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Completed

NCT Number: NCT01544647

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nancy university hospital center

Nancy, 54000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual spa protocol

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

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.

Primary outcomes

  1. 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

    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 outcomes

  1. Achievement of the patient acceptable symptom state

    Time frame: 3 and 6 months

  2. evolution of quality of life scores

    Time frame: 3 and 6 months

  3. medical care consumption

    Time frame: 3 and 6 months

    particularly NSAIDs, pain killers

  4. postural abnormalities

    Time frame: 3 and 6 months

    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.

  5. adverse events

    Time frame: 3 and 6 months

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: Nancythermal

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 6, 2012
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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