<?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>IRCT20210321050752N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-12-19</date_registration>
      <primary_sponsor>Self Supported</primary_sponsor>
      <public_title>Effects of electrical dry needling in addition to routine physiotherapy on pain, range of motion and functional disability in patients with moderate knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of electrical dry needling in addition to routine physiotherapy on pain, range of motion and functional disability in patients with moderate knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73814</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The lottery method will be used for randomization by using random numbers and further concealed envelop method will be used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group, Blinding description: Assessor will only assess the patient at baseline and after follow-up for treatment outcomes.  Assessor safe the data for follow-up and will not share it with any therapist or patient.  At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Pain. Condition 2: Functional disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group (B) participants will receive Electrical Dry Needling with routine physical therapy exercises. Initially Routine physical therapy exercises will be performed including hot pack for 10 minutes of duration, manual therapy including passive mobilization of knee joint and muscle stretching. Then exercises like riding a stationary bicycle, range of motion exercises and strengthening exercises of the lower limbs with the hold of 5-10 seconds with 10 repetitions and 3 sets each. Group B participants will have Electrical Dry Needling for 10 minutes at frequency of 2 Hz , width of 100us and continuous biphasic waveform through 2 diagonal channels of 4 needles for 3 times a week along with routine physical therapy exercises. The electrical stimulation would be applied on the most painful knee of the patients in 3 sessions in a week. Intervention 2: Control group: Group (A) participants will receive routine physical therapy exercises. Initially routine physical therapy exercises will be performed including hot pack for 10 minutes of duration, manual therapy including passive mobilization of knee joint and muscle stretching. Then exercises like riding a stationary bicycle, range of motion exercises and strengthening exercises of the lower limbs with the hold of 5-10 seconds with 10 repetitions and 3 sets each. Each session will last for 30 minutes with 12 sessions on alternate days (3 sessions / week) will be given.</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:
Pain and functional disability status

When:
6 months after publication.

To whom:
Academic and clinical research writers.

Conditions:
Never without permission.

Where to obtain:
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf

How to obtain:
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhammad Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54840</zip>
        <telephone>+92 323 5043603</telephone>
        <email>drwaqasfayyaz@gmail.com</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhammad Waqas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shalamar Town</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54920</zip>
        <telephone>+92 323 5043603</telephone>
        <email>muhammad.waqas@uipt.uol.edu.pk</email>
        <affiliation>The University of Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group 30-60 years.
Patients with degenerated osteoarthritis.
Unilaterally, most painful knee will be treated.
Moderate osteoarthritis, Grade II and III.
Radiologically diagnosed knee osteoarthritis.
Chronic knee pain for a duration of more than three months.
Less than half hour of morning stiffness.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any previous trauma, fracture, subluxation, dislocation, surgery or bony abnormalities around knee joint in the past 6 months.
Cancer or Suppression of immune system.
Any neurological deficits in lower extremity.
Pregnancy.
Any dermatological issues.
Unexplained weight loss/gain.
Dysfunction of bladder OR Recent infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89</hc_code>
      <hc_code>Z73.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, not elsewhere classified</hc_keyword>
      <hc_keyword>Limitation of activities due to disability</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: Group (B) participants will receive Electrical Dry Needling with routine physical therapy exercises. Initially Routine physical therapy exercises will be performed including hot pack for 10 minutes of duration, manual therapy including passive mobilization of knee joint and muscle stretching. Then exercises like riding a stationary bicycle, range of motion exercises and strengthening exercises of the lower limbs with the hold of 5-10 seconds with 10 repetitions and 3 sets each. Group B participants will have Electrical Dry Needling for 10 minutes at frequency of 2 Hz , width of 100us and continuous biphasic waveform through 2 diagonal channels of 4 needles for 3 times a week along with routine physical therapy exercises. The electrical stimulation would be applied on the most painful knee of the patients in 3 sessions in a week.</i_keyword>
      <i_keyword>Control group: Group (A) participants will receive routine physical therapy exercises. Initially routine physical therapy exercises will be performed including hot pack for 10 minutes of duration, manual therapy including passive mobilization of knee joint and muscle stretching. Then exercises like riding a stationary bicycle, range of motion exercises and strengthening exercises of the lower limbs with the hold of 5-10 seconds with 10 repetitions and 3 sets each. Each session will last for 30 minutes with 12 sessions on alternate days (3 sessions / week) will be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pain, range of motion and functional disability will be assess at baseline, week 4 and follow up after 2 months. Method of measurement: Numeric Pain Rating Scale (NPRS).</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: Pain, range of motion and functional disability will be assess at baseline, week 4 and follow up after 2 months. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).</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>Self Supported</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-17</approval_date>
        <contact_name>The University of Lahore</contact_name>
        <contact_address>Raiwind Road Campus: 1-Km, Raiwind Road, Near Thokar Niaz Big, Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
