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Are You Interested in Supporting the National RLS Opioid Registry?

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To donate to our research, please go to the Massachusetts General Hospital donations webpage and designate your gift to “Sleep Disorders Clinical Research Program (National RLS Registry)”. Alternatively, you can contact us at 617-643-2082 or RLSregistry@partners.org for more information.

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Restless Legs Syndrome (RLS) is a neurological disorder that causes an irresistible urge to move the legs accompanied by leg discomfort. Without adequate treatment, RLS symptoms can interfere with sleep and reduce quality of life.

Common Treatments for RLS

The FDA has approved four drugs for treating RLS:

Ropinirole (Requip®)
Pramipexole (Mirapex®)
Rotigotine (Neupro®)
Gabapentin enacarbil (Horizant®)

These non-opioid medications work for some people, but there are limitations to current treatments for RLS. For example, long-term use of certain medications can make RLS worse for some people.

Opioid Medications for RLS

Opioid medications have been used to successfully treat the symptoms in many patients with severe RLS or in patients who have found that conventional treatments have lost effectiveness.

However, the current climate of escalating opioid addiction and deaths from opioid overdose has resulted in increasingly strict regulation of these medications. Further regulations may make obtaining opioids for RLS more difficult, so both patients and physicians need more scientific evidence to assess the risks and benefits of treating RLS with opioids.

Learn more about the use of opioid medications for RLS: Opioids in the Treatment of RLS, Restless Legs Syndrome Foundation.

The RLS Opioid Registry

We have built an RLS Opioid Registry based at Massachusetts General Hospital with patients all around the country to assess the long-term safety and effectiveness of opioid medications for RLS. The registry is supported by a grant from the RLS Foundation, whose Executive Director Karla Dzienkowski recently noted, 'This is the first study in which patients with RLS who use opioids are monitored over time to evaluate the effectiveness and tolerability of this treatment long-term.'

A registry is an observational (non-intervention) study method that collects long-term data on a certain group of people. The RLS Opioid Registry collects data from people who have been diagnosed with RLS and are taking a prescribed opioid as treatment for RLS. This data will be used to evaluate specific treatments and outcomes for those living with RLS. Visit the Restless Legs Syndrome Foundation website to learn more about RLS symptoms, treatment and ongoing research.

Note: We do not provide any consultation, advice about clinical care or medication through this study.

What Does Participation Involve?

Participants in the RLS Registry are asked to do the following:

An initial phone interview about RLS symptoms, current and past treatments and other medical conditions
Filling out an online questionnaire regarding RLS symptoms, sleep quality, habits and mood two times per year for up to 5 years

All data is stored anonymously in a secure electronic database at Mass General. We will summarize group data on long-term dosages, effectiveness and side effects of using opioids for RLS.

Who Participates?

Interest in the RLS Registry has far surpassed expectations. After easily surpassing our original goal of 200 participants, we recently closed recruitment at 500. Individuals who participate in this registry:

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Are 18-90 years old
Have a current RLS diagnosis
Are currently taking an opioid medication to treat RLS, including oxycodone (i.e. Percocet®, OxyContin®), methadone, buprenorphine (i.e. Suboxone®), hydrocodone (i.e. Vicodin®)

Similar to the RLS population as a whole, the RLS Registry consists of slightly more women than men and is largely made up of individuals over the age of 60. Registry participants come from 44 US states and from 6 countries around the world.

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What Have We Found So Far?

RLS Registry participants use 12 different kinds of opioids; whereas the majority of participants treat their RLS with a single opioid, a portion of participants use two. Methadone is the most common, with nearly half of participants using this medication. The average daily dose of methadone is 10 mg. Other commonly used opioids are oxycodone formulations, hydrocodone, and tramadol.

Many RLS Registry participants report that opioids are controlling their symptoms. At baseline, nearly all participants reported that their RLS symptoms were “very much improved” or “much improved” since starting an opioid. Over 20% of RLS Registry participants had experienced no RLS symptoms in the week before the baseline phone interview, and slightly more than 50% of participants reported just mild to moderate RLS symptoms in the past week.

Very few participants reported ever feeling “high” as a result of their opioid medication. However, a number of participants did report other side effects from their opioid treatments, with the most common being constipation, fatigue, and itching.

Brief data updates are periodically sent to RLS Registry participants. These can be accessed using the following links:

Moving forwards, there is much work to do. Among numerous research aims, we plan to assess whether opioid medications continue to control RLS symptoms over time, and whether or not dose escalation is needed for this to occur.

To learn more about Dr. Winkelman’s research grant, please visit the RLS Foundation Blog.

To learn more about RLS, visit the Restless Legs Syndrome Foundation website.

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By Ms. Suzanne Ovel (Regional Health Command Pacific)June 18, 2019

MADIGAN ARMY MEDICAL CENTER, Joint Base Lewis-McChord, Wash. -- When she underwent ankle surgery in December, Jess Smith had no idea the path she would navigate.She unexpectedly experienced an allergic reaction to the internal sutures in her ankle and contracted an unusual bacteria as well -- both of which set off the perfect biological storm for a chronic wound to form.'Since I'm a nonstop kind of person, there came to a point where I actually had to be admitted … I had an open wound down to the bone basically,' said Smith, who is both a Madigan patient and a nurse in the Limb Preservation Clinic.In stepped the Wound Care Service's inpatient team, which stood up just six months ago to provide dedicated expertise to hospitalized patients with chronic wounds. The two-nurse team, which boasts 25 years of wound care experience between them, joined forces with the service's long-standing outpatient clinic to provide a continuum of care for patients like Smith with chronic wounds.'In addition to providing hands-on inpatient wound care, the goal was to work very closely with the staff nurses to educate them on the importance, for example, of the skin assessment. Joanie (Santucci) and Eloa (Reid) spend a lot of time working with the inpatient nurses to make sure there's an appropriate focus on assessing patients, preventing ulcers, identifying early skin breakdown with education, writing policies and hands-on care,' said Dr. Charles Andersen, chief of Madigan's Wound Care Service.Although most wounds don't require the extra care of this specialty, some just don't heal as expected and become chronic. In these cases, patients might be referred to the Wound Care Service.Regardless of the type of the wound -- such as a pressure sore, burn or surgical site -- treating them involves three factors: treating the wound itself, addressing the cause of the wound, and remedying any negative healing factors, such as poor blood flow.While the most common treatments for chronic wounds are advanced synthetic dressings and negative pressure wound therapies, an almost innumerable amount of treatment options exist with the common goal of creating an environment that contains the right level of moisture for optimal healing.In Smith's case, regrowing tissues and receiving a skin graft required the inpatient nurse team to treat her with a Wound Vacuum-Assisted Closure device to increase blood flow and reduce edema (swelling caused by excess fluid buildup), and an instillation negative wound therapy that infused antibiotics directly into her wound bed for set periods of time.'Their knowledge and ability to adapt to whatever the issue is, is amazing,' said Smith of the team.'We're often asked to see people to figure out what the etiology is (what caused it), how to best treat it and manage it and include possibly surgical teams, and then work directly with doctors and nurses and write wound care orders,' said Santucci, who along with nurse Nancy Hodges also formally provides wound care education as a satellite site for the University of Washington's Wound Care Fundamentals Course.The team works directly with multidisciplinary medical teams on a daily basis -- from nurses to doctors and from case managers to physical therapists.'It's a cultural change; it's new for everybody,' said Reid, who emphasized the team's role in offering consults. 'We always leave the door open for the nurses.'In the inpatient setting, wound care is a focus for patients from admission to discharge, starting with nurses scanning the skin conditions of all patients. The inpatient Wound Care Service team focuses particular attention on identifying patients who are more susceptible to pressure ulcers, which can occur when patients are less mobile. In fact, patients who are in at-risk situations, to include surgical patients, are assessed more frequently, said Santucci. If patients do develop or come in with ulcers or other wounds, she and Reid work with care teams to treat the wounds early on.To ensure wounds are still treated even after hospitalization, patients who need additional follow-up care are then set up with appointments with the outpatient clinic as a part of their discharge process.'The idea is to make that seamless between the outpatient and the inpatient,' said Andersen about the wound care pathway; patients can also now be more easily admitted if needed thanks to referrals from the outpatient wound clinic.Smith took part in that pathway herself as she transitioned to the outpatient clinic after discharge. After four weeks as an inpatient, she offered nothing but praise for the service's inpatient nurse team.'They literally don't stop until the day is done … There are days where they're still here well past their shift,' she said. 'That's the kind people they are, and how dedicated they are to their jobs here and to the patients.'