Restless Legs Syndrome (RLS)

What is RLS?

Willis-Ekbom Disease, also known as Restless Legs Syndrome (RLS), is a neurological disorder characterized by the irresistible urge to move one’s body to stop uncomfortable sensations. It is estimated that between 7-10% of the UK population is living with RLS.

It most commonly affects the legs, but can also affect other parts of the body, including the arms and torso. The unpleasant sensations that accompany RLS may be described as creeping, tugging, or pulling. Symptoms most often occur in the evening, which may severely disrupt sleep and impair quality of life.

RLS is most frequently diagnosed in middle-aged individuals, but the disease can affect people of all ages, even children. It is a hereditary disease in about 50% of affected individuals, a condition referred to as primary RLS. In others, RLS appears as the result of another condition, which is referred to as secondary RLS.

Currently there is no cure for either form of RLS, but there are treatment options available to manage symptoms.

Do I have Restless Legs Syndrome?

The symptoms of RLS, also known as Willis-Ekbom Disease, are often difficult to put into words, as each person’s experience is different. The primary symptom associated with RLS is an overwhelming, uncontrollable urge to move the legs when they are at rest.

If you answer “yes” to any of the following questions, you may have RLS and should speak with your health care professional about your symptoms.
  • When you sit or lie down, do you have a strong desire to move your legs?
  • Does the desire to move your legs feel impossible to resist?
  • Would you describe the sensations in your legs as: unpleasant, creepy-crawly, itchy, tugging, itchy, or creeping?
  • Does your need to move your legs often occur when you are resting or sitting?
  • Does moving your legs help soothe or calm your symptoms?
  • Are your symptoms worse in the evening or night than during the day, or only occur in the evening or night?
  • Do you ever have involuntary leg movements while you are awake?
  • Do any of your family members have similar symptoms?
  • Has a discussion with your health care professional not revealed any other physical cause for your discomfort (i.e. Leg cramps, arthritis, leg swelling)?
Many patients suffering from RLS symptoms find it helpful to keep a journal to record their symptoms and daily habits that may be contributing to or improving their RLS symptoms. We have created a symptom journal that may be helpful in evaluating your RLS symptoms and in discussions with your healthcare provider. Download the RLS symptom journal here.

Restless Legs Syndrome treatment options

  • restiffic is a revolutionary product for the treatment of Restless Legs Syndrome (RLS). It is a completely drug-free foot wrap that exerts a soothing topical pressure to targeted muscles in the foot to relax the uncontrollable impulses occurring in the legs. Before restiffic, there existed three primary treatment options for managing RLS: pharmaceutical productss, homeopathic remedies, and lifestyle choices.

  • Pharmaceutical products are a common treatment method for RLS. Opiates, central nervous system depressants, and anticonvulsants are different families of frequently prescribed drugs to manage RLS symptoms. These pharmaceuticals are often accompanied by long lists of negative side effects, including nausea, vomiting, hallucinations, daytime sleepiness, addiction, and more.

  • With pharmaceutical products, there is also the risk of augmentation. Augmentation occurs when a  pharmaceutical product relieves symptoms at night, but eventually symptoms begin to develop earlier in the day and spread from the legs to the rest of the body, such as to the arms and trunk. When experiencing augmentation, increasing the dosage usually worsens symptoms. Other common side effects associated with pharmaceutical treatment for RLS include the rebound effect (which is the re-emergence of symptoms that were either absent or controlled while taking a medication, but reappear when medication is reduced or discontinued), addiction or dependency on medication, and the need to increase the dosage of medication.

  • Homeopathic or herbal remedies are another form of treatment for RLS. These medicines are available without prescription and can be purchased over the counter or on the internet. However, as with pharmaceutical productss, homeopathic remedies may be accompanied by negative side effects.
restiffic
  • Drug-free RLS treatment
  • 30-day money back guarantee
  • Comfortable soothing effect
£ 199.00
  • Lifestyle choices, such as limiting alcohol, nicotine, and caffeine may be recommended for treating RLS. Maintaining a healthy diet and ensuring that that your diet has adequate levels of iron may also be suggested. Presently, there is no single lifestyle choice that has been shown to markedly reduce symptoms of RLS.

restiffic – a revolutionary drug-free therapy for Restless Legs Syndrome

restiffic is a revolutionary foot wrap for the treatment of Restless Legs Syndrome (RLS). restiffic is composed of two primary parts: the Flexor-T pad and the outer wrap. The Flexor-T pad exerts a relaxing pressure on targeted muscles in the foot while the outer wrap holds the pressure pad in place, and allows for the application of adjustable pressure specific to your needs. By applying pressure to targeted muscles in the foot, restiffic relaxes the muscles to lessen the symptoms of RLS.

An innovative drug-free treatment option with zero risk of addiction, restiffic is a breakthrough in the treatment of RLS. Patients who wore restiffic experienced a 69% reduction in the severity of their RLS symptoms, and restiffic was found to be 40% more effective than the leading pharmaceutical treatment for RLS.

Restless no more

  • Drug-free treatment providing lower risk of negative side effects and zero risk of addiction
  • Creates a comfortable soothing effect which allows you to relax and enjoy uninterrupted sleep
  • Clinically proven
  • A lightweight and compact size that won’t interfere with sleep and relaxation

Effectiveness of restiffic

Restless legs syndrome (RLS) is a neurological disorder that causes unpleasant sensations and a need or urge to move the legs. The sensations are often described as burning, creeping, tugging, or feeling like insects are crawling inside the legs. The symptoms commonly develop when a person is at rest and tries to relax or go to sleep. RLS inhibits people from sleeping, which can lead to depression and a poor quality of life.
  • Drug-free treatment providing lower risk of negative side effects and zero risk of addiction.
  • Clinically proven to reduce symptoms of RLS.
  • Easily adjustable to allow instant customization of compression for each wearer.
  • Flexor-T pad cradles the ball of the foot for an intuitive fit.
  • Anatomic design and cushioning for maximum comfort throughout the foot.
  • Easy application and removal makes nightly use simple.
  • Lightweight and compact size that won’t interfere with sleep and relaxation.
  • Primary Restless Legs Syndrome (RLS)

  • Do not use when engaging in activity that puts pressure on the feet (ex. Walking, running, operating a vehicle). Do not use in water.
  • Do not use if you have neuropathy, poor circulation, peripheral vascular disease, varicose veins, deep vein thrombosis, a history of blood clots, or foot and/or leg swelling.
  • Do not wear if you have breaks, bruises, sprains, wounds, sores, fragile skin, cuts, rashes, or abrasions involving your feet and/or legs.
  • Consult with your doctor if you have diabetes, kidney failure, heart problems, are pregnant, or have any other medical condition that may contraindicate the use of restiffic.
In the event of pain, numbness, burning, cramping, tingling, or other sensations in the feet, loosen the straps of the device immediately. If the symptoms are not relieved after loosening the device, remove it completely. If the symptoms are not relieved shortly after removing the device, consult with your health care professional.

How it works

  • Promotes gentle relaxing pressure on specific areas of the foot
  • Reduces uncontrollable impulses to move the legs
  • Creates a comfortable soothing effect which allows you to relax and enjoy uninterrupted sleep
  • 30 Day Money Back Guarantee: Experience relief with restiffic within 30 days or your money back
At medi, we know that it’s important to have all the facts when beginning treatment for your RLS. That’s why we’ve created informational flyers for both you and your physician. For everything you need to know about restiffic and tips for managing your RLS, download our patient brochure here. When discussing restiffic with your physician, share the restiffic Clinician Information Pack with them.

Many patients suffering from RLS find it helpful to keep a journal to record their symptoms and daily habits that may be contributing to or improving their RLS symptoms. We have created a symptom journal that may be helpful in evaluating your RLS symptoms and in discussions with your healthcare provider.

Sometimes it can feel lonely or isolating to deal with RLS symptoms, as it can be difficult to describe your condition to family members and friends. But did you know that RLS is estimated to affect 7-10% of the UK population? You are not alone and medi wants to help.

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Clinical trial

Introduction

  • Restless legs syndrome (RLS) is a neurological disorder that causes unpleasant sensations and a need or urge to move the legs. The sensations are often described as burning, creeping, tugging, or feeling like insects are crawling inside the legs. The symptoms commonly develop when a person is at rest and tries to relax or go to sleep. RLS inhibits people from sleeping, which can lead to depression and a poor quality of life.
  • Until now, potent drugs have been used to ease symptoms, but each of these is accompanied by many negative side effects. Examples include dizziness, nausea, vomiting, and the risk of addiction.
  • restiffic is a drug-free solution to RLS. It is a revolutionary foot wrap consisting of a compressive pad and a hook and loop system, designed to exert a gentle, relaxing pressure on the abductor hallucis and flexor hallucis brevis muscles in the foot. This pressure reduces the symptoms of RLS.

Method

  • A clinical trial was administered to test the efficacy and safety of restiffic. The Principal Investigator of the clinical trial was Daniel J. Olson, DPM; Sub-Investigators were John P. Sullivan, MD and Frederick J. Tomassi, DPM. It was a single arm, open label clinical trial with a repeated measures design. The study population consisted of 30 otherwise healthy adults, mean age 51.5 years (range 30 to 75 years), diagnosed with moderate to severe primary RLS.
  • Efficacy was measured using the International RLS Study Group (IRLSS) Rating Scale, with scores ranging from 0 to 30 (30 being the most severe), and the physician-generated Clinical Global Impression (CGI) Scale, measuring severity, improvement, and Efficacy Index (EI). Safety was assessed by recording adverse events, analyzing the severity, and the relationship to the restiffic device.
  • During the study, patients recorded their RLS symptoms over 8 weeks. After one week of observation without treatment, patients were given a pair of restiffic devices for Weeks 2 through 4. The devices were removed for Week 5, and returned to the patients for Weeks 6 through 8.

Results

  • In Week 1, all patients exhibited severe symptoms of RLS, with an average patient IRLSS score of 25.05 (“severe”). When patients began wearing the devices, many experienced relief after just 24 hours of therapy (Day 8), with the mean IRLSS score decreasing from 25.05 to 16.94 (“moderate”) in just one day. Patients’ RLS symptoms decreased significantly and continually over the course of the next three weeks, with an average IRLSS scores at the end of Week 4 of 10.88 (“mild”). When the devices were removed for Week 5, patients once again experienced severe RLS symptoms, though not as high as initially seen in Week 1. In Weeks 6 through 8, patients again showed significant and continued decreases in their RLS symptoms while wearing the restiffic devices.
  • Over the course of the trial, patients exhibited an average 69% reduction in the severity of their symptoms, with the average patient IRLSS score at the end of the trial being 7.83, for an overall reduction of 17.22 points. This represents an improvement from “severe” to “mild” symptoms. Based on the study results and the low-risk nature of the device, restiffic was cleared by the FDA as a Class 1 device for prescription use to support positive RLS diagnosis.

Key statistics

  • 97% of patients experienced a decrease in the severity of their RLS symptoms.
  • Patients exhibited 69% reduction in the severity of symptoms after 6 weeks of using restiffic.
  • restiffic was shown to be 40% more effective than the leading drug treatment for RLS.
  • Physicians reported observing no side effects in 93% of patients.
  • Only 9 Adverse Events definitely related to restiffic occurred in seven patients. These included pain, tingling, and irritability. All AEs were relieved by loosening the device’s straps.

What does my clinician need to know about restiffic?

Download the restiffic Clinician Information Pack. This has information on restiffic’s clinical trial and an RLS symptom journal.

Drug treatment for RLS has not helped me. Could restiffic work in my case?
Yes! restiffic is an exciting new option for patients who have not had success with drug treatments or do not want to use drug treatments. In a clinical trial, restiffic was found to be 40% more effective than the leading drug treatment for RLS.

Further FAQs

  • Are there any side effects? If the device is placed too loosely on the foot, it can come loose and may cause you to trip if you try to stand or walk. If the device is placed too tightly on the foot or applied when you are using your feet or putting pressure on your feet, you may experience pain. restiffic should not be used during any activity which puts pressure on the feet (e.g. walking, driving, running, biking).
  • How do I purchase a device?  You can purchase your restiffic here, or call 01432 373500 to order over the phone. You can also email restiffic@mediuk.co.uk.
  • How soon will I experience benefits? Many patients report positive changes in their RLS symptoms within minutes of putting on their restiffic. Some patients experience gradual changes over several days or weeks.
  • Can I use the device at the same time I am taking medication?  Yes. restiffic does not have any contraindications for use with medication. However, restiffic has not been clinically studied on people who are taking RLS medication. We recommend that you speak with your healthcare provider before beginning any treatment.
  • Is there a return policy or warranty? All restiffic devices are backed by a 30-day satisfaction guarantee. If during the first 30 days after purchase the device is considered not acceptable, you may return the device for a refund with no questions asked. restiffic devices have a 6 month workmanship warranty. The warranty is only valid if the instructions for care are properly followed and does not cover normal wear and tear, abnormal care and use, or where it can be shown that the application instructions have not been followed correctly.
  • How does restiffic work? restiffic works by applying topical, soothing pressure to targeted muscles in the foot, which relaxes the uncontrollable impulses in the legs. 
  • What does wearing restiffic feel like? The pressure applied by restiffic on the feet is soothing and relaxing and should never feel constricting or painful. If the device feels too tight, simply loosen the straps. If the device feels too loose and is not exerting enough pressure on the feet, tighten the straps to a comfortable level.
  • How do I know if I’m wearing my restiffic correctly? Read the directions for use carefully before putting on your restiffic, or watch our short application video. When restiffic is on correctly, your foot should be in direct contact with the Flexor-T pad, the ball of your foot should be positioned in the divot in the Flexor-T pad, and you should feel a firm but comfortable pressure along the inner sides of your feet.
  • How do I know if my restiffic is on too tight or too loose? If the restiffic is causing you pain or numbness in your feet, loosen the straps accordingly. If the restiffic is sliding off your foot, tighten the straps to a firm but comfortable compression level.
  • Can I wear socks with restiffic? Yes, you can wear socks with restiffic if you wish. However, we recommend that you do not wear thick socks, as they may inhibit the device’s ability to work.
  • Is there anyone who should not use restiffic? restiffic should not be used by anyone with neuropathy, poor circulation, peripheral vascular disease, varicose veins, deep vein thrombosis, a history of blood clots, or foot and/or leg swelling. The device should not be worn if you have breaks, bruises, sprains, wounds, sores, fragile skin, cuts, rashes, or abrasions involving your feet and/or legs. Consult with your doctor if you have diabetes, kidney failure, heart problems, are pregnant, or have any other medical condition that may prohibit the use of restiffic.
  • What activities can I do while wearing my restiffic? restiffic can be worn during any activity in which you are off your feet, such as reading a book, watching television, or sleeping. The device should never be worn during any activity in which you are on your feet (ex. walking, driving, biking, running).
  • Is restiffic patented? Yes.
  • How do I know what size to order my restiffic in? restiffic size charts can be seen here.

More information