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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Usual spa protocol
Active spa protocol
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, spa therapy, spa modalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nancy university hospital center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual spa protocol

Active spa protocol

Arm Description

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

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.

Outcomes

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
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
evolution of quality of life scores
medical care consumption
particularly NSAIDs, pain killers
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.
adverse events

Full Information

First Posted
February 16, 2012
Last Updated
August 13, 2014
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT01544647
Brief Title
Spa Therapy in Knee Osteoarthritis (OA): Nancy-thermal
Acronym
Nancythermal
Official Title
Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: To compare the efficacy of the 2 protocols at 3 months. To determine the evolution of quality of life and medical care consumption To describe postural abnormalities 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, spa therapy, spa modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual spa protocol
Arm Type
Active Comparator
Arm Description
4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
Arm Title
Active spa protocol
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Usual spa protocol
Intervention Description
In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
Intervention Type
Other
Intervention Name(s)
Active spa protocol
Intervention Description
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 Outcome Measure Information:
Title
Composite response criteria: achievement of the minimal clinically important improvement of pain VAS and/or the WOMAC score and no knee surgery
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Achievement of the patient acceptable symptom state
Time Frame
3 and 6 months
Title
evolution of quality of life scores
Time Frame
3 and 6 months
Title
medical care consumption
Description
particularly NSAIDs, pain killers
Time Frame
3 and 6 months
Title
postural abnormalities
Description
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.
Time Frame
3 and 6 months
Title
adverse events
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nancy university hospital center
City
Nancy
ZIP/Postal Code
54000
Country
France

12. IPD Sharing Statement

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

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