Evidence map›Paper›PMID 37990163›Full record

Trial reportBMC neurology2023

Adjunctive tonic motor activation enables opioid reduction for refractory restless legs syndrome: a prospective, open-label, single-arm clinical trial.

Mark J Buchfuhrer, Asim Roy, Stephanye Rodriguez, Jonathan D Charlesworth

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04698343 (Exploratory Study Assessing the Response of Restless Legs Syndrome), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04698343 nacompletednot on this map

Exploratory Study Assessing the Response of Restless Legs Syndrome (RLS) Patients to Non-invasive Peripheral Nerve Stimulation (NPNS) During Opioid Medication Reduction

TypeinterventionalSponsorNoctrix Health, Inc.Ran2021 to 2023Enrolled21ConditionsRestless Legs SyndromeArmsNoninvasive Peripheral Nerve Stimulation (NPNS)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Observational
  4. Article
  5. Observational
  6. The Impact of Nonpharmacological Interventions on Opioid Use for Chronic Noncancer Pain: A Scoping Review.International journal of environmental research and public health · 2024
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Mark J BuchfuhrerStanford University School of Medicine, Stanford, CA, USA.
Asim RoyOhio Sleep Medicine Institute, Dublin, OH, USA.
Stephanye RodriguezPrivate Practice, Downey, CA, USA.
Jonathan D CharlesworthDepartment of Clinical Research, Noctrix Health, Inc, Pleasanton, CA, USA. jcharlesworth@noctrixhealth.com.

Funding

Treatment of Restless Legs Syndrome through non-invasive peripheral nerve stimulationR44NS117294 · NINDS · NOCTRIX HEALTH, INC · PI Jonathan David Charlesworth · 2020 to 2026
$4.6M
NINDS NIH HHS R44 NS117294NINDS NIH HHS R44NS117294
6 · The paper itself

Abstract

backgroundThere is a large population of restless legs syndrome (RLS) patients who are refractory to medication. Whereas experts recommend off-label opioids as an effective long-term treatment for refractory RLS, reducing opioid dose could substantially reduce side effects and risks. Tonic motor activation (TOMAC) is a nonpharmacological therapeutic device indicated for refractory RLS. Here, we investigated if TOMAC could enable opioid dose reduction for refractory RLS.

methodsThis prospective, open-label, single-arm clinical trial [NCT04698343] enrolled 20 adults taking ≤ 60 morphine milligram equivalents (MMEs) per day for refractory RLS. Participants self-administered 30-min TOMAC sessions bilaterally over the peroneal nerve when RLS symptoms presented. During TOMAC treatment, opioid dose was reduced iteratively every 2-3 weeks until Clinician Global Impression of Improvement (CGI-I) score relative to baseline exceeded 5. Primary endpoint was percent of participants who successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Secondary endpoints included mean successful percent opioid dose reduction with CGI-I ≤ 5.

resultsOn average, participants were refractory to 3.2 medications (SD 1.6) and were taking a stable dose of opioids for 5.3 years (SD 3.9). Seventy percent of participants (70%, 14 of 20) successfully reduced opioid dose ≥ 20% with CGI-I ≤ 5. Mean percent opioid dose reduction with CGI-I ≤ 5 was 29.9% (SD 23.7%, n = 20) from 39.0 to 26.8 MME per day. Mean CGI-I score at the reduced dose was 4.0 (SD 1.4), indicating no change to RLS severity.

conclusionsFor refractory RLS, TOMAC enabled substantial opioid dose reduction without increased RLS symptoms. These results suggest that TOMAC has the potential to reduce the risk profile associated with opioid therapy for refractory RLS.

trial registrationClinicalTrials.gov trial number NCT04698343 registered on January 6, 2021.

Indexed as

Analgesics, OpioidRestless Legs SyndromeAdultDopamine AgonistsHumansProspective StudiesTreatment OutcomeAnalgesics, OpioidDopamine AgonistsBioelectronicsNeurological disorderNeuromodulationOpioidsPeripheral nerve stimulationRrestless legs syndromeSleep disorder

Identifiers

PMID37990163
PMCPMC10662398

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.