Back to resultsBenefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis (LARYTHERM)
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spa therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring pain, spa therapy, functional disability
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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)
Sites / Locations
- Centre thermal de Saint-Lary SoulanRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spa therapy
Arm Description
Protocol of spa therapy in rheumatology for 3 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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.
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.
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.
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).
Relative change from baseline in BMI at 6 months after the end of the 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.
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)
Occurrence of episodes of joint effusion requiring puncture/infiltration during the 6 months after spa therapy.
Occurrence of adverse events during spa therapy and the 6 months after spa therapy.
Occurrence of work stoppages due to knee osteoarthritis during the 6 months after spa therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05790824
Brief Title
Benefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis
Acronym
LARYTHERM
Official Title
Benefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
pain, spa therapy, functional disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
External comparison study between Larytherm cohort patients and Thermarthrose control patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
171 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spa therapy
Arm Type
Experimental
Arm Description
Protocol of spa therapy in rheumatology for 3 weeks
Intervention Type
Other
Intervention Name(s)
Spa therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of patients with Minimal Clinically Important Improvement (MCII)
Description
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.
Time Frame
6 months after the end of spa therapy
Secondary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Title
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.
Description
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).
Time Frame
Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Title
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.
Description
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.
Time Frame
Baseline, end of spa therapy (week 3) and 6 months after the end of the spa therapy
Title
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.
Description
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.
Time Frame
Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Title
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.
Description
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.
Time Frame
Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Title
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.
Description
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).
Time Frame
Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy
Title
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
Title
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.
Description
The patient self-questionnaire includes yes/no questions and pre-listed options.
Time Frame
Baseline and 6 months after the end of spa therapy
Title
Evolution from baseline of physical activity measured with the International Physical Activity Questionnaire (IPAQ-short version) at 6 months after the spa therapy.
Description
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)
Time Frame
Baseline and 6 months after the end of spa therapy
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Blin, Dr
Phone
00 33 5 57 57 95 63
Email
patrick.blin@u-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laure Carcaillon-Bentata
Phone
00 33 5 57 57 95 64
Email
laure.carcaillon-bentata@u-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Blin
Organizational Affiliation
Bordeaux PharmacoEpi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre thermal de Saint-Lary Soulan
City
Saint-Lary Soulan
ZIP/Postal Code
65170
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Galaup
Phone
00 33 5 62 40 71 73
Email
stephanie.galaup@valvital.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
19734131
Citation
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.
Results Reference
result
Learn more about this trial
Benefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis
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