xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05962515</url>
    </required_header>
    <id_info>
      <org_study_id>2022/2/1</org_study_id>
      <nct_id>NCT05962515</nct_id>
    </id_info>
    <brief_title>Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise in Piriformis Muscle Syndrome</brief_title>
    <official_title>Evaluation of the Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise Programme in Piriformis Muscle Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tepecik Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tepecik Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Piriformis muscle syndrome (PMS) is a neuromuscular disorder that can cause symptoms of hip&#xD;
        joint motion limitation, buttock pain and tenderness, and numbness radiating to the back of&#xD;
        the thigh due to compression or irritation of the sciatic nerve.In the etiology of PMS&#xD;
        myofascial trigger points are the most common cause and also hypertrophy in the piriformis&#xD;
        muscle tissue, inflammation, trauma, anatomical variations of the piriformis muscle or&#xD;
        sciatic nerve may also cause the development of PMS . Physical examination supports the&#xD;
        diagnosis of PMS and may help to eliminating competing diagnoses. Multiple physical&#xD;
        examination maneuvers have been identified to help diagnose but no physical examination&#xD;
        maneuver is diagnostic for PMS. Compression and deep palpation may also exacerbate buttock or&#xD;
        gluteal pain. Electrodiagnostic tests are usually normal in FMS and useful in excluding other&#xD;
        conditions such as lumbosacral radiculopathy .There is no gold standard treatment option for&#xD;
        PMS, conservative treatment and lifestyle changes remain the mainstays for the treatment.&#xD;
        Piriformis muscle stretching is the form of an exercise technique in physiotherapy method&#xD;
        that is generally used for those patients. The exercises focused on relaxing the priformis&#xD;
        muscle to increase the resting length of the muscle and reduce the potential sciatic nerve&#xD;
        compression because of this thigtness. Dry needling (DN) therapy is a treatment method where&#xD;
        myofascial trigger points are stimulated using acupuncture needles or injection needles .DN&#xD;
        can be applied according to the anatomical landmark method or under the guidance of&#xD;
        ultrasound (US) and fluoroscopic imaging. US guidance is important in the management of PMS,&#xD;
        which allows imaging of specific deep muscle groups and avoids complications such as&#xD;
        procedural pain and damage of neurovascular structures . There are no randomized controlled&#xD;
        studies other than case series on the use and frequency of application of the US-guided DN&#xD;
        technique in PMS. The aim of this study is to compare the effectiveness of dry needling&#xD;
        treatment applied to the piriformis muscle once a week for a total of 3 times under US&#xD;
        guidance and 3-week exercise program treatment in PMS. The secondary outcomes of this study&#xD;
        is to evaluate and compare the effect of these treatment modalities on Visuel Analg Scale&#xD;
        (VAS) scores ,Oswestry Disability Index (ODI), lower extremity functional scale (LEFS) and&#xD;
        (Douleur Neuropathique 4 Questionare ) DN4 scores in PMS patients at 3 months follow up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this observational study, between January 2022 and April 2023, after excluding other hip,&#xD;
        lumbar, sacroiliac region and lower extremity pain etiology diagnoses, 44 patients aged 18-70&#xD;
        years who are clinically diagnosed with PMS are planned to be included in the study. The&#xD;
        diagnosis is based on patient's history and physical examination, bearing positive FAIR test&#xD;
        and/or tenderness or trigger point at the priformis muscle area and/or revealing the pain&#xD;
        with maneuvers; such as Freiberg's maneuver , Beatty's maneuver and Pace's maneuver . The&#xD;
        demographic data (age, sex, occupation, body mass index scores), the side of the pain will be&#xD;
        noted. Each patient in the study will receive and sign an informed consent form.The patients&#xD;
        will divide into two groups ; group 1 (n:22)will have DN treatment to the piriformis muscle&#xD;
        once a week for a total of 3 times under US guidance, all patients in group 2 (n:22) will&#xD;
        have exercise programme for 3 weeks. Overall pain severity will measure by using visual&#xD;
        analogue scale (VAS). Pain disability will assess with the Oswestry Disability Index (ODI)&#xD;
        questionnaire, Physical function will rate with Lower Extremity Functional Scale (LEFS).&#xD;
        Presence and severity of neuropathic pain will evaluate according to Douleur Neuropathique 4&#xD;
        questionnare (DN4). To identify the outcomes of the treatment modalities, pre-treatment,&#xD;
        post-treatment 1st month and 3th-month scores will be used. Patients with comorbidities that&#xD;
        prevented interventional treatment (e.g., inflammatory diseases, uncontrolled diabetes&#xD;
        mellitus, uncontrolled hypertension, malignancy, pregnancy, and severe psychiatric&#xD;
        disorders), patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc&#xD;
        herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies) those aged&#xD;
        under 18 years old and patients who did not accept interventional or physical therapy&#xD;
        modalities are going to exclude from the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 20, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">April 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Months</target_duration>
    <primary_outcome>
      <measure>Visuel Analogue Scale</measure>
      <time_frame>change from baseline VAS scores at 3 months</time_frame>
      <description>Overall pain severity was measured by using a 0 to 100 mm scale visual analogue scale (VAS).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oswestry Disability Index (ODI) questionnaire,</measure>
      <time_frame>change from baseline ODI scores at 3 months</time_frame>
      <description>Oswestry Disability Index (ODI) questionnaire, which measures pain disability consists of ten questions, each with six options . The questions include the pain intensity, ability to work, perform self care, sit ,stand, travel, lift, sleep pattern, socializing and sexual life. Every question was scored between 0 and 5 points. The highest score is 50 if all questions were answered, and indicates severe disability for the participant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lower extremity functional scale (LEFS)</measure>
      <time_frame>change from baseline LEFS scores at 3 months</time_frame>
      <description>The LEFS consists of 20 items to rate the ability of functional status in performing different physical activities due to musculoskeletal problems affecting the lower extremities. Each question has five point scale, from 0 to 4 (0: unable to do the activity, 1: quite, 2: moderate, 3: somewhat, 4: no difficulty). The total score ranges from 0 to 80, with higher scores indicate better functional status</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Douleur Neuropathique 4 questionnare (DN4)</measure>
      <time_frame>change from baseline DN4 scores at 3 months</time_frame>
      <description>The questionnaire derived from this list, called DN4, included a series of four questions consisting of both sensory descriptors and signs related to bedside sensory examination. This provisional questionnaire was not intended to be exhaustive and was deliberately restricted to a minimum of simple and presumably discriminant items requiring yes or no responses.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">44</enrollment>
    <condition>Piriformis Muscle Syndrome</condition>
    <condition>Dry Needling</condition>
    <condition>Ultrasonography</condition>
    <condition>Ultrasound Guided Dry Needling</condition>
    <condition>Exercise Treatment</condition>
    <arm_group>
      <arm_group_label>1</arm_group_label>
      <description>All patients in group 1 (n:22) had DN treatment applied to the piriformis muscle once a week for a total of 3 times under US guidance.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2</arm_group_label>
      <description>All patients in group 2(n:22) had exercise programme for 3 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ultrasound guided dry needling</intervention_name>
      <description>Dry needling was applied in the intervention room with sterile conditions the patient in the prone position.The low frequency (2-5 MHz) transducer is placed in the gluteal region in a slightly oblique position and sonographic scanning is started. First, the large mountain shadow of the iliac crest and gluteus maximus muscle is sonographically visualized in the midline. Then the transducer is shifted inferiorly until the sciatic notch is visualized. When the sciatic notch, sciatic nerve and the pear-shaped piriformis muscle above it are visualized, the patient's knee is flexed and the leg is rotated internally and externally, and the typical sliding motion of the piriformis muscle is observed. After the target point is determined, a 22 G spinal needle is applied from lateral to medial or from medial to lateral with in plane technique. The needle is inserted and withdrawn several times until the switch response in the piriformis muscle is observed and extinguished</description>
      <arm_group_label>1</arm_group_label>
      <arm_group_label>2</arm_group_label>
      <other_name>exercise programme</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patients were divided into two groups as those who will accept DN treatment (Group 1&#xD;
          -n: 22) and those who will have physical exercise treatment (Group 2- n: 22). All patients&#xD;
          in group 1 will have DN treatment to the piriformis muscle once a week for a total of 3&#xD;
          times under US guidance.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with isolated Piriformis Muscle Syndrome&#xD;
  &#xD;
            -  The diagnosis is based on patient's history and physical examination, bearing positive&#xD;
               FAIR (flexion, adduction, internal rotation) test and/or tenderness or trigger point&#xD;
               at the priformis muscle area and/or revealing the pain with maneuvers; such as&#xD;
               Freiberg's maneuver (forceful internal rotation of the extended thigh in the supine&#xD;
               position), Beatty's maneuver (actively abducting the affected thigh in the lateral&#xD;
               decubitus position) and Pace's maneuver (resisted abduction of both thighs in the&#xD;
               seated position).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with comorbidities that prevented interventional treatment (e.g.,&#xD;
               inflammatory diseases, uncontrolled diabetes mellitus, uncontrolled hypertension,&#xD;
               malignancy, pregnancy, and severe psychiatric disorders),&#xD;
  &#xD;
            -  Patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc&#xD;
               herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies)&#xD;
  &#xD;
            -  Aged under 18 years old&#xD;
  &#xD;
            -  Patients who will not accept interventional or physical therapy modalities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tepecik Training and Research Hospital</name>
        <address>
          <city>İzmir</city>
          <zip>35000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Tabatabaiee A, Takamjani IE, Sarrafzadeh J, Salehi R, Ahmadi M. Ultrasound-guided dry needling decreases pain in patients with piriformis syndrome. Muscle Nerve. 2019 Nov;60(5):558-565. doi: 10.1002/mus.26671. Epub 2019 Aug 27.</citation>
      <PMID>31415092</PMID>
    </results_reference>
    <results_reference>
      <citation>Fusco P, Di Carlo S, Scimia P, Degan G, Petrucci E, Marinangeli F. Ultrasound-guided Dry Needling Treatment of Myofascial Trigger Points for Piriformis Syndrome Management: A Case Series. J Chiropr Med. 2018 Sep;17(3):198-200. doi: 10.1016/j.jcm.2018.04.002. Epub 2018 Aug 26.</citation>
      <PMID>30228811</PMID>
    </results_reference>
    <results_reference>
      <citation>Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.</citation>
      <PMID>25794202</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tepecik Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>derya guner</investigator_full_name>
      <investigator_title>Pain Physician, MD</investigator_title>
    </responsible_party>
    <keyword>piriformis muscle syndrome</keyword>
    <keyword>pain</keyword>
    <keyword>dry needling</keyword>
    <keyword>exercise</keyword>
    <keyword>ultrasound</keyword>
    <keyword>neuralgia</keyword>
    <keyword>interventional ultrasonography</keyword>
    <keyword>physical therapy modalities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Piriformis Muscle Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962515
  org study id: 2022/2/1
  nct id: NCT05962515
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Piriformis muscle syndrome (PMS) is a neuromuscular disorder that can cause symptoms of hip
        joint motion limitation, buttock pain and tenderness, and numbness radiating to the back of
        the thigh due to compression or irritation of the sciatic nerve.In the etiology of PMS
        myofascial trigger points are the most common cause and also hypertrophy in the piriformis
        muscle tissue, inflammation, trauma, anatomical variations of the piriformis muscle or
        sciatic nerve may also cause the development of PMS . Physical examination supports the
        diagnosis of PMS and may help to eliminating competing diagnoses. Multiple physical
        examination maneuvers have been identified to help diagnose but no physical examination
        maneuver is diagnostic for PMS. Compression and deep palpation may also exacerbate buttock or
        gluteal pain. Electrodiagnostic tests are usually normal in FMS and useful in excluding other
        conditions such as lumbosacral radiculopathy .There is no gold standard treatment option for
        PMS, conservative treatment and lifestyle changes remain the mainstays for the treatment.
        Piriformis muscle stretching is the form of an exercise technique in physiotherapy method
        that is generally used for those patients. The exercises focused on relaxing the priformis
        muscle to increase the resting length of the muscle and reduce the potential sciatic nerve
        compression because of this thigtness. Dry needling (DN) therapy is a treatment method where
        myofascial trigger points are stimulated using acupuncture needles or injection needles .DN
        can be applied according to the anatomical landmark method or under the guidance of
        ultrasound (US) and fluoroscopic imaging. US guidance is important in the management of PMS,
        which allows imaging of specific deep muscle groups and avoids complications such as
        procedural pain and damage of neurovascular structures . There are no randomized controlled
        studies other than case series on the use and frequency of application of the US-guided DN
        technique in PMS. The aim of this study is to compare the effectiveness of dry needling
        treatment applied to the piriformis muscle once a week for a total of 3 times under US
        guidance and 3-week exercise program treatment in PMS. The secondary outcomes of this study
        is to evaluate and compare the effect of these treatment modalities on Visuel Analg Scale
        (VAS) scores ,Oswestry Disability Index (ODI), lower extremity functional scale (LEFS) and
        (Douleur Neuropathique 4 Questionare ) DN4 scores in PMS patients at 3 months follow up.
  In this observational study, between January 2022 and April 2023, after excluding other hip,
        lumbar, sacroiliac region and lower extremity pain etiology diagnoses, 44 patients aged 18-70
        years who are clinically diagnosed with PMS are planned to be included in the study. The
        diagnosis is based on patient's history and physical examination, bearing positive FAIR test
        and/or tenderness or trigger point at the priformis muscle area and/or revealing the pain
        with maneuvers; such as Freiberg's maneuver , Beatty's maneuver and Pace's maneuver . The
        demographic data (age, sex, occupation, body mass index scores), the side of the pain will be
        noted. Each patient in the study will receive and sign an informed consent form.The patients
        will divide into two groups ; group 1 (n:22)will have DN treatment to the piriformis muscle
        once a week for a total of 3 times under US guidance, all patients in group 2 (n:22) will
        have exercise programme for 3 weeks. Overall pain severity will measure by using visual
        analogue scale (VAS). Pain disability will assess with the Oswestry Disability Index (ODI)
        questionnaire, Physical function will rate with Lower Extremity Functional Scale (LEFS).
        Presence and severity of neuropathic pain will evaluate according to Douleur Neuropathique 4
        questionnare (DN4). To identify the outcomes of the treatment modalities, pre-treatment,
        post-treatment 1st month and 3th-month scores will be used. Patients with comorbidities that
        prevented interventional treatment (e.g., inflammatory diseases, uncontrolled diabetes
        mellitus, uncontrolled hypertension, malignancy, pregnancy, and severe psychiatric
        disorders), patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc
        herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies) those aged
        under 18 years old and patients who did not accept interventional or physical therapy
        modalities are going to exclude from the study.
  observational model: Case-Only
  time perspective: Prospective
  measure: Visuel Analogue Scale
  time frame: change from baseline VAS scores at 3 months
  description: Overall pain severity was measured by using a 0 to 100 mm scale visual analogue scale (VAS).
  measure: Oswestry Disability Index (ODI) questionnaire,
  time frame: change from baseline ODI scores at 3 months
  description: Oswestry Disability Index (ODI) questionnaire, which measures pain disability consists of ten questions, each with six options . The questions include the pain intensity, ability to work, perform self care, sit ,stand, travel, lift, sleep pattern, socializing and sexual life. Every question was scored between 0 and 5 points. The highest score is 50 if all questions were answered, and indicates severe disability for the participant.
  measure: lower extremity functional scale (LEFS)
  time frame: change from baseline LEFS scores at 3 months
  description: The LEFS consists of 20 items to rate the ability of functional status in performing different physical activities due to musculoskeletal problems affecting the lower extremities. Each question has five point scale, from 0 to 4 (0: unable to do the activity, 1: quite, 2: moderate, 3: somewhat, 4: no difficulty). The total score ranges from 0 to 80, with higher scores indicate better functional status
  measure: Douleur Neuropathique 4 questionnare (DN4)
  time frame: change from baseline DN4 scores at 3 months
  description: The questionnaire derived from this list, called DN4, included a series of four questions consisting of both sensory descriptors and signs related to bedside sensory examination. This provisional questionnaire was not intended to be exhaustive and was deliberately restricted to a minimum of simple and presumably discriminant items requiring yes or no responses.
  arm group label: 1
  description: All patients in group 1 (n:22) had DN treatment applied to the piriformis muscle once a week for a total of 3 times under US guidance.
  arm group label: 2
  description: All patients in group 2(n:22) had exercise programme for 3 weeks.
  intervention type: Procedure
  intervention name: ultrasound guided dry needling
  description: Dry needling was applied in the intervention room with sterile conditions the patient in the prone position.The low frequency (2-5 MHz) transducer is placed in the gluteal region in a slightly oblique position and sonographic scanning is started. First, the large mountain shadow of the iliac crest and gluteus maximus muscle is sonographically visualized in the midline. Then the transducer is shifted inferiorly until the sciatic notch is visualized. When the sciatic notch, sciatic nerve and the pear-shaped piriformis muscle above it are visualized, the patient's knee is flexed and the leg is rotated internally and externally, and the typical sliding motion of the piriformis muscle is observed. After the target point is determined, a 22 G spinal needle is applied from lateral to medial or from medial to lateral with in plane technique. The needle is inserted and withdrawn several times until the switch response in the piriformis muscle is observed and extinguished
  arm group label: 1
  arm group label: 2
  other name: exercise programme
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  citation: Tabatabaiee A, Takamjani IE, Sarrafzadeh J, Salehi R, Ahmadi M. Ultrasound-guided dry needling decreases pain in patients with piriformis syndrome. Muscle Nerve. 2019 Nov;60(5):558-565. doi: 10.1002/mus.26671. Epub 2019 Aug 27.
  PMID: 31415092
  citation: Fusco P, Di Carlo S, Scimia P, Degan G, Petrucci E, Marinangeli F. Ultrasound-guided Dry Needling Treatment of Myofascial Trigger Points for Piriformis Syndrome Management: A Case Series. J Chiropr Med. 2018 Sep;17(3):198-200. doi: 10.1016/j.jcm.2018.04.002. Epub 2018 Aug 26.
  PMID: 30228811
  citation: Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.
  PMID: 25794202
  responsible party type: Principal Investigator
  investigator affiliation: Tepecik Training and Research Hospital
  investigator full name: derya guner
  investigator title: Pain Physician, MD
  mesh term: Piriformis Muscle Syndrome
  mesh term: Syndrome
  sharing ipd: No