Intraoral Acupuncture for Sialorrhea in Stroke Patients: a Study Protocol for a Randomized Controlled Trial.

Importance: Post-stroke sialorrhea (PSS) refers to excessive saliva flowing out the lip border after a stroke. PSS negatively affects patient self-image and social communication and may lead to depression. Limited evidence supports the link between excessive salivation and PSS. No large-scale, strictly controlled randomized controlled trials have shown the effectiveness of acupuncture in treating PSS patients. Objective: We aim to compare the effects of intraoral and sham acupuncture in PSS patients and explore relationships among salivation and drooling severity and frequency and swallowing function in stroke patients. Design: Clinical study protocol, SPIRIT compliant. Setting: Prospective, single-center, randomized, and sham-controlled trial. Population: We will recruit 106 PSS patients to receive 4-week intraoral or sham acupuncture. Additionally, 53 stroke patients without PSS will undergo a conventional 4-week treatment program to compare salivation between PSS and non-PSS patients. Exposures: Intraoral or sham acupuncture. Main Outcomes and Measures: The main evaluation index will be the 3-minute saliva weight (3MSW), comparing changes in 3MSW from baseline to weeks 4 and 8. Secondary assessment indices will include the "Drooling Severity and Frequency Scale" and "Functional Oral Intake Scale." Results: The results from this study will be published in peer-reviewed journals. Conclusion: Comparing effects of intraoral and sham acupuncture in PSS patients, this study may contribute important evidence for future PSS treatment and provide valuable insights into whether salivation issues in stroke patients are attributed to heightened salivary secretion or dysphagia.

Deep brain stimulation of the subthalamic nucleus increases the risk of sialorrhea in patients with advanced Parkinson's disease.

INTRODUCTION: Sialorrhea is a common neurological manifestation of Parkinson's disease (PD). No specifically designed prospective study has tested the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on sialorrhea in patients with advanced PD. We focused on the effect of STN-DBS on the incidence of sialorrhea in patients with PD. METHODS: This multicenter, prospective, non-randomized concurrent clinical trial analyzed the incidence of sialorrhea during long-term follow-up in 170 patients with advanced PD (84 patients with STN-DBS and 86 patients with medication therapy). RESULTS: After STN-DBS, 58.1% of patients presented with sialorrhea (Drooling Rating Scale (DRS) > 5) compared with 39.3% of patients with medication therapy (P < 0.001). STN-DBS stimulation demonstrated a significant increase in DRS and Drooling Severity and Frequency Scale (DSFS) compared with the patients with medication therapy (P < 0.001). At follow-up, the onabotulinumtoxin-A (BTX-A) injection ratio was significantly higher in the STN-DBS group (29.8% vs. 11.9%, P = 0.0057) compared with the patients with medication therapy. CONCLUSIONS: STN-DBS increased the risk of sialorrhea in patients with advanced PD. TRIAL REGISTRATION: clinicaltrials. gov (NCT06090929).

Drooling and Aspiration of Saliva.

Drooling and aspiration of saliva can affect the quality of life and morbidity of patients with neuromuscular diseases. Practitioners must differentiate between drooling with and without aspiration of saliva, as the presence of aspiration affects respiratory health. There are several validated drooling scales, but validated assessments for aspiration of saliva are lacking. Once diagnosed, drooling can be treated with rehabilitative therapy, anticholinergics, botulinum toxin to the salivary glands, and surgery. Drooling with aspiration of saliva often requires multidisciplinary engagement to decrease the risk of respiratory complications.

Impact and management of drooling in children with neurological disorders: an Italian Delphi consensus.

BACKGROUND: The rate of chronic drooling in children older than 4 years is 0.5%, but it rises to 60% in those with neurological disorders. Physical and psychosocial consequences lead to a reduction in the quality of Life (QoL) of affected patients; however, the problem remains under-recognized and under-treated. We conducted an Italian consensus through a modified Delphi survey to discuss the current treatment paradigm of drooling in pediatric patients with neurological disorders. METHODS: After reviewing the literature, a board of 10 experts defined some statements to be administered to a multidisciplinary panel through an online encrypted platform. The answers to the questions were based on a 1-5 Likert scale (1 = strongly disagree; 5 = strongly agree). The scores were grouped into 1-2 (disagreement) and 4-5 (agreement), while 3 was discarded. The consensus was reached when the sum of the disagreement or agreement was ≥75%. RESULTS: Fifteen statements covered three main topics, namely clinical manifestations and QoL, quantification of drooling, and treatment strategies. All statements reached consensus (≥75% agreement). The 55 Italian experts agreed that drooling should be assessed in all children with complex needs, having a major impact on the QoL. Attention should be paid to investigating posterior hypersalivation, which is often neglected but may lead to important clinical consequences. Given that the severity of drooling fluctuates over time, its management should be guided by the patients' current needs. Furthermore, the relative lack of validated and universal scales for drooling quantification limits the evaluation of the response to treatment. Finally, the shared therapeutic paradigm is progressive, with conservative treatments preceding the pharmacological ones and reserving surgery only for selected cases. CONCLUSION: This study demonstrates the pivotal importance of a multidisciplinary approach to the management of drooling. National experts agree that progressive treatment can reduce the incidence of complications, improve the QoL of patients and caregivers, and save healthcare resources. Finally, this study highlights how the therapeutic strategy should be reconsidered over time according to the available drugs on the market, the progression of symptoms, and the patients' needs.

[Effect of intradermal needling combined with oral motor therapy for salivation in children with cerebral palsy: a randomized controlled trial].

OBJECTIVE: To compare the effect of combination of intradermal needling with oral motor therapy and simple oral motor therapy on salivation in children with cerebral palsy. METHODS: A total of 60 children with salivation in cerebral palsy were randomized into an observation group and a control group, 30 cases in each group. The observation group was treated with intradermal needling (kept for 24 hours each time at Jiache [ST 6], Dicang [ST 4], tongue three needles, etc. ) and oral motor therapy, while the control group was only given oral motor therapy. The intradermal needling was performed 3 times a week, and oral motor therapy was performed 5 times a week, 4 weeks as a course, totally 3 courses of treatment were required. The classification of teacher drooling scale (TDS), drooling severity and Kubota water swallow test, dysphagia disorders survey (DDS) score were compared before treatment and after 4, 8 and 12 weeks of treatment in both groups, and the clinical efficacy was evaluated. RESULTS: After 8 weeks of treatment in the observation group and after 12 weeks of treatment in the two groups, the classification of TDS and drooling severity were improved (P<0.05), and the observation group was better than the control group after 12 weeks of treatment (P<0.05). After 8 and 12 weeks of treatment, the DDS scores of oral period in the observation group were lower than those before treatment (P<0.05). The total effective rate in the observation group was 83.3% (25/30), which was higher than 53.3% (16/30) in the control group (P<0.05). CONCLUSION: The combination of intradermal needling with oral motor therapy can improve salivation symptoms and swallowing function in children with cerebral palsy, the effect is better than oral motor therapy alone, and the effect is earlier.

Effects of Kinesio Taping Compared with Manipulation Therapy on Drooling and Speech Intelligibility in Children with Oral Dysphagia: A Pilot Study.

OBJECTIVE: To determine the effectiveness of Kinesio Taping (KT) and Manipulation Therapy (MT) on drooling and speech intelligibility in children with oral dysphagia. METHODS: A randomized clinical trial was conducted at Helping Hand Institute of Rehabilitation Sciences in Mansehra, Pakistan. A total of 20 patients were recruited via the random sampling technique and later assigned to one of two groups: KT (n = 10) or MT (n = 10). Every patient in both groups received their intervention 5 days a week for 1 month (20 sessions total), and each session lasted 45 minutes. Data was collected and analyzed at baseline and 1 month. Drooling was assessed via the Modified Teachers' Drooling Scale and speech intelligibility determined via the 7-Point Intelligibility Rating Scale. Mann Whitney U-test was used for between-group comparisons and for within-group comparisons the Wilcoxon signed-rank test and their effect size was used. RESULTS: The mean age of study patients was 5.4 years. Of the 20 patients, 14 were male and 6 were female. Within-group comparisons showed significant improvement in both drooling and speech intelligibility (P < .05), while between-group comparisons showed no significant difference (P ≥ .05) in either the KT or MT group regarding drooling severity and speech intelligibility. CONCLUSION: KT and MT significantly improved drooling and speech intelligibility.

Expiratory Muscle Strength Training for Drooling in Adults with Parkinson's Disease.

One of the most debilitating symptoms of advanced Parkinson's disease is drooling. Currently, the main treatment that is offered for drooling is botulinum toxin injections to the saliva glands which have a number of side effects and do not treat the causes of drooling, such as impaired swallowing and lip closure. This study explored the effect of an alternative therapy approach for drooling that aimed at improving the swallow, expiratory muscle strength training (EMST). Sixteen participants received EMST over a 6- to 8-week period. Measurements were taken pre- and post-training for drooling (Sialorrhea Clinical Scale for Parkinson's Disease; SCS-PD), swallowing, lip strength and peak cough flow. Measures of drooling, swallowing and peak cough flow were stable over pre-training assessments and improved following training (p < 0.01). The most conservative estimate of the within-group change for SCS-PD was - 2.50 (95% confidence interval -  3.22 to -  1.22). No adverse effects were reported and participants gave high satisfaction ratings for the training. A programme of EMST offers promise as a therapy to reduce drooling for people with Parkinson's disease. Adequately powered randomised controlled trials of EMST are now needed.

The effect of Kinesio Taping on drooling in children with intellectual disability: A double-blind randomized controlled study.

PURPOSE: Drooling is an unintentional spillage of saliva, which can be caused by any condition that affects the neuromuscular control of mouth muscles. There are different treatments for drooling, some of which are novel therapies with unknown efficacy like Kinesio Taping (KT). This study aimed to investigate the effects of adding KT to oral-motor training (OMT) on drooling in children with intellectual disability. METHOD: This is a double-blind randomized controlled trial in which 18 children with intellectual disabilities participated through convenience sampling. Participants were randomly assigned into 2 groups by block randomization method. Kinesio taping of orbicularis oris, supra-hyoid and masseter muscles and routine OMT were performed for the intervention group. The control group received taping with no stretch as placebo. Pre-post assessment was carried out after four weeks of intervention by the drooling rating scale (DRS) and drooling quotient (DQ) test. RESULTS: Within-group analysis showed a significant reduction in drooling post-intervention in both groups based on DRS and DQ (p < 0.001). Between-group analysis indicated a significant improvement in the intervention group (P = 0.008) with moderate effect size using DQ assessment but this difference was not significant with moderate effect size based on parental reports using DRS. CONCLUSION: DQ assessment revealed that using KT plus OMT can produce greater improvement than sham taping plus OMT. However, there was not a statistically difference between the two groups based on parental reports using DRS. In addition, within-group analysis showed that drooling reduced in both groups after the intervention both based on DRS and DQ assessments. It can be concluded that adding taping with and without stretch to OMT can be considered as a complementary method to mitigate drooling in children with intellectual disabilities.

Surgery versus botulinum neurotoxin A to reduce drooling and improve daily life for children with neurodevelopmental disabilities: a randomized controlled trial.

AIM: To compare the effect of bilateral submandibular duct ligation and botulinum neurotoxin A (BoNT-A) on drooling severity and its impact on daily life and care in children and adolescents with moderate-to-severe drooling. METHOD: This was a randomized, interventional, controlled trial in which 53 children and adolescents (31 males, 22 females, mean age 11y, range 8-22y, SD 2y 10mo) with cerebral palsy (58.5%) or other non-progressive developmental disorders (41.5%) were randomized to BoNT-A (n=26) or bilateral submandibular duct ligation (n=27). A parent questionnaire on the severity of drooling in specific positions and daily activities and the impact of drooling on daily life and care was filled out at baseline and 8 and 32 weeks posttreatment. RESULTS: Both BoNT-A and bilateral submandibular duct ligation had a positive effect on daily care, damage to electronic equipment and/or furniture, social interactions, and self-esteem. However, bilateral submandibular duct ligation had a significant greater and longer-lasting short- (8wks) and medium-term (32wks) effect on daily care, reducing damage to electronic devices, and improving social interactions and satisfaction with life in general. INTERPRETATION: This randomized controlled trial confirms reduced drooling by both BoNT-A and bilateral submandibular duct ligation, but provides new evidence on improved well-being through a reduction in drooling. Even though there is a greater risk of complications and morbidity after bilateral submandibular duct ligation, compared to BoNT-A there was a significantly greater and longer-lasting positive effect on most outcomes. What this paper adds Bilateral botulinum neurotoxin A (BoNT-A) and submandibular duct ligation had a positive effect on the well-being of individuals with moderate-to-severe drooling. Bilateral submandibular duct ligation had a greater effect on the impact of drooling during daily care than BoNT-A. Bilateral submandibular duct ligation reduced damage to electronic devices and improved social interactions and satisfaction with life.

Acupuncture for drooling in children with cerebral palsy: A protocol for systematic review.

BACKGROUND: The aim of this study is to provide the methods used to evaluate the effectiveness and safety of acupuncture therapy for treating drooling in children with cerebral palsy. METHODS AND ANALYSIS: A comprehensive search of Pubmed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, 4 Chinese databases (China National Knowledge Infrastructure, Chinese Biomedical Literatures database, Wan-Fang Database and Chinese Science and Technology Periodicals will be conducted to identify randomized controlled trials of acupuncture for treating children with cerebral palsy salivation with no restriction on time or language. The primary outcome of this systematic review will be the effective rate. The risk of bias will be implemented according to Cochrane Handbook for Systematic Reviews of Interventions. We will conduct the meta-analysis to synthesize the evidence for each outcome, if possible. The heterogeneity will be evaluated statistically using the χ2 test and the I2 statistic. The random-effect model will be used to provide more conservative results, if significant heterogeneity is identified (I2 > 50% or P < .10). ETHICS/DISSEMINATION: Our findings will be disseminated in a peer-reviewed journal and at conference meetings. It is not necessary for formal ethical approval as no primary data are collected. TRIAL REGISTRATION NUMBER: INPLASY2020110024.

Posterior drooling in children with cerebral palsy and other neurodevelopmental disorders.

AIM: To evaluate the effect of botulinum neurotoxin A (BoNT-A) injections, submandibular gland excision (SMGE), and bilateral submandibular duct ligation (2DL) for the control of posterior drooling in children with neurological impairment. METHOD: In a retrospective cohort, children with neurological impairment (e.g. cerebral palsy) treated between 2000 and 2016 were identified. Mean age at time of surgery was 9 years (range 1-21y). The primary outcome was posterior drooling severity by a visual analogue scale (VAS; 0-10) at baseline, 8-weeks, and 32-weeks follow-up. The secondary outcome was lower respiratory tract infections during the follow-up period. RESULTS: Ninety-two patients (out of 475; 47 males, 45 females) were identified. They were undergoing three different treatments: BoNT-A (n=63), SMGE (n=16), and 2DL (n=13). A significant reduction in VAS over time was observed in the total group of 92 patients. After SMGE, VAS decreased significantly from 6.82 (SD 3.40) at baseline to 2.29 (SD 1.93) at 8 weeks, and 2.17 (SD 2.58) at 32 weeks (F[2.34]=11.618, p<0.001). There was no significant decrease after both BoNT-A and 2-DL. INTERPRETATION: Posterior drooling is an unfamiliar, potentially life-threatening condition that is treatable with medication, BoNT-A injections, or surgery. Although all treatments reduced signs and symptoms of posterior drooling, there is a greater effect after SMGE compared to BoNT-A and 2-DL. What this paper adds Submandibular gland excision has better results for posterior drooling than botulinum toxin A or submandibular duct ligation.

Sialorrhoea Management Practices in Residential Older Adults Care Settings: A Qualitative Study.

AIM: The aim of this research was to explore both older adults' and health care professionals' experience and views of sialorrhoea management practices in older adult residential care settings. BACKGROUND: Sialorrhoea is quite a bothersome symptom among patients with certain neurological conditions. The complexity of sialorrhoea and its complications can be quite challenging for health care professionals. In the management of sialorrhoea, a multidisciplinary approach is proposed as an effective way of sialorrhoea management. METHODS: Thematic analysis of collected data via semi-structured qualitative interviews with five focus groups involving 28 multidisciplinary health care members and 1 patient. RESULTS: The older adult and multidisciplinary health care professionals' view of the management of sialorrhoea in residential care settings were established under three main themes: 1) 'Sialorrhoea compromising patient's dignity', 2) 'Ad hoc local management' and 3) 'Further integration of care required'. CONCLUSION: At present, there have been no comprehensive multidisciplinary sialorrhoea management strategies to meet the various needs of older adults with sialorrhoea. IMPLICATION FOR NURSING MANAGEMENT: It is important to minimize the negative impact of sialorrhoea on the patients. The recognition of issues associated with sialorrhoea provides constructive scope for the health care professionals to further investigate and develop more effective integrated sialorrhoea care protocols.

Exploring treatments for drooling in children with neurological disorders.

Introduction: Drooling represents a major problem in the every-day life of pediatric patients with neurological disorders. The significant burden, both physical and socio-psychological, of the disorder requires adequate clinical evaluation and proper management. However, treating drooling remains a challenge for clinicians. This is a review of the most up-to-date therapeutic options for the treatment of drooling in the pediatric population, hence both conservative, pharmacological, and surgical approaches are discussed. Areas covered: Randomized clinical trials (RCTs), structured reviews, and case reports are included. Special focus is paid on the methods used to evaluate the efficacy and safety outcomes in the selected RCTs, trying to promote the use of more validated scales to assess drooling in the future. Expert opinion: The lack of reliable metrics to assess efficacy and safety outcomes in drooling limits researchers from identifying the best patient-suitable treatment. The relatively small number of clinical trials carried out over the last two decades is also due to the difficulty in assessing drooling using subjective scales. A key enabler for new efficient therapies stands in the introduction of accurate and robust metrics to measure treatment effectiveness on drooling.

Drooling in children with neurodisability: A survey of Australian speech-language pathologists' practice.

Purpose: In the absence of evidence-based guidelines, this study sought to understand current speech-language pathologists' (SLPs) practice when treating drooling in children with a neurodisability.Method: Descriptive research using cross-sectional survey methodology. Online survey methods were used to obtain specific information on Australian SLPs' self-reported assessment and treatment practices relative to working with children with neurodisability who drool. Questions focussed on level of expertise, treatment approaches and barriers to evidence-based practice (EBP) in this area. Participants were sourced through three targeted associations/organisations. Data were analysed using descriptive and non-parametric statistics.Result: Participants were Australian SLPs who had recent experience working with children with neurodisability who drool (n = 68). They favoured informal rather than formal methods for assessment. Preferred treatment techniques included behavioural intervention methods (46-53%) and modifying positioning (43.3%). Client suitability dominated reasoning regarding treatment selection (60%) with 57% of SLPs reporting EBP barriers.Conclusion: Drooling was perceived to be a complex practice area for which SLPs desire additional education. Despite availability, valid and reliable assessments of drooling were not commonly used. Clinicians have limited evidence to support their practice: further research is needed to establish evidence-based treatments for drooling.

When saliva becomes a problem: the challenges and palliative care for patients with sialorrhea.

Sialorrhea, or relative excess of salivary excretion, is a vexing problem for many patients. This symptom is precipitated by dysfunction in one of two interrelated processes-salivary production and oropharyngeal clearance. While medications primarily precipitate the former, dysphagia, often due to neurologic dysfunction, often causes the latter. This overabundance of saliva coupled with difficulty swallowing can predispose patients to respiratory issues, infections, and poor quality of life. There are, however, a myriad of treatment options that have shown clinical efficacy in treating this dysfunction. The purpose of this article is to present some background and etiology behind sialorrhea as well as present treatment options-non-pharmacologic, pharmacologic, surgical, and radiotherapeutic-that can help to ameliorate symptoms and improve quality of life for patients.

Drug-induced sleep endoscopy. / La endoscopia del sueño inducido.

This document introduces drug-induced sleep endoscopy to the specialist treating sleep breathing disorders and is intended as a guide for those willing to perform the procedure so that it can be reproducible.

Can muscle vibration be the future in the treatment of cerebral palsy-related drooling? A feasibility study.

Background: Drooling is an involuntary loss of saliva from the mouth, and it is a common problem for children with cerebral palsy (CP). The treatment may be pharmacological, surgical, or speech-related. Repeated Muscle Vibration (rMV) is a proprioceptive impulse that activates fibers Ia reaching the somatosensory and motor cortex. Aim: The aim of the study is to evaluate the effectiveness of rMV in the treatment of drooling in CP. Design, setting and population: This was a rater blinded prospective feasibility study, performed at the "Gli Angeli di Padre Pio" Foundation, Rehabilitation Centers (Foggia, Italy), involving twenty-two CP patients affected by drooling (aged 5-15, mean 9,28 ± 3,62). Children were evaluated at baseline (T0), 10 days (T1), 1 month (T2) and 3 months (T3) after the treatment. Methods: The degree and impact of drooling was assessed by using the Drooling Impact Scale (DIS), the Drooling Frequency and Severity Scale (DFSS), Visual Analogue Scale (VAS) and Drooling Quotient (DQ). An rMV stimulus under the chin symphysis was applied with a 30 min protocol for 3 consecutive days. Results: The statistical analysis shows that DIS, DFSS, VAS, DQ improved with significant differences in the multiple comparisons between T1 vs T2, T1 vs T3 and T1 vs T4 (p≤0.001). Conclusion This study demonstrates that rMV might be a safe and effective tool in reducing drooling in patients with CP. The vibrations can improve the swallowing mechanisms and favor the acquisition of the maturity of the oral motor control in children with CP.