Status:
COMPLETED
The Effect of Rebox Current in Pain Management
Lead Sponsor:
Rebox Therapy s.r.o.
Collaborating Sponsors:
F.D. Roosevelt University Hospital in Banská Bystrica, Slovakia
Conditions:
Electric Stimulation Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05968274
Start Date
October 1 2023
End Date
November 10 2024
Last Update
November 26 2024
Active Locations (1)
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1
F.D. Roosevelt University Hospital
Banská Bystrica, Slovakia