TY - JOUR
T1 - A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee
AU - Garland, D.
AU - Holt, P.
AU - Harrington, J. Timothy
AU - Caldwell, J.
AU - Zizic, T.
AU - Cholewczynski, J.
N1 - Funding Information:
Supported by a grant from BioniCare Medical Technologies, Inc.
PY - 2007/6
Y1 - 2007/6
N2 - Objective: To investigate the efficacy and safety of a capacitively coupled, pulsed electrical stimulation device in treating knee osteoarthritis (OA). Design: Fifty-eight outpatients with moderate to severe OA of the knee entered a 3-month, double-blind, placebo-controlled trial, using either an active or placebo device at home for 6 to 14 h/day. Outcome measures included a patient global evaluation, a patient report of knee pain severity, and the Western Ontario and McMaster Universities (WOMAC) questionnaire. Results: Active treatment provided superior outcomes between baseline and 3-month follow-up measurements: 50.6% greater improvement than placebo in patient global (P = 0.03), 31.2% in patient pain (P = 0.04), 25.1% in WOMAC stiffness (P = 0.03), 29.5% in WOMAC function (P = 0.01), 19.9% in WOMAC pain (P = 0.11), and 27% in total WOMAC (P = 0.01). The percent of patients who improved by more than 50% was 38.5 active vs 5.3 placebo in patient global (P = 0.01), 43.6 vs 15.8 in patient pain (P = 0.04), 38.5 vs 10.5 in WOMAC pain (P = 0.03), 28.2 vs 5.3 in WOMAC stiffness (P = 0.08), 23.1 vs 5.3 in WOMAC function (P = 0.14), and 23.1 vs 5.3 in total WOMAC (P = 0.14). Twenty-one percent of placebo and 18% of actively treated patients developed a transient rash at the electrode sites. No other adverse device effects were reported. Conclusion: A highly optimized, capacitively coupled, pulsed electrical stimulus device significantly improved symptoms and function in knee OA without causing any serious side effects.
AB - Objective: To investigate the efficacy and safety of a capacitively coupled, pulsed electrical stimulation device in treating knee osteoarthritis (OA). Design: Fifty-eight outpatients with moderate to severe OA of the knee entered a 3-month, double-blind, placebo-controlled trial, using either an active or placebo device at home for 6 to 14 h/day. Outcome measures included a patient global evaluation, a patient report of knee pain severity, and the Western Ontario and McMaster Universities (WOMAC) questionnaire. Results: Active treatment provided superior outcomes between baseline and 3-month follow-up measurements: 50.6% greater improvement than placebo in patient global (P = 0.03), 31.2% in patient pain (P = 0.04), 25.1% in WOMAC stiffness (P = 0.03), 29.5% in WOMAC function (P = 0.01), 19.9% in WOMAC pain (P = 0.11), and 27% in total WOMAC (P = 0.01). The percent of patients who improved by more than 50% was 38.5 active vs 5.3 placebo in patient global (P = 0.01), 43.6 vs 15.8 in patient pain (P = 0.04), 38.5 vs 10.5 in WOMAC pain (P = 0.03), 28.2 vs 5.3 in WOMAC stiffness (P = 0.08), 23.1 vs 5.3 in WOMAC function (P = 0.14), and 23.1 vs 5.3 in total WOMAC (P = 0.14). Twenty-one percent of placebo and 18% of actively treated patients developed a transient rash at the electrode sites. No other adverse device effects were reported. Conclusion: A highly optimized, capacitively coupled, pulsed electrical stimulus device significantly improved symptoms and function in knee OA without causing any serious side effects.
KW - Knee osteoarthritis
KW - Pulsed electrical stimulation treatment
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U2 - 10.1016/j.joca.2007.01.004
DO - 10.1016/j.joca.2007.01.004
M3 - Article
C2 - 17303443
AN - SCOPUS:34248581862
VL - 15
SP - 630
EP - 637
JO - Osteoarthritis and Cartilage
JF - Osteoarthritis and Cartilage
SN - 1063-4584
IS - 6
ER -