<?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>IRCT20200513047421N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-10</date_registration>
      <primary_sponsor>District Head Quarter (DHQ) Hospital, Sargodha.</primary_sponsor>
      <public_title>Comparison of Primal Reflex Release Technique and Stretching Exercises in Coccydynia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Primal Reflex Release Technique and Stretching Exercises in Coccydynia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57779</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Written informed consent will be taken. After enrollment into study, patient will be allocated either to Group A or Group B by lottery method. No. of Chits will be equal to
total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coccygodynia, is also referred as coccydynia, coccygeal neuralgia, coccalgia, or tailbone pain, is the term that describes the symptoms of pain occurring in the coccyx region. During sitting position pain is most commonly started , but may happen if individual changes his position from sitting to standing. Conservative, manual, surgical and other treatments are used to treat coccydynia depending on severity of condition..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After taking baseline measures, Group A will be treated with hot pack for 10  minutes. A gluteal set will be performed while the physical therapist karate chops the gluteal musculature bilaterally from the sacrum to the coccyx. The first coccyx release technique will be performed 10 times for duration of 30 seconds each treatment session. In second coccyx release technique maximal muscle contraction for 10 seconds against manual force applied in a diagonal of hip flexion adduction. The patient relaxes for 30 seconds. Thus, the contract-relax ratio will be 10:30. It will be performed at 1 set of 6 repetitions of contract relax each treatment session. Intervention 2: Intervention group: After taking baseline measures group B will be treated with hot pack for 10 minutes. Stretching will be performed for Piriformis and Iliopsoas. It will be applied 5 times alternately for both sides for 30 second each with 10 second relaxation between each application.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further decision and information decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pakeeza Seemal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House# 411, street#07, Al Farooq colony, Sargodha.</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 48 3726938</telephone>
        <email>pakeezaseemal212@gmail.com</email>
        <affiliation>Sargodha Institute of Health Sciences (SIHS)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pakeeza Seemal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House# 411, street#07, Al Farooq colony, Sargodha.</address>
        <city>Sargodha</city>
        <country1>Pakistan</country1>
        <zip>40100</zip>
        <telephone>+92 48 3726938</telephone>
        <email>pakeezaseemal212@gmail.com</email>
        <affiliation>Sargodha Institute of Health Sciences (SIHS)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pain in or around coccyx without radiation
Tenderness on palpation over coccyx
Age group above 20 including both male and females
Difficulty in pain free sitting for long duration</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with cancer or cysts in pelvic area
Any tumor, surgery or fracture, recent trauma
Pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, bony spurs, cysts, or infections etc.
Pregnancy and coccyx dislocation
If any overt neurologic signs/conditions, such as sensory paresthesia or motor paresis, present during the initial evaluation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M53.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sacrococcygeal disorders, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After taking baseline measures, Group A will be treated with hot pack for 10  minutes. A gluteal set will be performed while the physical therapist karate chops the gluteal musculature bilaterally from the sacrum to the coccyx. The first coccyx release technique will be performed 10 times for duration of 30 seconds each treatment session. In second coccyx release technique maximal muscle contraction for 10 seconds against manual force applied in a diagonal of hip flexion adduction. The patient relaxes for 30 seconds. Thus, the contract-relax ratio will be 10:30. It will be performed at 1 set of 6 repetitions of contract relax each treatment session</i_keyword>
      <i_keyword>Intervention group: After taking baseline measures group B will be treated with hot pack for 10 minutes. Stretching will be performed for Piriformis and Iliopsoas. It will be applied 5 times alternately for both sides for 30 second each with 10 second relaxation between each application.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, after treatment (4 weeks). Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Functional performance. Timepoint: Before treatment, after treatment (4 weeks). Method of measurement: Dallas Pain Questionnaire (DPQ).</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before treatment, after treatment (4 weeks). Method of measurement: Pain free sitting duration.</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>District Head Quarter (DHQ) Hospital, Sargodha</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-17</approval_date>
        <contact_name>Sargodha Institute of Health Sciences(SIHS) Research Ethical Committee (REC)</contact_name>
        <contact_address>117-C, Zafar Ullah Road, Satellite Town, Sargodha Sargodha Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
