<?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>IRCT20220626055278N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-05</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of Integrated Neuromuscular Inhibition technique in patients with lateral elbow pain.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of Integrated Neuromuscular Inhibition technique on pain, function, grip strength and muscles activity in patients with lateral epicondylitis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82416</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be easy and accessible, taking into account the characteristics of the entry. A permutation block randomization method will be used to assign individuals to groups. Initially, individuals will be randomly divided into four equal blocks by drawing lots and numbered. Then, the block numbers are randomly selected by a person who is not involved in the sampling process so that the blocks are placed in two different treatment groups, respectively, until the groups reach the desired sample size, Blinding description: Patients will be unaware of the grouping. Physiotherapy modalities are explained to the patients and they are told that  modalities and manual therapy are used in their treatment, but they will be unaware of what aproach are used in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>lateral epicondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  includes Integrated Neuromuscular Inhibition Techniques with routine physiotherapy. This technique includes several different manual therapies:Ischemic pressure, Strain CounterStrain, and Muscle energy techniques. After finding tender point at the lateral epicondyle, pressure is applied for 90 seconds, then the patient is given a rest, and this procedure is repeated 3 times. To perform the strain-contrastrain technique, we move the patient's wrist to a position that reduces the patient's pain by at least 70 percent, maintain pressure in this position for 90 seconds, and repeat this process 3 times. To perform the Muscle Energy Technique, we bend the patient's wrist slightly and obtain a resistive contraction in the direction of wrist extension from the patient. Hold the contraction for 7 seconds and then rest. During the rest period, the wrist is further flexed and this process is repeated 3 times. Finally, a soft tissue extensor stretch is performed for 30 seconds. Intervention 2: Control group: This group only received routine physiotherapy treatments, including: hot packs, transcutaneous electrical nerve stimulation, ultrasound, education and exercises. The hot pack is placed on the epicondyle for 20 minutes. Transcutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes, will be applied through two electrodes that we are placing on the extensor origion muscle of the patient. Ultrasound waves with  frequency of 1 MHz and an intensity of 1.5 watts/cm2 are applied around the lateral epicondyle for 3-5 minutes. Transcutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. Patient education includes avoiding lifting, repetitive wrist activities, using screwdrivers and mice, and any activity that aggravates pain. The patient's exercises include 3 groups: 1- Stretching of the wrist extensors and flexors, each stretch should be maintained for 30 seconds and repeated 3 times. 2- Active flexion and extension movements of the patient's wrist and elbow, each movement includes 3 sets and each set has 20 repetitions. 3- Isometric grip and wrist extension movements, each contraction should be maintained for 20 seconds and has 20 repetitions.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arezu Naseri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7 , Nasrin 9 St., Gaffari Ave</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717916819</zip>
        <telephone>+98 56 3223 6047</telephone>
        <email>arezunaseri98@gmail.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Namvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modares St., next to medical imaging, Namvaran Doctors Building, Atieh Physiotherapy</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816677389</zip>
        <telephone>+98 54 3344 6819</telephone>
        <email>hassan_753@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18 to 60 years.
The patient's pain intensity at the initial visit should be at least 3 on the Visual Analog scale.
Unilateral elbow pain that lasts more than 3 months.
Tenderness near or over the lateral epicondyle.
Positive results in 3 of the following 4 tests to confirm epicondylitis: grip strength test, Cozen test, Mill test, Maudsley test.
Absence of cardiovascular disease.
Absence of neurological diseases.
Absence of neuromuscular diseases and nerve entrapments.
No history of trauma to the lateral epicondyle.
No history of previous surgery.
No other treatment received in the last 6 months.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to complete treatment sessions.
Exacerbation of symptoms or patient dissatisfaction with the continuation of treatment sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M77.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lateral epicondylitis</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:  includes Integrated Neuromuscular Inhibition Techniques with routine physiotherapy. This technique includes several different manual therapies:Ischemic pressure, Strain CounterStrain, and Muscle energy techniques. After finding tender point at the lateral epicondyle, pressure is applied for 90 seconds, then the patient is given a rest, and this procedure is repeated 3 times. To perform the strain-contrastrain technique, we move the patient's wrist to a position that reduces the patient's pain by at least 70 percent, maintain pressure in this position for 90 seconds, and repeat this process 3 times. To perform the Muscle Energy Technique, we bend the patient's wrist slightly and obtain a resistive contraction in the direction of wrist extension from the patient. Hold the contraction for 7 seconds and then rest. During the rest period, the wrist is further flexed and this process is repeated 3 times. Finally, a soft tissue extensor stretch is performed for 30 seconds.</i_keyword>
      <i_keyword>Control group: This group only received routine physiotherapy treatments, including: hot packs, transcutaneous electrical nerve stimulation, ultrasound, education and exercises. The hot pack is placed on the epicondyle for 20 minutes. Transcutaneous electrical nerve stimulation with frequency of 60 Hertz and pulse duration of 100 milliseconds and tolerable intensity of 10 to 30 milliamps for 20 minutes, will be applied through two electrodes that we are placing on the extensor origion muscle of the patient. Ultrasound waves with  frequency of 1 MHz and an intensity of 1.5 watts/cm2 are applied around the lateral epicondyle for 3-5 minutes. Transcutaneous electrical nerve stimulation and ultrasonic waves will be performed by devices manufactured by Novin Medical Engineering company. Patient education includes avoiding lifting, repetitive wrist activities, using screwdrivers and mice, and any activity that aggravates pain. The patient's exercises include 3 groups: 1- Stretching of the wrist extensors and flexors, each stretch should be maintained for 30 seconds and repeated 3 times. 2- Active flexion and extension movements of the patient's wrist and elbow, each movement includes 3 sets and each set has 20 repetitions. 3- Isometric grip and wrist extension movements, each contraction should be maintained for 20 seconds and has 20 repetitions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain that is more than 3 or 3 befor intervention. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Visual Analoge Scale.</prim_outcome>
      <prim_outcome>Function. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Patient Rated Tennis Elbow Evaluation Questionnaire.</prim_outcome>
      <prim_outcome>Grip strength. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Dynamometer device.</prim_outcome>
      <prim_outcome>Muscle activity. Timepoint: Measurement befor the start of the intervention and 4 weeks after the application of the intervention. Method of measurement: Surface Electromyography Device.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-13</approval_date>
        <contact_name>Ethics committee of Zahedan University of Medical Sciences.</contact_name>
        <contact_address>Dr. Hesabi Square, Imam Hossein Blvd, compus of university of medical sciences. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
