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Spa Therapy in Knee Osteoarthritis (OA): Nancy-thermal

NCT01544647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2014-08-15

No results posted yet for this study

Summary

Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.

The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.

The secondary objectives are:

1. To compare the efficacy of the 2 protocols at 3 months.
2. To determine the evolution of quality of life and medical care consumption
3. To describe postural abnormalities
4. To determine predictive factors to a favourable response at 3 and 6 months

Conditions

Interventions

OTHER

Usual spa protocol

In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.

OTHER

Active spa protocol

4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-05-31
Completion
2014-01-31

Countries

  • France

Study Locations

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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 NCT01544647 on ClinicalTrials.gov