,  Arabi Ave., Yemen St., Tehran, Tehran Province Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
