Randomized, prospective, double-blind study to objectively demonstrate the performance and safety of the Rayocomp bioresonance device in patients with cervical spine disorder

Phase 4

• Conditions: M54; M53; Other dorsopathies, not elsewhere classified; Dorsalgia

• Registration Number: DRKS00017381
• Lead Sponsor: Rayonex Biomedical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-22
• Study Completion: 2019-12-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 54

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eck pain, as measured by the Neck Disability Index (NDI), before and after treatment with the Rayocomp bioresonance device compared to placebo

Secondary Outcome Measures

Name	Time	Method
Safety, as measured by the incidence of adverse events<br><br>Quality of life measured on the SF-36 before and after treatment with the Rayocomp bioresonance device compared to the placebo<br><br>VAS before and after treatment with the Rayocomp bioresonance device compared to placebo