Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.
Psoriasis is one of the most common skin diseases, affecting 2-3% of the general population; more than 1 million people in France. This auto-immune erythematosquamous inflammatory dermatosis occurs on a particular genetic background and has a chronic course. Psoriasis has a history as an indication for dermatological spa treatment (water cures in the Dead Sea). As these treatments are a combination of balneotherapy and heliotherapy, many recent studies have attempted to assess the value and position the relative benefit of each therapeutic element. Over the last four decades various different phototherapy techniques have been widely used in the treatment of psoriasis. The thermal option for many psoriasis patients depends on personal choice, or their doctor's or dermatologist's recommendation. In 1994 only one third of the 16,875 spa treatments for dermatological conditions (about 5625 cures) were for psoriasis, suggesting that spa treatment is underused as a treatment for psoriasis. Nobody can challenge the therapeutic contribution of biotherapy in the treatment of anatomically destructive diseases such as rheumatoid arthritis and psoriatic arthritis, but the use of these treatments is not without risk and economic impact. There is thus a need for less intensive treatments that have little risk of serious side effects and are less expensive. The use of spa therapy in psoriasis should be understood as complementary and not an alternative to all other treatments. The choice of treatment is guided by the patient's characteristics and pathology (concomitant diseases, extent of lesions, treatment history) and the specialty (adverse effects, cumulative dose). In psoriasis it may be necessary to use different lines of treatment because psoriasis is a lifetime disease. Side effects of systemic treatments such as biotherapy, cyclosporine, methotrexate, synthetic retinoids, and also phototherapy (PUVA and UVB) are cumulative over time. A course of spa treatment should allow a respite before resorting to other systemic therapy. However, the spa dermatology still suffers from a lack of large-scale evaluation and especially an objective assessment using reliable methodologies that limit bias. This is the purpose of this study. There are no randomized controlled multicenter clinical trials evaluating spa treatment for psoriasis, although an Italian non-randomized study included a few dozen patients and confirmed the clinical benefit of the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
128
soon after randomization: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all participating of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)
soon after 4,5 months visit: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)
Station Thermale Avene
Avène, Languedoc-Rousillon, France
Thermes de Molitg les bains
Molitg-les-Bains, Languedoc-Roussillon, France
Thermes La Roche Posay
La Roche-Posay, Poitou-Charentes, France
Les thermes de ST-GERVAIS
Le Fayet, Rhône-Alpe, France
Dermatology Quality of Life Index (DQLI)
proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care.
Time frame: 4 ½ months after randomisation
Specific Quality Of Life
proportion of patients in each arm of the study (spa treatment versus usual care) for the following specific dermatology questionnaires : DLQI score ≤ 10 at 6, 9 and 12 months and VQ Dermato score \> 35 at 4 1/2, 6, 9 and 12 months
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Global Quality Of Life
EuroQOL 5D questionnaire at 4 1/2, 6, 9 and 12 months
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Clinical benefit of the psoriasis
proportion of patients with a PASI (Psoriasis Area and Severity Index) 50 and PASI 75 at 4½, 6, 9 and 12 months in each arm of the study, spa treatment versus usual care.
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
pain and pruritus
Self-administered questionnaire with Visual Analogue Scale for pain and for pruritus at 4 1/2, 6, 9, 12 months
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Treatment follow up
* Assessment of topical treatments within 12 months (number of tubes used per month) * Number of phototherapy sessions * Use of conventional systemic therapies (acitretin, methotrexate, cyclosporine) (number of weeks of treatment and dosage) * Number of weeks of treatment by biotherapy * Reduction in the use of the health care system (Number of hospitalizations and specialized consultations in connection with psoriasis or not) within 12 months * Reports on the use of complementary and alternative medicines within12 months
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Etablissement thermal d'Uriage
Uriage-les-Bains, Rhône-Alpe, France
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
patient's examination
Impact of the spa treatment on overall metabolism indicators in the year Will be collected at 4 1/2, 6, 9 and 12 months in the two groups: * height an weight (BMI calculation) * Waist measurement * Blood pressure
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Safety evaluation
Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Stress evaluation
self administered questionnaire (PSS: Assessment of stress) at inclusion in the study only
Time frame: 4 1/2, 6, 9 and 12 months after randomisatio
Long term evaluation
Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.
Time frame: 12 months