Effect of "He Tiao Du Ren An Shen Acupuncture" on restless leg syndrome: A randomized trial.

BACKGROUND: This study aimed to observe the clinical effects of "He Tiao Du Ren An Shen Acupuncture" (HTDRAS Acupuncture) for treating restless leg syndrome (RLS). METHODS: We randomly divided 66 RLS patients into 2 groups: the observation group received "He Tiao Du Ren An Shen Acupuncture" and the control group received conventional acupuncture. All participants were treated once a day, 6 days a week, with 1 day off, for a total of 1 month. Clinical effectiveness of the 2 groups was compared, neurotransmitter levels, the International Restless Leg Syndrome Scale and the Hamilton Anxiety Scale were assessed in both groups. RESULTS: The curative effect in the observation group was better than that in the control group (P < .05). After treatment, the expression of 5-hydroxytryptamine in the observation group was higher than in the control group (P < .05). The International Restless Leg Syndrome Scale and Hamilton Anxiety Scale scores in observation group were lower than those in control group (P < .05). CONCLUSION: "He Tiao Du Ren An Shen Acupuncture" for RLS is significantly effective and safe. It can effectively improve the levels of 5-hydroxytryptamine in RLS patients, alleviate clinical symptoms and reduce anxiety. This treatment has a high clinical application value and is worthy of clinical promotion.

The effect of compression stockings on the complaints well-being and sleep quality of pregnant women with restless legs syndrome: a randomized controlled study.

OBJECTIVE: The aim of this study was to determine the effect of compression stockings on complaints, well-being, and sleep quality in pregnant women with restless legs syndrome. METHODS: This randomized placebo-controlled study was conducted on 63 pregnant women (placebo group [PG]=31; experimental group [EG]=32) at the Perinatology Outpatient Clinic of a Health Research and Application Centre in Turkey. Pregnant women in the experimental group wore compression stockings when they got up in the morning for 3 weeks and took them off at bedtime. Placebo group women wore a placebo stocking. Data were collected using the restless legs syndrome Severity Rating Scale, the Pittsburgh Sleep Quality Index, the World Health Organization-5 Well-Being Index, and the Application Satisfaction Form on the 22nd day of the first interview. Statistical significance was accepted as p<0.05. RESULTS: Post-test mean scores of both the experimental group and placebo group in the restless legs syndrome Severity Rating Scale (post-test:;8.87±5.27, 12.19±5.60; pre-test:;21.28±5.63, 21.0±5.61; p<0.05), the Pittsburgh Sleep Quality Index (post-test:;5.34±3.28, 6.12±3.12; pre-test:;10.15±4.23, 9.61±4.59; p<0.05), and Well-Being Index (post-test:;18.06±4.59, 19.00±4.47; pre-test:;12.71±5.85, 15.09±5.62; p<0.05) showed recovery according to the pre-tests. However, the post-test restless legs syndrome Severity Rating Scale of the experimental group was lower than that of the placebo group (p<0.05). The effect of their application started in 3.93±1.74 days on average in the experimental group, while it started in 5.09±1.55 days in the placebo group (p<0.05). CONCLUSION: Both applications reduced the severity of restless legs syndrome in pregnant women and increased sleep quality and well-being. However, compression stockings were more effective in reducing restless legs syndrome severity. Nurses can use compression and placebo stockings in the care of pregnant women with restless legs syndrome. CLINICAL TRIAL REGISTRATION NUMBER: NCT05795868.

Rethinking clinical trials in restless legs syndrome: A roadmap.

The number of large clinical trials of restless legs syndrome (RLS) have decreased in recent years, this coincides with reduced interest in developing and testing novel pharmaceuticals. Therefore, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force of global experts to examine the causes of these trends and make recommendations to facilitate new clinical trials. In our article, we delve into potential complications linked to the diagnostic definition of RLS, identify subpopulations necessitating more attention, and highlight issues pertaining to endpoints and study frameworks. In particular, we recommend developing alternative scoring methods for more accurate RLS diagnosis, thereby improving clinical trial specificity. Furthermore, enhancing the precision of endpoints will increase study effect sizes and mitigate study costs. Suggestions to achieve this include developing online, real-time sleep diaries with high-frequency sampling of nightly sleep latency and the use of PLMs as surrogate markers. Furthermore, to reduce the placebo response, strategies should be adopted that include placebo run-in periods. As RLS is frequently a chronic condition, priority should be given to long-term studies, using a randomized, placebo-controlled, withdrawal design. Lastly, new populations should be investigated to develop targeted treatments such as mild RLS, pregnancy, hemodialysis, or iron-deficient anemia.

Efficacy and safety of TOMAC for treatment of medication-naïve and medication-refractory restless legs syndrome: A randomized clinical trial and meta-analysis.

OBJECTIVE/BACKGROUND: There is a significant unmet need for safe and effective nonpharmacological therapies for restless legs syndrome (RLS). The objective was to evaluate the efficacy and safety of tonic motor activation (TOMAC) in patients with RLS. PATIENTS/METHODS: A multicenter, randomized, participant-blinded, sham-controlled trial enrolled 45 adults with primary moderate-to-severe RLS who were either medication-naïve (n = 20) or medication-refractory (n = 25). Participants were 1:1 randomized to TOMAC (n = 22) or sham (n = 23) for two weeks and instructed to self-administer 30-min TOMAC sessions when they experienced RLS symptoms. The primary outcome was mean change in International RLS Study Group Rating Scale (IRLS) total score. A subsequent meta-analysis included the present trial and a previous randomized clinical trial that enrolled medication-naïve RLS patients. RESULTS: IRLS reduction was significantly greater for TOMAC than sham (TOMAC -6.59 vs. sham -2.17; mean difference (MD) = -4.42; 95 % confidence interval [CI] -1.57 to -7.26; p = 0.0040). Subgroup analysis showed similar IRLS mean difference for medication-refractory (MD = -4.50; p = 0.02) and medication-naïve (MD = -4.40; p = 0.08) cohorts, which was significantly different from sham only for the medication-refractory cohort. Meta-analysis of combined data from 33 medication-naïve RLS patients showed a significant reduction in mean IRLS score after two weeks for TOMAC compared to sham (MD = -4.30; 95 % CI -1.36 to -7.24; p = 0.004). CONCLUSIONS: The present trial confirmed previous reports documenting efficacy and safety of TOMAC in refractory RLS and indicated similar effect sizes in refractory versus naïve subgroups. The meta-analysis demonstrated that TOMAC significantly improves RLS symptoms in naïve participants.

Effect of Non-Pharmacological Methods Used for Restless Leg Syndrome in Pregnancy on the Severity of the Syndrome and Sleep: A Systematic Review and Meta-Analysis.

Background: Non-pharmacological methods are primarily recommended for the treatment and care of pregnant women with restless legs syndrome. This study aimed to determine the effectiveness of non-pharmacological methods in reducing the severity of restless legs syndrome and improving sleep quality in pregnant women, based on the results of previous studies. Methods: A systematic review and meta-analysis of randomized controlled trials and quasi-experimental studies was conducted. Studies published between 14 February 2022 and 22 March 2023 in DergiPark, Turkish Clinics, ULAKBIM, Higher Education Council National Thesis Center, ProQuest Dissertations, EBSCOhost (Medline, CINAHL), OVID-LWW, Web of Science, PubMed, Scopus, and ClinicalStudys.gov databases were identified by keywords. Results: Six articles with a total sample size of 359 (intervention group: 312; control group: 107) were included in the meta-analysis. The combined results of these studies showed that non-pharmacological methods significantly reduced the severity of restless legs syndrome (MD: -13.00, Z = 7.29, P < .0001). In the subgroup analysis performed based on the type of intervention methods used, relaxing background music, progressive muscle relaxation exercises, sleep hygiene training, and hot and cold water applications were found to be effective. In addition, this meta-analysis showed that non-pharmacological methods significantly improved sleep quality (MD: -3.73, Z = 12.49, P < .00001). Conclusion: By using a non-pharmacological method with proven effectiveness, it is possible to reduce the discomfort associated with pregnancy-related restless legs syndrome and improve sleep quality.

Sleep-related disorders in patients with precapillary pulmonary hypertension.

Precapillary pulmonary hypertension (PcPH) is associated with the development of sleep-related disorders and impairment of sleep quality. With growing recognition of the clinical relevance of sleep-related conditions in PcPH, this narrative review seeks to discuss the spectrum of disorders encountered in clinical practice, pathophysiological mechanisms linking PcPH with sleep-related disorders, and potential therapeutic considerations. Current evidence demonstrates a higher prevalence of impaired sleep quality, sleep-disordered breathing, sleep-related hypoxia, and restless leg syndrome in patients with PcPH. These sleep-related disorders could further lead to impairment of quality of life in a patient population with already a high symptom burden. Recent data suggest that sleep-related hypoxia is strongly linked to worse right ventricular function and higher risk of transplantation or death. However, limited studies have investigated the role of oxygen therapy or positive airway pressure therapy improving symptoms or outcomes. Abnormal iron homeostasis is highly prevalent in PcPH and may contribute to the development of restless legs syndrome/periodic limb movement of sleep. To improve sleep management in PcPH, we highlight future research agenda and advocate close collaboration between pulmonary hypertension specialists and sleep physicians.

Experiences of facilitators and barriers for fulfilment of human needs when living with restless legs syndrome: a qualitative study.

PURPOSE: Restless Legs Syndrome (RLS) is a widespread condition that affects sleep leading to daytime sleepiness, depression, and reduced quality of life. This study aims to determine and describe how patients with RLS experience their everyday life, with a focus on facilitators and barriers related to Maslow's hierarchical theory of human needs. METHOD: Semi-structured interviews were analysed with qualitative content analysis resulting in facilitators and barriers affecting the fulfilment of the five human needs. RESULTS: Addressing RLS symptoms through medications and a quiet sleep environment fulfils psychological needs. Control over RLS symptoms, engagement in activities, trust in treatments, and social support meet safety and security needs. Social inclusion, close relationships, and meaningful interactions fulfil a sense of belongingness and love needs despite RLS. Competence in managing RLS, effective self-care strategies, confident communication, and trust-building support esteem needs. Finally, comprehensive understanding through person-centred interventions and coping fulfils the self-actualization needs in managing RLS. CONCLUSION: Holistic and person-centred interventions, including facilitators for the fulfilment of physiological, psychological, and social needs could help healthcare professionals to provide holistic care.

Efficacy and Safety of Acupuncture for Restless Legs Syndrome in Patients with End-Stage Renal Disease: A Randomized-Controlled Trial at Hospital-Based Hemodialysis Center.

Background: Restless legs syndrome (RLS) is frequent in patients with hemodialysis (HD) and occurs predominantly in its most severe forms. The study was conducted to evaluate the efficacy and safety of acupuncture for RLS in patients with end-stage renal disease (ESRD) at hospital-based HD center. Methods: This single-blind, randomized controlled trial was performed on patients with HD and RLS who were randomly assigned to the experimental group and control group. Data were collected using the International Restless Legs Syndrome Rating Scale (IRLSRS), Insomnia Severity Index (ISI), and heart rate variability (HRV) records at baseline, after the therapeutic course (12 times/4 weeks), and 1-week follow-up. Result: A total of 47 patients were evaluated with IRLSRS score from 11 to 30 in this study. There were 41 patients enrolled in the study based on inclusion/exclusion criteria and allocated randomly into two groups. A total of 35 participants completed the trial, including 18 subjects in the experimental group and 17 subjects in the control group. The comparison of IRLSRS and ISI showed a significant reduction between two groups after acupuncture treatment (p = 0.002, p = 0.003). The ISI after 1-week follow-up also revealed significant decrease (p = 0.003). This HRV results showed that high frequency (HF%) increased significantly (p = 0.021) and low frequency (LF%) decreased significantly in the acupuncture group (p = 0.021). The generalized estimating equation showed that the IRLSRS improved by 2.902 points (p < 0.001) in the acupuncture group compared with the control group and by 1.340 points (p = 0.003) after 1-week follow-up. There were no adverse effects observed during HD in this study. Discussion: The authors conclude that acupuncture could effectively improve the symptoms of RLS significantly. The results from this study provide clinical evidence on the efficacy and safety of acupuncture to treat the patients with RLS at the HD center.

A survey-based approach on restless legs syndrome: practices and perspectives among Italian neurologists.

INTRODUCTION: Restless Legs Syndrome (RLS) is a widely prevalent and complex neurological disorder. Despite notable advancements in managing RLS, the disorder continues to face challenges related to its recognition and management. OBJECTIVE: This study seeks to gain comprehensive insights into the knowledge and clinical practices among Italian neurologists regarding RLS diagnosis, management, and treatment, comparing approaches among general neurologists, movement disorder specialists, and sleep experts. METHODS: Members of the Italian Society of Neurology, the Italian Society of Parkinson and Movement Disorders, and the Italian Association of Sleep Medicine were invited to participate in a 19-question online survey. RESULTS: Among the 343 surveyed neurologists, 60% categorized RLS as a "sleep-related movement disorder." Forty% indicated managing 5-15 RLS patients annually, with sleep specialists handling the highest patient volume. Of note, only 34% adhered strictly to all five essential diagnostic criteria. The majority (69%) favored low-dosage dopamine agonists as their first-line treatment, with movement disorder specialists predominantly endorsing this approach, while sleep experts preferred iron supplementation. Regular screening for iron levels was widespread (91%), with supplementation typically guided by serum iron alterations. In cases of ineffective initial treatments, escalating dopamine agonist dosage was the preferred strategy (40%). CONCLUSIONS: These findings underscore a lack of a clear conceptualization of RLS, with a widespread misconception of the disorder as solely a movement disorder significantly influencing treatment approaches. Disparities in RLS understanding across neurology subspecialties underscore the necessity for improved diagnostic accuracy, targeted educational initiatives, and management guidelines to ensure consistent and effective RLS management.

[Gastrointestinal disorders in hyperkinetic movement disorders and ataxia]. / Gastrointestinale Störungen bei hyperkinetischen Bewegungsstörungen und Ataxien.

Disorders of the gastrointestinal tract in patients suffering from hypokinetic movement disorders, and in particular Parkinson's disease, have increasingly been the subject of more intensive neuromedical research. So far, few data are available for patients with hyperkinetic movement disorders and ataxias. This review article summarizes the currently available and relevant publications on this topic. The particular focus is on essential tremor, restless legs syndrome, Huntington's disease and the group of hereditary ataxias. Further intensive research will be necessary in the future to collect detailed information also for these disease symptoms about specific disturbance patterns, in order to understand the underlying pathological pathways and to derive specific treatment approaches.

Transcutaneous electrical nerve stimulation in the management of restless legs syndrome symptoms: A single-blind, parallel-group clinical study.

The aim of this study was to investigate the additional effect of transcutaneous electrical nerve stimulation (TENS) on the control of the symptoms of restless legs syndrome (RLS). A total of 46 randomly selected patients diagnosed with RLS were divided into two groups in a single-blind study to either receive pramipexole (0.25 mg daily) plus 10 sessions of TENS or only pramipexole (0.25 mg daily) for 4 weeks. The severity of the symptoms was determined according to the International Restless Legs Syndrome Rating Scale (IRLSRS) and the Pittsburgh sleep quality index (PSQI) at the beginning of the treatment, post-treatment, and at an 8 week follow-up. A significant time interaction was observed between the groups for all measurement outcomes, revealing differences in favour of the experimental group's IRLSRS and PSQI scores. A notable improvement was also observed in the IRLSRS and PSQI scores in both groups at the end of treatment and during the 8 week follow-up period. In comparison with pramipexole monotherapy, the results of this study showed that the use of TENS therapy combined with a low dose of pramipexole (0.25 mg daily) is therapeutically beneficial in the treatment of RLS over an 8 week follow-up period.

Dorsal root ganglion stimulation (DRG-s) for potential resolution of restless leg syndrome symptoms and increased cost savings for patients: A case study.

INTRODUCTION: We report successful use of dorsal root ganglion stimulation (DRG-s) to treat a patient with persistent symptoms of restless leg syndrome (RLS). METHODS: The treatment involved the placement of a small device millimeters away from the patient's DRG, which are nerves near the spinal cord that carry sensory information from the periphery of the body to the brain. The device automatically delivers electrical impulse to the DRG to alter and decrease pain perception in the brain. RESULTS: Our case report elucidates the use of this procedure as a targeted therapy for RLS, with a nearly 90% reduction in reported symptoms in our patient, thus potentially reducing morbidity associated with this condition. Furthermore, we report a 10-year cost savings of nearly $90,000 following DRG-s for our patient. CONCLUSION: This case study aims to demonstrate the effectiveness of DRG-s neuromodulation in managing RLS, a condition that is often difficult and costly to treat.

Application of Repetitive Transcranial Magnetic Stimulation for the Treatment of Restless Legs Syndrome: A Pilot Study.

OBJECTIVE: To explore effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) on patients with restless legs syndrome (RLS). METHODS: In total, 18 patients with primary RLS were divided into rTMS group and sham stimulation group. The rTMS treatment group received 15-Hz high-frequency rTMS to stimulate the leg motor representative area of the frontal cortex for 14 days, and the sham stimulation group received 15 Hz high-frequency rTMS sham stimulation in primary motor cortex for 14 days. RESULTS: After rTMS, RLS severity scale score, Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAMA), as well as Hamilton Depression Rating Scale 24 (HAMD24) in rTMS treatment group were significantly lower than before treatment; 1 month and 2 months after treatment, the score remained at low level. Meanwhile, no significant changes have been observed in the aforementioned index before rTMS stimulation for the sham stimulation group after 14 days or after 1 month and 2 months. In addition, the results of correlation analysis suggested for all the 18 patients with RLS, there was a positive correlation between PSQI score and HAMA as well as HAMD24 scores before and after rTMS stimulation. In addition, the RLS severity score was also positively correlated with PSQI, HAMA, and HAMD24 scores. CONCLUSIONS: High-frequency rTMS stimulation reduces the frequency and severity of RLS; improves the quality of sleep, anxiety, as well as depression of the patients; and the curative effect can be sustained for 2 months. High-frequency rTMS may be used as an alternative treatment option for improving the quality of life of patients with RLS.

Stakeholder involvement in the optimization of a patient-centered exercise intervention for people with restless legs syndrome.

STUDY OBJECTIVES: Previous research supports exercise as a behavioral approach to manage symptoms of restless legs syndrome (RLS); however, completion rates in exercise studies are low. This study obtained key stakeholder feedback from people with RLS to modify and optimize a 12-week, evidence-based exercise program for RLS. METHODS: Participants with RLS (n = 513) completed a nationwide survey to provide feedback on the necessity, interest, feasibility, and efficacy of the program as well as perceived barriers and proposed modifications to improve the exercise program. RESULTS: Most respondents (67%) expressed the need for an exercise program designed specifically for people with RLS and 64% were interested in the program. Only 6% of participants thought the program would not be well tolerated and 6% responded that it would likely exacerbate symptoms. However, only 58% said they would be likely to participate in the program if it was available to them locally. Key barriers to participation were (1) accessibility, (2) personal factors, (3) trustworthiness, and (4) fear of injury, illness, or symptom exacerbations. Respondents highlighted modification considerations for the individualization of exercise features, adaptations for specific impairments/personal factors, inclusion of flexibility and balance exercises, and flexibility for more home-based activities. CONCLUSIONS: Interest in the program was driven by the desire to reduce medications and improve overall quality of life. Appropriately educated and trained exercise providers knowledgeable about RLS are integral to buy-in from stakeholders. This study provides an imperative step in clinical research that can increase the success of subsequent implementation efforts and may accelerate the adoption of exercise programs into practice. CITATION: Cederberg KLJ, Sikes EM, Mignot E. Stakeholder involvement in the optimization of a patient-centered exercise intervention for people with restless legs syndrome. J Clin Sleep Med. 2024;20(4):535-543.

Improvement of restless leg syndrome in maintenance hemodialysis patients with limb ischemic preconditioning: a single-center randomized controlled clinical trial.

OBJECTIVE: This study evaluated the efficacy and safety of limb ischemic preconditioning (LIPC) in treating restless leg syndrome (RLS) in maintenance hemodialysis (MHD) patients. METHODS: A total number of 45 patients participated in the study. They were randomly divided into LIPC group and control group. The LIPC was performed by inflating the limb ischemic preconditioning training device in the patient's thigh to 200 mmHg to create transient ischemia, whereas control group inflated the device to 20 mmHg. International Restless Legs Syndrome (IRLS), Clinical Global Impression Scale (CGI-S), and Medical Outputs Study Sleep Scale were employed to evaluate LIPC effectiveness. The primary endpoint was the 'rate of clinical improvement in RLS severity', defined as the percentage of patients who had an IRLS score decrease of ≥5 points in each group. RESULTS: After intervention, the rate of clinical improvement in RLS severity was 56.5% in the LIPC group and 13.6% in the control group (13 (56.5) vs 3 (13.6), p = 0.003). In addition, the LIPC group's IRLS, CGI-S scores, the sleep disturbance and somnolence scores showed a significant downward trend compared to the control group (-5.5 ± 5.3 vs - 1.0 ± 3.8, p = 0.002; -1.7 ± 1.2 vs - 0.5 ± 1.4, p = 0.003; -15.5 ± 17.8 vs 3.7 ± 12.0, p < 0.001; -9.9 ± 18.8 vs - 2.4 ± 8.6, p = 0.003). During the study, there were no serious adverse event in any of the patients. CONCLUSIONS: LIPC could be employed to effectively and safely alleviate the RLS symptoms in MHD patients.

[Restless sleep disorder a new entity to considered in children]. / Trastorno de sueño inquieto: una nueva entidad clínica a considerar en niños.

Restless sleep disorder (RSD) is a condition recently described by a group of sleep experts who developed diagnostic and polysomnographic criteria after conducting a comprehensive review of the available literature where poor sleep or restless sleep is a symptom alone or that accompanies other disorders. This group defined RSD as a condition characterized by parental complaints of frequent jerking movements during sleep, position changes, and sleep disruption that cause significant impairment during the day. Diagnostic criteria include the presence of symptoms for at least 3 months, 3 times a week, and at least 5 movements per hour on polysomnography. Changes in behavior during the day, such as drowsiness, irritability, and hyperactivity that are not explained by a medical, pharmacological, or behavioral condition, should be considered. Its estimated prevalence is 7.7% of children referred for sleep problems. Children often have ferritin levels below 50 µg/l, a point in common with restless legs syndrome. Treatment consists of iron supplements, which have shown benefits in these children. To establish the diagnosis, secondary symptoms of medical origin or other sleep disorders such as restless legs syndrome or periodic limb movement disorder must be ruled out. The objective of this report is to review the current recommendations on this entity, describe the clinical, pathophysiological, and polysomnographic keys, in order to highlight the need to publicize this condition and expand studies in age groups other than those already defined and to generate treatment guidelines.

Sleep and Women's Mental Health.

Women have increased risks for both sleep disturbances and disorders and for mental health issues throughout their lives, starting in adolescence. Women have a higher prevalence of insomnia disorder and restless legs syndrome (RLS) versus men, and obstructive sleep apnea (OSA) is more likely as women age. Hormonal transitions are important to consider in women's sleep. For women, insomnia, OSA, and RLS are predictive of depression, and insomnia and sleep-disordered breathing are predictive of Alzheimer disease. These findings underscore the importance of assessment, treatment, and future research examining sleep and mental health in women, given their unique and increased vulnerability.

History of Sleep Disorders in Chronic Kidney Disease: First Approach.

OBJECTIVES: In this study, we examined the history of sleep disorders in chronic kidney disease, 60 years after the advent of hemodialysis and renal transplant of genetically nonrelated organs, which have spurred a critical mass of data. MATERIALS AND METHODS: We analyzed selected literature on sleep disorders in chronic kidney disease from 1959 onward. RESULTS: Sleep disturbances are present in the general population. They cause loss of renal function and progressive nephron loss. Insomnia, sleep apnea, restless leg syndrome, and periodic limb movements represent sleep disturbances in chronic kidney disease. These symptoms manifest early in chronic kidney disease and are a rule in patients on dialysis and kidney transplant recipients. Sleep disturbances cause fatigue, excessive daily sleepiness, impaired daytime function, impaired health-related quality of life, increased morbidity, and increased mortality. CONCLUSIONS: Sleep disorders affect most patients with chronic kidney disease. No ascertained pharmacological therapy exists, and even a successful transplant does not totally restore a refreshing sleep. Longer nocturnal hemodialysis is of benefit. Sleep apnea may be cured with continuous positive airway pressure.