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The Effect of Rebox Current in Pain Management (REBOX)

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ClinicalTrials.gov Identifier: NCT05968274
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : November 24, 2023
Sponsor:
Collaborator:
F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
Information provided by (Responsible Party):
Rebox Therapy s.r.o.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Electric Stimulation Therapy Device: Rebox-Physio 4 (real stimulation) Device: Rebox-Physio 4 (sham stimulation) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Rebox Current in Pain Management
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : March 10, 2024
Estimated Study Completion Date : May 10, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Arm "A"
  1. First stimulation period: real stimulation, total 8 sessions, session frequency: weekdays every other day (i.e. duration 2.5 weeks)
  2. Washout period: no stimulation, duration: 1 week
  3. Second stimulation period: sham stimulation, total 8 sessions, session frequency: weekdays every other day (i.e. duration 2.5 weeks)
 Device: Rebox-Physio 4 (real stimulation)
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.

Device: Rebox-Physio 4 (sham stimulation)
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 "B"
  1. First stimulation period: sham stimulation, total 8 sessions, weekdays every other day (i.e. 2.5 weeks)
  2. Washout period: no stimulation, 1 week
  3. Second stimulation period: real stimulation, total 8 sessions, weekdays every other day (i.e. 2.5 weeks)
 Device: Rebox-Physio 4 (real stimulation)
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.

Device: Rebox-Physio 4 (sham stimulation)
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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).


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]

    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 %).

    1. Activity in general
    2. Mood
    3. Ability to walk
    4. Normal work (including work outside the home and housework)
    5. Relationships with other people
    6. Sleep
    7. Enjoyment of life

  3. 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) ]
    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 .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with pain based on the following diagnoses:

    • Myofascial musculoskeletal pain
    • Vertebrogenic algic syndrome in the cervical, thoracic and lumbosacral regions
    • Sacroileitis with sacroiliac joint block
    • Cervicocranialgia
    • Frozen shoulder syndrome
    • Arthrosis
    • Epicondylitis
    • Pain in tendons, ligaments and other enthesopathies
    • Postoperative pain
    • Post-traumatic pain
    • Postherpetic neuralgia
  • Duration of pain (de novo or exacerbation of chronic pain) prior to study inclusion ranges from 2 weeks to 3 months
  • The average pain intensity in a given period of 2 weeks to 3 months prior to study inclusion must be NRS (Numerical Rating Scale) >3
  • The patient may be concurrently treated with analgesics and may be undergoing manual physiotherapy (rehabilitation)

Exclusion Criteria:

  • Age <18 years

  • Local contraindications:

    • Impaired skin integrity at the site of application (open wound, skin ulcer, burns), Note: the area around the postoperative scar is not an exclusion criterion
    • Acute inflammation of the skin or subcutaneous tissue at the application site
    • Deep vein thrombosis (diagnosed or suspected)

  • General contraindications:

    • Implanted electrical device (pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, cochlear implant, etc.)
    • Pregnancy
    • Epilepsy
    • Malignant cancer (diagnosed or suspected)
    • Acute potentially life-threatening conditions
  • Concomitant other physical therapy (electrotherapy, magnetotherapy, laser therapy, ultrasound therapy, mechanotherapy, etc.)
  • The Rebox device was administered to the subject for any indication in the last 12 months prior to the study inclusion date
  • A recent change in analgesic medication (i.e., new agent or change in agent dose less than 1 week prior to the first stimulation session) or a planned change in analgesic medication during the course of the study (change in agent, change in dose), Note: modification of analgesic medication during the study is possible but must be recorded
  • Ongoing acute infection, surgery or trauma during the study
  • Concurrent subject participation in another clinical study
  • Subject is unable to sign informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05968274


Contacts
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Contact: Matěj Slovák, MD, PhD +420605909750 matej.slovak@rebox.cz
Contact: Vratislav Fabián, PhD fabian@medicton.com

Locations
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Slovakia
F.D. Roosevelt University Hospital Recruiting
Banská Bystrica, Slovakia
Contact: Igor Martuliak, MD, PhD         
Principal Investigator: Igor Martuliak, MD, PhD         
Sponsors and Collaborators
Rebox Therapy s.r.o.
F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
Investigators
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Principal Investigator: Igor Martuliak, MD, PhD F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
More Information
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Publications:
Low J, Reed A. Electrotherapy Explained, Principles and Practice, 3rd Edition. Butterworth-Heinemann. 2000; 121-122.

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Responsible Party: Rebox Therapy s.r.o.
ClinicalTrials.gov Identifier: NCT05968274    
Other Study ID Numbers: 14/2023
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: November 24, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebox Therapy s.r.o.:
Rebox therapy
electrotherapy
pain treatment
Rebox currents