Sham Device Research Articles

A flexible parylene probe for in vivo recordings from multiple subregions of the rat hippocampus.

The hippocampus is crucial to the formation of long-term memory and declarative memory. It is divided into three sub-fields the CA1, the CA3 and the DG. To understand the neuronal circuitry within the hippocampus and to study the role of the hippocampus in memory function requires the collection of neural activities from multiple subregions of the hippocampus simultaneously. Micro-wire electrode arrays are commonly used as an interface with neural systems. However, recording from multiple deep brain regions with curved anatomical structures such as the thin cell body layers of the hippocampus requires the micro-wires to be arranged into a highly accurate, complex layout that is difficult to fabricated manually. In this work, we designed and developed a flexible parylene-C based neural probe which can be easily micro-machined to the desired dimensions. Sixty-four electrical recording sites are micromachined on to 8 parylene shanks and spaced according to the distribution of hippocampal principal neurons in different hippocampus subregions. Together with our collaborators, we developed and optimized the implantation procedure of the flexible parylene probe and tested the insertion method both in brain tissue phantom and in vivo with a sham device. Immunohistochemistry (IHC) staining post-implantation of the sham probe was used to verify the location of the probe and to evaluate immune responses to the probe. Fully functional devices were fabricated and, in future studies, functional probes will be chronically implanted into the rat hippocampus, and neural activities will be recorded and compared with signals obtained with micro-wire arrays.

Interventions for female pattern hair loss.

Interventions for female pattern hair loss.

Efecto de Zhubin (KI9) para reducir el deseo de consumir alcohol en pacientes alcohólicos: un ensayo aleatorizado con grupo de placebo y control

ObjectiveTo examine the effect of acupuncture on Zhubin (KI9) in reducing alcohol craving in alcohol-dependent patients. MethodsTwenty male alcohol-dependent patients were randomly assigned to two groups, a treatment group (10 cases, age 43.0±6.8 years) and a placebo group (10 cases, age 44.5±7.9 years). The treatment group was treated with real needle acupuncture on Zhubin (KI9) twice a week for 4 weeks, and the control group was treated with placebo needle acupuncture. Both groups were given acupuncture treatment using Park Sham Device (PSD). Alcohol craving was measured by the Visual Analogue Scale (VAS) before treatment to establish a baseline, and after 1, 2, and 4 weeks of treatment. Repeated measures ANOVA was used to determine the main and interaction effects of time and on the outcome measure (VAS). ResultsThere was a significant effect of time on VAS score (df=3; F=13.3; P<.01). Main effect of group on VAS score was significant (df=1; F=10.9; P<.01) and the time símbolo de multiplicación group interaction was also significant (df=3; F=4.7; P<.01). ConclusionsReal-needle acupuncture therapy on Zhubin (KI9) showed effectiveness in reducing alcohol craving. These results strongly suggest the usefulness of acupuncture therapy on Zhubin (KI9) in preventing a relapse in alcohol dependent patients.

Effect of expiratory muscle strength training on swallowing-related muscle strength in community-dwelling elderly individuals: a randomized controlled trial.

This study aimed to investigate the effect of expiratory muscle strength training (EMST) on swallowing-related muscle strength in community-dwelling elderly individuals. Expiratory muscle strength training is an intervention for patients with oropharyngeal dysphagia. This training is associated with respiration, coughing, speech and swallowing, and its effectiveness has been proven in previous studies. However, the effects of EMST on elderly individuals and evidence are still lacking. This study included 24 community-dwelling senior citizens aged ≥65 years (12 men and 12 women). The experimental group trained at the 70% threshold value of the maximum expiratory pressure using an EMST device 5 days per week for 4 weeks and comprised five sets of five breaths through the device for 25 breaths per day. The placebo group trained with a resistance-free sham device. Post-intervention, muscle strength of the bilateral buccinator and the orbicularis oris muscles (OOM) was measured using the Iowa Oral Performance Instrument. Surface electromyography was used to measure activation of the suprahyoid muscles (SM). After intervention, the strength of the buccinator and the OOM in the experimental group showed statistically significant improvement. There was also statistically significant activation of the SM. In the placebo group, the strength of the orbicularis oris muscle alone improved. No statistically significant differences between groups were found for the strength of the buccinator and the OOM and the activation of the SM. EMST had a positive effect on swallowing-related muscle strength in elderly participants.

Effects of expiratory muscle strength training on oropharyngeal dysphagia in subacute stroke patients: a randomised controlled trial.

Expiratory muscle strength training (EMST) involves forcible blowing as a means of generating high expiratory pressure, against adjustable resistance. EMST has recently been introduced as a potential treatment for dysphagia. This study was performed to investigate the effects of EMST on the activity of suprahyoid muscles, aspiration and dietary stages in stroke patients with dysphagia. Twenty-seven stroke patients with dysphagia were randomly divided into two groups. The experimental group performed EMST with a 70% threshold value of maximal expiratory pressure, using an EMST device, 5 days a week for 4 weeks. The placebo group trained with a sham device. The EMST regime involved 5 sets of 5 breaths through the EMST device for a total of 25 breaths per day. Activity in the suprahyoid muscle group was measured using surface electromyography (sEMG). Further, the penetration-aspiration scale (PAS) was used to assess the results of the videofluoroscopic swallowing study (VFSS). In addition, dietary stages were evaluated using the Functional Oral Intake Scale (FOIS). The experimental group exhibited improved suprahyoid muscle group activity and PAS results, when compared to the placebo group. Following intervention, statistical analysis indicated significant differences in measured suprahyoid muscle activity (P = 0·01), liquid PAS outcomes (P = 0·03) and FOIS results (P = 0·06), but not semisolid type PAS outcomes (P = 0·32), between the groups. This study confirms EMST as an effective treatment for the development of suprahyoid muscle activity in stroke patients with dysphagia. Additionally, improvements in aspiration and penetration outcomes were observed.

Unanticipated Insights into Biomedicine from the Study of Acupuncture

Research into acupuncture has had ripple effects beyond the field of acupuncture. This paper identifies five exemplars to illustrate that there is tangible evidence of the way insights gleaned from acupuncture research have informed biomedical research, practice, or policy. The first exemplar documents how early research into acupuncture analgesia has expanded into neuroimaging research, broadening physiologic understanding and treatment of chronic pain. The second describes how the acupuncture needle has become a tool to enhance biomedical knowledge of connective tissue. The third exemplar, which illustrates use of a modified acupuncture needle as a sham device, focuses on emergent understanding of placebo effects and, in turn, on insights into therapeutic encounters in treatments unrelated to acupuncture. The fourth exemplar documents that two medical devices now in widespread use were inspired by acupuncture: transcutaneous electrical nerve stimulators for pain control and antinausea wrist bands. The final exemplar describes how pragmatic clinical trial designs applied in acupuncture research have informed current general interest in comparative effectiveness research. In conclusion, these exemplars of unanticipated outcomes of acupuncture research comprise an additional rationale for continued support of basic and clinical research evaluating acupuncture and other under-researched therapies.

Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial.

Looping is a common problem during colonoscopy that prolongs procedure time. We aimed to determine the efficacy and safety of ColoWrap, an external abdominal compression device, with respect to insertion time and other procedural outcomes. We performed a prospective study of outpatients undergoing elective colonoscopy (40-80 years old; mean age, 60.5 years) at endoscopy facilities in the University of North Carolina Hospitals from April 2013 through March 2014. Subjects were randomly assigned to groups that received either ColoWrap (n= 175) or a sham device (control, n= 175) during colonoscopy. Colonoscopists and staff were blinded to the application. The primary outcome was cecal intubation time (CIT). Secondary outcomes included use of manual pressure and position change. The mean CIT was similar for the control and ColoWrap groups (6.69 vs 6.67 minutes; P= .98). There were no statistical differences in the frequency of manual pressure (45% for controls vs 37% for ColoWrap group, P= .13) or position changes (4% for controls vs 2% for ColoWrap group, P= .36). Among patients with body mass index between 30 and 40 kg/m(2) (n= 78), CIT was significantly lower for patients in the ColoWrap group (4.69 minutes) than controls (6.10 minutes) (P= .03). Adverse events were similar between groups. In patients undergoing elective colonoscopy, application of an external abdominal compression device did not improve CIT or affect the frequency of ancillary maneuvers. A possible benefit was observed in patients with body mass index between 30 and 40 kg/m(2), but further studies are needed. ClinicalTrials.gov number: NCT02025504.

Improvement of Somatic Cervical Pain and Disability after the Application of a Portable TENS Device

Background: Cervical facet joints and neck muscles are common nociceptive pain generator, with neck and shoulder muscles pain, and limited retroflexion. Objective: To test the hypothesis that the portable TENS device would relieve cervical somatic pain. Methods: Forty-four patients with chronic cervical pain patients with somatic pain, but without radicular symptoms were evaluated in a double-blind, prospective, randomized fashion, divided into sham and active groups. The active TENS (TANYXò) or sham device was placed over C7-T1 spinous process, perpendicular to the spine, for 20 min at 12-hour interval during 3 days. The two groups were: placebo group (PG), with a sham device and the active TENS group (TG), which produced a mixed (85 Hz) frequency of stimulation, conventional, and burst. Diclofenac up to three times daily was available. Efficacy measures were pain relief, rescue analgesics and neck disability. Results: The active TENS device induced pain relief after its first application, which persisted during the 3-day treatment. By the end of the TENS application, the capability of rotation, lateral extension and retroflexion was improved (p < 0.05). The pain score and rescue analgesics consumption reduced in the TG (p < 0.01, p < 0.05, respectively), and the mean pain score dropped from 8 to 3 points (p < 0.01). There were no adverse events. Conclusions: Somatic cervical pain and disability improved after active TENS application during the three consecutive days, which persisted upon the 1-month reevaluation.

Supplemental vibrational force does not reduce pain experience during initial alignment with fixed orthodontic appliances: a multicenter randomized clinical trial.

This prospective randomized trial investigated the effect of supplemental vibrational force on orthodontic pain during alignment with fixed-appliances. Eighty-one subjects < 20 years-old undergoing extraction-based fixed-appliance treatment were randomly allocated to supplementary (20-minutes/day) use of an intra-oral vibrational device (AcceleDent®) (n = 29); an identical non-functional (sham) device (n = 25) or fixed-appliances only (n = 27). Each subject recorded pain intensity (using a 100-mm visual-analogue scale) and intake of oral analgesia in a questionnaire, following appliance-placement (T1) and first-adjustment (T2) for 1-week (immediately-after, 4, 24, 72-hours and at 1-week). Mean maximum-pain for the total sample was 72.96 mm [SD 21.59; 95%CI 68.19–77.74 mm] with no significant differences among groups (P = 0.282). Subjects taking analgesics reported slightly higher maximum-pain although this was not significant (P = 0.170). The effect of intervention was independent of analgesia (P = 0.883). At T1 and T2, a statistically and clinically significant increase in mean pain was seen at 4 and 24-hours, declining at 72-hours and becoming insignificant at 1-week. For mean alignment-rate, pain-intensity and use of analgesics, no significant differences existed between groups (P > 0.003). The only significant predictor for mean pain was time. Use of an AcceleDent vibrational device had no significant effect on orthodontic pain or analgesia consumption during initial alignment with fixed appliances.

Electroacupuncture for postoperative pain and gastrointestinal motility after laparoscopic appendectomy (AcuLap): study protocol for a randomized controlled trial.

BackgroundAcupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal motility and controlling pain after laparoscopic surgery.Methods/designThis study is a prospective randomized controlled trial with a three-arm, parallel-group structure evaluating the efficacy of electroacupuncture for gastrointestinal motility and postoperative pain after laparoscopic appendectomy. Patients with appendicitis undergoing laparoscopic surgery are included and randomized into three groups: 1) electroacupuncture group, 2) sham acupuncture group, and 3) control group. Patients receive 1) acupuncture with electrostimulation or 2) fake electroacupuncture with sham device twice a day or 3) no acupuncture after laparoscopic appendectomy. The primary outcome is time to first passing flatus after operation. Secondary outcomes include postoperative pain, analgesics, nausea/vomiting, bowel motility, time to tolerable diet, complications, hospital stay, readmission rates, time to recovery, quality of life, medical costs, and protocol failure rate. Patients and hospital staff (physicians and nurses) are blinded to which group the patient is assigned, electroacupuncture or sham acupuncture. Data analysis personnel are blinded to group assignment among all three groups. Estimated sample size to detect a minimum difference of time to first flatus with 80 % power, 5 % significance, and 10 % drop rate is 29 × 3 groups = 87 patients. Analysis will be performed according to the intention-to-treat principle.DiscussionThe AcuLap trial will provide evidence on the merits and/or demerits of electroacupuncture for bowel motility recovery and pain relief after laparoscopic appendectomy.Trial registrationThe trial was registered in Clinical Research Information Service (CRiS), Republic of Korea (KCT0001486) on 14 May 2015.

Effects of 100-μT extremely low frequency electromagnetic fields exposure on hematograms and blood chemistry in rats.

The aim of this study was to test whether extremely low frequency electromagnetic fields (ELF EMFs) affect health or not. Here, we constructed a 100-μT/50 Hz electromagnetic field atmosphere. A total of 128 rats were randomly assigned into two groups: the ELF EMF group and the sham group. The ELF EMF group was exposed to 100-μT/50-Hz ELF EMF for 20 h per day for three months; at the same time the other group was exposed to a sham device without ELF EMF. During the three months, the weight was recorded every 2 weeks, and the water intake and food intake of the animals were recorded weekly. The hematologic parameters were detected before and after the exposure, whereas blood chemistry analysis was performed every 4 weeks. The general condition of the exposed rats was not affected by ELF EMF. Compared with the sham group, the hematograms were not significantly altered in the ELF EMF group. Similarly, the blood chemistry (including lipid profile, blood glucose, liver function and renal function of rats) from the ELF EMF group showed no difference compared with rats from the control group during the three months exposure. The present study indicated that short-term exposure of 100-μT/50-Hz ELF EMF may not affect hematograms and blood chemistry in rats.

Efficacy of the device combining high-frequency transcutaneous electrical nerve stimulation and thermotherapy for relieving primary dysmenorrhea: a randomized, single-blind, placebo-controlled trial

ObjectiveTo investigate the efficacy and safety of the combined therapy with high-frequency transcutaneous electrical nerve stimulation (hf-TENS) and thermotherapy in relieving primary dysmenorrheal pain. Study designIn this randomized, single-blind, placebo-controlled study, 115 women with moderate or severe primary dysmenorrhea were assigned to the study or control group at a ratio of 1:1. Subjects in the study group used an integrated hf-TENS/thermotherapy device, whereas control subjects used a sham device. A visual analog scale was used to measure pain intensity. Variables related to pain relief, including reduction rate of dysmenorrheal score, were compared between the groups. ResultsThe dysmenorrheal score was significantly reduced in the study group compared to the control group following the use of the devices. The duration of pain relief was significantly increased in the study group compared to the control group. There were no differences between the groups in the brief pain inventory scores, numbers of ibuprofen tablets taken orally, and World Health Organization quality of life-BREF scores. No adverse events were observed related to the use of the study device. ConclusionsThe combination of hf-TENS and thermotherapy was effective in relieving acute pain in women with moderate or severe primary dysmenorrhea.

Static and dynamic compression application and removal on the intervertebral discs of growing rats.

Fusionless implants are used to correct pediatric progressive spinal deformities, most of them spanning the intervertebral disc. This study aimed at investigating the effects of in vivo static versus dynamic compression application and removal on discs of growing rats. A microloading device applied compression. 48 immature rats (28 d.o.) were divided into two groups (43d, 53d). Each group included four subgroups: control (no surgery), sham (device installed without loading), static (0.2 MPa) and dynamic compressions (0.2 MPa ± 30% with 0.1 Hz). In 43d subgroups, compression was applied for 15 days. In 53d subgroups, compression was followed by 10 days without loading. Disc heights, nucleus/annulus volumetric proportions and nucleus proteoglycan contents were analyzed using one-way ANOVA and post-hoc Tukey comparisons (p < 0.05). Disc heights of 43d and 53d static and dynamic loading rats were lower than shams (p < 0.05). Volumetric proportions remained similar. At 43d, nucleus proteoglycan contents increased in both static and dynamic loading rats. However, at 53d, static loading rats had lower proteoglycan content than dynamic loading rats (p < 0.05). Disc structure is altered following static compression removal, but nucleus proteoglycan content remaining elevated in dynamic group. Dynamic fusionless implants would better preserve disc integrity.

Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer.

PurposeWomen with breast cancer may experience symptoms of depression, anxiety, pain, fatigue and sleep disturbances during chemotherapy. However, there are few modalities that address multiple, commonly occurring symptoms that may occur in individuals receiving cancer treatment. Cranial electrical stimulation (CES) is a treatment that is FDA cleared for depression, anxiety and insomnia. CES is applied via electrodes placed on the ear that deliver pulsed, low amplitude electrical current to the head.MethodsThis phase III randomized, sham-controlled study aimed to examine the effects of cranial microcurrent stimulation on symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Patients were randomly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinicaltrials.gov, NCT00902330.ResultsThe sample included N = 167 women with early-stage breast cancer. Symptom severity of depression, anxiety, and fatigue and sleep disturbances were generally mild to moderate. Levels of pain were low. Anxiety was highest prior to the initial chemotherapy and decreased over time. The primary outcome assessment (symptoms of depression, anxiety, fatigue, pain, sleep disturbances) revealed no statistically significant differences between the two groups, actual CES vs. sham.ConclusionIn this study, women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range. Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer, further symptom management modalities should be evaluated to mitigate symptoms of depression, anxiety, fatigue, pain and sleep disturbances over the course of chemotherapy.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-015-1151-z) contains supplementary material, which is available to authorized users.

Randomized clinical trial of a handheld cooling device (Menopod®) for relief of menopausal vasomotor symptoms

Objective Anecdotal reports suggest that application of a cool device to the back of the neck at the onset of a hot flush can afford symptomatic relief. The effects of a novel handheld mechanical cooling device in a population of perimenopausal women with moderate-to-severe vasomotor symptoms were evaluated.Methods In this randomized, double-blind, sham-controlled pilot study, 40 perimenopausal women experiencing ≥ 7 moderate-to-severe hot flushes per day were recruited at a single university site. Women were randomized to the active (n = 20) or sham (n = 20) device, which was applied to the back of the neck with each hot flush over the 4-week treatment period. Hot flush scores were calculated based on frequency and severity of symptoms. The Carpenter Hot Flash Related Daily Interference Scale and Zung Anxiety Scale were used to evaluate impact on quality of life. At study end, participants completed an open-ended questionnaire to assess the degree of unblinding and overall subjective improvement in symptoms with use of the device.Results No statistically significant differences were observed between the effects of the active and sham device. However, thematic analysis of the open-ended questionnaire revealed that 12/17 women (70.6%) in the active group, compared to 4/18 (22.2%) women in the sham group felt the device provided some symptomatic relief.Conclusions Although the majority of women using the active device acknowledged that its cooling effect afforded a degree of symptomatic relief, the symptom scores chosen for this pilot study did not reflect a beneficial effect.

Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID).

Lipman, Grant S., Nicholas C. Kanaan, Caleb Phillips, Dave Pomeranz, Patrick Cain, Kristin Fontes, Becky Higbee, Carolyn Meyer, Michael Shaheen, Sean Wentworth, and Diane Walsh. Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID). High Alt Med Biol 16:154-161, 2015.--Acute mountain sickness (AMS) affects 25%-70% of the tens of millions of high altitude travelers annually, with hypoxia and nocturnal desaturations as major contributing factors. This is the first double blind randomized placebo controlled trial to assess expiratory positive airway pressure (EPAP) for AMS prevention and nocturnal hypoxic events. Healthy adult participants trekking in the Khumbu region of the Himalayas were randomized to a single-use EPAP nasal strip, or a visually identical sham device (placebo) prior to first night sleeping between 4371-4530 m (14,340-14,800 ft). The primary outcome was AMS incidence, measured by Lake Louise Questionnaire (LLQ), with secondary outcomes of AMS severity (by LLQ) and physiologic sleep indices measured by continuous sleep monitor. Intent-to-treat analysis included 219 participants with comparable demographic characteristics, of which 115 received EPAP and 104 placebo. There was no decrease in AMS with EPAP intervention (14% EPAP vs. 17% placebo; p=0.65; risk difference (-)3.15%, 95% CI (-)12.85%-6.56%). While overall AMS severity was not different between groups, EPAP reported decreased incidence of headache (64% vs. 76%; p<0.05, OR 0.51, 95% CI 0.27-0.95) and dizziness (81% vs. 98%; p<0.03, OR 0.29, 95% CI 0.09-0.78). During sleep, EPAP resulted in significant improvements in average peripheral oxygenation (Spo(2)) (80% versus 78%; p<0.01, mean difference=2, 95% CI 0.58-3.63) and a reduced percentage of time below 80% Spo(2) (31% vs. 46%; p<0.03, median difference=16, 95% CI 2.22-28.18). This lightweight and inexpensive EPAP device did not prevent acute mountain sickness, but did reduce the subgroup incidence of headache and dizziness while improving average nighttime peripheral oxygenation.

Neuromuscular taping versus sham therapy on muscular strength and motor performance in multiple sclerosis patients

Purpose: Purpose of this study is to evaluate differences in leg muscles strength and motor performance between neuromuscular taping (NT) and sham tape groups. Method: Relapsing-remitting (RR) multiple sclerosis (MS) patients were recruited and randomly assigned to NT or sham tape groups. All patients underwent the treatment 5 times at 5-d intervals. They were submitted to a 6-minute walk test and isokinetic test (peak torque) at the beginning (T0), at the end (T1) and 2 months after the end of the treatment (T2). Results: Forty MS patients (38 F; 2 M; mean age 45.5 ± 6.5 years) were assigned to NT group (n = 20) and to sham tape group (n = 20). Delta Peak Torque T1–T0 and T2–T0 between two groups were statistically significant in quadriceps (p = 0.007; 0.000) and hamstrings (p = 0.011; 0.007). The difference between the two groups according to 6-minute walk test was not statistically significant but in NT group it was noticed an increasing trend about the distance run. Conclusions: In this single-blind randomized controlled trial, NT seemed to increase strength in leg muscles, compared to a sham device, in RR MS patients. Further studies are needed to consider this therapy as a complement to classic physical therapy.Implications for RehabilitationNeuromuscular taping (NT) in multiple sclerosis:NT is well tolerated by multiple sclerosis patients and should be a complement to classic physical therapy.This technique normalizes muscular function, strengthens weakened muscles and assists the postural alignment.

Inspiratory resistance improves postural tachycardia: a randomized study.

The objective of this study was to determine the effect of inspiratory resistance through an impedance threshold device (ITD) on orthostatic tolerance in patients with postural tachycardia syndrome. We hypothesized that the ITD would result in a greater negative intrathoracic pressure to enhance cardiac venous return, improve stroke volume, and reduce heart rate in these patients. We compared the effect of a sham device (sham, no resistance) versus an ITD (increased inspiratory resistance) in 26 patients with postural tachycardia syndrome in a randomized, single-blind, crossover study. Hemodynamic assessments were performed at baseline while supine and during head-up tilt to 70° for 10 minutes. We did not find differences in baseline hemodynamic parameters between the ITD and the sham devices. After 10 minutes of head-up tilt, the heart rate was lower with the ITD versus sham device (102±4 versus 109±4 beat/min, respectively; P=0.003). The ITD also improved stroke volume compared with the sham device (35±2 versus 26±1 mL; P=0.006). These findings suggest that increasing negative intrathoracic pressure with ITD breathing improves heart rate control in patients with postural tachycardia syndrome during upright posture. clinicaltrials.gov; Unique Identifier: NCT00962728.

Supplemental Vibrational Force During Orthodontic Alignment

This prospective 3-arm parallel-group randomized clinical trial investigated the effect of supplemental vibrational force on rate of orthodontic tooth alignment with fixed appliances. Eighty-one subjects (40 males, 41 females; mean age, 14.1 y) undergoing first premolar extraction-based fixed appliance treatment were randomly allocated to treatment supplemented with daily use (20 min) of a removable intraoral vibrational device (AcceleDent; OrthoAccel Technologies Inc.; n = 29), an identical nonfunctional (sham) device (n = 25), or fixed appliances only (n = 27). Mandibular study casts were taken at baseline (treatment start: placement of 0.014-in. nickel-titanium arch wire), initial alignment (0.018-in. nickel-titanium arch wire), and final alignment (0.019 x 0.025–in. stainless steel arch wire). Overall mean irregularity index in the mandibular arch at baseline was 8.5 ± 3.8 mm (95% CI, 7.6 to 9.3) with no significant difference between groups (P = 0.73). For the total sample, mean irregularity index at initial alignment was 2.7 ± 2.8 mm (95% CI, 2.2 to 3.4) with no significant difference between groups (P = 0.40). Mean time from baseline to initial alignment was 59 ± 25 d (95% CI, 54.5 to 65.6); from initial to final alignment, 150 ± 62.5 d (95% CI, 136 to 165); and baseline to final alignment, 209 ± 65 d (95% CI, 195 to 224). Kaplan-Meier analysis demonstrated that patterns of alignment were not significantly different among the 3 groups (P = 0.66). Multivariate linear regression for initial and overall alignment rates using initial irregularity index as the covariate showed no significant differences among groups. The most important influence on both initial and overall rates of alignment was initial irregularity (P = 0.1 × 10−4). This prospective randomized clinical trial found no evidence that supplemental vibrational force can significantly increase the rate of initial tooth movement or reduce the amount of time required to achieve final alignment when used in conjunction with a preadjusted edgewise fixed appliance (ClinicalTrials.gov NCT02314975).

The New Portable Transcutaneous Electrical Nerve Stimulation Device Was Efficacious in the Control of Primary Dysmenorrhea Cramp Pain

Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief in dysmenorrhea. A feasible advantage would be the study of a portable device. The purpose of the study was to evaluate the effectiveness and safety of a new portable TENS device (TANYX®) for menstruation cramps. Forty women were evaluated in a double-blind, prospective, randomized fashion, divided into sham and active groups. TENS was applied medially at the suprapubic region, for 30-min duration at eight-hour intervals, up to seven days. The placebo group (PG) received sham device. The TENS group (TG) applied an active 85 Hz frequency TENS. Efficacy measures were pain relief evaluated on a visual analog scale (VAS) and diclofenac intake, and quality of life represented by: 1) capacity to get out of the bed, 2) food or drink intake, 3) missing routine daily activities such as work or school, and 4) quality of sleep. The active TENS device induced a prompt onset of pain relief in a strictly segmental manner nearby the dermatomes where the TENS was applied at the skin, and there was a drop in mean pain score from 8 to 2 cm (p < 0.001). Diclofenac consumption was also significantly reduced (p < 0.01), compared with the PG. Quality of life improved significantly in TG when compared with PG (p < 0.05). Three months after the beginning of the study, 14/20 of the women were still using the active device regularly. No adverse effects were observed. The portable, disposable, active TENS device induced a prompt onset of pain relief and improved the quality of life, without adverse effects, in patients with painful cramps associated with dysmenorrhea.