<?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>IRCT20230719058844N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-01-06</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effects of dry needling plus static stretching of hamstring muscle in chronic nonspecific low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Effects of dry needling plus static stretching on pain, hamstring flexibility, disability, and balance in patients with chronic non-specific low back pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88424</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the participants were divided into two groups by a simple randomization by Cards or Envelopes Shuffling which were prepared according to their number and one of the names of the intervention or control was written on it. All patients have the same chance of being placed in any of the two groups. This study is a double-blind study. In this study, due to the use of sham dry needling, patients in the control group will be blinded of their placement in the intervention and control groups.
Also, the assessor is blinded of the control and intervention groups and only knows them as groups A and B. Only the interventionist is aware of the research events completely, Blinding description: The assessor is the researcher and during the assessments, he is not aware of the grouping of the patients and only knows them into two groups A and B.
The use of sham dry needling in the control group causes the patient to be blinded to being in the control or intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-specific low back pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, patients received static stretching of the hamstring muscle in each treatment session after dry needling. Dry needling is preferred before static stretching with the aim of reducing muscle tension and allowing for more effective application of stretching in a greater range. A) Dry needling: A sterile disposable needle (0.25mm×0.60mm, SMC, Seoul, Korea) is used for dry needling. The patient is asked to lie prone on the bed and the Fast in Fast out technique is used deeply on three points of the hamstring muscle (long and short heads of the biceps femoris, semitendinosus and semimembranosus) for 3 minutes (1 minute at each point). The exact needle location is determined by connecting a line from the ischial tuberosity to the fibular head, and the needle enters the long and short heads of the biceps femoris muscle at 60% and 30% of this line, respectively. Another line from the ischial tuberosity is also connected to the medial femoral condyle, and at 60% of this line, the needle enters the semitendinosus and semimembranosus (29). The number of treatment sessions for dry needling is performed once a day, every other day, for 3 sessions (53). b) Static stretching: To apply static stretching, patients are asked to lie supine on the bed and, while maintaining the knee in extension, move the hip towards flexion using an exercise band, placing the hamstring muscle under maximum tension. This static stretching is applied in 3 sets of 2 minutes with 2 minutes of rest between sets. The number of treatment sessions for static stretching is performed once a day, every other day, for 3 sessions (18). Intervention 2: Control group: In the control group, in each treatment session, Sham dry needling will be performed by applying 10 grams of monofilament, and then static stretching will be applied according to the intervention group. The number of treatment sessions and the duration of the sessions will be the same as the intervention group.</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>Mahdi Esmaeeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, No 10, Rashidi Alley, Meghdad St, Pirouzi Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1766717194</zip>
        <telephone>+98 21 3317 0630</telephone>
        <email>mahdiesmaeeli@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Esmaeeli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd Floor, No 10, Rashidi Alley, Meghdad St, Pirouzi Ave, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1766717194</zip>
        <telephone>+98 21 3317 0630</telephone>
        <email>mahdiesmaeeli@yahoo.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women with non-specific low back pain
Decreased passive knee extension of more than 25 degrees
12 weeks after the onset of low back pain
Visual analog scale between 3 and 7
No contraindication for dry needling
No history of other neuromuscular system disorders
Ability to understand and follow the instructions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-cooperation in carrying out treatment protocols
Absence of the person in two consecutive treatment sessions
Inability to complete the pre and post assessments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</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: In the intervention group, patients received static stretching of the hamstring muscle in each treatment session after dry needling. Dry needling is preferred before static stretching with the aim of reducing muscle tension and allowing for more effective application of stretching in a greater range. A) Dry needling: A sterile disposable needle (0.25mm×0.60mm, SMC, Seoul, Korea) is used for dry needling. The patient is asked to lie prone on the bed and the Fast in Fast out technique is used deeply on three points of the hamstring muscle (long and short heads of the biceps femoris, semitendinosus and semimembranosus) for 3 minutes (1 minute at each point). The exact needle location is determined by connecting a line from the ischial tuberosity to the fibular head, and the needle enters the long and short heads of the biceps femoris muscle at 60% and 30% of this line, respectively. Another line from the ischial tuberosity is also connected to the medial femoral condyle, and at 60% of this line, the needle enters the semitendinosus and semimembranosus (29). The number of treatment sessions for dry needling is performed once a day, every other day, for 3 sessions (53). b) Static stretching: To apply static stretching, patients are asked to lie supine on the bed and, while maintaining the knee in extension, move the hip towards flexion using an exercise band, placing the hamstring muscle under maximum tension. This static stretching is applied in 3 sets of 2 minutes with 2 minutes of rest between sets. The number of treatment sessions for static stretching is performed once a day, every other day, for 3 sessions (18).</i_keyword>
      <i_keyword>Control group: In the control group, in each treatment session, Sham dry needling will be performed by applying 10 grams of monofilament, and then static stretching will be applied according to the intervention group. The number of treatment sessions and the duration of the sessions will be the same as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual Analogue Scale. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: with a ruler from 1-10.</prim_outcome>
      <prim_outcome>Passive knee extension test. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: By goniometer in degrees.</prim_outcome>
      <prim_outcome>Functional rating index. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Questionnaire with 10 items and scores between 0 and 40 as a percentage.</prim_outcome>
      <prim_outcome>Timed up and go test. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Time measured by a chronometer.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: European quality of life questionnaire.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-13</approval_date>
        <contact_name>Research Ethics committee of Baqiyarallah University of Medical Sciences</contact_name>
        <contact_address>3rd Floor, No 10, Rashidi Alley, Meghdad St, Pirouzi Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
