<?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>IRCT20220418054572N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-24</date_registration>
      <primary_sponsor>University of Lahore</primary_sponsor>
      <public_title>Effects of routine physical therapy with and without kinesiotaping on pain, range of motion and function in patients with dequervain tenosynovitis.</public_title>
      <acronym></acronym>
      <scientific_title>Effects of routine physical therapy with and without kinesiotaping on pain, range of motion and function in patients with dequervain tenosynovitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63565</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: in my study Random allocation is done by lottery method. Lottery method is example of Random sampling, in this researcher give each member of population a number and then draw numbers from box randomly to add in each group. in this method each member have equal chance of selection. Total 56 patients of both genders of age between 20-60 years are included. Patients are randomly allocated  by lottery method to Group A ( only physical therapy treatment which include theraputic ultrasound ,tens, icing and ROMS ) and Group B includes ( physical therapy treatment i-e theraputic ultrasound, Tens, icing and RoMS and kinesiotaping too). Patients do not know in which group they are allocated, Blinding description: study will be single binded , assessor will be kept blind. Assesor does not know that which subject is included in which group. Asseser does not know group A or group B is recieving which type of treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Dequervain's tenosynovitis is a condition which involves tendon entrapmentaffecting the first dorsal compartment of wrist. In ths condition thickening of tendon sheath around abductor pollicis longus and extensor pollicis brevis, which leads to irritation of muscles, causing pain and swelling over the radial side of wrist in patients alon with an increased difficulty in gripping obejcts..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Routine physical therapy (Theraputic Ultrasound, TENS, icing) Patient in this study group will get 25 minutes session, thrice weekly for 4 weeks. Therapeutic ultrasound will be performed for 10 minutes, icing for 5 minutes, TENS will be applied for 5 minutes and general ROMS of adjacent joints. Intervention 2: Intervention group: routine physical therapy with addition of kinesiotaping. Patients in this study group will get 25 minutes session, thrice weekly for 4 weeks. Kinesiotape will be applied to the subjects 3 times weekly (alternative days) in addition to routine physical therapy. We will use three types of taping I pieces of Kinesio tape, First of all, we will curve all borders of tapes to prevent early separation. The first strip will be used to unload from APL and EPB tendons. The tape will be placed on the insertion of EPB, the base of the thumb, and was stretched by approximately 70% over the original length applied along the radial aspect of the wrist and up onto the extensor surface, ending at the mid-forearm (origin of APL). The second and the third type have correction roles. The second one is named “function correcting” tape, with the wrist extended, putting the end of the tape at the dorsum of the hand and another end at the distal forearm, 1 inch upper than styloid. Then by flexing the wrist, the tape will be fixed. The third tape which is called “space correcting”, originates from the volar side of distal of radius and stretched obliquely to the dorsum of the hand with a lighter tension which is shown at 50%. Then we will fix them with a light massage and suggested not to use water for 6 hours in this area. All the taping will be applied by the physiotherapist carefully. These procedures of taping will be repeated for three times weekly.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sana Manzoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehmat street rana colony house no p441 G-56 rana colony Jhang, punjab Pakistan</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>35200</zip>
        <telephone>+92 336 3322506</telephone>
        <email>sanasaim51@gmail.com</email>
        <affiliation>University of Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sana Manzoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rehmat street, Rana colony House no p-441 G-56 Gojra road Jhang, Punjab Pakistan.</address>
        <city>Jhang</city>
        <country1>Pakistan</country1>
        <zip>35200</zip>
        <telephone>+92 336 3322506</telephone>
        <email>70101325@student.uol.edu.pk</email>
        <affiliation>University of Lahore, Lahore, Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Both genders
age between 20-60
Patients diagnosed with Dequervains tenosynovitis having unilateral symptoms more than 1 week
pre-diagnosed patients reffered by orthopedics
finklein's test positive</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patients with history of fracture
patients with inflammatory or other specific disorder of hand such as rheumatoid arthritis
dislocation
surgery
history of wrist injection
acute trauma
symptomatic ilateral radiculopathy
presence of any of red flag related to hand or arm</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M65.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Radial styloid tenosynovitis [de Quervain]</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:  Routine physical therapy (Theraputic Ultrasound, TENS, icing) Patient in this study group will get 25 minutes session, thrice weekly for 4 weeks. Therapeutic ultrasound will be performed for 10 minutes, icing for 5 minutes, TENS will be applied for 5 minutes and general ROMS of adjacent joints.</i_keyword>
      <i_keyword>Intervention group: routine physical therapy with addition of kinesiotaping. Patients in this study group will get 25 minutes session, thrice weekly for 4 weeks. Kinesiotape will be applied to the subjects 3 times weekly (alternative days) in addition to routine physical therapy. We will use three types of taping I pieces of Kinesio tape, First of all, we will curve all borders of tapes to prevent early separation. The first strip will be used to unload from APL and EPB tendons. The tape will be placed on the insertion of EPB, the base of the thumb, and was stretched by approximately 70% over the original length applied along the radial aspect of the wrist and up onto the extensor surface, ending at the mid-forearm (origin of APL). The second and the third type have correction roles. The second one is named “function correcting” tape, with the wrist extended, putting the end of the tape at the dorsum of the hand and another end at the distal forearm, 1 inch upper than styloid. Then by flexing the wrist, the tape will be fixed. The third tape which is called “space correcting”, originates from the volar side of distal of radius and stretched obliquely to the dorsum of the hand with a lighter tension which is shown at 50%. Then we will fix them with a light massage and suggested not to use water for 6 hours in this area. All the taping will be applied by the physiotherapist carefully. These procedures of taping will be repeated for three times weekly.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1st day before treatment, at 7th session and on day of 15th session(after last treatment session). Method of measurement: pain is measured by visual analogue scale. 0-100 points are given on scale. scoring for that scale is as given below: No pain (0 – 4 mm)Mild pain (5– 44mm)Moderate pain (45–74 mm)Severe pain (75–100 mm).  Patients are asked to fill this according to their pain , if they have no pain then 0 or 0-4mm, if they have mild pain then fill 5-44mm ,if have moderate pain (45-74mm) and if they have severe pain then fill 75-100mm.</prim_outcome>
      <prim_outcome>Functional disability. Timepoint: 1st day before treatment, at 7th session and on day of 15th session(after last treatment session). Method of measurement: Functional disability is measured by Quick Dash score. QuickDASH-9 SCORE = [(sum of final score) x 1.1] x 5/2, a missing response is added as the average of the remaining. score between 0-25 no disability, 26-50 mild disability, 51-75 moderate disability, 76-100 severe disability.  a scale score, ranging from 0 (no disability) to 100 (most severe disability), can be calculated.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: 1st day before treatment, at 7th session and on day of 15th session(after last treatment session). Method of measurement: Goniometer . Goniometer is placed on hand nd ask patient to extend the thumb.</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>University of Lahore</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-08</approval_date>
        <contact_name>University of Lahore</contact_name>
        <contact_address>1 km, defence road Bhobtian chowk, Raiwind road Lahore.IR Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
