Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis (VALS)

Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment

Assessment of the effect of spa treatment on the functional severity of arthrosis.

Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment.

Primary outcome measure:

  • Measuring the effect of spa treatment on functional severity of arthrosis

    • Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference)

Secondary outcome measures

  • Quantitative evaluation of pain

    • Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after
  • Quantitative evaluation of WOMAC

    • Comparison of mean WOMAC between enrollment and 6 months after
  • Impact of spa treatment on the patient's metabolism

    • Height and Weight (BMI calculation)
    • Blood pressure
    • Heart rate
  • Quality of life

    • 36-Item Short Form (SF36) at enrollment, 3 months and 6 months
    • EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months
  • Opinion of doctor and patient

    • Semi-quantitative scale collected at enrollment, 3 months and 6 months
  • Treatment follow-up
  • Self-evaluation of pain

    • Self-evaluation of pain with VAS pain scale every 6 week

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Arthrosis and rheumatic diseases on the whole consist in a huge and frequent public health problem, with consequences notably including the well-known pain phenomena.

Spa treatments are part of the mainstream therapeutic arsenal of non-medical treatments proposed to this kind of patients.

A recent French study estimated the direct cost of arthrosis in France to 1.6 billion euros in 2002. Half of it was attributable to hospital expenses (800 million euros). Arthrosis required 13 million consultations and drug expenses amounting to 570 million euros. These expenses were increased by 156% compared to 1993 due to the raise of the number of treated patients (+54%) and the cost for each patient (+2.5% per year). This study concerned patients with arthrosis on the lower limbs, with an significant portion of these expenses attributable to the disease.

Different thermal clinical trials of good quality have led to the recognition of spa in the treatment of chronic low back pain.

Several controlled and randomized prospective trials already evaluated the effect of spa treatment for the other main indications claimed by crenotherapy in rheumatology : chronic low back pain, coxarthrosis, hand arthrosis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis, chronic cervicalgia.

The THERMARTHROSE study by Forestier has demonstrated the efficacy of spa treatment as a rheumatologic indication for gonarthrosis on WOMAC and VAS pain scale. Following the model of this study, the sponsor chose to use the WOMAC as the primary endpoint for the VALS study.

It has been developed by Bellamy in 1988, and it is a functional index aimed on the locomotor system.

Nowadays, the WOMAC is more used than the Lequesne index because it has better internal consistency reliability. However, complementary validation efforts were necessary to calculate the minimal clinically important difference whereas the pertinence of the Lequesne index is immediately perceptible, being purely qualitative.

With studies in thermal environment, spa treatment is a composite entity including the effect of water itself, but also kinesiotherapy, rest, education… The spa of Vals-les-Bains wishes to obtain a new therapeutic orientation: the rheumatologic orientation. 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.

Toward this goal, the sponsor wish to undertake a prospective study with repeated measures in order to analyze the evolution at 6 month of the clinical state of patients with a rheumatologic disease on the lower limbs or the rachis and taken over for spa treatment at Vals-les-Bains. Since rheumatologic treatments at Vals-les-Bains are not covered by the health insurance, they will not be billed to the patients

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ardèche
      • Vals Les Bains, Ardèche, France, 07600
        • Thermes de Vals Les Bains

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with arthrosis or other rheumatic disease, located on the lower limbs or the rachis
  • Rheumatic indication for spa treatment
  • Diminution of mobility
  • Affiliation to the French social security system or equivalent
  • Available for a 6-months follow-up and an 18-days spa treatment

Exclusion Criteria:

  • Pregnancy, parturient or breast feeding
  • Psychiatric illness or social situation that would preclude study compliance
  • Contraindication to spa treatment
  • Predictable intolerance to thermal treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spa Treatment
Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm.
  • Bath with immersion shower
  • Overall shower, penetrating shower
  • Multiple local application cataplasm
  • Single local application cataplasm
  • Inhalation or collective steam bath
  • Individual physiotherapy technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the effect of spa treatment on functional severity of arthrosis
Time Frame: 6 months
Proportion of patients with a WOMAC score augmented by 9 or more, at 6 months compared to baseline (minimal clinically important difference)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative evaluation of pain
Time Frame: at baseline, 3 and 6 months
Comparison of mean VAS pain scale between baseline, 3 and 6 months
at baseline, 3 and 6 months
Quantitative evaluation of WOMAC
Time Frame: at baseline, 3 and 6 months
Comparison of mean WOMAC between baseline, 3 months and 6 months
at baseline, 3 and 6 months
Patient's BMI
Time Frame: at baseline, 3 and 6 months
weight and height will be combined to report BMI in kg/m2
at baseline, 3 and 6 months
Quality of life
Time Frame: at baseline, 3 and 6 months
SF36 questionnaire at baseline, 3 and 6 months
at baseline, 3 and 6 months
Quality of life
Time Frame: at baseline, 3 and 6 months
EQ5D questionnaire at baseline, 3 and 6 months
at baseline, 3 and 6 months
Opinion of doctor and patient
Time Frame: at baseline, 3 and 6 months
Semi-quantitative scale collected at baseline, 3 and 6 months
at baseline, 3 and 6 months
Number of treatments prescribed
Time Frame: at baseline, 3 and 6 months
Type of treatments prescribed at baseline, 3 and 6 months will be collected
at baseline, 3 and 6 months
Changes in treatments prescribed
Time Frame: at baseline, 3 and 6 months
changes in treatments prescribed at baseline, 3 and 6 months will be collected
at baseline, 3 and 6 months
Treatments duration
Time Frame: at baseline, 3 and 6 months
Duration of treatments prescribed at baseline, 3 and 6 months will be collected
at baseline, 3 and 6 months
Self-evaluation of pain
Time Frame: at baseline, 1.5, 3, 4.5 and 6 months
Self-evaluation of pain with VAS pain scale at baseline, 1.5, 3, 4.5 and 6 months
at baseline, 1.5, 3, 4.5 and 6 months
patient examination
Time Frame: at baseline, 3 and 6 months
heart rate
at baseline, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ludovic BACONNIER, Ardèche Méridionale Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2016

Primary Completion (Actual)

June 13, 2017

Study Completion (Actual)

June 13, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 8, 2017

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Protocol 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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