Targeted Pressure on Abductor Hallucis and Flexor Hallucis Brevis Muscles to Manage Moderate to Severe Primary Restless Legs Syndrome
| Autor: | John P. Sullivan, Phyllis J. Kuhn, Daniel J. Olson |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Complementary and Manual Therapy
Adult Male medicine.medical_specialty Indoles Placebo Flexor hallucis brevis muscle Severity of Illness Index 03 medical and health sciences 0302 clinical medicine Meta-Analysis as Topic Restless Legs Syndrome mental disorders Severity of illness medicine Pressure Humans Abductor hallucis muscle 030212 general & internal medicine Restless legs syndrome Muscle Skeletal Aged business.industry Foot Repeated measures design Drug Tolerance Middle Aged medicine.disease Placebo Effect Ropinirole Complementary and alternative medicine Anesthesia Dopamine Agonists Clinical Global Impression Physical therapy Female business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | The Journal of the American Osteopathic Association. 116(7) |
| ISSN: | 1945-1997 |
| Popis: | Context: 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. Objective: 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. Methods: 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. Results: 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]; PPPP Conclusion: 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.) J Am Osteopath Assoc. |
| Databáze: | OpenAIRE |
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