15 Aug The effect of Neuromuscular Electrostimulation (NMES) on VTE prevention and oedema reduction for enhanced recovery after orthopaedic surgery (ERAS)
In 2005, the House of Commons (HoC) Health Committee stated deaths attributed to preventable, hospital-acquired venous thromboembolism (VTE) numbered upwards of 25,000 per annum. Nationwide prevention of VTE became the topic of a major health campaign. The HoC Health Committee stated there was an unstratified VTE risk of between 45% and 51% associated with orthopaedic surgery1 – with VTE risk in upper limb surgery reported as lower in the literature.
Whatever the VTE relative risk in the lower limbs, the national prevention campaign remains a government focus, and alongside it within industry also, with the introduction of MedTech innovations that can prevent life-threatening blood clots, and more recently, a groundbreaking innovation that can reduce post-operative oedema also (the medical term for swelling) – a common complication following orthopaedic surgery, that can also be a symptom of VTE – further enabling the drive, with orthopaedics, for Enhanced Recovery After Surgery (ERAS).
The innovation in question is the clinically proven geko™ device. Small-in-size, the geko™ device is a self-adhesive, wearable neuromuscular electro stimulator that is applied to the surface of the skin just below the knee, over the head of the fibula bone. It delivers a gentle electrical pulse, once per second to the common peroneal nerve, activating the calf and foot muscle pumps to increase blood flow in the deep veins of the calf2 where early thrombosis forms. This is equal at a rate of 60% of walking3 without a patient having to move – effectively replicating the effects of exercise.
Two studies that demonstrate efficiency of the OnPulse™ Technology embedded in the geko™ device have been conducted by Wainwright et al. (2019, 2020): study one investigates the effects of the geko™ device versus standard of care in the prevention of DVT in patients recovering from elective total hip replacement surgery; study two investigates the firefly™ device (a product variant of the geko™ device, developed for elite sport recovery), to determine the efficacy of OnPulse™ technology to reduce oedema following acute ankle sprain.
Study one – DVT (Deep Vein Thrombosis) prevention in hip replacement patients
This single-centre, randomised, open-label study explored the post-operative recovery of 28 patients who had undergone elective hip replacement surgery. To measure the effectiveness of the geko™ device, the study consisted of two control groups. The first group were prescribed compression stockings (standard of care), the second group were prescribed the geko™ device. Both groups were treated continually, immediately post-surgery until discharge.
The primary endpoint compared DVT incidence in patients from two to four days after the surgery, determined by Duplex ultrasound. Results showed two incidences in group one (compression stocking) and no incidences in group two (the geko™ device arm).
Secondary measures compared: blood flow (hemodynamic response), hip range motion, swelling in the lower limb (oedema), sit-to-stand and timed-up-and-go (TUG). Patients in the geko™ device arm demonstrated an overall reduction in oedema (indicated by a decrease in leg volume) from post-surgery to discharge. Oedema in the compression stockings arm remained static.
Study two – Oedema reduction in acute ankle sprain patients
This single-centre, pilot randomised controlled trial (RCT) focused on the treatment stage in people with acute ankle sprain. This study randomised 22 subjects into two control groups: the first group received standard of care (including education, manual therapy when indicated, and personalised exercise prescription), and the second group received standard of care plus the firefly™ device. Participants received their designated treatments between one and five days after their injury and had a follow-up assessment on day seven.
Results showed that OnPulse™ technology in the firefly™ device was well tolerated and demonstrated statistically significant improvements in the reduction of oedema, as measured by fluid displacement. All participants were able to adhere to the treatment and to self-fit the device, wearing it for eight hours per day. They also anecdotally reported a reduction in pain from their baseline measurements to their follow-up clinic.
Conclusion
Patient ability to self-fit the devices, as demonstrated in study two, speaks strongest to Enhanced Recovery After Surgery (ERAS), providing the means to reduce the length of hospital stay, thereby releasing healthcare system savings. A true hospital-to-home therapy, the geko™ device enables patients to self-manage their recovery in the home setting, allowing rehabilitation to begin sooner, together with the dual benefit of VTE prevention.
Provided here are links to the papers:
Study one: A Single-Centre Feasibility Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between a Neuromuscular Electrostimulation Device and Thromboembolism Deterrent Stockings in Post-Operative Patients Recovering From Elective Total Hip Replacement Surgery
https://pubmed.ncbi.nlm.nih.gov/32250444/
Study two: Does Neuromuscular Electrical Stimulation Improve Recovery Following Acute Ankle Sprain? A Pilot Randomised Controlled Trial http://eprints.bournemouth.ac.uk/32322/1/FINAL%20COPY.pdf
References
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- Hastie GR, Pederson A, Redfern D. Venous thromboembolism incidence in upper limb orthopedic surgery: do these procedures increase venous thromboembolism risk? J Shoulder Elbow Surg. 2014 Oct;23(10):1481-4. doi: 10.1016/j.jse.2014.01.044. Epub 2014 Apr 18. PMID: 24751530.
- A.Nicolaides, M Griffin, Measurement of blood flow in the deep veins of the lower limb using the geko™ neuromuscular electro-stimulation device. Journal of International Angiology August 2016-04.
- Tucker A, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol. 2010 Spring; 19(1): e31–e37. doi: 10.1055/s-0031-1278361.
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