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

Knee Osteoarthritis Clinical Trial

— Nancythermal  

Official title:

Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544647
• Other study ID #: 2011-A01319-32
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: August 13, 2014
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: January 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria are:

• 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

Non inclusion criteria are:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Nancy university hospital center	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery	The main outcome endpoint is the number of patients achieving minimal clinically important improvement (MCII) 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.	6 months	No
Secondary	Achievement of the patient acceptable symptom state		3 and 6 months	No
Secondary	evolution of quality of life scores		3 and 6 months	No
Secondary	medical care consumption	particularly NSAIDs, pain killers	3 and 6 months	No
Secondary	postural abnormalities	The method used aimed at evaluating two modalities of postural regulation - quiet stance and during movement - and their related neurosensory organization. Postural control during quiet stance will be evaluated with and without sensory conflict by a static posturographic test and by a sensory organization test; postural control during movement will be evaluated by a dynamic posturographic test with slow sinusoidal oscillations.	3 and 6 months	No
Secondary	adverse events		3 and 6 months	Yes