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

November 7, 2017 updated by: Le Syndicat Intercommunal pour le Thermalisme et l'Environnement

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spa Treatment
Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm.
Other: Spa Treatment
  • 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Le Syndicat Intercommunal pour le Thermalisme et l'Environnement

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Floralis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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