Effects of Noninvasive Interactive Neurostimulation on Symptoms of Osteoarthritis of the Knee: A Randomized, Sham-Controlled Pilot Study

Abstract

Objective To explore the effects of noninvasive interactive neurostimulation used as an adjunct to usual care, on pain and other symptoms in adults with osteoarthritis of the knee. Design Randomized, sham-controlled trial. Setting A university in the southern United States. Subjects Thirty-seven (37) adults with knee osteoarthritis (based on American College of Rheumatology diagnostic criteria). Interventions Seventeen (17) noninvasive interactive neurostimulation (active or sham) sessions over 8 weeks with a week 12 follow-up. Outcome measures Eleven-point numeric rating scale for weekly pain; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), patient global assessment, and Short-Form Health Survey (SF-36) completed at baseline and weeks 4, 8, and 12. Results For the main outcome, pain, the differences between the groups over time did not reach statistical significance (all p > 0.05). However, a clinically important reduction in pain (defined as a 2-point or 30% reduction on an 11-point numeric rating scale) was maintained at week 12 by the active noninvasive interactive neurostimulation group (2.17 points, 34.55% reduction) but not the sham group (1.63, 26.04% reduction). Pain improved over time in participants regardless of group membership (numeric rating scale average pain, p = 0.002; numeric rating scale worst pain, p < 0.001; and WOMAC pain, p < 0.001), as did WOMAC function, WOMAC stiffness, and WOMAC total score (all p < 0.001). Repeated measures ANOVA revealed a statistically significant difference between the groups over time for the SF-36 Vitality scale, F (3, 105) = 3.54, p = 0.017. In addition, the active device group improved on the patient global assessment from baseline to week 8 compared to the sham device group, F (1, 35) = 4.025, p = 0.053. Conclusions In this pilot study, clinically important reductions in knee pain were maintained at week 12 in the active, but not the sham, noninvasive interactive neurostimulation group. Further study of this noninvasive therapy is warranted.

Effect of Interactive Neurostimulation Therapy on Inflammatory Response in Patients With Chronic and Recurrent Mechanical Neck Pain

“…19 It is difficult to reconcile the negative findings of our study with published reports of reduced pain, increased pain threshold, or improved functional scores in NP patients in response to treatment with the InterX or a similar device-the ENAR (Electro Neuro Adaptive Regulator). [20][21][22] According to 1 report, after twelve 15-minute sessions with ENAR over a 6-week period, patients reported a significant reduction in the intensity of NP and improved NDI and Patient-Specific Functional Scale (PSFS) scores measured up to 24 weeks post-treatment. 22 In agreement with our findings, Schabrun et al 7 reported no changes in pain or NDI scores in their study of InterX effects on patients with chronic NP, although improvements in the Patient-Specific Functional Scale scores were observed 5 days after a single 10-minute application of InterX.…”

A Comparison of the Hypoalgesic Effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Non-invasive Interactive Neurostimulation (InterX®) on Experimentally Induced Blunt Pressure Pain Using Healthy Human Volunteers

“…Selfe et al. (7) found that non‐invasive interactive neurostimulation scored better than a sham (no current) device for SF‐36 Vitality scale and patient global assessment, but not pain, in 37 patients with knee osteoarthritis. Gorodetskyi et al.…”

“…Manufacturers claim that non‐invasive interactive neurostimulation relieves pain and promotes healing of various injuries (6). All three randomized controlled clinical trials published to date have demonstrated superiority for non‐invasive interactive neurostimulation over placebo (i.e., a no current sham device) for knee osteoarthritis (7), postoperative recovery from bone fractures (8) and operative reduction and internal fixation of bimalleolar, AO type B2 ankle fractures (9).…”

Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomised, placebo- and active-controlled trial

“…Major secondary efficacy end‐points included changes from baseline in (i) the responder rate in average OAPI to the end of the DB phase (16 weeks) or to the cutoff date, whichever was earlier; (ii) ≥ 30% or ≥ 50% improvement in average OAPI to the end of weeks 12 and 16; (iii) average OAPI and WOMAC 3.1 Global Score, and subscales (pain, stiffness and physical function) to the end of weeks 2, 4, 8, 12 and 16; and (iv) Patient Global Assessment (11‐point NRS, 0 = very good; 10 = very bad) score to the end of weeks 4 and 16. The sponsor adapted the wording from Patient Global Assessments used in other studies .…”