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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

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Pain, Joint Lower Back Pain Rheumatic Diseases Other: Spa Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evolution of Patients Suffering From Lower Limb Rheumatological Conditions 6 Months After Spa Treatment
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spa treatment
Mineral water cares in Contrexéville thermal cure center, massage, cataplasm.
Other: Spa Treatment
  • Bath with immersion shower
  • Overall penetrating shower
  • Multiple local application cataplasm
  • Individual physiotherapy
  • Mobilisation pool




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Quantitative evaluation of pain [ Time Frame: At baseline and 6 months ]
    Comparison of mean VAS (Visual Analogic Scale from 0 to 10) pain scale

  3. Quantitative evaluation of WOMAC [ Time Frame: At baseline and 6 months ]
    Comparison of mean WOMAC questionnaire

  4. Quantitative evaluation of EIFEL [ Time Frame: At baseline and 6 months ]
    Comparison of mean EIFEL questionnaire

  5. Patient BMI [ Time Frame: At baseline, 3 and 6 months ]
    BMI evolution will be recorded (size, weight)

  6. 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.

  7. 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).

  8. 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

  9. 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)

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538470


Locations
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France
Conrozier
Belfort, France
BAUER
Nancy, France
Perrier Cornet
Nancy, France
Jeanmaire
Neufchâteau, France
Sponsors and Collaborators
SAEML Contrexéville
TIMC-IMAG
Investigators
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Study Chair: Jean Luc BOSSON, MD TIMC-IMAG
Publications:

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Responsible Party: SAEML Contrexéville
ClinicalTrials.gov Identifier: NCT03538470    
Other Study ID Numbers: Protocol 1.3
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Rheumatic Diseases
Arthralgia
Collagen Diseases
Low Back Pain
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Connective Tissue Diseases