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Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis

NCT03336099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-11-08

No results posted yet for this study

Summary

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

Conditions

  • Osteoarthritis, Knee
  • Pain

Interventions

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

Sponsors & Collaborators

  • Floralis

    collaborator INDUSTRY

  • Le Syndicat Intercommunal pour le Thermalisme et l'Environnement

    lead OTHER

Principal Investigators

  • Ludovic BACONNIER · Ardèche Méridionale Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-29
Primary Completion
2017-06-13
Completion
2017-06-13

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336099 on ClinicalTrials.gov