Clinical Trials Logo

Clinical Trial Summary

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) increase 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03538470
Study type Interventional
Source SAEML Contrexéville
Contact Carole ROLLAND
Phone 04 76 76 50 40
Email carole.rolland@univ-grenoble-alpes.fr
Status Not yet recruiting
Phase N/A
Start date June 2018
Completion date August 2019

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03225911 - Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis N/A
Recruiting NCT03161093 - A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip Phase 3
Not yet recruiting NCT03457051 - Unicompartmental Knee Arthroplasty (UKA) Versus Total Knee Arthroplasty (TKA) of Medial Osteoarthritis N/A
Not yet recruiting NCT03441607 - Safety & Efficacy FloGraft (Micronized Human Amnion Chorion Membrane)® in Adults With Pain Due to OA of the Knee Phase 2
Recruiting NCT02615522 - Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration N/A
Recruiting NCT02909257 - Motor-Sparing Femoral Nerve Block Dose Phase 4
Recruiting NCT02881775 - Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis N/A
Recruiting NCT02905747 - The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis N/A
Recruiting NCT02901964 - Effect of Strengthening the Hip Abductor in Patients With Knee Osteoarthritis: Randomized Controlled Trial N/A
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Not yet recruiting NCT02854176 - Somatosensory Stimulation in Knee Osteoarthritis Phase 2
Not yet recruiting NCT02826850 - Saphenous Nerve Radiofrequency for Knee Osteoarthritis Trial Phase 3
Not yet recruiting NCT02865174 - Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty Phase 4
Completed NCT03037489 - A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients Phase 2
Recruiting NCT02481427 - Finnish Unicompartmental and Total Knee Arthroplasty Investigation N/A
Recruiting NCT02680392 - Functional Outcome and Analgesia in TKA: Radiofrequency vs Continuous Adductor Canal Block N/A
Active, not recruiting NCT02440672 - JOURNEY™ II CR Total Knee System N/A
Active, not recruiting NCT02229279 - Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures N/A
Active, not recruiting NCT02405104 - Chlorzoxazone in Hip and Knee Arthroplasty Phase 4
Enrolling by invitation NCT02848027 - Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment Phase 3