<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/NCT03251703</url>
  </required_header>
  <id_info>
    <org_study_id>Sakaray University</org_study_id>
    <nct_id>NCT03251703</nct_id>
  </id_info>
  <brief_title>Ultrasound-Guided Suprascapular Pulsed Radiofrequency</brief_title>
  <acronym>PRF</acronym>
  <official_title>Effects of Ultrasound-Guided Suprascapular Pulsed Radiofrequency Therapy on Chronic Shoulder Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakarya University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakarya University</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>
      Shoulder pain is the second most common musculoskeletal disease in adults, and it often&#xD;
      becomes chronic due to treatment difficulties.&#xD;
&#xD;
      Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of&#xD;
      chronic shoulder pain due to its long duration of action and non-destructive method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      These patients lacked pain control despite systemic analgesics and conservative therapy and&#xD;
      applied to our pain polyclinics for shoulder pain lasting at least 3 months.&#xD;
&#xD;
      The ultrasound-guided SSPRF was performed in those patients with a reduction of 50% or more&#xD;
      VAS score and those that reported healing in the AROM in the diagnostic SNB.&#xD;
&#xD;
      The resting, motion and sleeping shoulder pain assessments of the patients were done using a&#xD;
      visual analog scale (VAS). The shoulder joint function was assessed using the Shoulder Pain&#xD;
      and Disability Index (SPADI) questionnaire and the active range of motion (AROM) of the joint&#xD;
      was measured using a goniometer In this study, investigators aimed to reveal the effects of&#xD;
      ultrasound-guided suprascapular PRF (SSPRF) therapy applied to patients with chronic shoulder&#xD;
      pain on both shoulder pain and function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency</measure>
    <time_frame>1 years</time_frame>
    <description>Retroscopic study</description>
  </primary_outcome>
  <enrollment type="Actual">74</enrollment>
  <condition>PAIN, INTRACTABLE, Shoulder</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-Guided Suprascapular Pulsed Radiofrequency .</intervention_name>
    <description>The ultrasound-Guided Suprascapular Pulsed Radiofrequency was administered under operating room conditions while the patient was monitored in a sitting position.An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) was pushed forward towards the suprascapular notch until it passed the transverse scapular ligament using an in-plane approach.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        shoulder pain lasting at least 3 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients 18 years of age or older who were diagnosed with at least one of the following:&#xD;
        adhesive capsulitis of the shoulder (M75.0), rotator cuff syndrome (M75.1), and impingement&#xD;
        syndrome of shoulder (M75.4) according to the ICD-10 classifications. These patients lacked&#xD;
        pain control despite systemic analgesics and conservative therapy (like physiotherapy) and&#xD;
        applied to our pain polyclinics for shoulder pain lasting at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with other diseases causing chronic pain, those with neuropathic pain, those who&#xD;
        had undergone surgery on the same shoulder, those with an allergy history from local&#xD;
        anesthesia, those with abnormal coagulation tests, and those with cardiac pacemakers were&#xD;
        excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakarya University</investigator_affiliation>
    <investigator_full_name>Serbülent Gökhan BEYAZ</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Intractable</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03251703
org study id: Sakaray University
nct id: NCT03251703
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shoulder pain is the second most common musculoskeletal disease in adults, and it often
      becomes chronic due to treatment difficulties.

      Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of
      chronic shoulder pain due to its long duration of action and non-destructive method.
These patients lacked pain control despite systemic analgesics and conservative therapy and
      applied to our pain polyclinics for shoulder pain lasting at least 3 months.

      The ultrasound-guided SSPRF was performed in those patients with a reduction of 50% or more
      VAS score and those that reported healing in the AROM in the diagnostic SNB.

      The resting, motion and sleeping shoulder pain assessments of the patients were done using a
      visual analog scale (VAS). The shoulder joint function was assessed using the Shoulder Pain
      and Disability Index (SPADI) questionnaire and the active range of motion (AROM) of the joint
      was measured using a goniometer In this study, investigators aimed to reveal the effects of
      ultrasound-guided suprascapular PRF (SSPRF) therapy applied to patients with chronic shoulder
      pain on both shoulder pain and function.
observational model: Other
time perspective: Retrospective
measure: Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency
time frame: 1 years
description: Retroscopic study
intervention type: Procedure
intervention name: Ultrasound-Guided Suprascapular Pulsed Radiofrequency .
description: The ultrasound-Guided Suprascapular Pulsed Radiofrequency was administered under operating room conditions while the patient was monitored in a sitting position.An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) was pushed forward towards the suprascapular notch until it passed the transverse scapular ligament using an in-plane approach.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Sakarya University
investigator full name: Serbülent Gökhan BEYAZ
investigator title: associate professor
mesh term: Pain, Intractable
sharing ipd: No