Osteoarthritis, KneeVALSNCT03336099
Assessment of the Effect of Spa Treatment on the Functional Severity of Arthrosis
A study testing Spa Treatment in people with Osteoarthritis, Knee and Pain, run by Le Syndicat Intercommunal pour le Thermalisme et l'Environnement at 1 site in France.
Trial summary
Assessment of the effect of spa treatment on the functional severity of arthrosis. Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- Spa Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2016to 13 Jun 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with arthrosis or other rheumatic disease, located on the lower limbs or the rachis
- Rheumatic indication for spa treatment
- Diminution of mobility
- Affiliation to the French social security system or equivalent
- Available for a 6-months follow-up and an 18-days spa treatment
Who cannot join
- Pregnancy, parturient or breast feeding
- Psychiatric illness or social situation that would preclude study compliance
- Contraindication to spa treatment
- Predictable intolerance to thermal treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment
Assessment of the effect of spa treatment on the functional severity of arthrosis.
Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment.
Read more
Primary outcome measure:
- Measuring the effect of spa treatment on functional severity of arthrosis
- Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference)
Secondary outcome measures
- Quantitative evaluation of pain
- Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after
- Quantitative evaluation of WOMAC
- Comparison of mean WOMAC between enrollment and 6 months after
- Impact of spa treatment on the patient's metabolism
- Height and Weight (BMI calculation)
- Blood pressure
- Heart rate
- Quality of life
- 36-Item Short Form (SF36) at enrollment, 3 months and 6 months
- EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months
- Opinion of doctor and patient
- Semi-quantitative scale collected at enrollment, 3 months and 6 months
- Treatment follow-up
- Self-evaluation of pain
- Self-evaluation of pain with VAS pain scale every 6 week
Read the detailed description
Arthrosis and rheumatic diseases on the whole consist in a huge and frequent public health problem, with consequences notably including the well-known pain phenomena.
Spa treatments are part of the mainstream therapeutic arsenal of non-medical treatments proposed to this kind of patients.
A recent French study estimated the direct cost of arthrosis in France to 1.6 billion euros in 2002. Half of it was attributable to hospital expenses (800 million euros). Arthrosis required 13 million consultations and drug expenses amounting to 570 million euros. These expenses were increased by 156% compared to 1993 due to the raise of the number of treated patients (+54%) and the cost for each patient (+2.5% per year). This study concerned patients with arthrosis on the lower limbs, with an significant portion of these expenses attributable to the disease.
Different thermal clinical trials of good quality have led to the recognition of spa in the treatment of chronic low back pain.
Several controlled and randomized prospective trials already evaluated the effect of spa treatment for the other main indications claimed by crenotherapy in rheumatology : chronic low back pain, coxarthrosis, hand arthrosis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis, chronic cervicalgia.
The THERMARTHROSE study by Forestier has demonstrated the efficacy of spa treatment as a rheumatologic indication for gonarthrosis on WOMAC and VAS pain scale. Following the model of this study, the sponsor chose to use the WOMAC as the primary endpoint for the VALS study.
It has been developed by Bellamy in 1988, and it is a functional index aimed on the locomotor system.
Nowadays, the WOMAC is more used than the Lequesne index because it has better internal consistency reliability. However, complementary validation efforts were necessary to calculate the minimal clinically important difference whereas the pertinence of the Lequesne index is immediately perceptible, being purely qualitative.
With studies in thermal environment, spa treatment is a composite entity including the effect of water itself, but also kinesiotherapy, rest, education… The spa of Vals-les-Bains wishes to obtain a new therapeutic orientation: the rheumatologic orientation. According to the recommendations of the Academy of Medicine, a prolonged observation of a cohort with repeated measures is required for any spa wishing to acquire the accreditation for a new orientation.
Toward this goal, the sponsor wish to undertake a prospective study with repeated measures in order to analyze the evolution at 6 month of the clinical state of patients with a rheumatologic disease on the lower limbs or the rachis and taken over for spa treatment at Vals-les-Bains. Since rheumatologic treatments at Vals-les-Bains are not covered by the health insurance, they will not be billed to the patients
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- Spa Treatment
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa TreatmentOther
- Bath with immersion shower
- Overall shower, penetrating shower
- Multiple local application cataplasm
- Single local application cataplasm
- Inhalation or collective steam bath
- Individual physiotherapy technique
| Study group | Role | What they receive |
|---|---|---|
| Spa Treatment | Experimental | Bicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm. Receives: Other: Spa Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the effect of spa treatment on functional severity of arthrosis
Proportion of patients with a WOMAC score augmented by 9 or more, at 6 months compared to baseline (minimal clinically important difference)
Measured: 6 months
Secondary outcomes (11)
Quantitative evaluation of pain
Comparison of mean VAS pain scale between baseline, 3 and 6 months
Measured: at baseline, 3 and 6 months
Quantitative evaluation of WOMAC
Comparison of mean WOMAC between baseline, 3 months and 6 months
Measured: at baseline, 3 and 6 months
Patient's BMI
weight and height will be combined to report BMI in kg/m2
Measured: at baseline, 3 and 6 months
Quality of life
SF36 questionnaire at baseline, 3 and 6 months
Measured: at baseline, 3 and 6 months
Quality of life
EQ5D questionnaire at baseline, 3 and 6 months
Measured: at baseline, 3 and 6 months
Opinion of doctor and patient
Semi-quantitative scale collected at baseline, 3 and 6 months
Measured: at baseline, 3 and 6 months
Number of treatments prescribed
Type of treatments prescribed at baseline, 3 and 6 months will be collected
Measured: at baseline, 3 and 6 months
Changes in treatments prescribed
changes in treatments prescribed at baseline, 3 and 6 months will be collected
Measured: at baseline, 3 and 6 months
Treatments duration
Duration of treatments prescribed at baseline, 3 and 6 months will be collected
Measured: at baseline, 3 and 6 months
Self-evaluation of pain
Self-evaluation of pain with VAS pain scale at baseline, 1.5, 3, 4.5 and 6 months
Measured: at baseline, 1.5, 3, 4.5 and 6 months
patient examination
heart rate
Measured: at baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start29 Mar 2016
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Syndicat Intercommunal pour le Thermalisme et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis
- Responsible party
- Sponsor
- Investigators
- Ludovic BACONNIER, Principal investigator, Ardèche Méridionale Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336099
- Sponsor's protocol ID
- Protocol 2.0
- Acronym
- VALS
- Status last verified
- Nov 2017
- First submitted
- 24 Apr 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.
PubMed 11354556Constant F, Collin JF, Guillemin F, Boulange M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.
PubMed 7562765Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82. doi: 10.1007/s002960050107.
PubMed 10776684Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902. doi: 10.1093/rheumatology/39.8.894.
PubMed 10952746Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I. Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis. 1992 Jun;51(6):820-2. doi: 10.1136/ard.51.6.820.
PubMed 1535495Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.
PubMed 9817119Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.
PubMed 11254234Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. doi: 10.1136/ard.2004.023028. Epub 2004 May 6.
PubMed 15130902van Tubergen A, Landewe R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, The HG, van der Linden S. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2001 Oct;45(5):430-8. doi: 10.1002/1529-0131(200110)45:53.0.co;2-f.
PubMed 11642642Van Tubergen A, Boonen A, Landewe R, Rutten-Van Molken M, Van Der Heijde D, Hidding A, Van Der Linden S. Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2002 Oct 15;47(5):459-67. doi: 10.1002/art.10658.
PubMed 12382292Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis. Cochrane Database Syst Rev. 2000;(2):CD000518. doi: 10.1002/14651858.CD000518.
PubMed 10796385Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
PubMed 19734131
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Clinical State of Patients With Rheumatic Disease on Lower Limbs or Rachis, 6 Months After Spa Treatment
- ClinicalTrials.gov ID
- NCT03336099
- Acronym / sponsor ID
- VALS / Protocol 2.0
- Conditions
- Osteoarthritis, Knee, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Le Syndicat Intercommunal pour le Thermalisme et l'EnvironnementUniversity, hospital or other
- Collaborators
- Floralis
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 8 Nov 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.
Assessment of the effect of spa treatment on the functional severity of arthrosis.
Official title: Evolution of clinical state of patients with rheumatic disease on lower limbs or rachis, 6 months after spa treatment.
Primary outcome measure:
- Measuring the effect of spa treatment on functional severity of arthrosis
- Proportion of patients with a WOMAC score augmented by 9 or more, 6 months after enrollment (minimal clinically important difference)
Secondary outcome measures
- Quantitative evaluation of pain
- Comparison of mean Visual Analogue Scale (VAS) pain scale between enrollment and 6 months after
- Quantitative evaluation of WOMAC
- Comparison of mean WOMAC between enrollment and 6 months after
- Impact of spa treatment on the patient's metabolism
- Height and Weight (BMI calculation)
- Blood pressure
- Heart rate
- Quality of life
- 36-Item Short Form (SF36) at enrollment, 3 months and 6 months
- EuroQol 5 Dimensions (EQ5D) questionnaire at enrollment, 3 months and 6 months
- Opinion of doctor and patient
- Semi-quantitative scale collected at enrollment, 3 months and 6 months
- Treatment follow-up
- Self-evaluation of pain
- Self-evaluation of pain with VAS pain scale every 6 week
Detailed description
Arthrosis and rheumatic diseases on the whole consist in a huge and frequent public health problem, with consequences notably including the well-known pain phenomena.
Spa treatments are part of the mainstream therapeutic arsenal of non-medical treatments proposed to this kind of patients.
A recent French study estimated the direct cost of arthrosis in France to 1.6 billion euros in 2002. Half of it was attributable to hospital expenses (800 million euros). Arthrosis required 13 million consultations and drug expenses amounting to 570 million euros. These expenses were increased by 156% compared to 1993 due to the raise of the number of treated patients (+54%) and the cost for each patient (+2.5% per year). This study concerned patients with arthrosis on the lower limbs, with an significant portion of these expenses attributable to the disease.
Different thermal clinical trials of good quality have led to the recognition of spa in the treatment of chronic low back pain.
Several controlled and randomized prospective trials already evaluated the effect of spa treatment for the other main indications claimed by crenotherapy in rheumatology : chronic low back pain, coxarthrosis, hand arthrosis, fibromyalgia, rheumatoid polyarthritis, psoriatic arthritis, chronic cervicalgia.
The THERMARTHROSE study by Forestier has demonstrated the efficacy of spa treatment as a rheumatologic indication for gonarthrosis on WOMAC and VAS pain scale. Following the model of this study, the sponsor chose to use the WOMAC as the primary endpoint for the VALS study.
It has been developed by Bellamy in 1988, and it is a functional index aimed on the locomotor system.
Nowadays, the WOMAC is more used than the Lequesne index because it has better internal consistency reliability. However, complementary validation efforts were necessary to calculate the minimal clinically important difference whereas the pertinence of the Lequesne index is immediately perceptible, being purely qualitative.
With studies in thermal environment, spa treatment is a composite entity including the effect of water itself, but also kinesiotherapy, rest, education… The spa of Vals-les-Bains wishes to obtain a new therapeutic orientation: the rheumatologic orientation. According to the recommendations of the Academy of Medicine, a prolonged observation of a cohort with repeated measures is required for any spa wishing to acquire the accreditation for a new orientation.
Toward this goal, the sponsor wish to undertake a prospective study with repeated measures in order to analyze the evolution at 6 month of the clinical state of patients with a rheumatologic disease on the lower limbs or the rachis and taken over for spa treatment at Vals-les-Bains. Since rheumatologic treatments at Vals-les-Bains are not covered by the health insurance, they will not be billed to the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spa Treatment | Experimental | Other: Spa TreatmentBicarbonate and sulfurated water cares in Vals-les-Bains thermal cure center, massage, cataplasm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with arthrosis or other rheumatic disease, located on the lower limbs or the rachis
- Rheumatic indication for spa treatment
- Diminution of mobility
- Affiliation to the French social security system or equivalent
- Available for a 6-months follow-up and an 18-days spa treatment
Key exclusion criteria (4 listed)
- Pregnancy, parturient or breast feeding
- Psychiatric illness or social situation that would preclude study compliance
- Contraindication to spa treatment
- Predictable intolerance to thermal treatment
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 Treatment* Bath with immersion shower * Overall shower, penetrating shower * Multiple local application cataplasm * Single local application cataplasm * Inhalation or collective steam bath * Individual physiotherapy technique | Other | Spa Treatment |
Primary outcome
Measuring the effect of spa treatment on functional severity of arthrosis
Time frame: 6 months
Proportion of patients with a WOMAC score augmented by 9 or more, at 6 months compared to baseline (minimal clinically important difference)
11 secondary outcomes
Quantitative evaluation of pain
Time frame: at baseline, 3 and 6 months
Quantitative evaluation of WOMAC
Time frame: at baseline, 3 and 6 months
Patient's BMI
Time frame: at baseline, 3 and 6 months
Quality of life
Time frame: at baseline, 3 and 6 months
Quality of life
Time frame: at baseline, 3 and 6 months
Opinion of doctor and patient
Time frame: at baseline, 3 and 6 months
Number of treatments prescribed
Time frame: at baseline, 3 and 6 months
Changes in treatments prescribed
Time frame: at baseline, 3 and 6 months
Treatments duration
Time frame: at baseline, 3 and 6 months
Self-evaluation of pain
Time frame: at baseline, 1.5, 3, 4.5 and 6 months
patient examination
Time frame: at baseline, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Background: PubMed 11354556Buskila D, Abu-Shakra M, Neumann L, Odes L, Shneider E, Flusser D, Sukenik S. Balneotherapy for fibromyalgia at the Dead Sea. Rheumatol Int. 2001 Apr;20(3):105-8. doi: 10.1007/s002960000085.
- Background: PubMed 7562765Constant F, Collin JF, Guillemin F, Boulange M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.
- Background: PubMed 10776684Elkayam O, Ophir J, Brener S, Paran D, Wigler I, Efron D, Even-Paz Z, Politi Y, Yaron M. Immediate and delayed effects of treatment at the Dead Sea in patients with psoriatic arthritis. Rheumatol Int. 2000;19(3):77-82. doi: 10.1007/s002960050107.
- Background: PubMed 10952746Franke A, Reiner L, Pratzel HG, Franke T, Resch KL. Long-term efficacy of radon spa therapy in rheumatoid arthritis--a randomized, sham-controlled study and follow-up. Rheumatology (Oxford). 2000 Aug;39(8):894-902. doi: 10.1093/rheumatology/39.8.894.
- Background: PubMed 4139420Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
- Background: PubMed 1535495Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I. Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis. 1992 Jun;51(6):820-2. doi: 10.1136/ard.51.6.820.
- Background: PubMed 9817119Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.
- Background: PubMed 11254234Neumann L, Sukenik S, Bolotin A, Abu-Shakra M, Amir M, Flusser D, Buskila D. The effect of balneotherapy at the Dead Sea on the quality of life of patients with fibromyalgia syndrome. Clin Rheumatol. 2001;20(1):15-9. doi: 10.1007/s100670170097.
- Background: PubMed 15130902Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. doi: 10.1136/ard.2004.023028. Epub 2004 May 6.
- Background: PubMed 11642642van Tubergen A, Landewe R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, The HG, van der Linden S. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2001 Oct;45(5):430-8. doi: 10.1002/1529-0131(200110)45:53.0.co;2-f.
- Background: PubMed 12382292Van Tubergen A, Boonen A, Landewe R, Rutten-Van Molken M, Van Der Heijde D, Hidding A, Van Der Linden S. Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial. Arthritis Rheum. 2002 Oct 15;47(5):459-67. doi: 10.1002/art.10658.
- Background: PubMed 10796385Verhagen AP, de Vet HC, de Bie RA, Kessels AG, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis. Cochrane Database Syst Rev. 2000;(2):CD000518. doi: 10.1002/14651858.CD000518.
- 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.
Ludovic BACONNIER principal investigator
Ardèche Méridionale Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa Treatment in people with Osteoarthritis, Knee and Pain, run by Le Syndicat Intercommunal pour le Thermalisme et l'Environnement at 1 site in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measuring the effect of spa treatment on functional severity of arthrosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03336099, which also lists 14 linked publications.
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 8 Nov 2017.