Efectivness of Spa Therapy in Severe Knee Osteoarthritis; Randomize Controlled Trial

1. Efectivness of Spa Therapy in Severe Knee Osteoarthritis; Randomize Controlled Trial Mine Karagülle,MD Istanbul, Turkey

2. Objective • We aimed to determine effectiveness of spa therapy during short and long term on pain and function in severe knee osteoarthritis

3. Study Design • Prospective • Randomized • Controlled • Assessor blinded • Follow-up 6 month • A pilot study

5. Spa Group (n:10) Spa Therapy: 10-day stay at spa hotel Süzer Paradise Hotel, Alaçatı, İzmir Control Group (n:10) Routine outpatient care: drug therapy (NSAID’s and Paracetamol) and counseling at Outpatient Clinic Istanbul Medical Faculty Study Groups

7. Spa Therapy • Balneotherapy • Massage • Milieu change • Rest • Free activities • NSAID and analgesic as needed, changes were noted by patients

8. Spa Therapy • Balneotherapy; Thermomineral water (brine; % 3 NaCl) • Twice daily (one in the morning and one in the afternoon) • 30 minutes duration • 36-37ºC thermal pool bathing • 4 patients total 20baths • 4 patients total 19 baths • 2 patients total 18 baths

9. Spa Therapy • Massage; • 4 patients = none • 3 patients = 5 times • 3 patients = 1 times

10. Spa Therapy • Drug use; • 1 patient NSAID • 1 patient paracetamol

11. Spa Therapy • Other Uncontrolled Factors; • Resting • Milieu change • Regular daily ritm

12. Routine outpatient care • NSAID’s • Paracetamol • Medical advice

13. Outcome Measures • Lequesne Knee index • WOMAC OA index • Pain (VAS) • Patient’s global assessment (VAS) • Physician’s global assessment (VAS) • 10 step ascending time (second) • 15m walking time (second) • 3 times squatting time (second)

14. Outcome Measures • Baseline • End of spa therapy (2 - 3 days later) • Long term • 3 month • 6 month

15. Lequesne Knee İndex • Significant improvement in spa group at the end of spa therapy, at 3 and 6 month • Significant improvement in control group only at 6 month (per protocol analyse) • No significant difference at 6 month between two groups P:0,0004 P:0,03 P:0,006 x x P:0,01 x x x x

16. WOMAC-total • Significant reduction of WOMAC scores in spa group at all assessments • Spa group is superior at end of spa therapy and 3 month compared to control group • Significant reduction in control group only at 6 month(per protocol analyse) P:0,04 P:0,01 x x P:0,01 x x x x

17. 10 Step Ascending Time (sc) P:0,04 P:0,03 • Significant improvement in spa group at end of spa therapy and 3 month • Worsening in control group is not significant • No difference between two study groups x x x

18. 15m walking time (sc) P:0,01 P:0,03 • Improvement in spa group, significant at end of spa therapy and 3 month • No significant change in control group • Spa group is significantly superior at 3 month compared to control group, no difference at 6 month P:0,01 x x x x x

19. 3 times squatting time (sc) • Improvement in spa group at all measures,significant at 6 month • Worsening in control group, not significant • Spa group is superior to control group, significant at 3 month (per protocol analyse) P:0,01 x x x x

20. Pain-VAS p:0,02 • Significant reduction in spa group at all assessments • Significant increase in control group at 3 month • Spa group is superior in reducing pain significantly at the end of spa therapy and 3 month, no significant differenceat 6 moth x p:0,01 x p:0,001 x x x x

21. Patient’s Global Assessments • Improvement in spa group at all assessments,significant at 3 and 6 months • No significant change in control group • Spa group is significantly superior in improvement at 3 month compared to control group P:0,01 x x

22. Physician’s global assessments • Significantimprovement inspa groupat all measurements • Significant superiority in spa group over routine therapy group at end of spa therapy, and 3 and 6. months • Significant improvement in control group only at 6 month (per protocol analyse) P:0,04 P:0,01 P:0,02 X X X X P:0,04 X X X X

23. Conclusion • In this pilot study we showed that 10 days spa therapy is effective in short and medium term up to 6 month in reducing pain and improving function of the patients with severe osteoarthritis of the knee

24. Conclusion • Inter group comparison showed that spa therapy group is superior to control group in most outcome measures • Routine out patient care has limited efficacy in reducing pain and improving function in patients with severe osteoarthritis

25. Conclusion • This type of spa therapy could be used as an adjunct or an alternative treatment modality to routine outpatient care in patients with severe knee osteoarthritis • However, it is needed further well designed randomised controlled clinical trials with a higher number of patients having sufficient statistical power

26. Further perspectives • Investigating the population effectiveness and cost-effectiveness of this kind of spa therapy is to be determined in further studies • Effectiveness of this kind of spa therapy in delaying the joint replacement surgery should also be determined

27. Thank you Teşekkür ederim Közsenöm sepa