Trial document
DRKS00017381
Trial Description
Title
Randomized, prospective, double-blind study to objectively demonstrate the performance and safety of the Rayocomp bioresonance device in patients with cervical spine disorder
Trial Acronym
R-HWS
URL of the Trial
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Brief Summary in Lay Language
The study will assess the pain relief and improvement in the quality of life of patients with cervical spine disorder who have been treated with the Rayocomp bioresonance device. The study participants fill in questionnaires on quality of life, performance and neck pain (NDI). The study also assesses demographic and medical history data. In addition, the safety of the treatment will be investigated by recording adverse events during the study. During the study phase, 10 sessions of therapy with the Rayocomp bioresonance device or with a non-functional device (placebo) take place within up to 21 days. The evaluation of the data collected in this study is intended to increase knowledge of bioresonance therapy and to improve the treatment of patients with cervical spine disorder.
Brief Summary in Scientific Language
This study is a randomized, prospective, double-blind study according to MPG §23b investigating treatment with the Rayocomp bioresonance device. The Rayocomp bioresonance device is a CE-certified medical device for alleviating the pain symptoms in patients with cervical spine disorder. The primary objective of the study is effectiveness as measured by the NDI; secondary objectives are safety, quality of life and VAS. A total of 52 patients shall be enrolled.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00017381
- 2019/05/22
- [---]*
- no
- Approved
- 11/2019, Ethikkommission bei der Ärztekammer Niedersachsen
Secondary IDs
- [---]*
Health Condition or Problem studied
- M54 - Dorsalgia
- M53 - Other dorsopathies, not elsewhere classified
Interventions/Observational Groups
- 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 - quality of life, performance, NID at BL and after last treatment, subjective assessment of therapeutic success after last treatment
- Treatment with non-functional Rayocomp Bioresonance Device (placebo), 10 treatments over 21 days with acquisition of AE, demography, med. history at BL, determination of VAS, pain medication, 3 questionnaires - quality of life, performance, NID at BL and after last treatment, subjective assessment of therapeutic success after last treatment
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist
- Placebo
- Treatment
- Parallel
- IV
- N/A
Primary Outcome
Neck pain, as measured by the Neck Disability Index (NDI), before and after treatment with the Rayocomp bioresonance device compared to placebo
Secondary Outcome
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 of Recruitment
- Germany
Locations of Recruitment
- Doctor's Practice
Recruitment
- Actual
- 2019/05/25
- 52
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional 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
Addresses
-
start of 1:1-Block address primary-sponsor
- Rayonex Biomedical GmbH
- Sauerland-Pyramiden 1
- 57368 Lennestadt
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +49 (0) 2721 6006-0
- +49 (0) 2721 6006-67
- info at rayonex.de
- http://www.rayonex.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Praxis Dr.med. Axel Schußmann
- Mr. Dr. med. Axel Schußmann
- Zur Ohe 2
- 21406 Melbeck
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 (0) 4134 900313
- +49 (0) 4134 900483
- k_schussmann at web.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Praxis Dr.med. Axel Schußmann
- Mr. Dr. med. Axel Schußmann
- Zur Ohe 2
- 21406 Melbeck
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 (0) 4134 900313
- +49 (0) 4134 900483
- k_schussmann at web.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Rayonex Biomedical GmbH
- Sauerland-Pyramiden 1
- 57368 Lennestadt
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 (0) 2721 6006-0
- +49 (0) 2721 6006-67
- info at rayonex.de
- http://www.rayonex.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2019/12/12