AzTrials
AzTrials

Osteoarthritis, KneeCONTREXEVILLENCT03538470

Assessment of the Effect of Spa Treatment on Rheumatological Conditions

A study testing Spa Treatment in people with Osteoarthritis, Knee and Pain, Joint, run by SAEML Contrexéville at 4 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee, Pain, Joint, Lower Back Pain
What is being tested?
Spa Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
4 sitesFrance
Study dates
1 Jun 2018to 1 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Conrozier

    Belfort

  • BAUER

    Nancy

  • Perrier Cornet

    Nancy

  • Jeanmaire

    Neufchâteau

Other trials in France

About this study

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.
  8. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and 6 months.
  9. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the medical visit at enrollment, 3 months and 6 months.
  10. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more precise time frame of the treatment's effect.
Read the 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.

Being tested
Spa Treatment
Medical subject headings
Osteoarthritis, Knee, Arthralgia, Low Back Pain, Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spa TreatmentOther

    • Bath with immersion shower
    • Overall penetrating shower
    • Multiple local application cataplasm
    • Individual physiotherapy
    • Mobilisation pool
Study groups in NCT03538470
Study groupRoleWhat they receive
Spa treatmentExperimentalMineral water cares in Contrexéville thermal cure center, massage, cataplasm.
Receives: Other: Spa Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of spa treatment on lower limb osteoarthritis

    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)

    Measured: At 6 months

Secondary outcomes (10)

  1. Effect of spa treatment on lower back pain

    Percentage of patients with an EIFEL score decrease of at least 5 points

    Measured: At 6 months

  2. Quantitative evaluation of pain

    Comparison of mean VAS (Visual Analogic Scale from 0 to 10) pain scale

    Measured: At baseline and 6 months

  3. Quantitative evaluation of WOMAC

    Comparison of mean WOMAC questionnaire

    Measured: At baseline and 6 months

  4. Quantitative evaluation of EIFEL

    Comparison of mean EIFEL questionnaire

    Measured: At baseline and 6 months

  5. Patient BMI

    BMI evolution will be recorded (size, weight)

    Measured: At baseline, 3 and 6 months

  6. Global quality of life

    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.

    Measured: At baseline, 3 and 6 months

  7. Health quality of life

    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).

    Measured: At baseline, 3 and 6 months

  8. Doctor / patient opinions

    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

    Measured: At baseline, 3 and 6 months

  9. Treatment follow-up

    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)

    Measured: At baseline, 3 and 6 months

  10. Self evaluation of pain

    Visual Analogic Scale (from 0 to 10) evaluation by patients

    Measured: With investigator at baseline, 3 and 6 months. Auto evaluation at 1.5 months and 4.5 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2018
  2. Study start1 Jun 2018
  3. Primary completion1 May 2019 (estimated)
  4. Study completion1 Aug 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03538470
Sponsor's protocol ID
Protocol 1.3
Acronym
CONTREXEVILLE
Status last verified
Apr 2019
First submitted
17 Apr 2018
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

    PubMed 3068365

  • Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.

    PubMed 11354556

  • Constant F, Collin JF, Guillemin F, Boulange M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.

    PubMed 7562765

  • Constant F, Guillemin F, Collin JF, Boulange M. Use of spa therapy to improve the quality of life of chronic low back pain patients. Med Care. 1998 Sep;36(9):1309-14. doi: 10.1097/00005650-199809000-00003.

    PubMed 9749654

  • Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82. doi: 10.1007/s002960050107.

    PubMed 10776684

  • Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. doi: 10.1007/s00296-002-0189-8. Epub 2002 Mar 29.

    PubMed 12070676

  • Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902. doi: 10.1093/rheumatology/39.8.894.

    PubMed 10952746

  • Guillemin F, Constant F, Collin JF, Boulange M. Short and long-term effect of spa therapy in chronic low back pain. Br J Rheumatol. 1994 Feb;33(2):148-51. doi: 10.1093/rheumatology/33.2.148.

    PubMed 8162480

  • Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

    PubMed 4139420

  • Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I. Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis. 1992 Jun;51(6):820-2. doi: 10.1136/ard.51.6.820.

    PubMed 1535495

  • Levy E, Ferme A, Perocheau D, Bono I. [Socioeconomic costs of osteoarthritis in France]. Rev Rhum Ed Fr. 1993 Jul;60(6 Pt 2):63S-67S. French.

    PubMed 8118454

  • Driscoll T, Jacklyn G, Orchard J, Passmore E, Vos T, Freedman G, Lim S, Punnett L. The global burden of occupationally related low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):975-81. doi: 10.1136/annrheumdis-2013-204631. Epub 2014 Mar 24.

    PubMed 24665117

  • Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.

    PubMed 9817119

  • Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.

    PubMed 11254234

  • Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. doi: 10.1136/ard.2004.022905. Epub 2004 Jun 18.

    PubMed 15208174

Questions about this trial

What is this clinical trial studying?

A study testing Spa Treatment in people with Osteoarthritis, Knee and Pain, Joint, run by SAEML Contrexéville at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of spa treatment on lower limb osteoarthritis (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03538470, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in