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/NCT05968274</url>
    </required_header>
    <id_info>
      <org_study_id>14/2023</org_study_id>
      <nct_id>NCT05968274</nct_id>
    </id_info>
    <brief_title>The Effect of Rebox Current in Pain Management</brief_title>
    <acronym>REBOX</acronym>
    <official_title>The Effect of Rebox Current in Pain Management</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rebox Therapy s.r.o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rebox Therapy s.r.o.</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This post-marketing monocentric double-blind sham controlled crossover study will assess the&#xD;
        efficacy of Rebox electrotherapy in the treatment of pain. Totally 72 patients will be&#xD;
        treated with both real and sham Rebox device in a crossover design with a 1:1 ratio over a&#xD;
        6-week period. The degree of pain intensity reduction after the real Rebox stimulation will&#xD;
        be evaluated in comparison with the sham stimulation. Moreover, differences in&#xD;
        multidimensional aspects of pain will be compared between the real and sham stimulation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">May 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 10, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in pain intensity</measure>
      <time_frame>1. at baseline (day of randomization); 2. after 8th session (at the end of week 2.5 from randomization); 3. before 9th session (at the end of week 3.5 from randomization); 4. after 16th session (at the end of week 6 from randomization)</time_frame>
      <description>The degree of change in pain intensity after the real vs. sham stimulation will be evaluated between 4 specified time points. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Pain scores will be assessed by completing the Brief Pain Inventory (BPI).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immediate analgesic effect</measure>
      <time_frame>At each stimulation session, total 16 times (at 8 weekdays every other day from randomization up to week 2.5 + at 8 weekdays every other day from week 3.5 up to week 6)</time_frame>
      <description>The trend of the intra-individual effect of the real vs. sham stimulation on immediate pain relief will be assessed. The Numerical Rating Scale (NRS) will be used to assess pain intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in multidimensional aspects of pain</measure>
      <time_frame>1. at baseline (day of randomization); 2. after 8th session (at the end of week 2.5 from randomization); 3. before 9th session (at the end of week 3.5 from randomization); 4. after 16th session (at the end of week 6 from randomization)</time_frame>
      <description>The degree of change in multidimensional aspects of pain after the real vs. sham stimulation will be evaluated between 4 specified time points. Items related to multidimensional aspects of pain will be included in the BPI questionnaire (items 9 a-g).&#xD;
  The degree to which pain affects the following aspects will be assessed (in tens of %).&#xD;
  Activity in general&#xD;
  Mood&#xD;
  Ability to walk&#xD;
  Normal work (including work outside the home and housework)&#xD;
  Relationships with other people&#xD;
  Sleep&#xD;
  Enjoyment of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tolerability outcome</measure>
      <time_frame>At each stimulation session, total 16 times (at 8 weekdays every other day from randomization up to week 2.5 + at 8 weekdays every other day from week 3.5 up to week 6)</time_frame>
      <description>The percentage of patients who complete the entire study will be determined. The application will be considered well tolerated by the patient if a minimum of 14 out of 16 sessions are completed. Overall, the application will be considered well tolerated if tolerated application is achieved in ≥ 90% of patients without the need for early discontinuation due to intolerance. Any technical complications/adverse effects during application will be recorded in the application protocol and will be analyzed by the study monitor at a minimum interval of once per month .</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Electric Stimulation Therapy</condition>
    <arm_group>
      <arm_group_label>Arm &quot;A&quot;</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>First stimulation period: real stimulation, total 8 sessions, session frequency: weekdays every other day (i.e. duration 2.5 weeks)&#xD;
  Washout period: no stimulation, duration: 1 week&#xD;
  Second stimulation period: sham stimulation, total 8 sessions, session frequency: weekdays every other day (i.e. duration 2.5 weeks)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm &quot;B&quot;</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>First stimulation period: sham stimulation, total 8 sessions, weekdays every other day (i.e. 2.5 weeks)&#xD;
  Washout period: no stimulation, 1 week&#xD;
  Second stimulation period: real stimulation, total 8 sessions, weekdays every other day (i.e. 2.5 weeks)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Rebox-Physio 4 (real stimulation)</intervention_name>
      <description>Rebox-Physio 4 is a CE-certified medical device class IIa. The device is a voltage-controlled generator of specific DC electric pulses with voltage amplitude 0-21 V, current intensity up to 200 uA, rectangular pulse shape, pulse frequency 3000 Hz and pulse duration 0.25 ms. Rebox currents are applied locally at the site of pain non-invasively transcutaneously with a touch of a flexible pin active treatment electrode (cathode) while the patient holds a cylindrical electrode (anode) to close electric circuit. Stimulation time in one point is 3-5 seconds until the current intensity reaches stable target values of 140-160 uA. During one session, total 20-50 points are systematically treated at a mutual distance of approx. 2 cm over the target region.</description>
      <arm_group_label>Arm &quot;A&quot;</arm_group_label>
      <arm_group_label>Arm &quot;B&quot;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Rebox-Physio 4 (sham stimulation)</intervention_name>
      <description>In the sham stimulation, the comparator will be a visually identical sham version of the real Rebox-Physio 4.The sham device has a resistor installed at the output generating current of negligible intensity (maximum 1 uA) assuming no relevant physiological effect. The application procedure will be identical to the real device. When applied to the patient, the sham device displays &quot;false&quot; voltage and current intensity values and responds to the operator´s actions in real time mimicking the real stimulation. The operator is therefore blinded.</description>
      <arm_group_label>Arm &quot;A&quot;</arm_group_label>
      <arm_group_label>Arm &quot;B&quot;</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient with pain based on the following diagnoses:&#xD;
  &#xD;
                 -  Myofascial musculoskeletal pain&#xD;
  &#xD;
                 -  Vertebrogenic algic syndrome in the cervical, thoracic and lumbosacral regions&#xD;
  &#xD;
                 -  Sacroileitis with sacroiliac joint block&#xD;
  &#xD;
                 -  Cervicocranialgia&#xD;
  &#xD;
                 -  Frozen shoulder syndrome&#xD;
  &#xD;
                 -  Arthrosis&#xD;
  &#xD;
                 -  Epicondylitis&#xD;
  &#xD;
                 -  Pain in tendons, ligaments and other enthesopathies&#xD;
  &#xD;
                 -  Postoperative pain&#xD;
  &#xD;
                 -  Post-traumatic pain&#xD;
  &#xD;
                 -  Postherpetic neuralgia&#xD;
  &#xD;
            -  Duration of pain (de novo or exacerbation of chronic pain) prior to study inclusion&#xD;
               ranges from 2 weeks to 3 months&#xD;
  &#xD;
            -  The average pain intensity in a given period of 2 weeks to 3 months prior to study&#xD;
               inclusion must be NRS (Numerical Rating Scale) &gt;3&#xD;
  &#xD;
            -  The patient may be concurrently treated with analgesics and may be undergoing manual&#xD;
               physiotherapy (rehabilitation)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years&#xD;
  &#xD;
            -  Local contraindications:&#xD;
  &#xD;
                 -  Impaired skin integrity at the site of application (open wound, skin ulcer,&#xD;
                    burns), Note: the area around the postoperative scar is not an exclusion&#xD;
                    criterion&#xD;
  &#xD;
                 -  Acute inflammation of the skin or subcutaneous tissue at the application site&#xD;
  &#xD;
                 -  Deep vein thrombosis (diagnosed or suspected)&#xD;
  &#xD;
            -  General contraindications:&#xD;
  &#xD;
                 -  Implanted electrical device (pacemaker, implantable cardioverter-defibrillator,&#xD;
                    deep brain stimulator, cochlear implant, etc.)&#xD;
  &#xD;
                 -  Pregnancy&#xD;
  &#xD;
                 -  Epilepsy&#xD;
  &#xD;
                 -  Malignant cancer (diagnosed or suspected)&#xD;
  &#xD;
                 -  Acute potentially life-threatening conditions&#xD;
  &#xD;
            -  Concomitant other physical therapy (electrotherapy, magnetotherapy, laser therapy,&#xD;
               ultrasound therapy, mechanotherapy, etc.)&#xD;
  &#xD;
            -  The Rebox device was administered to the subject for any indication in the last 12&#xD;
               months prior to the study inclusion date&#xD;
  &#xD;
            -  A recent change in analgesic medication (i.e., new agent or change in agent dose less&#xD;
               than 1 week prior to the first stimulation session) or a planned change in analgesic&#xD;
               medication during the course of the study (change in agent, change in dose), Note:&#xD;
               modification of analgesic medication during the study is possible but must be recorded&#xD;
  &#xD;
            -  Ongoing acute infection, surgery or trauma during the study&#xD;
  &#xD;
            -  Concurrent subject participation in another clinical study&#xD;
  &#xD;
            -  Subject is unable to sign informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Igor Martuliak, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Matěj Slovák, MD, PhD</last_name>
      <phone>+420605909750</phone>
      <email>matej.slovak@rebox.cz</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vratislav Fabián, PhD</last_name>
      <email>fabian@medicton.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Low J, Reed A. Electrotherapy Explained, Principles and Practice, 3rd Edition. Butterworth-Heinemann. 2000; 121-122.</citation>
    </reference>
    <reference>
      <citation>Johannsen F, Gam A, Hauschild B, Mathiesen B, Jensen L. Rebox: an adjunct in physical medicine? Arch Phys Med Rehabil. 1993 Apr;74(4):438-40.</citation>
      <PMID>8466428</PMID>
    </reference>
    <reference>
      <citation>Trudel D, Duley J, Zastrow I, Kerr EW, Davidson R, MacDermid JC. Rehabilitation for patients with lateral epicondylitis: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):243-66. doi: 10.1197/j.jht.2004.02.011.</citation>
      <PMID>15162109</PMID>
    </reference>
    <reference>
      <citation>Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.</citation>
      <PMID>6646795</PMID>
    </reference>
    <reference>
      <citation>Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.</citation>
      <PMID>18487245</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rebox therapy</keyword>
    <keyword>electrotherapy</keyword>
    <keyword>pain treatment</keyword>
    <keyword>Rebox currents</keyword>
    <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/NCT05968274
  org study id: 14/2023
  nct id: NCT05968274
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This post-marketing monocentric double-blind sham controlled crossover study will assess the
        efficacy of Rebox electrotherapy in the treatment of pain. Totally 72 patients will be
        treated with both real and sham Rebox device in a crossover design with a 1:1 ratio over a
        6-week period. The degree of pain intensity reduction after the real Rebox stimulation will
        be evaluated in comparison with the sham stimulation. Moreover, differences in
        multidimensional aspects of pain will be compared between the real and sham stimulation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in pain intensity
  time frame: 1. at baseline (day of randomization); 2. after 8th session (at the end of week 2.5 from randomization); 3. before 9th session (at the end of week 3.5 from randomization); 4. after 16th session (at the end of week 6 from randomization)
  description: The degree of change in pain intensity after the real vs. sham stimulation will be evaluated between 4 specified time points. The Numerical Rating Scale (NRS) will be used to assess pain intensity. Pain scores will be assessed by completing the Brief Pain Inventory (BPI).
  measure: Immediate analgesic effect
  time frame: At each stimulation session, total 16 times (at 8 weekdays every other day from randomization up to week 2.5 + at 8 weekdays every other day from week 3.5 up to week 6)
  description: The trend of the intra-individual effect of the real vs. sham stimulation on immediate pain relief will be assessed. The Numerical Rating Scale (NRS) will be used to assess pain intensity.
  measure: Change in multidimensional aspects of pain
  time frame: 1. at baseline (day of randomization); 2. after 8th session (at the end of week 2.5 from randomization); 3. before 9th session (at the end of week 3.5 from randomization); 4. after 16th session (at the end of week 6 from randomization)
  description: The degree of change in multidimensional aspects of pain after the real vs. sham stimulation will be evaluated between 4 specified time points. Items related to multidimensional aspects of pain will be included in the BPI questionnaire (items 9 a-g).
  The degree to which pain affects the following aspects will be assessed (in tens of %).
  Activity in general
  Mood
  Ability to walk
  Normal work (including work outside the home and housework)
  Relationships with other people
  Sleep
  Enjoyment of life
  measure: Tolerability outcome
  time frame: At each stimulation session, total 16 times (at 8 weekdays every other day from randomization up to week 2.5 + at 8 weekdays every other day from week 3.5 up to week 6)
  description: The percentage of patients who complete the entire study will be determined. The application will be considered well tolerated by the patient if a minimum of 14 out of 16 sessions are completed. Overall, the application will be considered well tolerated if tolerated application is achieved in ≥ 90% of patients without the need for early discontinuation due to intolerance. Any technical complications/adverse effects during application will be recorded in the application protocol and will be analyzed by the study monitor at a minimum interval of once per month .
  arm group label: Arm "A"
  arm group type: Other
  description: First stimulation period: real stimulation, total 8 sessions, session frequency: weekdays every other day (i.e. duration 2.5 weeks)
  Washout period: no stimulation, duration: 1 week
  Second stimulation period: sham stimulation, total 8 sessions, session frequency: weekdays every other day (i.e. duration 2.5 weeks)
  arm group label: Arm "B"
  arm group type: Other
  description: First stimulation period: sham stimulation, total 8 sessions, weekdays every other day (i.e. 2.5 weeks)
  Washout period: no stimulation, 1 week
  Second stimulation period: real stimulation, total 8 sessions, weekdays every other day (i.e. 2.5 weeks)
  intervention type: Device
  intervention name: Rebox-Physio 4 (real stimulation)
  description: Rebox-Physio 4 is a CE-certified medical device class IIa. The device is a voltage-controlled generator of specific DC electric pulses with voltage amplitude 0-21 V, current intensity up to 200 uA, rectangular pulse shape, pulse frequency 3000 Hz and pulse duration 0.25 ms. Rebox currents are applied locally at the site of pain non-invasively transcutaneously with a touch of a flexible pin active treatment electrode (cathode) while the patient holds a cylindrical electrode (anode) to close electric circuit. Stimulation time in one point is 3-5 seconds until the current intensity reaches stable target values of 140-160 uA. During one session, total 20-50 points are systematically treated at a mutual distance of approx. 2 cm over the target region.
  arm group label: Arm "A"
  arm group label: Arm "B"
  intervention type: Device
  intervention name: Rebox-Physio 4 (sham stimulation)
  description: In the sham stimulation, the comparator will be a visually identical sham version of the real Rebox-Physio 4.The sham device has a resistor installed at the output generating current of negligible intensity (maximum 1 uA) assuming no relevant physiological effect. The application procedure will be identical to the real device. When applied to the patient, the sham device displays "false" voltage and current intensity values and responds to the operator´s actions in real time mimicking the real stimulation. The operator is therefore blinded.
  arm group label: Arm "A"
  arm group label: Arm "B"
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Igor Martuliak, MD, PhD
  role: Principal Investigator
  affiliation: F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
  last name: Matěj Slovák, MD, PhD
  phone: +420605909750
  email: matej.slovak@rebox.cz
  last name: Vratislav Fabián, PhD
  email: fabian@medicton.com
  citation: Low J, Reed A. Electrotherapy Explained, Principles and Practice, 3rd Edition. Butterworth-Heinemann. 2000; 121-122.
  citation: Johannsen F, Gam A, Hauschild B, Mathiesen B, Jensen L. Rebox: an adjunct in physical medicine? Arch Phys Med Rehabil. 1993 Apr;74(4):438-40.
  PMID: 8466428
  citation: Trudel D, Duley J, Zastrow I, Kerr EW, Davidson R, MacDermid JC. Rehabilitation for patients with lateral epicondylitis: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):243-66. doi: 10.1197/j.jht.2004.02.011.
  PMID: 15162109
  citation: Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.
  PMID: 6646795
  citation: Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
  PMID: 18487245
  responsible party type: Sponsor
  sharing ipd: No