Third party funded individual grant
Acronym: RAD-ON02 Studie
Start date : 02.07.2018
End date : 31.12.2020
Extension date: 31.03.2021
Patients suffering from chronic musculoskeletal disorders are often
treated by a plethora of NSAIDs, DMARDs, Biologicals, or a combination
thereof. However, many patients are refractory to this treatment and
suffer from chronic pain over years, leading to a worsening of the
quality of life. Mobilization of these patients is one main therapeutic
goal. For drug refractory patients serial radon bath used in radon spa
therapy is a promising option, since pain-relieving effects of low-dose
of radiation in patients suffering from chronic painful degenerative
and/or inflammatory diseases have been described for centuries. Case
reports and prospective trials have demonstrated that radon spa therapy
significantly reduces pain in these patients, not only direct after
therapy, but also lasting for more than 12 month in many cases.
Additionally, the intake of pain-relieving drugs is significantly
reduced. In an explorative andbservational trial (RAD-ON01 study), the
study group of the RAD-ON02 study already revealed that radon spa
therapy in addition to significant reduction of pain impacts on the
peripheral immune system of the patients. While the major immune cells
were only marginally affected, in particular regulatory T cells and
dendritic cells were temporarily increased and activation markers on
immune cells were decreased. Further, a decrease of serum markers
related to bone erosion was observed.
Therefore, the RAD-ON01 study
showed for the first time systemic modulation of immune status after
radon spa therapy with approximately 0.3mSv cumulative effective dose of
radiation.
The consecutive RAD-ON02 trail now aims for the first
time to analyze in detail the immune status of patients suffering from
chronic musculoskeletal disorders before, during and after LD-RT in a
longitudinal manner and controlled by placebo spa application. With this
prospective, temporarily placebo-controlled and double-blinded trial
the evidence level of radon spa application and knowledge on
osteoimmunological modes of action of radon should be improved.
In dieser Studie soll primär der Einfluss von Radon auf Immunzellen,
entzündliche und anti-entzündliche Mediatoren des peripheren Blutes von
Patienten mit muskuloskelettalen Beschwerden untersucht werden. Diese
sogenannte Immunophänotypisierung wird bei den Patienten im Längsschnitt
vor und zu vier Zeitpunkten nach Abschluss der Therapie durchgeführt.
Dabei wird eine temporäre Placebo-Gruppe eingeführt, um den auf das
Radon zurückgehenden Effekt genau zu verstehen und um den
Wirkmechanismus der
Radonbalneologie maximal beleuchten zu können.
Zudem sollen auch die bisher nur sehr sporadisch beschriebenen
potentiellen strahlenbedingten Risiken durch eine radonbalneologische
Behandlung herausgearbeitet werden. In Zusammenarbeit mit
Kooperationspartnern an der Technischen Universität Darmstadt und der
Gesellschaft für Schwerionenforschung sollen mögliche Risiken durch die
Messung von Chromosomenabberation und durch biodosimetrische Messungen
genauer bestimmt werden.