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Assessment of the Effect of Spa Treatment on Rheumatological Conditions

NCT03538470 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-04-11

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee
  • Pain, Joint
  • Lower Back Pain
  • Rheumatic Diseases

Interventions

OTHER

Spa Treatment

* Bath with immersion shower * Overall penetrating shower * Multiple local application cataplasm * Individual physiotherapy * Mobilisation pool

Sponsors & Collaborators

  • TIMC-IMAG

    collaborator OTHER

  • SAEML Contrexéville

    lead OTHER

Principal Investigators

  • Jean Luc BOSSON, MD · TIMC-IMAG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-05-01
Completion
2019-08-01

Countries

  • France

Study Locations

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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 NCT03538470 on ClinicalTrials.gov