{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T00:10:27Z","timestamp":1785802227256,"version":"3.56.0"},"reference-count":20,"publisher":"Walter de Gruyter GmbH","issue":"7","license":[{"start":{"date-parts":[[2016,7,1]],"date-time":"2016-07-01T00:00:00Z","timestamp":1467331200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2016,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>\n                  <jats:bold>Context:<\/jats:bold> Restless legs syndrome (RLS) treatments have included medications with many adverse effects and limited utility. A noninvasive device would potentially have extensive use where RLS medications may not be appropriate, such as in pregnant or breastfeeding women, people with mild RLS, people who operate machinery or drive occupationally, people with severely impaired renal function, or people who are taking medications contraindicated with RLS medications.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Objective:<\/jats:bold> To assess the efficacy and safety of a device that produces targeted pressure on the abductor hallucis and the flexor hallucis brevis muscles to reduce the symptoms of moderate to severe RLS, and to compare the current findings with findings from studies of ropinirole use in patients with primary RLS.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Methods:<\/jats:bold> This 8-week single-arm, open-label, clinical trial with a repeated measures design was conducted between April 2009 and August 2012 in 2 offices in Erie, Pennsylvania. Adults with moderate to severe primary RLS were recruited for the study. Mean (SD) follow-up was 15.6 (6) months. Patients wore RLS devices (1 on each foot) for set periods intermittently throughout the course of the study. The primary end point was mean change in the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale from baseline to day 56, and the secondary measure was the Clinical Global Impression scale. A meta-analysis was used to compare the RLS device findings with the findings of 3 historic studies of ropinirole vs placebo. The demographics, disease severity, inclusion and exclusion criteria, and assessment tools were similar among the 4 studies.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Results:<\/jats:bold> Thirty patients (22 women, 8 men; mean age, 51.5 years [range, 30-75 years]) participated in the study. Change in mean (SD) IRLSSG score was significantly greater for the RLS device (17.22 [6.16]; <jats:italic>P<\/jats:italic>&lt;.001) compared with the ropinirole vs placebo findings (12 [0.86] vs 8.9 [0.86], respectively; <jats:italic>P<\/jats:italic>&lt;.05). Sleep loss significantly decreased from 119.5 (61.6) minutes to 22.1 (31.1) minutes per night (<jats:italic>P<\/jats:italic>&lt;.001). Global Improvement Scale scores indicated significantly greater improvement with the RLS device compared with ropinirole (27 of 30 [90%] vs 293 of 464 [63%], respectively; <jats:italic>P<\/jats:italic>&lt;.05). Mild, transient adverse effects of the device (eg, pain, paresthesia) were reported, but these effects were relieved by loosening the straps. The RLS device demonstrated none of the adverse effects associated with current dopamine agonist therapy, such as augmentation, tolerance, rebound, somnolence, and nausea.<\/jats:p>\n               <jats:p>\n                  <jats:bold>Conclusion:<\/jats:bold> Producing targeted pressure on the abductor hallucis and flexor hallucis brevis muscles with an external RLS device reduced the symptoms of moderate to severe primary RLS without the adverse effects of medication therapy. (ClinicalTrials.gov number NCT02386423.) <jats:italic>J Am Osteopath Assoc<\/jats:italic>.<\/jats:p>","DOI":"10.7556\/jaoa.2016.088","type":"journal-article","created":{"date-parts":[[2016,6,27]],"date-time":"2016-06-27T19:52:12Z","timestamp":1467057132000},"page":"440-450","source":"Crossref","is-referenced-by-count":2,"title":["Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome"],"prefix":"10.1515","volume":"116","author":[{"given":"Phyllis J.","family":"Kuhn","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel J.","family":"Olson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John P.","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2016,7,1]]},"reference":[{"issue":"2","key":"2022022617402606852_j_jaoa.2016.088_ref_001","first-page":"235","article-title":"Restless legs syndrome","volume":"78","author":"Bayard","year":"2008","journal-title":"Am Fam Physician"},{"issue":"6","key":"2022022617402606852_j_jaoa.2016.088_ref_002","doi-asserted-by":"crossref","first-page":"631","DOI":"10.1097\/SMJ.0b013e3181705832","article-title":"Internal medicine: guidance to the diagnosis and management of restless legs syndrome","volume":"101","author":"Ball","year":"2008","journal-title":"South Med J"},{"key":"2022022617402606852_j_jaoa.2016.088_ref_003","unstructured":"Restless legs syndrome fact sheet. National Institute of Neurological Disorders and Stroke website. http:\/\/www.ninds.nih.gov\/disorders\/restless_legs\/detail_restless_legs.htm. Accessed May 12, 2016."},{"issue":"8","key":"2022022617402606852_j_jaoa.2016.088_ref_004","doi-asserted-by":"crossref","first-page":"1039","DOI":"10.5665\/sleep.1986","article-title":"The treatment of restless legs syndrome and periodic limb movement disorder in adults\u2014an update for 2012: practice parameters with an evidence-based systematic review and meta-analyses","volume":"35","author":"Aurora","year":"2012","journal-title":"Sleep"},{"issue":"7","key":"2022022617402606852_j_jaoa.2016.088_ref_005","doi-asserted-by":"crossref","first-page":"496","DOI":"10.1001\/jamainternmed.2013.3733","article-title":"Pharmacologic therapy for primary restless legs syndrome: a systematic review and meta-analysis","volume":"173","author":"Wilt","year":"2013","journal-title":"JAMA Intern Med"},{"issue":"6","key":"2022022617402606852_j_jaoa.2016.088_ref_006","doi-asserted-by":"crossref","first-page":"317","DOI":"10.1097\/MD.0b013e31815b1319","article-title":"Sequential compression devices for treatment of restless legs syndrome","volume":"86","author":"Eliasson","year":"2007","journal-title":"Medicine (Baltimore)"},{"issue":"2","key":"2022022617402606852_j_jaoa.2016.088_ref_007","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1016\/S1389-9457(03)00010-8","article-title":"Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology: a report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health","volume":"4","author":"Allen","year":"2003","journal-title":"Sleep Med"},{"issue":"2","key":"2022022617402606852_j_jaoa.2016.088_ref_008","doi-asserted-by":"crossref","first-page":"121","DOI":"10.1016\/S1389-9457(02)00258-7","article-title":"Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome","volume":"4","author":"Walters","year":"2003","journal-title":"Sleep Med"},{"issue":"1","key":"2022022617402606852_j_jaoa.2016.088_ref_009","doi-asserted-by":"crossref","first-page":"17","DOI":"10.4065\/81.1.17","article-title":"TREAT RLS US Study Group. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial","volume":"81","author":"Bogan","year":"2006","journal-title":"Mayo Clin Proc"},{"issue":"1","key":"2022022617402606852_j_jaoa.2016.088_ref_010","first-page":"92","article-title":"Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries","volume":"75","author":"Trenkwalder","year":"2004","journal-title":"J Neurol Neurosurg Psychiatry"},{"issue":"12","key":"2022022617402606852_j_jaoa.2016.088_ref_011","doi-asserted-by":"crossref","first-page":"1414","DOI":"10.1002\/mds.20257","article-title":"Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study","volume":"19","author":"Walters","year":"2004","journal-title":"Mov Disord"},{"key":"2022022617402606852_j_jaoa.2016.088_ref_012","first-page":"218","volume-title":"ECDEU Assessment Manual for Psychopharmacology Revised","author":"Guy","year":"1976"},{"key":"2022022617402606852_j_jaoa.2016.088_ref_013","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1186\/1477-7525-3-79","article-title":"The reliability, validity and responsiveness of the Restless Legs Syndrome Quality of Life questionnaire (RLSQoL) in a trial population","volume":"3","author":"Abetz","year":"2005","journal-title":"Health Qual Life Outcomes"},{"issue":"5","key":"2022022617402606852_j_jaoa.2016.088_ref_014","doi-asserted-by":"crossref","first-page":"431","DOI":"10.1016\/j.sleep.2011.03.003","article-title":"Restless legs syndrome (RLS) augmentation associated with dopamine agonist and levodopa usage in a community sample","volume":"12","author":"Allen","year":"2011","journal-title":"Sleep Med"},{"issue":"12","key":"2022022617402606852_j_jaoa.2016.088_ref_015","doi-asserted-by":"crossref","first-page":"C1","DOI":"10.1111\/j.1525-1497.2006.00593.x","article-title":"Medication tolerance and augmentation in restless legs syndrome: the need for drug class rotation","volume":"21","author":"Kurlan","year":"2006","journal-title":"J Gen Intern Med"},{"key":"2022022617402606852_j_jaoa.2016.088_ref_016","unstructured":"Tenets of osteopathic medicine. American Osteopathic Association website. http:\/\/www.osteopathic.org\/inside-aoa\/about\/leadership\/Pages\/tenets-of-osteopathic-medicine.aspx. Accessed June 2, 2016."},{"issue":"4","key":"2022022617402606852_j_jaoa.2016.088_ref_017","doi-asserted-by":"crossref","first-page":"902","DOI":"10.1093\/brain\/awm244","article-title":"Where dopamine meets opioids: a meta-analysis of the placebo effect in restless legs syndrome treatment studies","volume":"131","author":"Fulda","year":"2008","journal-title":"Brain"},{"key":"2022022617402606852_j_jaoa.2016.088_ref_018","first-page":"107","article-title":"Placebo response in clinical trials with schizophrenia patients [review]","volume":"24","author":"Kinon","year":"2011","journal-title":"Curr Opin Psychiatry"},{"issue":"7","key":"2022022617402606852_j_jaoa.2016.088_ref_019","doi-asserted-by":"crossref","first-page":"574","DOI":"10.1513\/pats.200707-090JK","article-title":"Sham procedure versus usual care as the control in clinical trials of devices: which is better?","volume":"4","author":"Sutherland","year":"2007","journal-title":"Proc Am Thorac Soc"},{"key":"2022022617402606852_j_jaoa.2016.088_ref_020","doi-asserted-by":"crossref","DOI":"10.1002\/0470870168","volume-title":"Publication Bias in Meta-Analysis: Prevention, Assessment, and Adjustments","author":"Rothstein","year":"2005","edition":"eds"}],"container-title":["Journal of Osteopathic Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.7556\/jaoa.2016.088\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.7556\/jaoa.2016.088\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,26]],"date-time":"2022-02-26T17:41:02Z","timestamp":1645897262000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.7556\/jaoa.2016.088\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,7,1]]},"references-count":20,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2016,7,1]]},"published-print":{"date-parts":[[2016,7,1]]}},"alternative-id":["10.7556\/jaoa.2016.088"],"URL":"https:\/\/doi.org\/10.7556\/jaoa.2016.088","relation":{},"ISSN":["2702-3648"],"issn-type":[{"value":"2702-3648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,7,1]]}}}