Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial.

BACKGROUND: Lack of physical activity (PA) and sedentary behaviors are leading risk factors for noncommunicable diseases (NCDs). Web- and smartphone-based interventions are effective in increasing PA in older adults and in patients with NCD. In many countries, spa therapy, commonly prescribed to patients with NCD, represents an ideal context to initiating lifestyle changes. OBJECTIVE: This study aimed to evaluate, in patients attending spa therapy, the effectiveness of an intervention combining a face-to-face coaching and, when returning home, a web- and smartphone-based PA program on the achievement of PA guidelines (PAG) 12 months after the end of spa therapy. METHODS: This was a 12-month, prospective, parallel-group randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received PA usual advice. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants were assessed by phone every 2 months. Primary outcome was meeting PAG (PA ≥600 metabolic equivalent of task) at 12 months. Secondary outcomes were meeting current PAG at 6 months; sedentary time, weight, waist circumference, PA, and quality of life at 6 and 12 months. Objective use data of the web- and smartphone-based PA program were collected. Analytic methods included intention to treat and constrained longitudinal data analyses. RESULTS: The study sample included 228 participants (n=176, 77.2% females) with a mean age of 62.4 (SD 6.7) years and a mean BMI of 28.2 (SD 4.2) kg/m2. Approximately 53.9% (123/228) of the participants were retired. No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group than in the control group (81% vs 67% respectively, odds ratio 2.34, 95% CI 1.02-5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight, and waist circumference at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in the intervention group than in the control group (mean difference: 4.1, 95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 (SD 4.5) months. Attrition rate during the first 2 months was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS: PA increased in both the intervention group and the control group. However, at 12 months, more participants met PAG in the intervention group compared with the controls. This indicates that the web- and smartphone-based program could have maintained PA in the intervention group. In addition, a spa therapy seems to be an ideal time and framework to implement PA education. TRIAL REGISTRATION: ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial.

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: 'immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

The role of mineral elements and other chemical compounds used in balneology: data from double-blind randomized clinical trials.

The aims of this study were to conduct a systematic literature review on balneotherapy about the specific therapeutic role of mineral elements and other chemical compounds of mineral waters and derivate peloids/muds and to discuss the study methods used to evaluate it (in musculoskeletal conditions). We searched Medline by PubMed using the following key words: "spa therapy" "balneotherapy" "mud" "peloid" "mud pack Therapy" in combination with "randomized controlled trial" "double blind trial." We also reviewed the reference list of articles retrieved by the Medline search. We selected the double-blind randomized clinical trials that assessed the effects of mineral water or mud treatments compared to tap water, attenuated peloid/mud therapy or similar treatments without the specific minerals or chemical compounds of the treatment group ("non-mineral"). We evaluated the internal validity and the quality of the statistical analysis of these trials. The final selection comprised 27 double-blind randomized clinical trials, 20 related to rheumatology. A total of 1118 patients with rheumatological and other musculoskeletal diseases were evaluated in these studies: 552 of knee osteoarthritis, 47 of hand osteoarthritis, 147 chronic low back pain, 308 of reumathoid arthritis, and 64 of osteoporosis; 293 of these participants were assigned to the experimental groups of knee osteoarthritis, 24 in hand osteoarthritis, 82 of low back pain, 152 with reumathoid arthritis, and 32 with osteoporosis. They were treated with mineral water baths and/or mud/peloid (with or without other forms of treatment, like physical therapy, exercise…). The rest were allocated to the control groups; they received mainly tap water and/or "non-mineral" mud/peloid treatments. Mineral water or mud treatments had better and longer improvements in pain, function, quality of life, clinical parameters, and others in some rheumatologic diseases (knee and hand osteoarthritis, chronic low back pain, rheumatoid arthritis, and osteoporosis) compared to baseline and non-mineral similar treatments. Internal validity and other limitations of the study's methodology impede causal relation of spa therapy on these improvements. Randomized clinical trials are very heterogeneous. Double-blind randomized clinical trials seem to be the key for studying the role of mineral elements and other chemical compounds, observing enough consistency to demonstrate better and longer improvements for mineral waters or derivate compared to tap water; but due to heterogeneity and gaps on study protocol and methodology, existing research is not sufficiently strong to draw firm conclusions. Well-designed studies in larger patients' population are needed to establish the role of minerals and other chemical compounds in spa therapy.

[SPA therapy for pain of patients with chronic low back pain, knee osteo-arthritis and fibromyalgia]. / Médecines thermals et douleurs des lombalgies chroniques, gonarthrose ou fibromyalgia.

The data of 33 randomized controlled trials suggest that chronic pain of patients with chronic low back pain, knee osteo-arthritis, fibromyalgia is significantly improved by balneotherapy and significantly better improved than by control treatments. For chronic low back pain (10 RCT, 1192 patients) pain was better improved in balneotherapy group and the weighted mean of the differential improvement was 19.66 (95 % CI: 16.6 ; 22.8) and the effect size was 1.1 (95 %CI: 0.82 ; 1.38) favouring balneotherapy. For knee osteo-arthritis pain (17 RCT, 1428 patients) pain was better improved in balneotherapy group and the weighted mean of the differential improvement was 13.24 (95 % CI: 5.52 ; 20.96) and the effect size was 0.72 (95 %CI: 0.51 ; 0.93) favouring balneotherapy. For fibromyalgia (6 RCT, 398 patients) pain was better improved in balneotherapy group and the weighted mean of the differential improvement was 19.32 (95 % CI: 10.62 ; 29.2) and the effect size was 0.79 (95 %CI: 0.27 ; 1.31) favouring balneotherapy. Mineral waters and healing muds appear to have a more powerful analgesic action: 13 RCT (701) patients) compared mineral water bathing to tap water bathing or peloid application to hot-apcks or neutral muds application : the effect size was 0.75 (95 % CI :0.71 ; 0.79) favouring balneotherapy. Balneotherapy is a safe treatment as only 1 % of the patients receiving balneotherapy had to interrupt the treatment. However several methodological biases were observed in many trials, mainly a lack of statistical power due to a limited enrolment of patients, an insufficient duration of follow-up, an inhomogeneity of treatments. The clinical benefit has to be confirmed by stronger data of evidence but these data are sufficient to perform a more complete scientific analysis (meta-analysis) ; but further clinical investigations with a better methodological quality remain necessary.

[Spa therapies, therapeutic education and osteoarthritis]. / Cures thermales, éducation thérapeutique et arthrose.

For people with osteoarthritis, spa therapies can provide care, education and prevention resources. The therapeutic education programme Educ'arthrose, currently being examined by a French Regional Health Agency, mobilises nurses.

Therapeutic Patient Education for Fibromyalgia during Spa Therapy: The FiETT Randomized Controlled Trial.

Spa therapy is known to improve quality of life and diminish pain. We assessed the efficacy (Fibromyalgia Impact Questionnaire-FIQ) and safety at 6 months of a fibromyalgia-specific therapeutic patient education (TPE) program added to fibromyalgia-specific standardized spa therapy (SST), compared to SST alone, in a controlled randomized trial. We enrolled 157 patients, mostly women, attending spa centers in Southwest France in 2015-2016, and randomized them to SST + TPE (79) or SST (78). The intention-to-treat with "missing as failure" analysis showed a tendency toward a higher, though non-significant, benefit with TPE than without for FIQ (-9 vs. -3; p = 0.053) or pain intensity (-0.9 vs. -1.1; p = 0.58). In addition, pain relief (+3.2 vs. +4.3; p = 0.03) and fatigue (-1.6 vs. -3.7; p = 0.02) were significantly improved, and 87% patients in the SST + TPE arm still regularly practiced the physical exercises taught to them at 6 months. We suspect significant and lasting improvement from spa therapy, as well as our already well-informed and well-managed participants, to have prevented the demonstration of a significant benefit of TPE on FIQ.

Spa Therapy for the Treatment of Fibromyalgia: An Open, Randomized Multicenter Trial.

Fibromyalgia is a common chronic pain pathology with an incidence of 4.3 per 1,000 person-years. An open, randomized clinical trial of patients with fibromyalgia comparing an immediate vs. delayed 18-day spa therapy in five spa therapy care facilities in France enrolled 220 patients. Randomization was in blocks of four, stratified by center, severity of fibromyalgia and previous spa therapy. Patients continued usual treatment. The main endpoint was the number of patients achieving minimal clinically important difference at 6 months, defined as 14% change in their baseline fibromyalgia impact questionnaire score. The intention-to-treat analysis included 100 and 106 patients in the intervention and control groups, respectively. At 6 months, 45/100 (45.0%) and 30/106 (28.3%) patients in the intervention and control groups, respectively, achieved a minimal clinically important difference (P= .013). There was also a significant improvement in pain, fatigue, and symptom severity (secondary outcomes) in the intervention group but not for generic quality of life (QOL), sleep or physical activity. None of the 33 serious adverse events reported by 25 patients were related to the spa therapy. Our results demonstrate the benefit of spa treatment in patients with fibromyalgia. PERSPECTIVE: A 12-month, open, randomized clinical trial of 220 patients with fibromyalgia compared an immediate versus delayed (ie, after 6 months) 18-day spa therapy. The results showed a clinically significant improvement at 6 months for those who received immediate therapy which was maintained up to 12 months. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT02265029.

[Crenobalneotherapy: a medical and scientific update]. / Médecine thermale: actualités médicales et scientifiques.

The PubMed database contains about eighty scientific papers on crenobalneotherapy (i.e., medical balneology or spa therapy) published in the last three years, mostly in journals with an impact factor. These studies focus on the actions of thermomineral products (waters, muds, gases, steam) on biological systems (immune system, antioxidant system, cytokine networks, nociception, etc.). Hot mineral waters can have an action on the circulatory system. Ingested mineral water can act on carbohydrate, lipid and mineral metabolism. Dermocosmetologic mineral products have shown real benefits. Medical benefits of thermal treatment have been observed in patients with rheumatic conditions, psoriasis, venous insufficiency, ENT conditions, gynecolgical disorders, and anxiety. Unfortunately, many publications in this area suffer from methodological flaws. Clinical investigations of thermal medicine encounter dificulties of a methodological and financial nature, and problems of patient recruitment. The aim of the French thermal research institute is to provide support and advice for teams wishing to conduct well-designed controlled trials.

Long term effect of spa therapy combined with patient education program on subjects with overweight and obesity - A controlled study.

The aim of this single center prospective controlled study in volunteers with obesity and overweight was to evaluate the effect of a patient therapeutic education program (PTE group) combined with spa therapy on weight, physical activity, eating habits and quality of life versus spa therapy alone (control group). The main endpoint was weight change at 5 months after the end of the program. The PTE group of 151 subjects with obesity or overweight followed a 3-week program combining patient education with spa therapy and 189 attended a course of spa therapy alone. At 5 months significant loss was observed in the PTE group compared to controls (-2.69kg vs -1.24kg, p=0.008), a relative weight loss of -2.8% vs -1.3%. At 11 months after spa therapy, only the PTE group maintained a weight loss in addition to the weight loss obtained during spa therapy. The control group returned to the weight they had at the end of spa therapy. In both groups, a significant increase in physical activity was observed at 5 (p<0.001) and 11 months (p<0.001) with a significant better improvement in the PTE group. In addition, while in both groups some quality of life parameters and dietary choices were improved, the improvement (more fruit, vegetables, fish and water) was significantly higher in the PTE group, at both 5 and 11 months after spa therapy. In conclusion, while spa therapy alone initiated positive changes in weight loss, physical activity and some quality of life parameters, the PTE program enhanced this effect.