The Effect of Rebox Current in Pain Management

NCT05968274 | Completed Phase 4

• 1 other identifier: 14/2023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Electric Stimulation Therapy

Keywords

Rebox therapy; electrotherapy; pain treatment; Rebox currents

Outcome Measures

Primary Outcomes (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).

  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)

• Immediate analgesic effect

  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)

• Change in multidimensional aspects of pain

  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)

• Tolerability outcome

  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)

Study Arms (2)

Arm "A"

OTHER

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

Arm "B"

OTHER

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

Interventions

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.

Arm "A"; Arm "B"

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.

Arm "A"; Arm "B"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The patient may be concurrently treated with analgesics and may be undergoing manual physiotherapy (rehabilitation)

You may not qualify if:

• Age \<18 years
• Local contraindications:
• 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.)
• 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

Sponsors & Collaborators

• Rebox Therapy s.r.o.: lead
• F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia: collaborator

Study Sites (1)

F.D. Roosevelt University Hospital

Banská Bystrica, Slovakia

Location

Related Publications (5)

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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor Martuliak, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: August 1, 2023
• Study Start: October 1, 2023
• Primary Completion: July 10, 2024
• Study Completion: November 10, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)