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

NCT ID: NCT01544647

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 283 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-01-31

Brief 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

Detailed Description

This is a monocentric randomised non inferiority trial comparing 2 spa therapy protocols in symptomatic knee OA.

In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks. In the second group, the same 4 treatments are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.

Data will be collected at inclusion, 3 and 6 weeks and 3 and 6 months.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual spa protocol

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

Group Type: ACTIVE_COMPARATOR

Usual spa protocol

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Active spa protocol

Intervention Type: OTHER

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.

Interventions

Usual spa protocol

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• both gender
• uni or bilateral symptomatic knee OA
• pain VAS > 3 on a 0-10 scale)
• fulfilling ACR criteria for knee OA
• Kellgren and Lawrence stage 2 or over on standard radiograph

• severe comorbidity
• isolated femoro-patellar knee OA
• total knee replacement surgery expected during the next year
• other joint disease
• a contraindication or intolerance to any aspect of spa treatment (immune deficiency, evolving cardiovascular conditions, cancer, infection),
• spa treatment within the previous 12 months
• knee injection within the past month for corticosteroids and within the past 3 months for hyaluronic acids
• osteoarthritis (SYSADOA) change in the past 3 months
• massages, physiotherapy or acupuncture in the past month
• Patients will not be allowed to modify their non-steroidal antiinflammatory drug (NSAID) or their analgesic drug within the past 5 days and in the previous 12 h respectively.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nancy university hospital center

Nancy, , France

Countries

France

Other Identifiers

2011-A01319-32

Identifier Type: -

Identifier Source: org_study_id