Tidal irrigation as treatment for knee osteoarthritis: a sham-controlled, randomized, double-blinded evaluation.
OBJECTIVE
To evaluate the effectiveness of tidal irrigation (TI) in comparison with a well-matched sham irrigation (SI) procedure as a treatment for knee osteoarthritis (OA).


METHODS
One hundred eighty subjects with knee OA were randomized to receive TI or SI, with clinical followup over the ensuing 12 months. The primary outcomes of interest were change in pain and function, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Subjects and the nurse assessor were blinded, and success of blinding was assessed.


RESULTS
Although the study groups were otherwise comparable, the baseline WOMAC pain and physical functioning scores were higher (worse) in the SI group. After adjustment for baseline, there were no differences between the effects of
Bradley
John D
JD
Indiana University School of Medicine, Indianapolis 46202, USA. jdbradle@iupui.edu
Heilman
Douglas K
DK
Katz
Barry P
BP
Gsell
Patricia
P
Wallick
Janine E
JE
Brandt
Kenneth D
KD
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D003646:Debridement / Q000009:adverse effects / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006073:Gout / Q000175:diagnosis; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000628:therapy*; D010147:Pain Measurement; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000379:methods*; D017211:Treatment Failure
D000894:Anti-Inflammatory Agents, Non-Steroidal