- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05968274
The Effect of Rebox Current in Pain Management (REBOX)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Matěj Slovák, MD, PhD
- Phone Number: +420605909750
- Email: matej.slovak@rebox.cz
Study Contact Backup
- Name: Vratislav Fabián, PhD
- Email: fabian@medicton.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Arm "A"
|
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.
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.
|
Other: Arm "B"
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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. 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
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 .
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Igor Martuliak, MD, PhD, F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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