Interactive Neurostimulation Research Articles

Noninvasive Interactive Neurostimulation Therapy for the Treatment of Low-Grade Lateral Ankle Sprain in the Professional Contact Sport Athlete Improves the Short-Term Recovery and Return to Sport: A Randomized Controlled Trial

Ankle injuries are very common between professional athletes and recreational sports. Lateral stable ligaments injury can be treated conservatively. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of this prospective, double-blinded, randomized controlled trial was to compare the results in terms of improvement of a foot functional score, lower level of reported pain, and return to sports in 2 groups of contact sport athlete affected by a grade I or II lateral ankle sprain. Patients were randomized using random blocks to the NIN program (group I) or a sham device (group II). The outcome measurements were the use of a self-reported Inability Walking Scale, patient-reported subjective assessment of the level of pain using a standard visual analogue scale, and daily intake of nonsteroidal antiinflammatory drugs (etoricoxib 60 mg). Patients were also reached by telephone at 2 and 4 months of follow-up to register their return to sport activity. Beyond baseline evaluation, follow-ups were done after 5 (1 week) and 10 sessions (2 weeks) of treatment, and then at 30 days after the end of therapy. Of the 70 athletes admitted to the study, 61 eligible patients were randomized using random blocks to group I (n = 32) and group II (n = 29). Group I patients showed better improvement in terms of functional impairment (Inability Walking Scale), reported pain (visual analogue scale), and daily intake of etoricoxib 60 mg. Athletes of group I registered a faster resuming of sport activities. This prospective, randomized trial showed NIN can improve short-term outcomes in athletes with acute grade I or II ankle sprain and that it can hasten resuming of sport activities.

Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis.

Plantar fasciitis is one of the most common causes of adult heel pain. The aim of this study is to comprehensively compare the effectiveness of various therapies for plantar fasciitis using network meta-analysis. Studies were comprehensively searched on Embase, MEDLINE via PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and the Physiotherapy Evidence Database (PEDro) up to December 4, 2017. Randomized controlled trials that used extracorporeal shock wave therapy, ultrasound, ultrasound-guided pulsed radiofrequency treatment (UG-PRF), intracorporeal pneumatic shock therapy (IPST), low-level laser therapy (LLLT), and noninvasive interactive neurostimulation (NIN) for the treatment of plantar fasciitis were included. The primary outcome is change in pain relief. Risk of bias was assessed using the Cochrane risk of bias tool. Quality assessment was performed using the GRADE system. Nineteen trials with 1676 patients with plantar fasciitis plantar fasciitis were included. In the pair-wise meta-analysis, radial extracorporeal shock wave therapy (RSW), LLLT, and IPST showed a significant pooled reduction in the visual analogue scale (VAS) compared with placebo at 0 to 6 weeks [mean difference (MD) = 6.60, 95% confidence interval (CI): (6.04, -7.16); MD = 2.34, 95% CI: (1.60, 3.08); MD = 2.24, 95% CI: (1.44, 3.04), respectively]. Compared with placebo, UG-PRF [MD = 2.31, 95% CI: (1.26, 3.36)] and high-intensity focused extracorporeal shock wave (H-FSW) [MD = 0.82, 95% CI: (0.20, 1.45)] showed superior pain-relieving effects at 2 to 4 months; UG-PRF [MD = 1.11, 95% CI: (0.07, 2.15)] and IPST [MD = 4.92, 95% CI: (4.11, 5.73)] showed superior effects at 6 to 12 months. In the network meta-analysis, only RSW induced significant pain reduction compared with placebo at 0 to 6 weeks [MD = 3.67, 95% CI: (0.31, 6.9)]. No significant differences were found for the 2 to 4-month and 6 to 12-month periods because of the wide 95% CIs. We recommend treating plantar fasciitis with RSW. The commonly used ultrasound and focused extracorporeal shock wave (FSW) therapies can be considered as alternative treatment candidates. IPST, NIN, and LLLT may potentially be better alternatives, although their superiority should be confirmed by additional comprehensive evidence.PROSPERO registration number: PROSPERO (CRD42015017353).

Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study

The initial treatment of plantar fasciitis should be conservative, with most cases responding to standard physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), heel pads, and stretching. In cases of chronic refractory symptoms, more invasive treatment could be necessary. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of the present prospective randomized controlled study was to evaluate whether the use of NIN for chronic plantar fasciitis could result in greater improvement in a foot functional score, lower levels of reported pain, reduced patient consumption of NSAIDs, and greater patient satisfaction compared with electric shockwave therapy in patients without a response to standard conservative treatment. The patients were randomized using random blocks to the NIN program (group 1) or electric shockwave therapy (group 2). The outcome measurements were the pain subscale of the validated Foot Function Index (PS-FFI), patient-reported subjective assessment of the level of pain using a standard visual analog scale, and daily intake of NSAID tablets (etoricoxib 60 mg). The study group was evaluated at baseline (time 0), week 4 (time 1), and week 12 (final follow-up point). Group 1 (55 patients) experienced significantly better results compared with group 2 (49 patients) in term of the PS-FFI score, visual analog scale score, and daily intake of etoricoxib 60 mg. NIN was an effective treatment of chronic resistant plantar fasciitis, with full patient satisfaction in >90% of cases. The present prospective randomized controlled study showed superior results for noninvasive neurostimulation compared with electric shockwave therapy, in terms of the functional score, pain improvement, and use of NSAIDs.

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

ObjectiveThe purpose of this study is to evaluate the effect of treatment with a novel noninvasive interactive neurostimulation device (InterX5000) on the production of inflammatory biomarkers in chronic and recurrent mechanical neck pain (NP) syndrome. MethodsThis study represents pilot biological data from a randomized controlled clinical trial. Twenty-five NP patients and 14 asymptomatic subjects included for baseline comparison only completed the study. The patients received 6 InterX5000 or placebo treatments within 2 weeks, and pretreatment and post-treatment blood samples were collected for in vitro determination of biomarker production. Whole blood cell cultures were activated by lipopolysaccharide or by the combination of lipopolysaccharide and phytohemagglutinin for 24 to 48 hours. The levels of tumor necrosis factor α (TNFα) and its soluble type II receptor (sTNFR II), interleukin (IL) 1, IL-1 receptor antagonist (IL-1RA), IL-6, IL-10, and monocyte chemotactic protein (CCL2/MCP-1) were determined by specific immunoassays. ResultsCompared with asymptomatic subjects, baseline production levels of all proinflammatory mediators (TNFα, IL-1β, IL-6, and CCL2/MCP-1) were significantly augmented or trended higher (P = .000-.008) in patients with NP. Of the anti-inflammatory markers, only IL-1RA was significantly elevated (P = .004). The increase in IL-10 and tumor necrosis factor receptor II levels did not reach statistical significance. Neither InterX5000 nor placebo therapy had any significant effect on the production of the inflammatory mediators over the study period. ConclusionThis investigation determined that inflammatory cytokine pathways are activated in NP patients but found no evidence that a short course of InterX5000 treatment normalized the production of inflammatory biomarkers.

Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis

To investigate the efficacy of different electrical stimulation (ES) therapies in pain relief of patients with knee osteoarthritis (OA). Electronic databases including MEDLINE, Embase and Cochrane Library were searched through for randomized controlled trials (RCTs) comparing any ES therapies with control interventions (sham or blank) or with each other. Bayesian network meta-analysis was used to combine both the direct and indirect evidence on treatment effectiveness. 27 trials and six kinds of ES therapies, including high-frequency transcutaneous electrical nerve stimulation (h-TENS), low-frequency transcutaneous electrical nerve stimulation (l-TENS), neuromuscular electrical stimulation (NMES), interferential current (IFC), pulsed electrical stimulation (PES), and noninvasive interactive neurostimulation (NIN), were included. IFC is the only significantly effective treatment in terms of both pain intensity and change pain score at last follow-up time point when compared with the control group. Meanwhile, IFC showed the greatest probability of being the best option among the six treatment methods in pain relief. These estimates barely changed in sensitivity analysis. However, the evidence of heterogeneity and the limitation in sample size of some studies could be a potential threat to the validity of results. IFC seems to be the most promising pain relief treatment for the management of knee OA. However, evidence was limited due to the heterogeneity and small number of included trials. Although the recommendation level of the other ES therapies is either uncertain (h-TENS) or not appropriate (l-TENS, NMES, PES and NIN) for pain relief, it is likely that none of the interventions is dangerous. LevelⅡ, systematic review and network meta-analysis of RCTs.

The Effect of Interactive Neurostimulation Therapy on Myofascial Trigger Points Associated with Mechanical Neck Pain: A Preliminary Randomized, Sham-Controlled Trial

This trial was conducted to assess the effectiveness of interactive neurostimulation (INS) therapy on the treatment of pain associated with myofascial trigger points (MTPs) in adults with mechanical neck pain. This was a preliminary, randomized, sham-controlled trial. The trial was conducted in a tertiary-care institution. The participants were 23 adults with pain and MTPs in the neck or shoulder lasting>2 weeks. INS (active or sham) was delivered for 10 minutes in a single session over the MTP area in each patient. Immediately following the intervention, subjects were tested for pressure pain thresholds (PPTs) and 10-cm visual analogue scale score (VAS) for pain intensity. At the 5 day follow-up, two additional tests were performed: the neck disability index (NDI) and the patient specific functional scale (PSFS) for function. Improvements in function (PSFS) were observed in the treatment group, which were of clinical significance in selected subjects. These effects were statistically greater than those obtained in the sham group but were overall not at a level of clinical significance in this small population. Improvements in pain intensity (VAS) and neck disability (NDI) were observed in both the treatment and sham groups, indicating that INS had no greater benefit using these measures. There was no change in PPTs following either the active or sham treatment. INS is a new and emerging therapy, which may be efficacious for managing musculoskeletal conditions, such as myofascial pain syndrome. This study demonstrated improvements in function in individuals with MTPs following INS therapy, which may be of clinical significance in certain patients with neck or shoulder pain. Further large-scale clinical trials are required to confirm this effect and to determine if INS also reduces pain and neck disability.

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

Non-invasive interactive neurostimulation (InterX(®)) delivers high amplitude electrical pulsed currents at points of low impedance on the skin. This study compared the hypoalgesic effect of non-invasive interactive neurostimulation with transcutaneous electrical nerve stimulation (TENS). A repeated measures parallel group study on healthy human volunteers randomized to receive strong non-painful TENS or non-invasive interactive neurostimulation for 21 min on the forearm (N= 10/group). Pressure algometry was used to determine blunt pressure pain threshold at baseline, 10, and 20 min during stimulation, and 5 min post stimulation. Low impedance sites were found in half of the participants receiving non-invasive interactive neurostimulation. ANOVA found no effects for intervention (p= 0.923), time × intervention interaction (p= 0.21), or time (p= 0.094). Given the limited power of this study, we show that there were no significant differences in hypoalgesia between non-invasive interactive neurostimulation and TENS. Unlike our previous studies we also failed to detect a change pain threshold during TENS. Nevertheless, our findings can be used to inform the design of an appropriately powered study on pain patients.

Non-invasive interactive neurostimulation (InterX ™) reduces acute pain in patients following total knee replacement surgery: a randomised, controlled trial

BackgroundAdequate post-operative pain relief following total knee replacement (TKR) is very important to optimal post-operative recovery. Faster mobilisation and rehabilitation ultimately results in optimum recovery outcomes, but pain is often the limiting factor. This study evaluates the potential clinical benefit of the InterX neurostimulation device on pain reduction and rehabilitative outcome.MethodsA clinical trial under the Hywel Dda Clinical Audit Committee to validate the clinical benefit of Non-invasive Interactive Neurostimulation (NIN) therapy using the InterX device was performed in patients undergoing TKR. 61 patients were randomised to treatment groups in blocks of two from the Theatre Operation List. The control group received the standard hospital course of pain medication and rehabilitation twice daily for 3 post-op days. The experimental group received 8 sessions of NIN therapy over 3 post-op days in addition to the standard course received by the Control group. Pain and range of motion were collected as the primary study measures.ResultsSixty one subjects were enrolled and randomised, but 2 subjects (one/group) were excluded due to missing data at Baseline/Final; one subject in the InterX group was excluded due to pre-existing rheumatoid pain conditions confounding the analysis.The experimental group pre- to post-session Verbal Rating Scale for pain (VRS) showed that NIN therapy consistently reduced the pain scores by a mean of 2.3 points (SE 0.11). The NIN pre-treatment score at Final was used for the primary ANCOVA comparison, demonstrating a significantly greater cumulative treatment effect of a mean 2.2 (SE 0.49) points pain reduction (p = 0.002). Control subjects only experienced a mean 0.34 (SE 0.49) point decrease in pain. Ninety degrees ROM was required to discharge the patient and this was attained as an average despite the greater Baseline deficit in the InterX group. Eight control patients and three experimental patients did not achieve this ROM.ConclusionsThe results clearly demonstrated the clinical benefit of NIN therapy as a supplement to the standard rehabilitation protocol. The subjects receiving InterX fared significantly better clinically. Within a relatively short 3-day period of time, patients in the experimental group obtained the necessary ROM for discharge and did it experiencing lower levels of pain than those in the control group.

Use of Noninvasive Interactive Neurostimulation to Improve Short-Term Recovery in Patients with Surgically Repaired Bimalleolar Ankle Fractures: A Prospective, Randomized Clinical Trial

We undertook a trial with 60 patients who had undergone operative reduction and internal fixation of bimalleolar, AO type B2 ankle fractures with comminution. Patients were randomized into 2 groups, one of which received postoperative treatment using a noninvasive interactive neurostimulation device (InterX ®) and the other with a sham device. The trial was designed to test the hypothesis that incorporation of noninvasive interactive neurostimulation into the rehabilitation protocol would result in reduced pain, increased range of motion, reduced edema, and reduced consumption of pain medication, in comparison with the sham therapy group. Outcome measurements included the patient's subjective assessment of level of pain, range of motion, and the extent of edema in the involved ankle, and the use of ketorolac for postoperative control of pain. The results showed significantly better results in the patients receiving treatment with active neurostimulation (repeated measures analysis of variance, P < .001).

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

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. Randomized, sham-controlled trial. A university in the southern United States. Thirty-seven (37) adults with knee osteoarthritis (based on American College of Rheumatology diagnostic criteria). Seventeen (17) noninvasive interactive neurostimulation (active or sham) sessions over 8 weeks with a week 12 follow-up. 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. 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. 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.

Non-invasive interactive neurostimulation in the post-operative recovery of patients with a trochanteric fracture of the femur

We undertook a trial on 60 patients with AO 31A2 fractures of the hip who were randomised after stabilisation of the fracture into two equal groups, one of which received post-operative treatment using a non-invasive interactive neurostimulation device and the other with a sham device. All other aspects of their rehabilitation were the same. The treatment was continued for ten days after operation. Outcome measurements included the use of a visual analogue scale for pain, the brief pain inventory and Ketorolac for post-operative control of pain, and an overall assessment of outcome by the surgeon. There were significantly better results for the patients receiving treatment by active electrical stimulation (repeated measures analysis of variance, p < 0.001). The findings of this pilot trial justify a larger study to determine if these results are more generally applicable.