Knee OsteoarthritisLARYTHERMNCT05790824
Benefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis
A study testing Spa therapy in people with Knee Osteoarthritis, run by University of Bordeaux at 1 site in France.
Trial summary
The hypothesis is that the use of spa therapy in Saint-Lary Soulan for knee osteoarthritis treatment would have a therapeutic effect on this pathology. The main objective of this external comparison study is to evaluate the comparative effectiveness at 6 months of spa therapy in the Saint-Lary Soulan spa center on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 12 Jan 2024
- 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
- painful knee due to knee osteoarthritis diagnosed for more than 6 months (confirmed by the general practitioner responsible for the identification of the patient) with at least three of the six clinical criteria defined by the American College of Rheumatology:
- age > 50 years
- morning stiffness lasting < 30 minutes
- articular crepitation when moving the knee
- globular knee with bony hypertrophy on physical examination
- periarticular bone pain on physical examination
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- absence of local heat on palpation
- Visual Analogue Scale for the evaluation of pain felt over the last eight days with a score greater than or equal to 3/10
- affiliated or benefiting from a Social Security plan
- agreeing to participate in the study, having completed and signed the Patient's Free and Informed Consent Form
Who cannot join
- knee osteoarthritis limited to the patello-femoral joint
- at least one of the following diseases/conditions:
- Contra-indications for the realization of spa therapy: evolving cancer, dementia, severe dermatosis, infectious state not stabilized, pregnancy, severe cardiac and respiratory insufficiency, phlebitis, inflammatory rheumatism, psychosis, acute spinal pain
- Acute arthritis of septic or inflammatory origin
- an index knee arthroplasty within the last 6 months or a planned arthroplasty on the index knee within the next 6 months
- corticosteroids infiltration or viscosupplementation within the last 3 months
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- spa therapy within the previous 6 months
- link with the staff of the Saint-Lary Soulan spa center or the physicians participating in the study (family, employee, etc.)
- language barrier (unable to read the information letter, complete the patient agreement form or self-questionnaires)
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that the use of spa therapy in Saint-Lary Soulan for knee osteoarthritis treatment would have a therapeutic effect on this pathology.
The main objective of this external comparison study is to evaluate the comparative effectiveness at 6 months of spa therapy in the Saint-Lary Soulan spa center on functional disability and pain (MCII: Minimal Clinical Important Improvement) in knee osteoarthritis compared to the control group of the Thermarthrose multicenter randomized clinical trial, receiving standard cares.
The patients included in the Larytherm cohort will undergo a three-week spa therapy in Saint-Lary Soulan with a follow-up of 6 months after the end of spa therapy.
Read the detailed description
Knee osteoarthritis is a frequent disease with important consequences for quality of life of patients. In France, prevalence was estimated at 7.6% among subjects between 40-75 years old. The management of knee osteoarthritis is essentially based on lifestyle and dietary measures and the use of analgesic treatment. Spa treatments are also part of the overall management of this pathology.
In this context, the spa town Saint-Lary Soulan requests the approval of the " Rheumatology " therapeutic orientation for its new borehole water (SL5), which requires a study (Larytherm) conducted according to the criteria of the French Academy of Medicine.
Secondary objectives are to evaluate 6 months after spa therapy in Saint-Lary Soulan, the evolution of:
- Body Mass Index (BMI),
- knee pain due to knee osteoarthritis,
- functional impact,
- fatigue,
- physical activity,
- quality of life,
- consumption of analgesic treatments,
- the occurrence of episodes of joint effusion requiring puncture/infiltration,
- the occurrence of adverse events.
The patients will be identified by local physicians or through a local public communication campaign. The patients with criteria of eligibility will complete a self-reported questionnaire before the beginning of spa therapy, after the spa therapy and 6 months after the end of spa therapy, and the physicians practising at the spa center will complete a medical questionnaire at inclusion and after the spa therapy.
- Conditions
- Knee Osteoarthritis
- Being tested
- Spa therapy
- Keywords
- pain, spa therapy, functional disability
- 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 therapyOther
The "RH2" rheumatology treatment protocol will propose treatments that can be carried out with water from the SL5 borehole and will be composed of:
- 54 treatments among the following treatments:
- Swimming pool, 15 minutes (code 201)
- Bath with aerobath, 10 minutes (code 205)
- Bath with immersion shower, 10 minutes (code 206)
- Cataplasm in multiple local application, 10 minutes (code 408)
- 18 sessions of mobilization pool, 15 minutes (code 601)
| Study group | Role | What they receive |
|---|---|---|
| Spa therapy | Experimental | Protocol of spa therapy in rheumatology for 3 weeks Receives: Other: Spa therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Minimal Clinically Important Improvement (MCII)
Improvement from baseline of at least 9.1 points on the Western Ontario and McMaster University osteoarthritis (WOMAC) index standardized functional subscale of 0-100 and/or at least 1.99 cm on the Visual Analogue Scale (VAS) for pain without knee surgery, at 6 months.
WOMAC index (functional subscale): functional assessment index for knee osteoarthritis, exploring the daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4).
Visual Analogue Scale for the evaluation of knee osteoarthritis-related pain for the index knee experienced over the last eight days. The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no pain and the right end (= 10 cm) to the maximum imaginable pain.
This outcome will be evaluated in the Larytherm cohort and compared to the control group of the Thermarthrose study.
Measured: 6 months after the end of spa therapy
Secondary outcomes (12)
Relative change from baseline in the WOMAC functional subscale index at the end of the spa therapy and at 6 months after the end of the spa therapy.
WOMAC index (functional subscale): functional assessment index for knee osteoarthritis, exploring the daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4).
Measured: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in the WOMAC index (full questionnaire) at the end of the spa therapy and at 6 months after the end of the spa therapy.
WOMAC index (full questionnaire): functional assessment index for knee osteoarthritis, exploring three areas of analysis: pain, stiffness and daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4).
Measured: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in the knee osteoarthritis pain measured by the Visual Analogue Scale (VAS) for pain at the end of the spa therapy and at 6 months after the end of the spa therapy.
Visual Analogue Scale for the evaluation of knee osteoarthritis-related pain for the index knee experienced over the last eight days. The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no pain and the right end (= 10 cm) to the maximum imaginable pain.
Measured: Baseline, end of spa therapy (week 3) and 6 months after the end of the spa therapy
Relative change from baseline in fatigue measured by the Visual Analogue Scale (VAS) for fatigue at the end of the spa therapy and at 6 months after the end of the spa therapy.
Visual Analogue Scale for the evaluation of fatigue on the day of filling out the self-questionnaire.The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no fatigue and the right end (= 10 cm) to the maximum imaginable fatigue.
Measured: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in Lequesne's algo-functional index at the end of the spa therapy and at 6 months after the end of the spa therapy.
Questionnaire to assess the functional abilities and discomfort experienced by patients with knee osteoarthritis. Each question is scored, and the final score is classified as follows: 0-4: modest disability, 5-7: moderate disability, 8-10 points: significant disability, 11-13 points: very significant disability, ≥14 points: unbearable extreme disability.
Measured: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in quality of life measured with the 12-item Short-Form health survey (SF12) at the end of the spa therapy and at 6 months after the end of the spa therapy.
Quality of life questionnaire exploring 8 dimensions of quality of life and calculating two Summary Psychological and Physical Scores, ranging from 0 (no quality of life) to 100 (maximum quality of life).
Measured: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in BMI at 6 months after the end of the spa therapy.
Measured: Baseline and 6 months after the end of spa therapy
Consumption of analgesic treatments (analgesics, chondroprotective or anti-arthritic, intra-articular injections of corticoids and hyaluronic acid, physical treatments) with a patient self-questionnaire at baseline and 6 months after the spa therapy.
The patient self-questionnaire includes yes/no questions and pre-listed options.
Measured: Baseline and 6 months after the end of spa therapy
Evolution from baseline of physical activity measured with the International Physical Activity Questionnaire (IPAQ-short version) at 6 months after the spa therapy.
Questionnaire for the assessment of physical activity performed for at least 10 minutes in a row during the last 7 days, including questions on heavy lifting. The score is expressed in metabolic equivalent task (MET-minutes/week) or categorically in 3 levels (low/moderate/high)
Measured: Baseline and 6 months after the end of spa therapy
Occurrence of episodes of joint effusion requiring puncture/infiltration during the 6 months after spa therapy.
Measured: 6 months after the end of spa therapy
Occurrence of adverse events during spa therapy and the 6 months after spa therapy.
Measured: End of spa therapy (week 3) and 6 months after the end of spa therapy
Occurrence of work stoppages due to knee osteoarthritis during the 6 months after spa therapy.
Measured: 6 months after the end of spa therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 May 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- External comparison study between Larytherm cohort patients and Thermarthrose control patients
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick BLIN, University of Bordeaux
- Investigators
- Patrick Blin, Principal investigator, Bordeaux PharmacoEpi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790824
- Sponsor's protocol ID
- 2021-A02899-32
- Other IDs
- 74119
- Acronym
- LARYTHERM
- Status last verified
- Aug 2024
- First submitted
- 24 Feb 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Forestier 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 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05790824
- Acronym / sponsor ID
- LARYTHERM / 2021-A02899-32
- Conditions
- Knee Osteoarthritis
- Keywords
- pain, spa therapy, functional disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 30 Mar 2023 (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.
The hypothesis is that the use of spa therapy in Saint-Lary Soulan for knee osteoarthritis treatment would have a therapeutic effect on this pathology.
The main objective of this external comparison study is to evaluate the comparative effectiveness at 6 months of spa therapy in the Saint-Lary Soulan spa center on functional disability and pain (MCII: Minimal Clinical Important Improvement) in knee osteoarthritis compared to the control group of the Thermarthrose multicenter randomized clinical trial, receiving standard cares.
The patients included in the Larytherm cohort will undergo a three-week spa therapy in Saint-Lary Soulan with a follow-up of 6 months after the end of spa therapy.
Detailed description
Knee osteoarthritis is a frequent disease with important consequences for quality of life of patients. In France, prevalence was estimated at 7.6% among subjects between 40-75 years old. The management of knee osteoarthritis is essentially based on lifestyle and dietary measures and the use of analgesic treatment. Spa treatments are also part of the overall management of this pathology.
In this context, the spa town Saint-Lary Soulan requests the approval of the " Rheumatology " therapeutic orientation for its new borehole water (SL5), which requires a study (Larytherm) conducted according to the criteria of the French Academy of Medicine.
Secondary objectives are to evaluate 6 months after spa therapy in Saint-Lary Soulan, the evolution of:
- Body Mass Index (BMI),
- knee pain due to knee osteoarthritis,
- functional impact,
- fatigue,
- physical activity,
- quality of life,
- consumption of analgesic treatments,
- the occurrence of episodes of joint effusion requiring puncture/infiltration,
- the occurrence of adverse events.
The patients will be identified by local physicians or through a local public communication campaign. The patients with criteria of eligibility will complete a self-reported questionnaire before the beginning of spa therapy, after the spa therapy and 6 months after the end of spa therapy, and the physicians practising at the spa center will complete a medical questionnaire at inclusion and after the spa therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- External comparison study between Larytherm cohort patients and Thermarthrose control patients
| Arm | Type | Receives |
|---|---|---|
| Spa therapy | Experimental | Other: Spa therapyProtocol of spa therapy in rheumatology for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- painful knee due to knee osteoarthritis diagnosed for more than 6 months (confirmed by the general practitioner responsible for the identification of the patient) with at least three of the six clinical criteria defined by the American College of Rheumatology:
- Visual Analogue Scale for the evaluation of pain felt over the last eight days with a score greater than or equal to 3/10
- affiliated or benefiting from a Social Security plan
- agreeing to participate in the study, having completed and signed the Patient's Free and Informed Consent Form
Key exclusion criteria (9 listed)
- knee osteoarthritis limited to the patello-femoral joint
- at least one of the following diseases/conditions:
- an index knee arthroplasty within the last 6 months or a planned arthroplasty on the index knee within the next 6 months
- corticosteroids infiltration or viscosupplementation within the last 3 months
- spa therapy within the previous 6 months
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 therapyThe "RH2" rheumatology treatment protocol will propose treatments that can be carried out with water from the SL5 borehole and will be composed of: * 54 treatments among the following treatments: * Swimming pool, 15 minutes (code 201) * Bath with aerobath, 10 minutes (code 205) * Bath with immersion shower, 10 minutes (code 206) * Cataplasm in multiple local application, 10 minutes (code 408) * 18 sessions of mobilization pool, 15 minutes (code 601) | Other | Spa therapy |
Primary outcome
Number of patients with Minimal Clinically Important Improvement (MCII)
Time frame: 6 months after the end of spa therapy
Improvement from baseline of at least 9.1 points on the Western Ontario and McMaster University osteoarthritis (WOMAC) index standardized functional subscale of 0-100 and/or at least 1.99 cm on the Visual Analogue Scale (VAS) for pain without knee surgery, at 6 months. WOMAC index (functional subscale): functional assessment index for knee osteoarthritis, exploring the daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4). Visual Analogue Scale for the evaluation of knee osteoarthritis-related pain for the index knee experienced over the last eight days. The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no pain and the right end (= 10 cm) to the maximum imaginable pain. This outcome will be evaluated in the Larytherm cohort and compared to the control group of the Thermarthrose study.
12 secondary outcomes
Relative change from baseline in the WOMAC functional subscale index at the end of the spa therapy and at 6 months after the end of the spa therapy.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in the WOMAC index (full questionnaire) at the end of the spa therapy and at 6 months after the end of the spa therapy.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in the knee osteoarthritis pain measured by the Visual Analogue Scale (VAS) for pain at the end of the spa therapy and at 6 months after the end of the spa therapy.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of the spa therapy
Relative change from baseline in fatigue measured by the Visual Analogue Scale (VAS) for fatigue at the end of the spa therapy and at 6 months after the end of the spa therapy.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in Lequesne's algo-functional index at the end of the spa therapy and at 6 months after the end of the spa therapy.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in quality of life measured with the 12-item Short-Form health survey (SF12) at the end of the spa therapy and at 6 months after the end of the spa therapy.
Time frame: Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Relative change from baseline in BMI at 6 months after the end of the spa therapy.
Time frame: Baseline and 6 months after the end of spa therapy
Consumption of analgesic treatments (analgesics, chondroprotective or anti-arthritic, intra-articular injections of corticoids and hyaluronic acid, physical treatments) with a patient self-questionnaire at baseline and 6 months after the spa therapy.
Time frame: Baseline and 6 months after the end of spa therapy
Evolution from baseline of physical activity measured with the International Physical Activity Questionnaire (IPAQ-short version) at 6 months after the spa therapy.
Time frame: Baseline and 6 months after the end of spa therapy
Occurrence of episodes of joint effusion requiring puncture/infiltration during the 6 months after spa therapy.
Time frame: 6 months after the end of spa therapy
Occurrence of adverse events during spa therapy and the 6 months after spa therapy.
Time frame: End of spa therapy (week 3) and 6 months after the end of spa therapy
Occurrence of work stoppages due to knee osteoarthritis during the 6 months after spa therapy.
Time frame: 6 months after the end of spa therapy
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 20 Aug 2024.
- Results publication: PubMed 19734131Forestier 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.
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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.
Patrick Blin principal investigator
Bordeaux PharmacoEpi
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 therapy in people with Knee Osteoarthritis, run by University of Bordeaux 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 10 inclusion and 9 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 20 Aug 2024. 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?
Number of patients with Minimal Clinically Important Improvement (MCII) (time frame: 6 months after the end of spa therapy). 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 NCT05790824, which also lists 1 linked publication.
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 20 Aug 2024.