<?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>IRCT20091214002851N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-30</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Neuromobilization in Subacromial Pain Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Neuromobilization on Pain in Subacromial Pain Syndrome: a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85550</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization:
In this parallel randomized clinical trial study, taking into account that not all patients are included in the study at the same time, and the researchers cannot predict which group each patient will belong to, in order to assign each patient to one of the two groups, the block randomization method will be used. In order to hide the random assignment, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to.
In this study, the eligible participating patients, after receiving informed consent, according to the block randomization protocol (produced by Random Allocation Software) were allocated to one of the two control and intervention groups with a ratio of 1:1 and in blocks of 6 in such a way that the researcher cannot predict which group the next person will be placed in. The codes will be placed in the opaque envelopes, and with the entry of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined.

Allocation Concealment:
In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that the next person to be assigned to each group is not known.
Based on the sample size of this study, a number of opaque envelopes (to avoid clarity of the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain random order, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the beginning of registration, based on the order of entry of eligible participants into the study, one of the letter envelopes will be opened in order and the allocated group of that participant will be revealed, Blinding description: This study will be conducted in a single-blind manner. In this way, the evaluator will be completely unaware of which group the patients belong to in order to measure the results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subacromial pain syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients in both groups will undergo treatment for 4 weeks with a frequency of three sessions per week (every other day). In the control group, patients will receive 20 minutes of infrared lamp therapy on the shoulder and arm area simultaneously with HIGH TENS, with a pulse duration of 50-80 microseconds and a frequency of 100-150 Hz. Additionally, in the first session, exercises will be taught to patients in both groups, and they will be asked to perform the exercises during the same treatment session under the supervision of a physiotherapist. The exercises include strengthening of the Rotator cuff muscles, Scapular muscles, and Pendulum exercises. Patients will be instructed to perform each exercise in three sets of ten repetitions with one minute rest between sets. If the patient experiences no pain while performing the exercises, resistance can be progressed by increasing the resistance of Pilates resistance bands as follows: orange band in the first week, purple band in the second week, and pink band in the third and fourth weeks. If the patient has difficulty with a specific exercise, modifications will be made to the exercise, or it will be removed from the individual’s exercise program. Exercises include : Towel exercise - Scapular protraction - Row exercise - Full can- External rotation in side-lying - Pendular exercise. Intervention 2: Intervention group: In this group, in addition to the control group interventions, Median nerve mobilization is performed. The technique is first applied as sliding, followed by progression to tension technique. The modified Median nerve tension position is used, where the patient lies supine with the shoulder and forearm in a neutral position and the elbow flexed at 90 degrees. The therapist places one hand on the patient's upper shoulder to prevent shoulder elevation and with the other hand sequentially positions the shoulder at 45 degrees abduction and slight external rotation, the forearm in supination, then extends the elbow while maintaining the wrist and fingers in a neutral position. For the sliding technique, the patient is asked to laterally flex the head toward the affected side while the therapist simultaneously extends the wrist and fingers. Next, the patient flexes the head toward the opposite side while the therapist flexes the wrist and fingers simultaneously. The sliding technique is performed in three sets of ten repetitions, with one minute rest between sets .The tension technique is performed at level 2 standard. The patient maintains a neutral head position while the therapist extends the wrist and fingers, holding this position for 10 seconds. This is repeated five times.</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:
All data can potentially be shared after unidentified individuals

When:
Access period starts 2 months after the results are published

To whom:
Researchers working in academic, scientific and medical institutions

Conditions:
To cite other researchers from the results of our research

Where to obtain:
Dr. Mohammad Taghipour, Babol University of Medical sciences, college of rehabilitation 00989126899352, taghipour@mubabol.ac.ir
Omid shirzad, Babol University of Medical sciences, college of rehabilitation, 009117867750, omid.shirzad7899@gmail.com

How to obtain:
2-4 weeks after request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Omid Shirzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol University of Medical Sciences, Ganj Afrooz Ave</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 4641</telephone>
        <email>Omid.shirzad7899@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Taghipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babol Medical Sciences University, Ganj Afrooz Ave</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4717647745</zip>
        <telephone>+98 11 3219 4641</telephone>
        <email>taghipour@mubabol.ac.ir</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 60 years
Shoulder pain for at least four weeks
Positive results from at least three out of five clinical diagnostic tests: Neer test, Hawkins-Kennedy test, Painful Arc, Jobe or Empty Can test, Resisted External Rotation</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of Shoulder surgery, dislocation, or fracture
Cervical radicular pain exacerbated by active neck movement
Clinical signs of complete Rotator cuff tear and Biceps tendon rupture with the Drop arm test and observation of Popeye deformity
Other shoulder disorders (such as Frozen shoulder or Degenerative joint changes)
Rheumatic disorders
Clear limitation of range of motion in the wrist and elbow joint of the affected hand
History of receiving Corticosteroid injections or any physiotherapy interventions for shoulder pain in the past 6 months.
Acute pain with VAS ≥ 7.5</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M75.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rotator cuff tear or rupture, not specified as traumatic</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Patients in both groups will undergo treatment for 4 weeks with a frequency of three sessions per week (every other day). In the control group, patients will receive 20 minutes of infrared lamp therapy on the shoulder and arm area simultaneously with HIGH TENS, with a pulse duration of 50-80 microseconds and a frequency of 100-150 Hz. Additionally, in the first session, exercises will be taught to patients in both groups, and they will be asked to perform the exercises during the same treatment session under the supervision of a physiotherapist. The exercises include strengthening of the Rotator cuff muscles, Scapular muscles, and Pendulum exercises. Patients will be instructed to perform each exercise in three sets of ten repetitions with one minute rest between sets. If the patient experiences no pain while performing the exercises, resistance can be progressed by increasing the resistance of Pilates resistance bands as follows: orange band in the first week, purple band in the second week, and pink band in the third and fourth weeks. If the patient has difficulty with a specific exercise, modifications will be made to the exercise, or it will be removed from the individual’s exercise program. Exercises include : Towel exercise - Scapular protraction - Row exercise - Full can- External rotation in side-lying - Pendular exercise</i_keyword>
      <i_keyword>Intervention group: In this group, in addition to the control group interventions, Median nerve mobilization is performed. The technique is first applied as sliding, followed by progression to tension technique. The modified Median nerve tension position is used, where the patient lies supine with the shoulder and forearm in a neutral position and the elbow flexed at 90 degrees. The therapist places one hand on the patient's upper shoulder to prevent shoulder elevation and with the other hand sequentially positions the shoulder at 45 degrees abduction and slight external rotation, the forearm in supination, then extends the elbow while maintaining the wrist and fingers in a neutral position. For the sliding technique, the patient is asked to laterally flex the head toward the affected side while the therapist simultaneously extends the wrist and fingers. Next, the patient flexes the head toward the opposite side while the therapist flexes the wrist and fingers simultaneously. The sliding technique is performed in three sets of ten repetitions, with one minute rest between sets .The tension technique is performed at level 2 standard. The patient maintains a neutral head position while the therapist extends the wrist and fingers, holding this position for 10 seconds. This is repeated five times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain in Shoulder Abduction. Timepoint: Before the intervention and after 4 weeks of the intervention. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional Disability. Timepoint: Before the intervention and after 4 weeks of the intervention. Method of measurement: Persian version of Shoulder Pain And Disability Index(SPADI) questionnaire.</sec_outcome>
      <sec_outcome>Grip Strength. Timepoint: Before the intervention and after 4 weeks of the intervention. Method of measurement: Hand-Held Dynamometer(HHD).</sec_outcome>
      <sec_outcome>Pain free range of motion of 1)Abduction 2)Flexion 3)Internal and External Rotation. Timepoint: Before the intervention and after 4 weeks of the intervention. Method of measurement: Android mobile application Clinometer + Bubble Level.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-13</approval_date>
        <contact_name>Ethics Committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Sciences, Ganj Afrooz Ave Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
