Assessment of the Effect of Spa Treatment on Rheumatological Conditions

NCT03538470 | Unknown

• 1 other identifier: Protocol 1.3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

1. 1.Primary outcome measure: measuring the effect of spa treatment in patients suffering from lower limb osteoarthritis or any other lower limb rheumatological condition.
2. 2.Measuring the effect of spa treatment in patients with concomitant chronic lower back pain.
3. 3.Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6 months after spa treatment.
4. 4.Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment and 6 months after spa treatment.
5. 5.Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment and 6 months after spa treatment.
6. 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. 7.8\. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D) questionnaires at enrollment, 3 months and 6 months.

Conditions

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

Outcome Measures

Primary Outcomes (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)

  At 6 months

Secondary Outcomes (10)

• Effect of spa treatment on lower back pain

  At 6 months

• Quantitative evaluation of pain

  At baseline and 6 months

• Quantitative evaluation of WOMAC

  At baseline and 6 months

• Quantitative evaluation of EIFEL

  At baseline and 6 months

• Patient BMI

  At baseline, 3 and 6 months

Study Arms (1)

Spa treatment

EXPERIMENTAL

Mineral water cares in Contrexéville thermal cure center, massage, cataplasm.

Other: Spa Treatment

Interventions

Spa Treatment OTHER

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

Spa treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• SAEML Contrexéville: lead
• TIMC-IMAG: collaborator

Study Sites (4)

Conrozier

Belfort, France

Location

BAUER

Nancy, France

Location

Perrier Cornet

Nancy, France

Location

Jeanmaire

Neufchâteau, France

Location

Related Publications (29)

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MeSH Terms

Conditions

Osteoarthritis, Knee; Arthralgia; Low Back Pain; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean Luc BOSSON, MD

  TIMC-IMAG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 29, 2018
• Study Start: June 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)