Skip to main content
OpenTrials
Completed

NCT Number: NCT05968274

The Effect of Rebox Current in Pain Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Electric Stimulation Therapy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

F.D. Roosevelt University Hospital

Banská Bystrica, Slovakia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 %).

    • Activity in general
    • Mood
    • Ability to walk
    • Normal work (including work outside the home and housework)
    • Relationships with other people
    • Sleep
    • 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 .

Sponsors and collaborators

Lead sponsor

Rebox Therapy s.r.o.

Industry

Collaborators

  • F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia

Registry information

Acronym: REBOX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.