Trial document



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  DRKS00017381

Trial Description

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Title

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

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Trial Acronym

R-HWS

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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.

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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.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017381
  •   2019/05/22
  •   [---]*
  •   no
  •   Approved
  •   11/2019, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M54 -  Dorsalgia
  •   M53 -  Other dorsopathies, not elsewhere classified
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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
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

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

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/05/25
  •   52
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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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

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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

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Addresses

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    • Rayonex Biomedical GmbH
    • Sauerland-Pyramiden 1
    • 57368  Lennestadt
    • Germany
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    • Praxis Dr.med. Axel Schußmann
    • Mr.  Dr. med.  Axel  Schußmann 
    • Zur Ohe 2
    • 21406  Melbeck
    • Germany
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    • Praxis Dr.med. Axel Schußmann
    • Mr.  Dr. med.  Axel  Schußmann 
    • Zur Ohe 2
    • 21406  Melbeck
    • Germany
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Sources of Monetary or Material Support

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    • Rayonex Biomedical GmbH
    • Sauerland-Pyramiden 1
    • 57368  Lennestadt
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/12/12
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Trial Publications, Results and other Documents

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