| Purpose. The purpose of this 12 week pilot study was to explore the effects of an electrical simulation device, the InterX 5000(TM), on pain and other symptoms in adults with osteoarthritis of the knee.; Methods. This randomized, sham controlled, single blind clinical trial explored the effectiveness of InterX 5000(TM) therapy, when used in addition to usual care, on reducing symptoms of osteoarthritis of the knee. Participants were scheduled for 17 device sessions over 8 weeks, plus a Week 12 follow-up visit.; Sample. Participants (N = 37) ranging in age from 50 to 91 years of age were recruited from the Charlottesville, Virginia area by local newspaper ads, flyers and brochures.; Measures. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to measure knee pain, function, and stiffness. The primary outcome, knee pain, was also measured using an 11-point numeric rating scale. A patient global assessment of the degree to which arthritis impacted the participant was included. The SF-36 was used to measure health-related quality of life.; Results. Repeated measures ANOVA revealed a statistically significant (p = .02) group by time interaction for the SF-36 Vitality scale. Simple contrast tests revealed a between group difference from Week 0 to Week 8 for Patient Global Assessment (p = .053). There was a main effect for time for the following: WOMAC pain, function, stiffness, and total; NRS average and worst pain; patient global assessment; and 4 of 8 SF-36 scales. The percent improvement in the active device group was comparable to that seen in larger studies with statistically significant differences between groups across time.; Conclusions. Adjunctive InterX therapy was not shown to be statistically superior to sham therapy in reducing knee pain, dysfunction, or stiffness in participants with osteoarthritis of the knee. Even so, the patient assessment of overall impact of arthritis improved significantly more for the active versus sham device group. Further study of a larger sample using a three group design (active, sham, and standard care) with more frequent treatment over a longer intervention period is recommended. Use of a self-treatment device would make this more intensive treatment feasible. |
