<?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>IRCT20240901062926N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-22</date_registration>
      <primary_sponsor>Ghurki Trust Teaching Hospital</primary_sponsor>
      <public_title>The Efficacy of intra-articular shoulder injection verses combined supra scapular and axillary nerve block for adhesive capsulitis: A double-blind Randomized Control Trial</public_title>
      <acronym>AC adhesive capsulitis supra scapular nerve block SSNB axillary nerve blockAND</acronym>
      <scientific_title>The Efficacy of intra-articular shoulder injection verses combined supra scapular and axillary nerve block for adhesive capsulitis: A double-blind Randomized Control Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78811</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: N/A, Randomization description: computer-generated random numbers will be used, Blinding description: The participants in the study will not know which treatment they are receiving—whether it is the intra-articular shoulder injection or the combined suprascapular and axillary nerve block. To ensure blinding, both interventions will be performed in a manner that appears identical to the participant. For instance, both procedures will involve a similar preparation process, positioning, and the application of local anesthetic. This approach prevents participants' expectations or psychological effects from influencing the outcomes.
The outcome assessor, who is responsible for evaluating the effectiveness of the treatments, will also be blinded to which intervention each participant received. This means that the assessor will not have access to information regarding the group allocation during the assessment process. Blinding the outcome assessor helps eliminate potential bias in measuring outcomes such as pain, range of motion, and functional recovery, ensuring that the results are based purely on the effects of the interventions rather than on any preconceived notions.</study_design>
      <phase>1</phase>
      <hc_freetext>Adhesive capsulitis AC or Frozen Shoulder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: We will gather baseline measurements of shoulder discomfort, range of motion (ROM), and functional status in addition to demographic information and medical history. Next, using computer-generated random numbers in a 1:1 ratio, participants will be randomly assigned to two of three treatment groups: intra-articular shoulder injection or combination suprascapular and axillary nerve block. Participants in the combined suprascapular and axillary nerve block group will receive ultrasound-guided nerve blocks that target the corresponding nerves, while those in the intra-articular shoulder injection group will receive a Prednisolone 40mg of 1 ml corticosteroid injection directly into the glenohumeral joint. Suprascapular and axillary nerve blocks are the two forms of nerve blocks used in Group I of this experimental treatment to alleviate shoulder pain. One milliliter of 40 mg Prednisolone and two milliliters of 0.125% bupivacaine and two milliliters of lidocaine 0.125% will be mixed with five milliliters of normal saline. A total of ten milliliters solution six milliliters of solution used for the suprascapular nerve block, and four milliliters of the same substance and for the axillary nerve block. Using the combined effects of a local anesthetic and a corticosteroid to give both instant and long-lasting pain relief, both operations are guided by ultrasonography to assure accurate medication distribution. Intervention 2: Intervention group: Additionally, an intra-articular shoulder injection is used in Group II of this investigational treatment to address shoulder pain. Using a combination of a local anesthetic and a corticosteroid to reduce inflammation and give both immediate and long-lasting pain relief, the operation is guided by ultrasonography to ensure exact medicine distribution straight into the shoulder joint. An intra-articular shoulder injection is another name for this course of treatment.</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:
The Efficacy of intra articular shoulder injection Verses combined suprascapular and axillary nerve block for adhesive capsulitis: A double blind Randomized Control Trial

When:
20th January 2025 and so on

To whom:
to the journal while publishing the data

Conditions:
Journal can access to the data after publishing

Where to obtain:
To obtain the necessary documents or data files, the applicant should contact the organization directly. The preferred method of communication is via email, which allows for a quick and efficient response. Applicants can also reach out by telephone for urgent inquiries, or by postal mail if a formal request is required. For online requests, visiting the organization's website and following specific procedures is recommended.

How to obtain:
To obtain data files from Ghurki Hospital, the applicant should follow a few steps.  Prepare a formal request detailing the data needed. The preferred method of communication is via email, as it typically offers a quicker response time, ranging from a few hours to a few days.

If submitting the request via postal mail, account for additional time due to delivery and internal processing, which can extend the timeline by several weeks. Ghurki Hospital may also offer an online portal for document requests, which is usually the fastest option, providing immediate confirmation and estimated processing times.

After submission, the hospital may require further information, such as proof of identity, additional forms, or a processing fee, which could add a few more days to the process. Once approved, the documents or data files will typically be sent via email or through a secure download link. If physical copies are needed, these will be sent by postal mail, with additional time required for delivery. Overall, expect the process to take from one to several weeks, so it’s advisable to start the request well in advance of any deadlines.

Comments:
we are planning to publish it in reputed journal for better clinical practice and EBP</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>G.T RD-Burki Rd Link</zip>
        <telephone>+92 307 8625941</telephone>
        <email>tayyabm851@gmail.com</email>
        <affiliation>Ghurki Trust Teaching Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>G.T RD-Burki Rd Link, Band Road, Jallo Morr, Lahore, Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>G.T RD-Burki Rd Link</zip>
        <telephone>+92 307 8625941</telephone>
        <email>tayyabm851@gmail.com</email>
        <affiliation>Ghurki Trust Teaching Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Stage 2-3 AC unilateral
No shoulder injuries in the previous three months•
Absence of shoulder injections
Absence of bleeding disorders
no prior history of cancer•
absence of inflammatory illness history
Ages Eligible for Study:  30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study: All</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Malignancy
Inflammatory disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Adhesive capsulitis of unspecified shoulder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: We will gather baseline measurements of shoulder discomfort, range of motion (ROM), and functional status in addition to demographic information and medical history. Next, using computer-generated random numbers in a 1:1 ratio, participants will be randomly assigned to two of three treatment groups: intra-articular shoulder injection or combination suprascapular and axillary nerve block. Participants in the combined suprascapular and axillary nerve block group will receive ultrasound-guided nerve blocks that target the corresponding nerves, while those in the intra-articular shoulder injection group will receive a Prednisolone 40mg of 1 ml corticosteroid injection directly into the glenohumeral joint. Suprascapular and axillary nerve blocks are the two forms of nerve blocks used in Group I of this experimental treatment to alleviate shoulder pain. One milliliter of 40 mg Prednisolone and two milliliters of 0.125% bupivacaine and two milliliters of lidocaine 0.125% will be mixed with five milliliters of normal saline. A total of ten milliliters solution six milliliters of solution used for the suprascapular nerve block, and four milliliters of the same substance and for the axillary nerve block. Using the combined effects of a local anesthetic and a corticosteroid to give both instant and long-lasting pain relief, both operations are guided by ultrasonography to assure accurate medication distribution.</i_keyword>
      <i_keyword>Intervention group: Additionally, an intra-articular shoulder injection is used in Group II of this investigational treatment to address shoulder pain. Using a combination of a local anesthetic and a corticosteroid to reduce inflammation and give both immediate and long-lasting pain relief, the operation is guided by ultrasonography to ensure exact medicine distribution straight into the shoulder joint. An intra-articular shoulder injection is another name for this course of treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shouder Pain And Disability, Range of Motion, Quailty of Life. Timepoint: 2, 4, 6, 8, 10, and 12 weeks. Method of measurement: for Shoulder Pain and Disability Index  SPADI, for pain assessment VAS, for Range of Motion will be assess by Goniometer.  assessing quality of life SF-36 will be used.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The secondary outcome of the study is assesment of quaility of life at different interval. Quaility of life will assess by SF-36 questionnaire. Timepoint: 2nd ,4th ,6th ,8th, and 12th  weeks. Method of measurement: Quality of life SF-36  The SF-36 will be used to assess quality of life at baseline as well as three weeks, three months, and twelve months after the intervention. 36 items total, divided into eight domains by this widely used self-administered questionnaire: five for vitality, five for mental health, two for bodily pain, two for social function, ten for physical function, four for physical role, three for emotional role, and five for general health. A lower figure indicates a worse situation. From 0 to 100 is the range of scores.</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>Ghurki Trust Teaching Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-26</approval_date>
        <contact_name>GHURKI TRUST AND TEACHING HOSPITAL</contact_name>
        <contact_address>Band Road GT RD-Burki Rd Link, Jallo More Lahore, Punjab Lahore PUNJAB Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
