Chronic degenerative spine and/or joint disorders with pain perception of at least 1 year and pain intensity on visual analogue scale =4
Conditions
Interventions
Product Name: Radon
Product Code: none
Pharmaceutical Form: Bath additive
INN or Proposed INN: none
CAS Number: 14859-67-7
Current Sponsor code: RAD-ON02
Concentration unit: Bq/l becquerel(s)/litre
Co
Sponsors
Kurort Forschungsverein Bad Steben e.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) age between 40 and 75 years b) chronic degenerative spine and ankle pain c) pain Duration more than one year d) pain Intensity more than 4 on VAS (visual analog scale) e) highly effective contraception (PEARL Index =65 years) yes F.1.3.1 Number of subjects for this age range 116
Exclusion criteria
Exclusion criteria: a) Pregnant or nursing woman b) fertile patients who refuse effective contraception during study treatment c) heart failure > NYHA II or EF 180/90 mmHg e) cardiac arrhythmia LOWN-Kategorie > Iva f) patients with distinct constraints in cardiac capacity g) apparent and non-drug-adjustable hyperthyroidism h) acute and underlying wasting diseases i) patients with skin diseases, which are not allowed to have spa regimen j) last radon spa regimen less than 9 month before inclusion k) radiation therapy upon cancer treatment l) persistent drug and/or alcohol abuse m) patients not able or willing to behave according to study protocol n) patients how refuse the collection and the recording their personal and disease related date in an pseudonymized form o) concurrent participation at another trial or the time to the previously attended trial is shorter than the five-fold half-life of the IMP, minimum 60 days p) intolerance against the “Wellnessbad Latschenkiefer” or against a ingredient of the bath additive q) patients with extensive concomitant diseases r) patients where the investigator has significant objections against the participation, because patients’ welfare is in danger
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: * Change of circulating immune cells of treated patients by deep immunophenotyping. Deep immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers. The analyses are conducted at time points before and after spa therapy: before therapy (day 0), end of first round of spa therapy (day 21), month 3 (day 111) and month 6 (day 201) after spa therapy. The intervention scheme is repeated at day 241 to enable a cross-over design. Theses analyses are also conducted after the second intervention (identical scheme as the first intervention, however, the randomized groups are changed) (day 262), month 3 (day 352) and month 6 (day 442) after second spa therapy. * Detection of the inflammatory and anti-inflammatory cytokines alterations in the sera of the patients. * Detection of inflammatory mediators in blood cells by analysis of transcriptional copy number (RNA);Secondary Objective: * Erfassung von Schmerzparametern mittels Druckschmerzanalgometrie und ein vom Patienten eigenverantwortlich geführtes Analogskala-Schmerztagebuch. * Erfassung von Herz-Kreislaufparametern mit Langzeit-EKG und Pulswellen-Messungen. * Erfassung des oxid. Stress durch Bestimmung von Superoxid-Dismutase und des „Antioxidative Defense-Systems“. * Bestimmung der Strahlenwirkung durch biodosimetrische Methoden in Blut-Lymphozyten. * Bestimmung von Chromosomenabberationen in Blutlymphozyten. * Funktionelle Analysen an Blutlymphozyten. * Bestimmung des Fettstoffwechsels anhand zirkulierender Botenstoffe. * Erfassung von Schmerzparametern mittels VAS und Schmerzanamnese (Dauer, Häufigkeit, Maximum, Qualität und Auftreten der Schmerzen). Bestimmung von messbaren Schmerzindikatoren (Rotation, Kinn-Sternum Abstand, Schober Maß, Ott Maß Finger-Boden-Abstand) und des Gesundheitszustandes des Patienten mittels Funktionsfragebogen Hannover (FFbH-R) und Gesundheitsfragebogen (EQ5DL) ;Primary end point(s): End of the trial with f | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
Germany
Contacts
Public ContactTrial Information
Kurort Forschungsverein Bad Steben e.V.
Outcome results
None listed