The Effect of Peloid Application in Out-patient Setting on Knee Osteoarthritis Results of a Pilot Study E Odabaşı, R Tekin, H Erdem, İ.Şimşek, M Turan.

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Presentation transcript:

The Effect of Peloid Application in Out-patient Setting on Knee Osteoarthritis Results of a Pilot Study E Odabaşı, R Tekin, H Erdem, İ.Şimşek, M Turan Gülhane Askeri Tıp Fakültesi, Ankara

Purpose Provide a pilot for a randomised, double-blind, controlled study to evaluate the efficacy of mud pack treatment on knee osteoarthritis in out- patient setting

Patients 19 female patients with bilateral knee osteoarthritis None of them have hip or ankle osteoarthritis, peripheral vascular disease

Mud packs Classification: Moor Origin: Sarayköy, Denizli Initial temperature: 45 o C Duration: 30 min.s/12 days Setting: In the hometown, out-patient settings

Primary Outcome Measures WOMAC Pain intensity (100 mm. VAS) Patient global assessment (5 grade scale) Physician global assessment (5 grade scale)

Response rate at least twenty-percent improvement in the primary outcome measurements AND the persistence of the improvements during the follow-up

Statistical analyses Data distribution: Shapiro-Wilks Multiple comparisons: ANOVA Significant differences between the pairs: post- hoc tests (LSD and TamhaneT2) Alpha: 0,05 Power: 0,78 (post-hoc, due to LTF cases)

Results VariableBaselineEOTFirst mo.Sixth mo.Significance* WOMAC 61,11±10,87 (55, ,34) 31,74±13,29 (25, ,14) 30,68±14,55 (23, ,70) 30,74±15,31 (23, ,12) 23,18 < 0,001 Pain Intensity 7,25±1,67 (6,44 - 8,05) 4,37±1,70 (3,55 - 5,19) 4,31±1,54 (3,56 - 5,05) 4,26±1,80 (3,40 - 5,13) 14,49 < 0,001 GA (pts) 3,47±1,07 (2,96 - 3,99) 1,68±0,58 (1,40 - 1,96) 1,58±0,61 (1,29 - 1,87) 1,58±0,69 (1,25 - 1,91) 28,17 < 0,001 GA (phy) 3,47±0,77 (3,10 - 3,85) 1,79±0,63 (1,49 - 2,09) 1,68±0,67 (1,36 - 2,01) 30,96 <0,001 All results are given as mean±SD. Numbers in paranthesis represents the CI (95%). * one-way ANOVA test.

Response Rate WOMAC : 16 / 19 Pain intensity : 13 / 19 GA (pts): 17 / 19 GA (phy) : 18 / 19