Osteoarthritis, Knee Clinical Trial
— CONTREXEVILLEOfficial title:
Clinical Evolution of Patients Suffering From Lower Limb Rheumatological Conditions 6 Months After Spa Treatment
Verified date | April 2019 |
Source | SAEML Contrexéville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
1. Primary outcome measure: measuring the effect of spa treatment in patients suffering
from lower limb osteoarthritis or any other lower limb rheumatological condition.
Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS)
or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) improvement
of at least 9 points (minimal clinically important difference), 6 months after
enrollment.
Secondary outcome measures:
2. Measuring the effect of spa treatment in patients with concomitant chronic lower back
pain.
Percentage of patients presenting clinical benefits according to the EIFEL score, with a
decrease of at least 5 points, 6 months after enrollment.
3. Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6
months after spa treatment.
4. Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment
and 6 months after spa treatment.
5. Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment
and 6 months after spa treatment.
6. Impact of spa treatment on the patient's metabolism. Height and weight (BMI
calculation), blood pressure and heart rate measured at enrollment and throughout the
follow-up.
7. 8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D)
questionnaires at enrollment, 3 months and 6 months.
9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and
6 months.
10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the
medical visit at enrollment, 3 months and 6 months.
11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more
precise time frame of the treatment's effect.
Status | Active, not recruiting |
Enrollment | 150 |
Est. completion date | August 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient presenting an indication for rheumatological spa treatment - Patient with osteoarthritis or other rheumatic disease, located on the lower limbs with or without chronic lower back pain. - Functional impairment with reduced mobility - Life expectancy > 6 months - VAS pain evaluation > 30 mm - Available for a 6-months follow-up and an 18-days spa treatment - Affiliation to the French social security system or equivalent - Patient living within 100 kms of recruitment center Exclusion Criteria: - Patient having already underwent a spa treatment for rheumatic indication 6 months within enrollment - Pregnancy, parturient or breast feeding - Psychiatric illness or social situation that would preclude study compliance - Predictable intolerance to thermal treatment (immunodeficiency, advanced cardiopathy, active cancer, active pulmonary tuberculosis, severe renal failure, cirrhosis, advanced dementia and severe mental conditions) |
Country | Name | City | State |
---|---|---|---|
France | Conrozier | Belfort | |
France | BAUER | Nancy | |
France | Perrier Cornet | Nancy | |
France | Jeanmaire | Neufchâteau |
Lead Sponsor | Collaborator |
---|---|
SAEML Contrexéville | TIMC-IMAG |
France,
Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. Review. — View Citation
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40. — View Citation
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. — View Citation
Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20. — View Citation
Constant F, Guillemin F, Collin JF, Boulangé M. Use of spa therapy to improve the quality of life of chronic low back pain patients. Med Care. 1998 Sep;36(9):1309-14. — View Citation
Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB. [French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire)]. Rev Rhum Ed Fr. 1993 May;60(5):335-41. French. — View Citation
Driscoll T, Jacklyn G, Orchard J, Passmore E, Vos T, Freedman G, Lim S, Punnett L. The global burden of occupationally related low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):975-81. doi: 10.1136/annrheumdis-2013-204631. Epub 2014 Mar 24. — View Citation
Elkayam 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. — View Citation
Evcik D, Kizilay B, Gökçen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. Epub 2002 Mar 29. — View Citation
Forestier R, Desfour H, Tessier JM, Françon 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. — View Citation
Franke 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. — View Citation
Grotle M, Brox JI, Vøllestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine (Phila Pa 1976). 2004 Nov 1;29(21):E492-501. — View Citation
Guillemin F, Constant F, Collin JF, Boulange M. Short and long-term effect of spa therapy in chronic low back pain. Br J Rheumatol. 1994 Feb;33(2):148-51. — View Citation
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. — View Citation
Konrad 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. — View Citation
Leplège 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. — View Citation
Levy E, Ferme A, Perocheau D, Bono I. [Socioeconomic costs of osteoarthritis in France]. Rev Rhum Ed Fr. 1993 Jul;60(6 Pt 2):63S-67S. French. — View Citation
Marty M, Courvoisier D, Foltz V, Mahieu G, Demoulin C, Gierasimowicz A, Norberg M, de Goumoëns P, Cedraschi C, Rozenberg S, Genevay S; Section Rachis de la Société Française de Rhumatologie. How much does the Dallas Pain Questionnaire score have to improve to indicate that patients with chronic low back pain feel better or well? Eur Spine J. 2016 Jan;25(1):304-9. doi: 10.1007/s00586-015-3957-3. Epub 2015 Apr 23. — View Citation
Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010 Sep;19(9):1484-94. doi: 10.1007/s00586-010-1353-6. Epub 2010 Apr 17. — View Citation
Neumann 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. — View Citation
Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. — View Citation
Sun SF, Hsu CW, Lin HS, Liou IH, Chen YH, Hung CL. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety. J Bone Joint Surg Am. 2017 Mar 15;99(6):462-471. doi: 10.2106/JBJS.16.00469. — View Citation
Tubach 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 changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005 Jan;64(1):29-33. Epub 2004 Jun 18. — View Citation
Tubach 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. Epub 2004 May 6. — View Citation
Van Tubergen A, Boonen A, Landewé R, Rutten-Van Mölken 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. — View Citation
van Tubergen A, Landewé R, van der Heijde D, Hidding A, Wolter N, Asscher M, Falkenbach A, Genth E, Thè 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. — View Citation
Verhagen 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. Review. Update in: Cochrane Database Syst Rev. 2003;(4):CD000518. — View Citation
Ware 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. — View Citation
Woodforde JM, Merskey H. Some relationships between subjective measures of pain. J Psychosom Res. 1972 Jun;16(3):173-8. — View Citation
* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of spa treatment on lower limb osteoarthritis | Percentage of patients with a WOMAC score improvement of 9 or more points and/or with a decrease in VAS of at least 19,9 mm (minimal clinically important difference) | At 6 months | |
Secondary | Effect of spa treatment on lower back pain | Percentage of patients with an EIFEL score decrease of at least 5 points | At 6 months | |
Secondary | Quantitative evaluation of pain | Comparison of mean VAS (Visual Analogic Scale from 0 to 10) pain scale | At baseline and 6 months | |
Secondary | Quantitative evaluation of WOMAC | Comparison of mean WOMAC questionnaire | At baseline and 6 months | |
Secondary | Quantitative evaluation of EIFEL | Comparison of mean EIFEL questionnaire | At baseline and 6 months | |
Secondary | Patient BMI | BMI evolution will be recorded (size, weight) | At baseline, 3 and 6 months | |
Secondary | Global quality of life | SF36 (The Short Form (36) Health Survey) questionnaire will be recorded. The SF36 questionnaire includes 36 questions from which eight dimensions and two aggregate scores (the physical dimension and the psychic dimension) are calculated. The correction of the missing data and the different methods of adjustment and calculation of the scores will be carried out according to the procedure recommended by the manual. The scores of the different dimensions range from 0: less good health and 100: the best. | At baseline, 3 and 6 months | |
Secondary | Health quality of life | EQ5D questionnaire will be recorded. EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ5D has 6 items intended to measure general health. The top 5 rate mobility, independence, daily activities, pain / discomfort, and anxiety / depression, and are rated according to 3 values from "No problem" to "Problem" or "Incapacity". This results in an index score. The last item deals with perceived health on the day the questionnaire is filled in and uses a visual analogue scale from 0 (worst) to 100 (best health possible) (Visual Analog Scale Score). | At baseline, 3 and 6 months | |
Secondary | Doctor / patient opinions | Semi-quantitative scale in 7 points collected will be recorded. This is a semi-quantitative evaluation of the effect of the cure on the state of health of the patient by the patient himself and the same questions by the doctor. Responses will be grouped into 3 classes: aggravated / neither aggravated nor improved / improved. The numbers and percentages of each answer will be calculated | At baseline, 3 and 6 months | |
Secondary | Treatment follow-up | Description of treatments consumption by the patient at baseline, 3 and 6 months. To avoid any risk of confusion, drug consumption will be related to daily consumption. Drug use for 72 hours (day before and before the day of visit, day of visit: d-2, d-1, D0) | At baseline, 3 and 6 months | |
Secondary | Self evaluation of pain | Visual Analogic Scale (from 0 to 10) evaluation by patients | With investigator at baseline, 3 and 6 months. Auto evaluation at 1.5 months and 4.5 months. |
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