<?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>IRCT20231026059863N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-31</date_registration>
      <primary_sponsor>The First People's Hospital</primary_sponsor>
      <public_title>effect of Ultrasound-Guided Internal Heat Acupuncture for Alleviating Posterior Lumbar Nerve Pain and Modulating Serum IL1-β, TNF-α, and PGE2 Levels.</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Ultrasound-Guided Internal Heat Acupuncture for Alleviating Posterior Lumbar Nerve Pain and Modulating Serum IL1-β, TNF-α, and PGE2 Levels.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73432</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants who fulfilled the inclusion criteria were selected convenient sampling technique and were then allocated randomly to Group A and Group B using lottery method. This distribution process is hidden between participants and researchers. This was done by a research assistant who did not participate in any further research, Blinding description: This study was double-blinded. The outcome assessor who was blinded to the therapy group was recruited to take readings at pre-treatment and post-treatment values. And the patients were also blinded as they didn’t know they all have the same disorder and different techniques had been given to these patients.</study_design>
      <phase>1</phase>
      <hc_freetext>Posterior Lumbar Nerve Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1.	Ultrasound-guided internal heat acupuncture  Group: Patients in the UGIHA group received acupuncture sessions twice a week for four weeks. A 0.3 mm × 40 mm disposable needle (DongBang Acupuncture Inc., Korea) was percutaneously inserted and advanced to a depth of 15-25 mm into the intervertebral foramen under real-time ultrasound guidance. The needle was then electronically activated to produce heat. Acupuncture points targeted specific regions of discomfort or dysfunction. Intervention 2: Control group: Participants in the control group received non-therapeutic ultrasound therapy sessions twice a week for four weeks. The ultrasound therapy was administered without the application of heat and did not involve needle insertion.</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:
Effectiveness of Ultrasound-Guided Internal Heat Acupuncture for Alleviating Posterior Lumbar Nerve Pain and Modulating Serum IL1-β, TNF-α, and PGE2 Levels.

When:
When the trial has been completed after the end November 2023.The data will be available for the future use and after the completion of the trial when it get published approximately after the 4 weeks in the end of the November 2023.The summary will be available after the article get published

To whom:
It will be available to all teaching institue and hospital for the better cure of the patient and more over it will be avilable for the researcher as wel

Conditions:
Only for the research and for the benefits of the public

Where to obtain:
Daojing Su 
Orthopedic Rehabilitation(1 Ward) of Shiyan Taihe Hospital affiliated to Hubei University of Medicine 
32 renmin south road,maojian district,shiyan city,hubei province
605278189@qq.com

How to obtain:
By application sent to 605278189@qq.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Daojing Su</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Wudang Mountain Branch, Shiyan City,Hubei Province</address>
        <city>Shiyan</city>
        <country1>China</country1>
        <zip>442000</zip>
        <telephone>+86 150 0273 5690</telephone>
        <email>605278189@qq.com</email>
        <affiliation>Taihe Hospital affiliated to Hubei University of Medicine</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zengfeng Chen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Wudang Mountain Branch, Shiyan City,Hubei Province</address>
        <city>Shiyan</city>
        <country1>China</country1>
        <zip>442000</zip>
        <telephone>+86 150 0273 5690</telephone>
        <email>284133170@qq.com</email>
        <affiliation>First People's Hospital of Jiangxia District, Wuhan/Concorde Jiangnan Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>China</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged between 18-65 years diagnosed with PLNP and reporting a pain level of at least 4 on a 10-point visual analog scale (VAS) were eligible for the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria included pregnancy, current use of anti-inflammatory medications, history of spinal surgery, and contraindications to acupuncture</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54. 16</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Posterior Lumbar Nerve Pain</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: 1.	Ultrasound-guided internal heat acupuncture  Group: Patients in the UGIHA group received acupuncture sessions twice a week for four weeks. A 0.3 mm × 40 mm disposable needle (DongBang Acupuncture Inc., Korea) was percutaneously inserted and advanced to a depth of 15-25 mm into the intervertebral foramen under real-time ultrasound guidance. The needle was then electronically activated to produce heat. Acupuncture points targeted specific regions of discomfort or dysfunction</i_keyword>
      <i_keyword>Control group: Participants in the control group received non-therapeutic ultrasound therapy sessions twice a week for four weeks. The ultrasound therapy was administered without the application of heat and did not involve needle insertion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>1.	Primary Outcome: Pain severity was assessed using a 10-point visual analog scale (VAS) at baseline, after the 4-week intervention period, and during follow-up visits. Timepoint: 4 weeks. Method of measurement: 1.	Primary Outcome: Pain severity was assessed using a 10-point visual analog scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary Outcomes: Serum levels of IL1β, TNF-α, and PGE2 were measured before and after the treatment period using established biochemical assays. Timepoint: 4 weeks. Method of measurement: Secondary Outcomes: Serum levels of IL1β, TNF-α, and PGE2 were measured before and after the treatment period using established biochemical assays.</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>No</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-01</approval_date>
        <contact_name>Ethical Committee of the First People's Hospital</contact_name>
        <contact_address>Zhifang Culture Avenue, Jiangxia Distric Wuhan City Wuhan Hubei China</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
