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

4. Study Diagram

5. Study Groups  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

6. Patients Spa Group N:10 Control Group N:10 Age mean (SD), Female/Male 57.3 (±11.2) 8/2 62.7 (± 8.4) 9/1 Duration of disease year, mean 22,4 23.3 Radiological grade (Lawrence & Kellgren) II. 6 patient III. 4 patient II. 7 patient III. 3 patient Drug therapy NSAID and paracetamol as needed NSAID and paracetamol as prescribed

7. Spa Therapy Balneotherapy Balneotherapy Massage Massage Milieu change Milieu change Rest Rest Free activities Free activities NSAID and analgesic as needed, changes were noted by patients 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) Twice daily (one in the morning and one in the afternoon) 30 minutes duration 30 minutes duration 36-37ºC thermal pool bathing 36-37ºC thermal pool bathing 4 patients total 20 baths 4 patients total 20 baths 4 patients total 19 baths 4 patients total 19 baths 2 patients total 18 baths 2 patients total 18 baths

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

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

11. Spa Therapy  Other Uncontrolled Factors; Resting Resting Milieu change Milieu change Regular daily ritm 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 3 month 6 month 6 month

15. Lequesne Knee İndex 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 x x x P:0,0004 P:0,006P:0,03 x x x P:0,01

16. WOMAC-total 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) x x P:0,04 x x P:0,01 x x

17. 10 Step Ascending Time (sc)  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 P:0,03 P:0,04 xx x

18. 15m walking time (sc)  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:0,03 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) x P:0,01 x x x

20. Pain-VAS  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 difference at 6 moth x x x x p:0,01 p:0,001 p:0,02 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 x x P:0,01

22. Physician’s global assessments  Significant improvement in spa group at 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) X X X X P:0,01P:0,02 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