Knee OsteoarthritisFONTCAUDENCT03289078
Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center
A study testing Spa Treatment in people with Knee Osteoarthritis, run by University Hospital, Montpellier.
Trial summary
Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Spa Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 40 to 75 years with radiologic and gonarthrosis radiologic et painful gonarthrosis, unilateral ou bilateral, whatever is the radiographic stage
- Patient presenting a EVA ≥3 with a corresponding radiology at least of 1year
- Patient affiliated with a social security system
Who cannot join
- Realization of a water cure in the last 6 months
- Infiltration of the knee of less than 3 months
- Impossibility to sign the informed consent or which for reasons geographical, social or psychological could not be regularly followed,
- Person major placed under guardianship or trusteeship,
- Private person of freedom by court or administrative order, nobody being the object of a legal protective measure,
- Patient already included in an interventional clinical protocol,
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- Pregnant women
- Contraindication in the water cure:
- Severe change of the general state or debilitating afflictions
- Acute affections and pushed acute(sharp) of the chronic affections
- Grave cardiac insufficiency, unstable arterial high blood pressure
- Severe renal or hepatic insufficiency
- Not healed cutaneous hurts
- Contagious or evolutionary diseases
- Evolutionary Cancers
- Current immunomodulator or immunosupressor Treatment, waves of inflammation.
About this study
Official title: Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis
Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI.
In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical improvement for patients, as demonstrated in the Thermarthrose study. This center is near Montpellier and could improve patients localised in this area.
Read the detailed description
Methods: randomised prospective clinical trial of patients with knee osteoarthritis.
The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group received 18 days of therapy over 3 weeks after the 6-month follow-up visit.
Follow-up was at 3 and 6 months, by a visit to the examination.
The hypothesis of our study is to demonstrate clinical improvement at six months. The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defi ned 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Spa Treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa TreatmentOther
The spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily)
| Study group | Role | What they receive |
|---|---|---|
| Thermal care | Experimental | Spa Treatment realised daily 6 days a week during 18 days Receives: Other: Spa Treatment |
| Standard Care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of minimal clinically important improvement (MCII) at 6 months
The main 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 osteoart
Measured: 30 months
Secondary outcomes (1)
Achievement of minimal clinically important improvement (MCII) at 3 months
The second outcome measure is the number of patients achieving minimal clinically important improvement (MCII) at 3 months, defi ned 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 also the safety.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study startOct 2017 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionOct 2020 (estimated)
Why it stopped: No financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- FONTCAUDE's Vichy SPA center, Juvignac
- Responsible party
- Sponsor
- Investigators
- Isabel TAVARES, PH, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289078
- Sponsor's protocol ID
- 9846
- Acronym
- FONTCAUDE
- Status last verified
- May 2021
- First submitted
- 18 Sep 2017
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03289078
- Acronym / sponsor ID
- FONTCAUDE / 9846
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- FONTCAUDE's Vichy SPA center, Juvignac
- Study start
- Oct 2017 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of functional improvement after spa therapy in Fontcaude center, for knee osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in rheumatology. This therapeutic represents a non pharmacological treatment and is recommended by OARSI.
In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical improvement for patients, as demonstrated in the Thermarthrose study. This center is near Montpellier and could improve patients localised in this area.
Detailed description
Methods: randomised prospective clinical trial of patients with knee osteoarthritis.
The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group received 18 days of therapy over 3 weeks after the 6-month follow-up visit.
Follow-up was at 3 and 6 months, by a visit to the examination.
The hypothesis of our study is to demonstrate clinical improvement at six months. The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defi ned 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermal care | Experimental | Other: Spa TreatmentSpa Treatment realised daily 6 days a week during 18 days |
| Standard Care | No intervention | –Usual care |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 40 to 75 years with radiologic and gonarthrosis radiologic et painful gonarthrosis, unilateral ou bilateral, whatever is the radiographic stage
- Patient presenting a EVA ≥3 with a corresponding radiology at least of 1year
- Patient affiliated with a social security system
Key exclusion criteria (16 listed)
- Realization of a water cure in the last 6 months
- Infiltration of the knee of less than 3 months
- Impossibility to sign the informed consent or which for reasons geographical, social or psychological could not be regularly followed,
- Person major placed under guardianship or trusteeship,
- Private person of freedom by court or administrative order, nobody being the object of a legal protective measure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa TreatmentThe spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily) | Other | Thermal care |
Primary outcome
Achievement of minimal clinically important improvement (MCII) at 6 months
Time frame: 30 months
The main 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 osteoart
1 secondary outcome
Achievement of minimal clinically important improvement (MCII) at 3 months
Time frame: 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel TAVARES, PH principal investigator
CHU de Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Spa Treatment in people with Knee Osteoarthritis, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of minimal clinically important improvement (MCII) at 6 months (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.