Osteoarthritis, Knee Clinical Trial
Official title:
Clinical Evolution of Patients Suffering From Lower Limb Rheumatological Conditions 6 Months After Spa Treatment
1. Primary outcome measure: measuring the effect of spa treatment in patients suffering
from lower limb osteoarthritis or any other lower limb rheumatological condition.
Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS)
or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) improvement
of at least 9 points (minimal clinically important difference), 6 months after
enrollment.
Secondary outcome measures:
2. Measuring the effect of spa treatment in patients with concomitant chronic lower back
pain.
Percentage of patients presenting clinical benefits according to the EIFEL score, with a
decrease of at least 5 points, 6 months after enrollment.
3. Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6
months after spa treatment.
4. Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment
and 6 months after spa treatment.
5. Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment
and 6 months after spa treatment.
6. Impact of spa treatment on the patient's metabolism. Height and weight (BMI
calculation), blood pressure and heart rate measured at enrollment and throughout the
follow-up.
7. 8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D)
questionnaires at enrollment, 3 months and 6 months.
9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and
6 months.
10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the
medical visit at enrollment, 3 months and 6 months.
11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more
precise time frame of the treatment's effect.
Osteoarthritis and rheumatic conditions in general are a major public health issue, notably
causing chronic pain disorders.
Spa treatments currently play a central role in the non-medical therapeutic arsenal for
patients suffering from these rheumatic diseases.
A French study estimated the direct costs generated by osteoarthritis in France up to 1,6
billion euros in 2002, half of which was due to hospital expenses (800 million euros).
Osteoarthritis required 13 millions consults and drug expenses of 570 million euros. Compared
to 1993, these expenses increased by 156% due to the raise of the number of patients treated
(+54%) and of the cost for each patient (+2,5% per year). This study concerned patients with
lower limb osteoarthritis, and a significant portion of these expenses were attributable to
the disease.
Chronic lower back pain is also a major health issue for its impact on patients' functional
capacities as well as for the economic and social costs it generates. This is a frequent
condition, it is estimated that 80% of the population will present lower back pain at some
point in their life. Furthermore, epidemiological studies show an increase in the prevalence
of lower back pain (3,9% in 1992 to 10,2% in 2006 in the American population).
Different well-conducted studies around the impact of spa treatments have led to the
recognition of its beneficial outcome on the treatment of chronic lower back pain.
Several controlled, randomized, prospective trials have already evaluated the effect of spa
treatment for other main indications claimed by crenotherapy in rheumatology such as hip and
hand osteoarthritis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis and chronic
neck pain.
The THERMARTHROSE study by Forestier demonstrated the efficacy of spa treatments as a
rheumatological indication for knee osteoarthritis using the WOMAC questionnaire and VAS pain
scale. Following the model of this study, the investigators chose to use the WOMAC and VAS
pain scale as the primary endpoints of the investigator's study.
The WOMAC questionnaire was developed by Bellamy in 1988, it is a functional index centered
on the locomotor system.
The pain VAS is an auto-evaluation tool derived from visual analogue scales developed in
psychiatry to measure patients' well-being. Today, this statistically measurable and
reproductible tool is commonly used in clinical trials to monitor the evolution of pain and
more precisely to evaluate the impact of a treatment on a given chronic disease such as
osteoarthritis. For this study, pain will be measured using pain VAS according to Huskinsson
and following methodology as recommended by French health authorities, with one measure.
During clinical studies in thermal environment, spa treatment is a composite entity including
the effect of the water itself, but also physiotherapy, rest, education… The spa of
Contrexéville wishes to obtain a new rheumatic indication. According to the recommendations
of the Academy of Medicine, a prolonged observation of a cohort with repeated measures is
required for any spa wishing to acquire the accreditation for a new orientation.
Towards this aim, the investigators wish to undertake a prospective study with repeated
measures in order to analyze the evolution of the clinical state of patients with a rheumatic
disease on the lower limbs or the rachis, 6 months after receiving a spa treatment in the
Contrexéville thermal institute. Since rheumatological treatments at Contrexéville are not
covered by health insurance, they will not be billed to the patients.
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