Effect of footplate neuromuscular electrical stimulation on functional and quality-of-life parameters in patients with peripheral artery disease: pilot, and subsequent randomized clinical trial

Abstract

Background Supervised exercise programmes for intermittent claudication have poor access and limited compliance. Neuromuscular electrical stimulation (NMES) may be an effective alternative. A proof‐of‐concept study and RCT were conducted. Methods In study 1, eligible patients underwent baseline assessment; treadmill testing for initial (ICD) and maximum (MCD) claudication distance; EuroQoL Five Dimensions five‐level instrument (EQ‐5D‐5L™) and Intermittent Claudication Questionnaire (ICQ) assessment; and measurement of ultrasound haemodynamics of the superficial femoral artery. After familiarization with the NMES device, participants underwent a 30‐min session of stimulation with concomitant recording of haemodynamic measures at 15 min, and after device cessation. Measurements were repeated after 6 weeks of daily use of NMES. In study 2, consecutive patients underwent baseline assessment before online randomization to a supervised exercise programme only, or adjunctive NMES treatment for 6 weeks, followed by repeat measurements. Results Study 1 (20 patients) showed a significant improvement in MCD (46 per cent; P < 0·001) and ICD (71 per cent; P < 0·001). The RCT (42 patients) showed a significant adjunctive benefit of NMES in ICD (46 per cent; P = 0·014). Improvements were seen in the ICQ (9 points; P = 0·009) and EQ‐5D‐5L™ (P = 0·007) in study 1, and there was a significant adjunctive benefit of NMES on the ICQ score in patients who did supervised exercise (11·2 points; P = 0·031). Blood volume flow and time‐adjusted mean velocity increased significantly with the device on (P < 0·050). Overall, NMES compliance exceeded 95 per cent. Conclusion Footplate NMES significantly improved walking distance in patients with intermittent claudication when used independently and also as an adjunct to supervised exercise. Registration number: trial 1, NCT02436200; trial 2, NCT02429310 (http://www.clinicaltrials.gov).

Effects of combining electrical stimulation of the calf and thigh muscles in patients with osteoarthritis of the knee: protocol for a double-blind, randomised, sham-controlled trial

“…The device consists of electrodes for quadriceps stimulation and footplate electrodes for stimulation of the calf and foot. The footplate has previously been investigated for its influence on peripheral artery disease and chronic venous disease and was found to significantly improve circulation and walking distance 32 33. These investigations did not include quadriceps stimulation and there have been no investigations into the effects of the device for KOA.…”

Neuro-Muscular Dentistry: the “diamond” concept of electro-stimulation potential for stomato-gnathic and oro-dental conditions

“…The RCT study later used the same treatment protocol and found a significant adjunctive benefit of NMES to supervised exercise program alone for ICD. The QoL survey results also improved significantly in both studies when using/applying NMES [34].…”

A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status

“…23 Recent publications have asessed its use in claudicants. 38,39 Despite limitations of the pilot data, mainly pertaining the small sample size, the positive results compared to a sham device were encouraging. Previous work has suggested that graduated compression stockings (GCS) worn for 6 hours have a significantly larger effect on limb volume compared to this NMES device (a single session of 30 minutes of treatment).…”