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Assessment of the Effect of Spa Treatment on Rheumatological Conditions (CONTREXEVILLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03538470
Recruitment Status : Active, not recruiting
First Posted : May 29, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
TIMC-IMAG
Information provided by (Responsible Party):
SAEML Contrexéville

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE May 29, 2018
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
Effect of spa treatment on lower limb osteoarthritis [ Time Frame: At 6 months ]
Percentage of patients with a WOMAC score improvement of 9 or more points and/or with a decrease in VAS of at least 19,9 mm (minimal clinically important difference)
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Effect of spa treatment on lower limb osteoarthritis [ Time Frame: At 6 months ]
Percentage of patients with a WOMAC score increase of 9 or more points and/or with a decrease in VAS of at least 19,9 mm (minimal clinically important difference)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2018)
  • Effect of spa treatment on lower back pain [ Time Frame: At 6 months ]
    Percentage of patients with an EIFEL score decrease of at least 5 points
  • Quantitative evaluation of pain [ Time Frame: At baseline and 6 months ]
    Comparison of mean VAS (Visual Analogic Scale from 0 to 10) pain scale
  • Quantitative evaluation of WOMAC [ Time Frame: At baseline and 6 months ]
    Comparison of mean WOMAC questionnaire
  • Quantitative evaluation of EIFEL [ Time Frame: At baseline and 6 months ]
    Comparison of mean EIFEL questionnaire
  • Patient BMI [ Time Frame: At baseline, 3 and 6 months ]
    BMI evolution will be recorded (size, weight)
  • Global quality of life [ Time Frame: At baseline, 3 and 6 months ]
    SF36 (The Short Form (36) Health Survey) questionnaire will be recorded. The SF36 questionnaire includes 36 questions from which eight dimensions and two aggregate scores (the physical dimension and the psychic dimension) are calculated. The correction of the missing data and the different methods of adjustment and calculation of the scores will be carried out according to the procedure recommended by the manual. The scores of the different dimensions range from 0: less good health and 100: the best.
  • Health quality of life [ Time Frame: At baseline, 3 and 6 months ]
    EQ5D questionnaire will be recorded. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D has 6 items intended to measure general health. The top 5 rate mobility, independence, daily activities, pain / discomfort, and anxiety / depression, and are rated according to 3 values from "No problem" to "Problem" or "Incapacity". This results in an index score. The last item deals with perceived health on the day the questionnaire is filled in and uses a visual analogue scale from 0 (worst) to 100 (best health possible) (Visual Analog Scale Score).
  • Doctor / patient opinions [ Time Frame: At baseline, 3 and 6 months ]
    Semi-quantitative scale in 7 points collected will be recorded. This is a semi-quantitative evaluation of the effect of the cure on the state of health of the patient by the patient himself and the same questions by the doctor. Responses will be grouped into 3 classes: aggravated / neither aggravated nor improved / improved. The numbers and percentages of each answer will be calculated
  • Treatment follow-up [ Time Frame: At baseline, 3 and 6 months ]
    Description of treatments consumption by the patient at baseline, 3 and 6 months. To avoid any risk of confusion, drug consumption will be related to daily consumption. Drug use for 72 hours (day before and before the day of visit, day of visit: d-2, d-1, D0)
  • Self evaluation of pain [ Time Frame: With investigator at baseline, 3 and 6 months. Auto evaluation at 1.5 months and 4.5 months. ]
    Visual Analogic Scale (from 0 to 10) evaluation by patients
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Effect of spa treatment on lower back pain [ Time Frame: At 6 months ]
    Percentage of patients with an EIFEL score decrease of at least 5 points
  • Quantitative evaluation of pain [ Time Frame: At baseline and 6 months ]
    Comparison of mean VAS (Visual Analogic Scale from 0 to 10) pain scale
  • Quantitative evaluation of WOMAC [ Time Frame: At baseline and 6 months ]
    Comparison of mean WOMAC questionnaire
  • Quantitative evaluation of EIFEL [ Time Frame: At baseline and 6 months ]
    Comparison of mean EIFEL questionnaire
  • Patient BMI [ Time Frame: At baseline, 3 and 6 months ]
    BMI evolution will be recorded (size, weight)
  • Global quality of life [ Time Frame: At baseline, 3 and 6 months ]
    SF36 (The Short Form (36) Health Survey) questionnaire will be recorded. The SF36 questionnaire includes 36 questions from which eight dimensions and two aggregate scores (the physical dimension and the psychic dimension) are calculated. The correction of the missing data and the different methods of adjustment and calculation of the scores will be carried out according to the procedure recommended by the manual. The scores of the different dimensions range from 0: less good health and 100: the best.
  • Health quality of life [ Time Frame: At baseline, 3 and 6 months ]
    EQ5D questionnaire will be recorded. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D has 6 items intended to measure general health. The top 5 rate mobility, independence, daily activities, pain / discomfort, and anxiety / depression, and are rated according to 3 values from "No problem" to "Problem" or "Incapacity". This results in an index score. The last item deals with perceived health on the day the questionnaire is filled in and uses a visual analogue scale from 0 (worst) to 100 (best health possible) (Visual Analog Scale Score).
  • Doctor and patient opinions [ Time Frame: At baseline, 3 and 6 months ]
    Semi-quantitative scale in 7 points collected will be recorded. This is a semi-quantitative evaluation of the effect of the cure on the state of health of the patient by the patient himself and by the doctor. Responses will be grouped into 3 classes: aggravated / neither aggravated nor improved / improved. The numbers and percentages of each answer will be calculated
  • Treatment follow-up [ Time Frame: At baseline, 3 and 6 months ]
    Description of treatments consumption by the patient at baseline, 3 and 6 months. To avoid any risk of confusion, drug consumption will be related to daily consumption. Drug use for 72 hours (day before and before the day of visit, day of visit: d-2, d-1, D0)
  • Self evaluation of pain [ Time Frame: With investigator at baseline, 3 and 6 months. Auto evaluation at 1.5 months and 4.5 months. ]
    Visual Analogic Scale (from 0 to 10) evaluation by patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effect of Spa Treatment on Rheumatological Conditions
Official Title  ICMJE Clinical Evolution of Patients Suffering From Lower Limb Rheumatological Conditions 6 Months After Spa Treatment
Brief 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) 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.

Detailed 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Pain, Joint
  • Lower Back Pain
  • Rheumatic Diseases
Intervention  ICMJE Other: Spa Treatment
  • Bath with immersion shower
  • Overall penetrating shower
  • Multiple local application cataplasm
  • Individual physiotherapy
  • Mobilisation pool
Study Arms  ICMJE Experimental: Spa treatment
Mineral water cares in Contrexéville thermal cure center, massage, cataplasm.
Intervention: Other: Spa Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient presenting an indication for rheumatological spa treatment
  • Patient with osteoarthritis or other rheumatic disease, located on the lower limbs with or without chronic lower back pain.
  • Functional impairment with reduced mobility
  • Life expectancy > 6 months
  • VAS pain evaluation > 30 mm
  • Available for a 6-months follow-up and an 18-days spa treatment
  • Affiliation to the French social security system or equivalent
  • Patient living within 100 kms of recruitment center

Exclusion Criteria:

  • Patient having already underwent a spa treatment for rheumatic indication 6 months within enrollment
  • Pregnancy, parturient or breast feeding
  • Psychiatric illness or social situation that would preclude study compliance
  • Predictable intolerance to thermal treatment (immunodeficiency, advanced cardiopathy, active cancer, active pulmonary tuberculosis, severe renal failure, cirrhosis, advanced dementia and severe mental conditions)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03538470
Other Study ID Numbers  ICMJE Protocol 1.3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SAEML Contrexéville
Study Sponsor  ICMJE SAEML Contrexéville
Collaborators  ICMJE TIMC-IMAG
Investigators  ICMJE
Study Chair: Jean Luc BOSSON, MD TIMC-IMAG
PRS Account SAEML Contrexéville
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP