Revitive Overview & Clinical Evidence

Registered Medical Device Designed to Temporarily Reduce Leg Pain & Swelling

Revitive Circulation Booster is a registered medical device indicated as an adjunctive treatment to temporarily reduce lower extremity pain and swelling in patients with conditions or diseases associated with poor blood flow in the legs and feet. Revitive is also indicated to increase blood circulation in leg muscles.1

Revitive uses Neuromuscular Electrical Stimulation (NMES) also known as Electrical Muscle Stimulation (EMS) technology to deliver electrical impulses to leg muscles through the feet. The NMES causes muscles in the calf and foot to contract, which leads to increased circulation and relieved pain in lower legs during use. Revitive comes with an IsoRocker that rocks feet back and forth to allow for natural ankle movement and increased circulation in the lower legs.1

The NMES technology has been shown to significantly improve pain,3 as well as increase arterial and venous blood flow in several clinical trials.2-5 Revitive is clinically proven to increase leg blood flow in both healthy people and people with conditions or diseases associated with poor blood flow in the legs and feet during use.2-4

Clinical Study in Healthy Individuals

Significantly increased arterial and venous blood flow during use2

In a pilot study, 30 healthy individuals with no known underlying conditions used Revitive for 30 minutes.2

Compared with blood flow and time averaged mean velocity (TAMV) at baseline, Revitive use at 15 minutes resulted in:2

  • Significant increase in median venous blood flow by 88 cc/min (31%, p = .014) and increase in TAMV by 1.1 cm/s (38%, p = .065).
  • Significant increases in median arterial blood flow by 39 cc/min (53%, p < .0001) and TAMV by 2.2 cm/s (62%, p = .0003).

Revitive was reported to be safe and well-tolerated.2

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Clinical Study in Peripheral Artery Disease (PAD)

Studied as an adjunctive therapy in a randomized controlled trial3

In a study by Babber et al, patients with intermittent claudication (IC) who were able to complete a supervised exercise program (SEP) were randomized to either the SEP only group or the SEP with Revitive (NMES) group. Patients in the SEP/Revitive group received a brief induction and training with the Revitive device. These patients were instructed to use the device at home for minimal of 30 minutes daily for a total of 6 weeks. A total of 37 patients (20 in the SEP group and 17 in the SEP/Revitive group) completed the study.3

Combination of Revitive and SEP significantly improved walking distances, blood flow, and quality of life at 6 weeks3

Compared with Supervised Exercise Program (SEP) alone, the combination of Revitive and SEP resulted in:3

  • 46% greater walking distance before the onset of claudication at week 6 as measured by the initial claudication distance (ICD) (p = .014)
  • Significantly greater change in ICD over 6 weeks (Revitive/SEP: 40.4 m, SEP only: 7.5 m, p = .012)
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  • Blood volume flow increased significantly with the device on (P<0⋅050).
  • Significant improvement in the Intermittent Claudication Questionnaire score change (Revitive/SEP: -11.2 vs. SEP only: -4.2, p = .037)

 

High adherence rate3

Revitive achieved 96% adherence rate among patients who completed the study (n=17) with good tolerance of device use.3

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Clinical Study in people with Varicose Veins

Randomized Controlled Trial Pilot Study with Sham control.4

Revitive was studied in a pilot randomized controlled trial with 22 patients who were diagnosed with superficial and/or deep venous disease with Clinical Etiological Anatomical and Pathophysiological (CEAP) clinical class C2–C4. Patients were randomized in a 1:1 ratio to the Revitive (NMES) group or the sham device group.4

Patients in the Revitive group were advised to use Revitive at the highest intensity comfortable for them for 30 minutes daily for 6 weeks. Patients in the sham group received a device identical to the test device but without electrical impulses. These patients were instructed to place their feet on the sham device, simulating the effect of sitting still for 30 minutes.4

Baseline Characteristics

No significant between-group differences in CEAP classification and the use of compression stockings.4

There were significant between-group differences in patient’s age and BMI, primarily due to the small sample size. A larger RCT trial has been completed demonstrating similar benefit in using Revitive.4

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Significantly improved venous flow parameters during and after device use4

Compared with patients in the sham group, patients in the Revitive group had:4

  • Significantly higher improvement in time-averaged mean velocity (TAMV) (median change in Revitive group:102.4% vs. sham group: -9.1%, p < .0001) and peak venous velocity (PV) (median change in Revitive group: 264.8% vs. sham group: -6.8%, p < .0001) during device use at week 0. Similar improvements were seen at week 6.

Significantly higher improvement in TAMV (Revitive: 8.9% vs. sham: -14.8%, p = .001) and PV (Revitive: 16.0% vs. sham: -8.0%, p = .003) at week 0 after the device was turned off

Reduced median increase in limb volume4

Patients in the Revitive group had a lower increase in limb volume at week 0 and week 6 than those in the sham group (week 0: Revitive 0.8% vs. sham 2.0%, p = .0001; week 6: Revitive 1.0% vs. sham 1.2%, p = .002).4

High compliance rate without adverse events4

Revitive achieved an overall compliance rate of 94.6% with no reported adverse events.4

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Clinical Study in in people with Varicose Veins

Randomized Control Trial.5

Revitive was studied in a randomized controlled trial with 76 participants who were diagnosed with superficial and/or deep venous disease with Clinical Etiological and Pathophysiological (CEAP) clinical class C3-C5. Participants were randomized into three groups, control (No NMES), 30 min NMES group, and 60 min NMES group.

Patients in the Revitive groups were advised to use Revitive each day at the highest intensity comfortable for them for the required time of their allocated intervention group for a total of 6 weeks. The control group did not receive an intervention.

Baseline Characteristics5

There were no significant between-group differences in the CEAP classification. Analysis of the duplex data indicates no difference between groups except for a higher incidence of iliac vein reflux and obstruction in the 30 min and 60 min NMES groups (p=0.006). This suggests worsened anatomical venous disease in the NMES groups compared to the control group despite randomization.

table_patientdemographic_new_trial

Significantly improved venous flow parameters during use.5

Compared with the participants in the controlled group, participants in both NMES groups demonstrated:5

  • At week 0, a significantly higher improvement in Peak Velocity (PV) (p<0.001).
  • At week 0, a significantly higher improvement in Volume Flow (VF) for 30 min NMES group (p=0.004) and 60 min NMES group (p<0.001).
  • Similar significant improvements were seen at week 6.
Venous-flow-during-use.2

Significantly improved microcirculation blood flow during use.5

Compared with the participants in the controlled group, participants in both NMES groups demonstrated:

  • At week 0, there was an increase microcirculation blood flux in the feet in the 30 mins NMES group (167.7 (45.5 – 446.8)) and the 60 min NMES group (254.5 (141.9 – 580.5)), while the control group seen a reduction (-3.0 (-21.5 -15.1)).
  • A significant difference in microcirculatory flux in the feet (p<0.001) compared to the hands (p=0.0465) between the groups.

This was associated with a significant increase in temperature in the foot (p=0.039) compared to the hand (p=0.381). The control group seen a decrease in temperature (-0.7 (-2.1 – 1.1)) compared to an increase in temperature in 30 min NMES group (0.9 (-1.4-2.6)) and 60 min NMES group (0.9 (0.1-2.2)).

 

Prevention of increase of limb volume during use.5

Limb volume is a measurement of the size of the limb and is used to determine swelling or blood pooling.

Compared with participants in the control group, participants in the 60 min NMES group demonstrated a significant decrease in limb volume compared with the control group during device use:

  • At week 0, limb volume was significantly less in the 60 min NMES group during device use compared with the control group with no NMES (p=0.0191).6
  • At week 6, the control group demonstrated a significant increase in limb volume (p<0.001) but remained static in the 30 min NMES group (p=0.726) and 60 min NMES group (p=0.681).5 Limb volume was significantly less in the 60 min NMES group after device use compared with the control group with no NMES (p=0.0195).6 

Significant Improvement in disease specific Quality of Life (QoL) score.5

The Aberdeen Varicose Veins Questionnaire (AVVQ) is a survey that evaluates physical symptoms of varicose veins, such as pain, ankle oedema, and limitations on daily activities.

Compared with the participants in the control group, participants in the 60 min NMES group saw a significant improvement in their disease specific QoL.

  • Between week 0 and week 6, the 60 min NMES group saw a significant improvement of 6.3 points (p=0.029) for the disease specific QoL score, AVVQ, which suggested a clinically significant difference was met.5
  • Participants in the 60 min NMES group demonstrated a significant improvement in the AVVQ score compared to the control group, (p=0.025) over the 6 weeks.

Significant improvement in Clinical Severity Score.5

The Venous Clinical Severity Score (VCSS) assesses disease severity by monitoring the effects of the condition on outcomes such as skin changes.

Compared with the participants in the control group, participants in the 60 min NMES group demonstrated a significant improvement in their clinical severity scores.

  • Between week 0 and week 6, the 60 min NMES group demonstrated a significant improvement in Venous Clinical Severity Score (VCSS), (p<0.01), represented by a 4-point reduction. While the control group saw a significant worsening in clinical severity score (p<0.05), with a 1-point increase. Score differences between the groups suggest a clinically significant difference was met.5
  • At week 6, participants in the 60 min NMES group saw a significant improvement in the VCSS score compared to the control group, (p=0.001).

High adherence Rate without adverse events.5

Revitive achieved an overall compliance rate of 94 % in the 30 min NMES group and 92 % in the 60 min NMES group, with no reported adverse events.

FIG.8.2

Summary of evidence from other Clinical Studies using Revitive Circulation Booster

Improving leg circulation - with Electrical Muscle Stimulation

A study in healthy individuals found that Electrical Muscle Stimulation (EMS) delivered through the foot plantar surface using Revitive was at least as effective as voluntary exercise for increasing lower limb blood flow and tissue oxygenation. Painless foot plantar surface stimulation is simple and safe to use and therefore could be effective for clinical groups who experience venous insufficiency as part of their disease progression.

Study: Zaidell LN et al. Plantar surface electrical stimulation increases blood flow and tissue oxygenation in the human lower limb. Poster Communications, Physiology 2014, London, UK. Proc Physiol Soc 31, PCA134

 

Electrical Muscle Stimulation (EMS) of the plantar foot surface at twice the level of the motor threshold, combined with enabling ankle joint motion via a rocker built into the Revitive device, is perceived as non-painful but is effective at increasing lower limb perfusion and tissue oxygenation at least as effectively as voluntary exercise. Foot and calf temperature was maintained or raised after EMS where it dropped after voluntary exercise. This could explain the additional effects of EMS on cutaneous circulation.

Study: Hunter SP et al. Electrically stimulated lower leg exercise, incorporating ankle flexion/extension, increases lower limb perfusion in humans. Poster Communications, Physiology 2014, London, UK. Proc Physiol Soc 31, PCA135

 

Reducing pain from osteoarthritis - with Electrical Muscle Stimulation

In this trial, knee osteoarthritis patients were randomised into either of two groups: a group receiving an exercise program and a group receiving the same exercise program plus electrical stimulation of the quadriceps femoris for 6 weeks. Both groups demonstrated a statistically significant reduction in pain comparing pre- with post- measures. Statistical analysis indicated a statistically significantly greater improvement in pain for the 'exercise plus electrical stimulation' group. This result shows that the addition of EMS to an exercise program increases the improvement in pain state for these patients. The authors suggest that EMS provides an alternative intervention in those who find exercise difficult or for whom exercise is contraindicated.

Durmuş, D., Alaylı, G., & Cantürk, F. (2007). Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis. Clinical rheumatology, 26(5), 674-678

 

Reducing foot pain caused by Diabetic Peripheral Neuropathy - with Electrical Muscle Stimulation.

For this study patients diagnosed with Diabetic Peripheral Neuropathy were enrolled into the study and randomised into one of two groups: a group receiving amitriptyline and EMS and a group receiving amitriptyline and sham EMS. Results showed that the overall reduction in pain scores and the incremental relief (above the amitriptyline effect) were significantly greater with EMS as compared with sham treatment.

Study: Kumar, D., Alvaro, M. S., Julka, I. S., & Marshall, H. J. (1998). Diabetic peripheral neuropathy: effectiveness of electrotherapy and amitriptyline for symptomatic relief. Diabetes Care, 21(8), 1322-1325.

 

Help reduce swelling in legs & feet - with Electrical Muscle Stimulation

This study assessed whether the increase in foot and ankle volume (swelling) after 30 min of standing in healthy subjects could be minimised by Electrical Muscle Stimulation (EMS). Foot and ankle volume in healthy subjects was measured before and after 30 min of standing or standing while EMS was applied to the lower leg. Post-test foot and ankle volume was significantly greater than pre-test volume after 30 min of standing, whereas no significant differences were found after 30 min of standing while applying EMS. By activating the musculo-venous pump, EMS may help minimise the increase in foot and ankle volume by increasing venous return, reducing venous stasis, increasing lymph flow and increasing interstitial hydrostatic pressure, which could in turn assist with fluid reabsorption.

Study: Lepar, G. S., Morrissey, M. C., & Cywinski, J. K. (2003). Effect of neuromuscular electrical stimulation on foot/ankle volume during standing. Medicine and science in sports and exercise, 35(4), 630-634.

References: 

  1. Revitive User’s Manual. Australia; Actegy Health Pty Ltd, 2021 
  2. Varatharajan L, Williams K, Moore H, Davies AH. The effect of footplate neuromuscular electrical stimulation on venous and arterial haemodynamics. 2015 Oct;30(9):648-650. DOI: 10.1177/0268355514542682. 
  3. Babber A, Ravikumar R, Onida S, Lane TRA, Davies AH. 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. Br J Surg. 2020;107(4):355-363. doi:10.1002/bjs.11398. 
  4. Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised controlled trial: Potential benefit of a footplate neuromuscular electrical stimulation device in patients with chronic venous disease. Eur J Vasc Endovasc Surg. 2017;53(1):114-121. doi:10.1016/j.ejvs.2016.09.015.
  5. Ravikumar, R., Lane, T. R., Babber, A., Onida, S., & Davies, A. H. (2021). A randomised controlled trial of neuromuscular stimulation in non-operative venous disease improves clinical and symptomatic status. Phlebology: The Journal of Venous Disease, 36(4), 290–302. https://doi.org/10.1177/0268355520968640
  6. Independent Statistical Report of Ravikumar 2020 Limb Volume Results [on File at Actegy.]

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