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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01544647
First received: February 16, 2012
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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

Condition Intervention
Knee Osteoarthritis
Other: Usual spa protocol
Other: Active spa protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Achievement of the patient acceptable symptom state [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • evolution of quality of life scores [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • medical care consumption [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    particularly NSAIDs, pain killers

  • postural abnormalities [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    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.

  • adverse events [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 283
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual spa protocol
4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
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 Comparator: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544647

Locations
France
Nancy university hospital center
Nancy, France, 54000
Sponsors and Collaborators
Central Hospital, Nancy, France
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01544647     History of Changes
Other Study ID Numbers: 2011-A01319-32
Study First Received: February 16, 2012
Last Updated: August 13, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
Knee osteoarthritis
spa therapy
spa modalities

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 21, 2014