Phase
Condition
N/ATreatment
Rebox-Physio 4 (sham stimulation)
Rebox-Physio 4 (real stimulation)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 inclusionranges from 2 weeks to 3 months
The average pain intensity in a given period of 2 weeks to 3 months prior to studyinclusion must be NRS (Numerical Rating Scale) >3
The patient may be concurrently treated with analgesics and may be undergoing manualphysiotherapy (rehabilitation)
Exclusion
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 exclusioncriterion
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 12months prior to the study inclusion date
A recent change in analgesic medication (i.e., new agent or change in agent doseless than 1 week prior to the first stimulation session) or a planned change inanalgesic medication during the course of the study (change in agent, change indose), Note: modification of analgesic medication during the study is possible butmust 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 Design
Connect with a study center
F.D. Roosevelt University Hospital
Banská Bystrica,
SlovakiaSite Not Available
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