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.
The RAD-ON02 trial is the first trial conducted according to national drug law dealing with the pain relieving effects of radon spa therapy. The trial is designed to prove the often described pain relieving effect of radioactive radon bathes in patients with chronic musculoskeletal diseases. The trial population will be randomized (randomly distributed) to two groups, while one group receives placebo (warm water) and the other group verum (radon water). Neither the examining trial physician, nor the patient knows which bath was applied to the patient since the bathes are also “blinded” by a bath additive. The RAD-ON02 trial will help to ultimately prove the often described pain reducing capacity, in an actual and a by the whole medical science accepted manner. If the trial has a positive outcome, the last option for patients with musculoskeletal pain can further strongly recommended to the patients. The group of patients, which participate in the trial, has different musculoskeletal and chronic diseases with medium pain intensity and pain duration of more than one year. The trail is performed in a cross-over-design, so the effects of the radon bathes as well as the safety can be determined to the full extend. In addition the cross-over-designs allows us to spent each patient at least one bath with radon water, without falsifying the results.