<?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>IRCT20230512058156N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-14</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Dry needling on the Popliteus muscle in Patellar maltracking</public_title>
      <acronym></acronym>
      <scientific_title>Study of Electromyographic Variables in People with Patellar Maltracking Received Dry Needling of Popliteus Muscle: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70088</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be entered into the treatment group or the control group by the block randomization method. The sample size for each group is 12 patients (24 patients in total). The patients, the therapist and the evaluator do not know about the grouping. Also, two groups will be homogenized in terms of weight, age and gender distribution. In order to create randomization, we use the permuted block randomization method. Random block sequence was obtained using Random allocation software. In total, we will have 6 blocks of 4 and the patients will enter the study based on it, Blinding description: A physiotherapist will be in charge of the treatment process of the intervention group, and another physiotherapist will evaluate the desired variables. Therefore, the future study will be a single-blind study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patellar maltracking.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group (12 people), three sessions of dry needling are performed per week (48 hours apart), for two weeks and a total of 6 sessions of dry needling. We should check the popliteus for active or latent myofascial trigger points. The patient is asked to take a bath before the sessions. The area to be needled should be cleaned well with alcohol. The needles used are sterile and disposable. We insert the needle very quickly through the skin with a flick of the wrist or a strong tap into the trigger points. For needling, we place the trigger points between the thumb, index and middle finger, and the needle is directed towards the trigger points, and the therapist's fingers are placed in the lower part of the tissue. The person lies on the side with his knee and hip flexed at 90 degrees, and in this position, the muscle is touched just behind the proximal one-fifth of the tibia. The needle is inserted from the medial to the lateral with a slight superior-anterior orientation towards the trigger points. We keep the needle near the posterior part of the tibia or as a reference, the bone can be touched with the tip of the needle. Needles with a size of 0.3 x 50 mm are inserted into the muscle with a 40 mm tube and remain in the muscle for 6 minutes and are rotated ten times at the beginning, after three minutes and at the end of 6 minutes. In order to reduce the amount and duration of irritation caused by dry needling, after removing the needle, ischemic pressure is applied to the relevant area for one minute. Intervention 2: Control group: Due to the invasive nature of dry needling and the difficulty of using placebo studies for this intervention, as well as to find the net effect of dry needling on the myofascial trigger points of the popliteus muscle in people with patellar maltracking, the control group does not receive treatment and they are evaluated only on the first day, the end of the second week, and the end of the fourth week.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemezahra Khammar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Quds Blvd.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519698375</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>Fkhammar9@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Cyrus Taghizadeh Delkhoush</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neuromuscular Rehabilitation Research Center, Quds Blvd.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519698375</zip>
        <telephone>+98 23 3332 8502</telephone>
        <email>cyrustaghizadeh@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18-39.
Having pain in at least two of the following: climbing stairs, descending stairs, squatting, prolonged sitting, running, isometric quadriceps contraction and kneeling.
Pain of at least 30 out of 100 on the Visual Analog Scale in the past three weeks (maximum pain 70).
Positive Clarke and McConnell tests.
Having at least one period of routine physical therapy without impact for patellar maltracking in the past.
Presence of one of the factors that cause disorders in the direction of the patella including defects in supporting muscles and guiding mechanisms, bone abnormalities, lower limb abnormalities, quadriceps muscle abnormalities such as vastus medialis oblique weakness, internal retinaculum laxity, external retinaculum stiffness, iliotibial band stiffness, hamstring shortness, gastrocnemius shortness , patella tendon elongation and patella alta, Q angle increase, genu valgum, genu recurvatum, femoral antiversion, trochlear dysplasia, external tilt of the patella, external displacement of the tibial tubercle or external rotation of the tibia and excessive pronation of the foot.
Presence of at least one trigger point in the popliteus muscle.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>39 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Systemic diseases such as diabetes, rheumatoid arthritis, etc.
Neurological diseases such as multiple sclerosis, epilepsy, etc.
Peripheral nerve entrapment (acute disc herniation, spondylolisthesis, etc).
Connective tissue injuries (torn meniscus, ligament, patella tendinopathy, etc).
History of knee, hip and lower limb surgery.
Injury to the lower limb in the past year or fracture, dislocation and sublaxation.
Pathologies and other similar anterior knee pain include knee osteoarthritis, patellar chondromalacia, osteochondritis dissecans, articular cartilage damage, osgood schlatter, plica syndrome, bone tumors, patellar stress fracture, knee and pes anserine bursitis, fat pad impingement, patellar tendonitis and quadriceps tendinopathy.
Receiving medicine in the previous two weeks.
People who have received rehabilitation treatment, acupuncture or dry needling for patellar maltracking in the last 6 months.
Dry needling contraindications, such as pregnancy, cardiovascular diseases, cancer, epilepsy, presence of lymphedema in the body, history of allergy to needles and injections, needle phobia and patient dissatisfaction.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M22.2X9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Patellofemoral disorders, unspecified knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group (12 people), three sessions of dry needling are performed per week (48 hours apart), for two weeks and a total of 6 sessions of dry needling. We should check the popliteus for active or latent myofascial trigger points. The patient is asked to take a bath before the sessions. The area to be needled should be cleaned well with alcohol. The needles used are sterile and disposable. We insert the needle very quickly through the skin with a flick of the wrist or a strong tap into the trigger points. For needling, we place the trigger points between the thumb, index and middle finger, and the needle is directed towards the trigger points, and the therapist's fingers are placed in the lower part of the tissue. The person lies on the side with his knee and hip flexed at 90 degrees, and in this position, the muscle is touched just behind the proximal one-fifth of the tibia. The needle is inserted from the medial to the lateral with a slight superior-anterior orientation towards the trigger points. We keep the needle near the posterior part of the tibia or as a reference, the bone can be touched with the tip of the needle. Needles with a size of 0.3 x 50 mm are inserted into the muscle with a 40 mm tube and remain in the muscle for 6 minutes and are rotated ten times at the beginning, after three minutes and at the end of 6 minutes. In order to reduce the amount and duration of irritation caused by dry needling, after removing the needle, ischemic pressure is applied to the relevant area for one minute.</i_keyword>
      <i_keyword>Control group: Due to the invasive nature of dry needling and the difficulty of using placebo studies for this intervention, as well as to find the net effect of dry needling on the myofascial trigger points of the popliteus muscle in people with patellar maltracking, the control group does not receive treatment and they are evaluated only on the first day, the end of the second week, and the end of the fourth week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Signal amplitude. Timepoint: Before and After the Intervention and Follow up. Method of measurement: Surface Electromyography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual Analog Scale score. Timepoint: Before and After the Intervention and Follow up. Method of measurement: Visual Analog Scale.</sec_outcome>
      <sec_outcome>Kujala Patellofemoral Scale System score. Timepoint: Before and After the Intervention and Follow up. Method of measurement: Kujala Patellofemoral Scale System.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-01</approval_date>
        <contact_name>Research Ethics Committees of Semnan University Of Medical Sciences and Health Services</contact_name>
        <contact_address>Basij Blvd, Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
