The Effect of Rebox Current in Pain Management (REBOX)

Rebox Therapy

Status and phase: Completed; Phase 4

Conditions: Electric Stimulation Therapy

Treatments: Device: Rebox-Physio 4 (real stimulation); Device: Rebox-Physio 4 (sham stimulation)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05968274

14/2023

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

Arm "A"

Other group

Description:

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)

Treatment:

Device: Rebox-Physio 4 (sham stimulation)

Device: Rebox-Physio 4 (real stimulation)

Arm "B"

Other group

Description:

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)

Treatment:

Device: Rebox-Physio 4 (sham stimulation)

Device: Rebox-Physio 4 (real stimulation)