Rheumatoid Arthritis
Conditions
Brief summary
Prospective open label crossover self controlled study. The study population will randomly be divided into two groups. The study will take place in Lot Spa Hotel at the Dead Sea in two cycles (one of 16 participants and one of 14 participants) and will be comprised of 3 main stages: 1. Initial exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol) 2. 12-month washout period 3. Crossover of the two groups and second exposure to treatment for 14 days excluding Friday and Saturday (each of the two groups will have its own treatment protocol). The population in the study will be composed of patients diagnosed and treated for rheumatoid arthritis at the Soroka University Medical Center who are 18 and above of age. The patients will be selected by the PI and his team and addressed regarding their willingness to participate in the study.
Interventions
OTHERDead Sea Solar and Water Treatment
OTHERSulfur Pool & Medicinal Mud
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female ≥ 18 2. Patients with diagnosed rheumatoid arthritis 3. Patients with moderate disease activity (DAS28 \> 3.2)
Exclusion criteria
1. Patients who suffer from Photosensitivity 2. Patients with Suspected Lupus Erythematoides 3. Patients with tendency to sudden loss of consciousness and/or dizziness 4. Patients under chemotherapeutic treatment 5. Patients with Active Malignancy 6. Patients with lowest level of physical functioning (class 4) 7. Patients with serious uncontrolled concomitant chronic disease 8. Drug Abuser 9. Patients with severe peripheral venous insufficiency 10. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the change in DAS28 (Disease Activity Score) between the baseline and several occasions after each one of the proposed treatments. | up to 4 months | DAS28 will be evaluated before and immediately after the treatment, as well as one and 3 months after treatment has started |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the change between baseline and several occasions after each one of proposed the treatments | up to 4 months | Composite outcome measure : Assessing the change between baseline and several occasions after each one of proposed the treatments by the following parameters: * CRP * ESR * Vitamine D 25 (OH) * TNF-α * Cytokines (IL1, IL6, IL10, IL17, IL23) The various markers levels will be obtained from serum samples collected before and right after treatment, one month after treatment and 3 months after treatment has started using ELISA method |
Countries
Israel
Outcome results
None listed