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Electric Stimulation TherapyPhase 4REBOXNCT05968274

The Effect of Rebox Current in Pain Management

A Phase 4 study testing Rebox-Physio 4 (real stimulation) in people with Electric Stimulation Therapy, run by Rebox Therapy s.r.o. at 1 site in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Electric Stimulation Therapy
What is being tested?
Rebox-Physio 4 (real stimulation)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteSlovakia
Study dates
1 Oct 2023to 10 Nov 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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:
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Slovakia1 site

  • F.D. Roosevelt University Hospital

    Banská Bystrica

Other trials in Slovakia

About this study

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.

Being tested
Rebox-Physio 4 (real stimulation), Rebox-Physio 4 (sham stimulation)
Keywords
Rebox therapy, electrotherapy, pain treatment, Rebox currents
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rebox-Physio 4 (real stimulation)Device

    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.

  • Rebox-Physio 4 (sham stimulation)Device

    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.

Study groups in NCT05968274
Study groupRoleWhat they receive
Arm "A"Other1. 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)
Receives: Device: Rebox-Physio 4 (real stimulation); Device: Rebox-Physio 4 (sham stimulation)
Arm "B"Other1. 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)
Receives: Device: Rebox-Physio 4 (real stimulation); Device: Rebox-Physio 4 (sham stimulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity

    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).

    Measured: 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)

Secondary outcomes (3)

  1. Immediate analgesic effect

    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.

    Measured: 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)

  2. Change in multidimensional aspects of pain

    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

    Measured: 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)

  3. Tolerability outcome

    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 .

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start1 Oct 2023
  3. Primary completion10 Jul 2024
  4. Study completion10 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05968274
Sponsor's protocol ID
14/2023
Acronym
REBOX
Status last verified
Nov 2024
First submitted
15 Jul 2023
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Low J, Reed A. Electrotherapy Explained, Principles and Practice, 3rd Edition. Butterworth-Heinemann. 2000; 121-122.

  • 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.

    PubMed 8466428

  • 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.

    PubMed 15162109

  • 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.

    PubMed 6646795

  • 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.

    PubMed 18487245

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rebox-Physio 4 (real stimulation) in people with Electric Stimulation Therapy, run by Rebox Therapy s.r.o. at 1 site in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05968274, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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