M54 M53
Conditions
Interventions
Group 1: Treatment with the Rayocomp Bioresonance Device, 10 treatments over 21 days with acquisition of AE, demography, med. history at BL, determination of VAS, pain medication, 3 questionnaires - q
Sponsors
Rayonex Biomedical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Gender: male and female 2) Age: at least 18 years 3) At least moderate pain (= 5 on the VAS) in the cervical spine area 4) Neck disabilty index with at least medium restriction (score = 15) 5) Patients must be able to understand the patient information 6) Patients must be willing and able to meet the requirements of the study 7) Signed ICF
Exclusion criteria
Exclusion criteria: 1) Systemic or inflammatory musculoskeletal disease (e.g., muscular dystrophies, polymyositis) 2) Trauma with fractures and surgical treatment 3) Severe systemic disease with a life expectancy <6 months (e.g., advanced heart failure, malignancies) 4) Massive degenerative disease with marked restriction of motility (e.g., polyarthritis) 5) Pregnant or breastfeeding female patients without effective contraception 6) Patients who, due to mental illness, are unable to understand the study information, give their consent, or adhere to the study's guidelines 7) Patients who, in the opinion of the investigator, are not suitable for the study 8) Alcohol or drug abuse 9) patients incapable of giving consent 10) Persons who are in a dependency or employment relationship with the sponsor or investigator 11) Detained persons 12) Participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neck pain, as measured by the Neck Disability Index (NDI), before and after treatment with the Rayocomp bioresonance device compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, as measured by the incidence of adverse events Quality of life measured on the SF-36 before and after treatment with the Rayocomp bioresonance device compared to the placebo VAS before and after treatment with the Rayocomp bioresonance device compared to placebo | — |
Countries
Germany
Contacts
Public ContactAxel Schußmann
Praxis Dr.med. Axel Schußmann
Outcome results
None listed