The effect of an 8-week treatment program using a novel foot neuromuscular electrical stimulator on physical function, leg pain, leg symptoms, and leg blood flow in community-dwelling older adults: a randomized sham-controlled trial.

BACKGROUND: Neuromuscular electrical stimulation (NMES) is an established therapy that has been widely used for many decades to improve circulation in the legs. However, studies using NMES devices in an elderly, ambulant, and otherwise apparently healthy population are lacking; this is despite the use of such devices being indicated for lower leg symptoms (such as aches, pain, and cramps) that are frequently seen in older individuals. The main purpose of this study is to evaluate the effect of non-invasive foot NMES (administered using Revitive Medic©) on such symptoms compared to a sham in a 12-week period. METHODS: This is a single-center, single (participant)-blind, parallel-group, randomized, placebo-controlled (sham group), interventional study. Participants will be randomized to 1 of 3 groups (1:1:1) with each study group receiving a different type of foot NMES: Revitive sham; Revitive Medic© Program 1; or Revitive® Program 2. Each participant will be instructed to self-administer the foot NMES device for 30 min twice daily for 8 weeks. During the study, all participants will continue with their normal life, activities, medications, and diet with no restrictions. Following the 8-week NMES treatment program participants will be assessed for Canadian Occupational Performance Measure performance (COPM-P) and satisfaction (COPM-S) scores, lower leg pain, lower leg symptoms (heaviness, tiredness, aching and cramps), and blood flow volume and intensity. DISCUSSION: Revitive® foot NMES has been proven to increase blood circulation in the legs during use, which may help to relieve symptoms such as pain, heaviness, cramps, and tiredness. When NMES is applied to the plantar surface of the feet it indirectly induces contraction of the calf muscle, activating the musculo-venous pump and thus improving circulation. This study aims to provide data informing on the applicability of foot NMES for the management of leg symptoms that are likely to be indicative of poor circulation in an elderly (> 65 years) community population. TRIAL REGISTRATION: ISRCTN10576209.

Thermophysiological responses to capacitive resistive monopolar radiofrequency electromagnetic radiation in patients with osteoarthritis of the knee joint: A randomised controlled experimental study.

This study investigated the effect of 448 kHz capacitive resistive monopolar radiofrequency (CRMRF) on the superficial and deep physiological responses of patients with osteoarthritis (OA) of the knee(s). Forty-five patients diagnosed with OA in their knee(s) were enrolled into a three-group randomised controlled study, from the waiting list of a local hospital. They received localized treatment with either CRMRF, CRMRF placebo or a control (no treatment) to the knee for 15 minutes. Pre, post, and 20 min follow-up measurements of skin temperature (SKT) and skin blood flow (SBF) were obtained from the knee using the FlexComp Infiniti (SA7550) physiological measurement system. Pre and post-treatment deep blood flow were recorded using Doppler ultrasound. Core temperature, blood pressure (BP) and pulse rate (PR) were concurrently monitored. Group data were compared using the ANOVA model. Statistical significance was set at p ≤ 0.05, 0.8 power, and 95% CI. Significant increases and sustenance of SKT and SBF, and significant increases in volume and intensity of deep blood flow were demonstrated with CRMRF over the placebo and control interventions in all comparisons (p< .001). No meaningful changes in blood flow velocity, core temperature, BP, or PR were noted for any condition. The findings were markedly more pronounced than those previously reported in asymptomatic adults. However, the patients had received a higher average dose of CRMRF (mean (SD): 46.87 (4.08) W) compared to the asymptomatic sample (mean (SD): 42.37 (4.64) W); therefore, further research is needed to better understand the differences in physiological responses between patients and asymptomatic people.

Treatment using 448kHz capacitive resistive monopolar radiofrequency improves pain and function in patients with osteoarthritis of the knee joint: a randomised controlled trial.

OBJECTIVE: This study investigated whether capacitive resistive monopolar radiofrequency (CRMRF)-based treatment improves pain and function among patients with osteoarthritis of the knee. DESIGN AND SETTING: Three-group randomised controlled trial with concealed allocation, participant blinding and intention-to-treat analysis. Forty-five patients diagnosed with osteoarthritis, from the waiting list for physiotherapy at a local hospital were enrolled. INTERVENTION: Participants in the active and sham groups received eight sessions of CRMRF and sham-CRMRF respectively over four weeks, along with standard care. The control group received standard care only. ASSESSMENT: Pain and function were measured at four time points: week zero (baseline), week four (post intervention), week eight and week 16 (two follow-ups) using visual analogue scale (VAS), Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, timed up and go (TUG) test and knee range of motion (ROM). RESULTS: For pain (VAS), there were clinically significant changes in the active group at post treatment compared to sham (Mean difference: 0.79 (95% CI: 0.29 to 1.3), effect size: 1.3) and control (Mean difference: 0.82 (95% CI: 0.32 to 1.3), effect size: 1.5), and at one-month follow-up compared to control (Mean difference: 0.68 (95% CI: 0.10 to 1.3), effect size: 1.1). For function (WOMAC), there was clinically significant change in the active group at post treatment compared to control (Mean difference: 1.3 (95% CI: 0.02 to 2.6), effect size: 0.94), but not compared to sham. No meaningful differences were noted for TUG or knee ROM. No differences were noted at three-month follow-up for any outcomes. CONCLUSION: CRMRF treatment can improve pain and function in patients with knee osteoarthritis in the short term. TRIAL REGISTRATION: NIHR-CRN study ID: 20264.

Skin thermophysiological effects of 448 kHz capacitive resistive monopolar radiofrequency in healthy adults: A randomised crossover study and comparison with pulsed shortwave therapy.

Radiofrequency-based electrophysical agents (EPA) have been used in therapy practice over several decades (e.g., shortwave therapies). Currently, there is insufficient evidence supporting such devices operating below shortwave frequencies. This laboratory-based study investigated the skin physiological effects of 448 kHz capacitive resistive monopolar radiofrequency (CRMRF) and compared them to pulsed shortwave therapy (PSWT). In a randomised crossover study, seventeen healthy volunteers received four treatment conditions - High, Low and Placebo dose conditions receiving 15-min CRMRF treatment and a Control condition receiving no intervention. Fifteen participants also received high dose PSWT for comparison. Treatment was applied to the right lower medial thigh. Pre, post and 20-min follow-up measurements of skin temperature (SKT), skin blood flow (SBF) and nerve conduction velocity (NCV) were obtained using Biopac MP150 system. Group data were compared using the ANOVA model. Statistical significance was set at p ≤ 0.05 (0.8P, 95%CI). Significant increase and sustenance of SKT with both high and low dose CRMRF was demonstrated over the other groups (p < 0.001). PSWT increased SKT significantly (p < 0.001) but failed to sustain it over the follow-up. However, among the five conditions, only high dose CRMRF significantly increased and sustained SBF (p < 0.001). Overall, the CRMRF physiological responses were significantly more pronounced than that of PSWT. No significant changes in NCV were noted for any condition. Physiological changes associated with CRMRF were more pronounced when compared to PSWT, placebo or control. Any potential stronger therapeutic benefits of CRMRF need to be confirmed by comparative clinical studies.

Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults.

PURPOSE: Radiofrequency-based electrophysical agents are widely used in therapy-related clinical practice for their thermal effects, mainly relieving pain and inflammation and improving tissue extensibility. The most commonly used and researched are shortwave therapies that operate at 27.12 MHz. Although relatively new, electrophysical agents employing much lower frequencies have also emerged. Capacitive resistive monopolar radiofrequency employing 448 kHz is one such therapy. This laboratory-based study was aimed to investigate the skin thermal responses to 448 kHz radiofrequency-based therapy in healthy adults. METHODS: In a two-group randomised crossover study, 15 volunteers attended two modes (capacitive and resistive) of 448 kHz radiofrequency-based therapy (using 'Indiba Activ 902') administered locally to the lower thigh region. Starting at minimum, the intensity was increased incrementally until thermal discomfort was felt. Participants reported three time points: thermal onset, definite thermal sensation, and onset of thermal discomfort. Local skin temperature was measured before, immediately post-treatment and up to 45 min post-treatment. RESULTS: Both capacitive and resistive modes of therapy significantly increased the skin temperature and sustained it over the 45-min follow-up. There was statistically significant difference between the thermal response patterns produced by the two modes. Peak post-treatment temperatures attained were not significantly different between the two; however, the retention rate at follow-up was significantly higher for the resistive mode. CONCLUSIONS: This study confirms that radiofrequency-based therapy at 448 kHz can significantly increase and sustain skin temperature. The study also provides useful baseline data for further research in the low frequency ranges of radiofrequency-based therapy that remain largely unexplored.