<?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>IRCT20220115053712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-02</date_registration>
      <primary_sponsor>Muhammad Institute of Medical and Allied Sciences, Multan</primary_sponsor>
      <public_title>Comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis</public_title>
      <acronym>GS,OA</acronym>
      <scientific_title>Comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61283</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients were assessed by radiological finding (x-ray) and by physical assessment, Randomization description: Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes. Each participant will randomly choose the sealed envelope and open this sealed envelope, Blinding description: In a single-blinded study, participants will be blinded. Participants will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial. subjects will choose between two samples. both the samples are in the same packing. In one sample, glucosamine sulfate gel with conventional exercises i.e.,  ankle pumps, quadriceps isometrics, and calf stretch. In another sample, an aqueous gel with no effects for the satisfaction of subjects and proprioceptive exercises will be given. Subjects will be completely unaware of the type and effects of both interventions.</study_design>
      <phase>4</phase>
      <hc_freetext>Knee Osteoarthritis with grade 1, 2 and 3.</hc_freetext>
      <i_freetext>Intervention 1: intervention group 2; group-B will be treated with proprioceptive exercises. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand [Akron, OH]), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of treatment is 6 weeks. The frequency of treatment is 3 times per week exercise sessions lasted 30 minutes. Intervention 2: Intervention group: Group-A will be treated with topical glucosamine sulfate, ankle pumps, quads strengthening, and calf stretching. The drug will purchase from stand pharmaceuticals. The duration of treatment is 6 weeks. Glucosamine sulfate will apply topically twice daily, 3 times per week. The dosage of glucosamine sulfate gel will be 250mg two times a day. Subjects will be instructed to clean the skin adjacent to their throbbing knee and apply the cream.</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:
Title of my study comparative analysis of Topical Glucosamine Sulfate and Proprioceptive Exercises on Pain and Functional Disability in Knee Osteoarthritis.
The basic purpose of this research is to compare the effects of Proprioceptive exercises and glucosamine sulfate on knee osteoarthritis. The expected outcome of this study is proprioceptive exercises may be more effective than glucosamine sulfate. Proprioceptive exercise may improve ADLs and reduce pain. A randomized clinical trial was conducted at Muhammad physical therapy clinic and rehabilitation center, Multan and Faiz Hospital, Multan. 30 patients were selected who met the inclusion criteria will be randomized into two groups; treatment group (A) and treatment group (B). patients were recruited by using the lottery method. Group (B) will be treated with proprioceptive exercises and group (A) will be treated with glucosamine sulfate.

When:
This is expected that this study or data will be available at the end of this year 2022. No exact date can be expected.

To whom:
Nimra Arif

Conditions:
For research purposes

Where to obtain:
researchgate.net
https://scholar.google.com/
hifzaa630@gmail.com

How to obtain:
open access

Comments:
I want randomized clinical trial registration. please provide me as soon as possible. so that I can continue my study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Zahid Manzoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street, near Sabzazar metro station, Bosan road Multan, Pakistan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 309 7697428</telephone>
        <email>drhifzaarif@mimas.edu.pk</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nimra Arif</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>HBL street, sbzazar station, Bosan road, Multan, Pakistan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60700</zip>
        <telephone>+92 333 3877032</telephone>
        <email>angelnimra95@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>bilateral knee OA with grade 1,2 and 3
Age 45-70 years
Both genders (male and female)
Cartilage degeneration
Local biomechanical factors (e.g., obesity, joint deformity, muscle weakness)
Nutritional factors
Postmenopausal women</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Rheumatoid arthritis
Neurological disorders (e.g., Alzheimer’s disease, Parkinson’s disease)
Knee replacement
Steroidal injection in the past 2 months
Neuropathy
Tumor
Knee fractures
Knee OA with grade 4</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group 2; group-B will be treated with proprioceptive exercises. The proprioceptive exercises are Standing on 1 leg [eyes open and closed], Knee flexion and extension exercises (sitting position with a chair and TheraBand [Akron, OH]), Walking on heel and toes (forward, backward, left, right, carioca crossover with eyes open and closed). Half squat on soft ground, Side lunge, One-legged balance exercise. The duration of treatment is 6 weeks. The frequency of treatment is 3 times per week exercise sessions lasted 30 minutes.</i_keyword>
      <i_keyword>Intervention group: Group-A will be treated with topical glucosamine sulfate, ankle pumps, quads strengthening, and calf stretching. The drug will purchase from stand pharmaceuticals. The duration of treatment is 6 weeks. Glucosamine sulfate will apply topically twice daily, 3 times per week. The dosage of glucosamine sulfate gel will be 250mg two times a day. Subjects will be instructed to clean the skin adjacent to their throbbing knee and apply the cream</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain and functional disability. Timepoint: before and after treatment (6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To reduce stiffness, muscle tone strength increases and joint receptor function raised. Timepoint: before and after treatment(6 weeks). Method of measurement: Numerical Pain Rating Scale (NPRS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC).</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>Muhammad Institute of Medical and Allied Sciences, Multan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-18</approval_date>
        <contact_name>The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences, Multan  st</contact_name>
        <contact_address>HBL street, Sbzazar metro station, Bosan road, Multan, Pakistan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
