Single Treatment Session Research Articles

Targeted Electrical Stimulation of the Superior Laryngeal Nerve – A Potential Treatment for Dysphagia in ALS

Electrical stimulation (ES) is a treatment for swallowing impairment (dysphagia) that uses surface electrodes on the anterior neck to repeatedly contract and strengthen swallowing musculature without evoking swallows. This treatment approach is generally avoided in ALS patients due to concerns over rapid muscle fatigue that may further compromise swallowing, breathing, and airway protection. However, swallowing is a sensorimotor reflex that relies on several “upstream” sensory, motor, and interneuron components that are also affected by ALS. We hypothesize that ES can be optimized for ALS by selectively stimulating the superior laryngeal nerve (SLN) to activate and treat the entire swallow reflex circuitry, rather than only the swallowing muscles. Our rationale is based on general knowledge that SLN stimulation reliably evokes swallowing in experimental studies. Here, our translational work establishes a safe and reliable ES‐SLN protocol in a mouse model of ALS with dysphagia, and then adapts the protocol for use in humans. For protocol development, ALS mice (transgenic SOD1‐G93A) underwent an invasive survival surgery at 6 months of age (clinical disease onset) for 30 minutes of direct ES‐SLN based on our prior work: 40 Hz; anodal, charge balanced rectangular pulses (400 µs pulse width, 400 µs interphase delay); up to 800 uA intensity and continuous trains of 20‐seconds ON, 10‐seconds OFF. Respiratory rate was monitored via an abdominal pneumatic sensor. Swallowing function was assessed via monthly videofluoroscopy. For translation to humans we used a noninvasive transcutaneous ES (tES) approach in five healthy adults (18‐30 years; 3 F, 2 M) using identical stimulus parameters as mice, except with a shorter pulse duration (100 µs pulse width, 25 μs interphase delay) to eliminate perceived muscle fatigue and higher stimulus intensity (up to 10 mA). Physiological monitoring (pulse oximetry, respiratory and heart rate) occurred throughout the 30‐minute session. Results showed that direct ES‐SLN in mice consistently evoked 2‐4 swallows per 20 second stimulus train without decay or adverse effects on respiratory rate (p>0.05). Moreover, this single treatment session nearly preserved lick and swallow rates at disease end stage. In humans, tES‐SLN reliably evoked 3‐6 saliva swallows per 20 second stimulus train without decay or adverse effects on physiological measures (p>0.05). However, trials were successful only in females likely due to differences in male anatomy and electrical impedance that we are troubleshooting. This preliminary work demonstrates ES can be adapted for targeted, noninvasive SLN stimulation to evoke swallowing in humans. Moreover, our preliminary work with ALS mice suggests an untapped therapeutic benefit of ES‐SLN, which provides rationale for proceeding with clinical trials for ALS patients as well as other neurological diseases. Continued investigations in mice will be essential to understand the treatment mechanisms of SLN stimulation for further optimization.

Epicanthus correction with a modified asymmetric Z-plasty

SummaryThe study aimed to explore the clinical efficacy of the modified asymmetric Z-plasty with a central axis from the point near the edge of the skin fold of the medial canthus to the point of the innermost palpebral edge of medial canthus for epicanthus correction. A total of 130 followed-up patients who received modified asymmetric Z-plasty for epicanthus correction in Hunan Provincial People's Hospital from January 2019 to December 2019 were included. All patients were followed up with at 1, 3, and 6 months after surgery, and the scarring and surgical outcomes were assessed. The results showed the surgical wounds were healing well, and the sutures were removed at 7 days postoperatively in all patients. At 6 months postoperatively, epicanthus correction was successful in all patients, the lacrimal caruncle was moderately exposed, the incision was not red, and there were no obvious prominent scars. Slightly prominent and uneven scars below the edge of the lower eyelid were observed in 3 patients. Among these 3 patients, 1 patient received no further treatment, and the outcomes were considered acceptable; the outcomes were improved in the remaining 2 patients after a single session of fractional laser treatment, and none of these patients received further surgery. In conclusion, the modified asymmetric Z-plasty with a central axis from the point near the edge of the skin fold of the medial canthus to the point of the innermost palpebral edge of medial canthus is relatively simple and provides good surgical results for epicanthus correction.

On Muscular Factor Question in the Correction of Transversal Incisor Occlusion

The aim of our study was to evaluate the role of the muscle factor and the effectiveness of manual treatment of masticatory muscle dysfunction in patients with transversal incisor occlusion (TIO). Methods and Results: We examined and treated 35 patients aged 18-25 years with clinical signs of TIO in the clinic of orthopedic dentistry. Diagnostic methods for TIO included an interview, face and oral cavity examination, and clinical functional tests. Occlusion was assessed using anthropometric measurements and examination of plaster jaw models in an articulator for additional diagnostics of the dental factor; a radiological method (jaw orthopantomography with the inclusion of articular joints) was also used for the articular factor diagnostics and examination of masticatory muscles and neck muscles. The treatment methods included manual treatment of masticatory muscle dysfunction: "myofascial trigger point release technique," "stretching-push," and "post-isometric relaxation." All patients' complaints were mainly confined to improper occlusion of the front teeth, namely, a misalignment of the centerline between the upper and lower anterior teeth. Moreover, 71.4% of patients noted intermittent clicking in one or both articular joints of the temporomandibular joint, 42.8% of patients reported pain in the region of one temporomandibular joint, 28.6% of patients noted noise in the ear of the same joint, as well as discomfort while chewing. On external examination, all patients had a slight asymmetry of the lips and cheeks on the habitual chewing side. The apex of the chin was positioned slightly to the side relative to the facial midline. All patients had a disturbed movement trajectory of the lower jaw. During mouth opening, the lower jaw trajectory changed relative to the facial midline: at first, it was straight, for a very short period, and then it deviated sideways, after which it returned to the center. There was a misalignment of the central line of the lower dentition relative to the midline of the face in the anterior region. The radiological picture showed signs of articular joint dysfunction: difference in the size of the articular gaps on the right and left sides. After a single session of manual treatment of masticatory muscles, all patients noted that the improper occlusion of the front teeth was corrected, pain and clicking sensations in the TMJ disappeared in 42.8% of patients, and pain disappeared in the area of one joint, along with noise in the ears and chewing discomfort. Headache in the parietal and temporal areas disappeared. The trajectory of lower jaw movements during mouth opening normalized in all patients after the performed manual treatment. Conclusion: We can conclude that when diagnosing and treating occlusal disorders, it is necessary to pay attention not only to the position of the teeth and the TMJ elements, but also to the muscular factor – the condition of the masticatory muscles. Special attention should be paid to the condition of the lateral wing muscles.

The effects of music & auditory beat stimulation on anxiety: A randomized clinical trial.

Background and objectivesMusic and auditory beat stimulation (ABS) in the theta frequency range (4–7 Hz) are sound-based anxiety treatments that have been independently investigated in prior studies. Here, the anxiety-reducing potential of calm music combined with theta ABS was examined in a large sample of participants.MethodsAn open-label randomized controlled trial was conducted with participants taking anxiolytics (n = 163). Participants were randomly assigned using the Qualtrics randomizer algorithm, to a single session of sound-based treatment in one of four parallel arms: combined (music & ABS; n = 39), music-alone (n = 36), ABS-alone (n = 41), or pink noise (control; n = 47). Pre- and post-intervention somatic and cognitive state anxiety measures were collected along with trait anxiety, personality measures and musical preferences. The study was completed online using a custom application.ResultsBased on trait anxiety scores participants were separated into moderate and high trait anxiety sub-groups. Among participants with moderate trait anxiety, we observed reductions in somatic anxiety that were greater in combined and music-alone conditions than in the pink noise condition; and reductions in cognitive state anxiety that were greater in the combined condition than in the music-alone, ABS-alone, and pink noise conditions. While we also observed reductions in somatic and cognitive state anxiety in participants with high trait anxiety, the conditions were not well differentiated.ConclusionsSound-based treatments are effective in reducing somatic and cognitive state anxiety. For participants with moderate trait anxiety, combined conditions were most efficacious.

Comparative Analysis of the Efficiency of Two Treatment Protocols for Posterior Canal Benign Paroxysmal Positional Vertigo

Background and objectiveBenign paroxysmal positional vertigo (BPPV) is the most common vertigo of labyrinthine origin, its social and healthcare impact is remarkable. It has recently been shown that single session treatment is as safe and effective as weekly treatment, which could have impact on direct and indirect costs related to the disease. The objective of this study is to determine whether single session treatment of unilateral posterior canal BPPV canalolithiasis is more efficient than conventional treatment. Materials and methodsA prospective randomized controlled trial was performed in 53 consecutive patients diagnosed with unilateral posterior canal BPPV canalolithiasis previously untreated: 26 patients were assigned to single session treatment and 27 patients to weekly treatment. Average and total cost of care, consultation time and the impact in terms of temporary disability and loss of productivity for the company due to patients’ medical visits were compared. ResultsAverage and total cost of care and loss of productivity for the company due to patients’ medical visits were significantly lower in the single session group. Consultation time was also better in this group when travelling time was considered. ConclusionsThe single session protocol is fast, effective and reduces direct and indirect cost of care related to disease justifying high resolution consultations.

Influence of Neck Pain, Cervical Extensor Muscle Fatigue, and Manual Therapy on Wrist Proprioception

ObjectiveThe purpose of this study was to examine the effects of submaximal isometric neck muscle fatigue and manual therapy on wrist joint position sense (JPS) within healthy individuals and individuals with subclinical neck pain (SCNP). MethodsTwelve healthy participants and 12 participants with SCNP were recruited. Each group completed 2 sessions, with 48 hours between sessions. On day 1, both groups performed 2 wrist JPS tests using a robotic device. The tests were separated by a submaximal isometric fatigue protocol for the cervical extensor muscles (CEM). On day 2, both groups performed a wrist JPS test, followed by a cervical treatment consisting of manual therapy (SCNP) or neck rest (20 minutes, control group) and another wrist JPS test. Joint position sense was measured as the participant's ability to recreate a previously presented wrist angle. Each wrist JPS test included 12 targets, 6 into wrist flexion and 6 into wrist extension. Kinematic data from the robot established absolute, variability, and constant error. ResultsAbsolute error significantly decreased (P = .01) from baseline to post-fatigue in the SCNP group (baseline = 4.48 ± 1.58°; post-fatigue = 3.90 ± 1.45°) and increased in the control group (baseline = 3.12 ± 0.98°; post-fatigue = 3.81 ± 0.90°). The single session of manual cervical treatment significantly decreased absolute error in participants with SCNP (P = .004). ConclusionThis study demonstrated that neck pain or fatigue can lead to altered afferent input to the central nervous system and can affect wrist JPS. Our findings demonstrate that acute wrist proprioception may be improved in individuals with SCNP by a single cervical manual therapy session.

A prospective randomized parallel-controlled pilot trial of stereotactic body radiation therapy versus radiofrequency ablation for the management of small renal masses.

363 Background: The potential of ablative technologies as an alternative to surgery for the treatment of small renal masses (SRMs) ≤4cm is unclear. Our objective was to evaluate the feasibility and toxicity of stereotactic body radiation therapy (SBRT) and radiofrequency ablation (RFA) for SRMs in a prospective randomized pilot trial. Methods: Patients scheduled for renal cell carcinoma (RCC) treatment at a single academic center were approached for the pilot trial, with the aim of recruiting 24 patients. Participants were assigned 1:1 to SBRT or RFA. Imaging (CT or MRI) using a renal tumor protocol is completed at 3, 6, 9, and 12 months post-procedure. Biopsies were completed prior to the procedure and at 12 months. Multiple clinical parameters were collected. Follow-up visits will occur at 6 month intervals following the trial up to 5 years. SBRT included an initial simulation session and a single image-guided treatment session with a prescribed dose of 25 Gy. RFA was conducted by either percutaneous or laparoscopic access with 2 cycles of 8 minutes duration each upon reaching target temperature. Results: Beginning in December 2019, 24 patients were recruited and randomized (SBRT = 11; RFA = 13). Eleven had SBRT, 8 RFA, 3 have not yet had treatment, and 2 became ineligible. Median age for all patients was 67 (53,85) and 17 were male. A total of 17 patients had clear cell RCC, 6 had papillary RCC (type 1), and 1 had chromophobe RCC. All patients had T1a disease. Mean procedure length (minutes) for SBRT and RFA was 15.5±7.4 and 10.5±3.9, respectively. Two patients (both SBRT) had a 12-month biopsy showing no evidence of recurrence or metastases, while two patients (1 RFA, 1 SBRT) had a 9-month CT showing no recurrence. Data are pending for the remaining patients. An early grade 2 flare-up occurred in one SBRT patient. Conclusions: Recruitment and randomization of patients with SRMs in a SBRT vs. RFA prospective trial is feasible on a timeline that allows for regular follow-up and imaging. To date, both treatment modalities have been shown to have excellent short-term safety profiles.

Favorable effect after single treatment session of 755-nm-picosecond laser with a diffractive optic lens on facial wrinkles and pore size in Asians.

Laser therapy has become one of the mainstay treatments for improvingsigns of aging including wrinkles, large pores, and skin pigmentation. However, in patients with pigmented skin, an increase in complicationsincludingpost-inflammatory hyperpigmentation (PIH) has been noted. The purpose ofthisstudy is to investigate not only the safety profile of 755-nmpicosecond laser withdiffractive lens array (DLA)at approximately 2250pulseson the facein people with darker skin, but also to evaluateitsefficacyin treating wrinkles and pore sizesafter one treatment sessionamong different age groups. This single-center, retrospective study enrolled patients between age 22 and 65 with both facial wrinkles and enlarged pore sizes. A total of 46 patients (7male, 39 female, mean age 43) with Fitzpatrick skin types III and IV were enrolled. Two independent data-blinded dermatologists assessed and scored the improvements of patients' wrinkles and pore sizes using photographs. After onetreatmentsession, statistically significant improvements were observed in lateral canthal wrinkles (p<0.001) and facial wrinkles (p=0.014).In addition, greater percentage of the patients from the aged group (50-65years) showed clinically significant improvement as compared with the younger group. For patients withtype III and IV skin,one session of DLApicosecond lasertreatment at around 2250 pulses to the face is safe and effective for clinically meaningful improvement of the wrinkles and pore sizes, especially forthe patients from 50- to 65-years of age.

Air-toxin technique: Introduction and analysis of effect using a photoimaging system.

As an alternative to other approaches to facial rejuvenation, the air-toxin technique (dermal injection of air with micro-doses of botulinum toxin) is a promising method. We aimed to describe this novel technique and assess the overall safety and efficacy of the air-toxin technique in facial rejuvenation. A retrospective chart review was performed on cases treated with the air-toxin technique. A total of 47Korean patients underwent a single treatment session. Treatment efficacy was assessed objectively with serial VISIA® (Canfield Scientific, NJ, USA) skin analysis data and subjectively based on the patients' assessment scores at Week 12. A significant improvement in wrinkle (p<0.001), UV spot (p<0.001), and porphyrin (p=0.005) was objectively seen at 12weeks follow-up. Patients noted improvement in the categories wrinkle (p<0.01), redness (p=0.029), texture (p<0.001), dilated pore (p<0.001), and lifting (p<0.001) at Week 12 compared to baseline. No major adverse event was reported. Our data show that the air-toxin technique is efficacious in facial rejuvenation as shown by improved skin analysis parameters and patient assessment scores. Notably, there was some discrepancy between the objective and subjective parameters of improvement.

Safety and efficacy of endoscopic ultrasound-guided combination therapy for treatment of gastric varices: a systematic review and meta-analysis.

EUS-guided combination therapy (coil and hemostatic glue) for bleeding and non-bleeding gastric varices has recently attracted considerable attention after promising results were published in multiple small studies. We performed a meta-analysis to investigate the safety and efficacy of EUS-guided combination therapy in the treatment of GVs. Publications investigating the safety and efficacy of EUS-guided combination therapy in patients with gastric varices were searched in Medline, Ovid Journals, Medline non-indexed citations and Cochrane Central Register of Controlled Trials. Pooling was conducted by both fixed and random effects model. In pooled analysis of 10 studies (N = 323), the technical success of EUS-guided combination therapy was 98.66% (95% CI 97.14-99.62). The pooled variceal obliteration rate after first session of treatment was 78.31% (95% CI 73.05-83.14). In patients requiring single or multiple treatment sessions, the overall variceal obliteration rate was 96.79% (95% CI 94.28-98.60). The pooled rate of hemorrhage from treated gastric varices was 4.92% (95% CI 2.85-7.52). After EUS-guided combination therapy, the pooled percentage of patients developing abdominal pain was 9.79% (95% CI 6.82-13.24), pulmonary embolism was 2.20% (95% CI 0.89-4.06), febrile episodes was 1.17% (95% CI 0.30-2.61), and procedure-related bleeding was noted in 2.62% (95% CI 1.18-4.63) of the patients. Subgroup analysis of studies using coil embolization and cyanoacrylate injection showed pooled variceal obliteration rate of 77.92% (95% CI 72.35-83.01) after first session of treatment. In patients requiring single or multiple treatment sessions, the overall variceal obliteration rate was 96.76% (95% CI 94.11-98.65). The pooled rate of re-bleeding from treated gastric varices was 5.09% (95% CI 2.90-7.83). This meta-analysis suggests that EUS-guided combination therapy is safe and effective for patients with gastric varices and should be considered in the clinical management of these patients.

Single session of combined microfat and subcision in the treatment of Grade 4 atrophic acne scars.

Severe atrophic acne scars (AAS) remain the "Achilles's heel" of AAS treatment. The combination of microfat and subcision treatment is a potential solution for severe AAS. This study aimed to evaluate the efficacy and safety of combined microfat and subcision treatment for severe (Grade 4) AAS. Data of patients with Grade 4 AAS who underwent combined microfat and subcision treatment between September 2016 and December 2020 were reviewed. Post-treatment evaluation was performed at least 3months postoperatively. The severity of AAS was graded based on Goodman's qualitative classification. The volume of concavities was measured using an Antera 3D camera. Complications were documented. A total of 42 patients received a single treatment session. Excellent response was observed in 5 (11.9%) patients, very good in 13 (31.0%), good in 22 (52.4%), and poor response in 2 (4.7%). The average reduction of the total volume of concavities was 28.0%. The most common minor side effects were mild swelling and bruising. No major complications were observed. Combined microfat and subcision treatment is a safe and effective treatment for severe AAS. The approach will be a significant treatment for severe AAS.

Intensive sleep retraining treatment for insomnia administered by smartphone in the home: an uncontrolled pilot study.

Intensive sleep retraining (ISR) is a behavioral treatment that involves a patient falling asleep repeatedly over 1 treatment session (< 24 hours in duration) to treat sleep-onset insomnia. ISR relies on high homeostatic sleep and circadian rhythm drives to facilitate rapid sleep onsets overnight. The high cost and inaccessibility of laboratory-based ISR is a significant practical barrier to treatment uptake. Smartphone-delivered ISR offers a significantly more affordable, flexible, and efficient method to treat chronic insomnia. The present study is the first trial of ISR administered via smartphone in the home environment. Smartphone-delivered ISR was investigated with 12 individuals with chronic insomnia (9 women, 3 men, aged 49.75 ± 7.71 years) using a single-group, repeated-measures, case-replication series design. Participants received a single overnight session of home-based ISR treatment administered by smartphone. Sleep onset trials started at 23:00 and concluded after 40 trials or at 11:00 the following morning, whichever occurred first. Sleep diary and psychological variables associated with insomnia were measured at pretreatment, post-treatment, and 4- and 7-week follow-up. Significant improvements with moderate to strong effects (d = 0.59-1.94) were indicated for sleep-onset latency, sleep efficiency, insomnia symptom severity, sleep self-efficacy, anticipatory sleep anxiety, dysfunctional beliefs about sleep, and daytime fatigue and functioning compared to baseline. Therapeutic benefits were largely maintained at the 7-week follow up. This pilot study suggests that ISR may be feasibly administered via smartphone in the home. With fewer trials and a shorter treatment session, smartphone-delivered ISR seemed to achieve similar outcomes to the earlier laboratory-based ISR procedure. Randomized controlled trials are warranted to investigate the efficacy of smartphone-administered ISR. Mair A, Scott H, Lack L. Intensive sleep retraining treatment for insomnia administered by smartphone in the home: an uncontrolled pilot study. J Clin Sleep Med. 2022;18(6):1515-1522.

Control-Focused Behavioral Treatment: A brief intervention for survivors of war and torture.

This article briefly reviews the evolution and evidence-base of Control-Focused Behav-ioral Treatment (CFBT), largely self-help-based treatment that involves no cognitive interventions, focuses solely on reducing avoidance behaviors through self-exposure to anxiety-evoking trauma cues, and, unlike other interventions, aims to enhance sense of control over traumatic stressors, rather than anxiety reduction. As such, it is radi-cally different from other interventions in both theory and practice. Our studies have shown improvement rates of 80%-85% with a single treatment session in earthquake survivors. When administered in an average of 6 sessions in war and torture survivors, it achieved 82% reduction in posttraumatic stress symptoms (PTSD), leaving 97% of the cases nearly asymptomatic or with only mild PTSD symptoms. Meta-analytical compari-sons suggest that such improvement rates are substantially higher than those achieved by other evidence-based treatments.

Analysis of potential time saving in brain arteriovenous malformation stereotactic radiosurgery planning using a new software platform.

To evaluate the utility of integrating a 3D vessel tree co-registration software platform into the stereotactic radiosurgery (SRS) workflow and its time saving for brain arteriovenous malformation (bAVM) treatment in adults compared to the conventional stereotactic head frame workflow. Eight consecutive adult bAVM cases were selected and retrospectively reviewed.Total number of angiograms and SRS procedures were 8. The electronic medical records were analyzed by time stamps to determine the length of time for each component of the set-up, transport, and frame removal. Times were averaged and the start of sedation by anesthesia used as a surrogate for the start of the frame application process. Reductions in workflow times were then modeled assuming cerebral angiography as a separate procedure. There were 8 adult bAVM cases included. Six were female. All patients had a single treatment session. Average age was 51.5 years (Range: 36-71). All patients were treated under monitored anesthesia care. In 6 patients, the AVM was deeply located (basal ganglia, midbrain, brainstem); in 2 cases, the lesion was frontal. Spetzler-Martin grades were 4 (50%) Grade 2 and 4 (50%) Grade 3. The average prescription isodose volume (PIV) and 12 Gy volumes (V12Gy) were 0.85 cc and 1.74 cc, respectively. The mean time from frame application to arrival in the angiography room was 111.5 minutes (range 40 to 171 min; median 107 min; SD 35.3 min); transport from angiography room to SRS was 47.5 minutes (range 15 to 107 min; median 36 min; SD 31.1 min), and frame removal after SRS was 20.5 minutes (range 10 to 47 min; median 16 min; SD 11.6 min). The average total additional time for the entire process of frame application, patient transportation, and frame removal was 132 minutes (range 87 to 181 min; median 127.5 min; SD 28.4 min). Therefore, assuming a non-frame based workflow and with angiography performed ahead of the actual radiosurgical treatment, the total time savings on the day of treatment was estimated at 132 minutes (range 87 to 181 min; median 127.5 min; SD 28.4 min). The ability to perform angiography, image fusion, and treatment planning for the actual day-of-delivery using 3-dimensional vessel tree co-registration could result in significant time savings over traditional workflow practices. Further experience with this system will evaluate its accuracy, reproducibility, and potential broader use in SRS workflow paradigms for the treatment of vascular pathologies.For bAVMs, the benefits of this time savings might allow for streamlined workflows on the day of SRS.

Control-Focused Behavioral Treatment: A brief intervention for survivors of war and torture.

This article briefly reviews the evolution and evidence-base of Control-Focused Behav-ioral Treatment (CFBT), largely self-help-based treatment that involves no cognitive interventions, focuses solely on reducing avoidance behaviors through self-exposure to anxiety-evoking trauma cues, and, unlike other interventions, aims to enhance sense of control over traumatic stressors, rather than anxiety reduction. As such, it is radi-cally different from other interventions in both theory and practice. Our studies have shown improvement rates of 80%-85% with a single treatment session in earthquake survivors. When administered in an average of 6 sessions in war and torture survivors, it achieved 82% reduction in posttraumatic stress symptoms (PTSD), leaving 97% of the cases nearly asymptomatic or with only mild PTSD symptoms. Meta-analytical compari-sons suggest that such improvement rates are substantially higher than those achieved by other evidence-based treatments.

EUS-guided radiofrequency ablation for pancreatic insulinoma: experience in 2 tertiary centers

Insulinoma is the most frequent functional neuroendocrine tumor of the pancreas, and preserving surgery is the treatment of choice. EUS-guided radiofrequency ablation (EUS-RFA) is a novel and promising technique that induces tissue necrosis of localized lesions. This article presents a preliminary clinical experience in treating pancreatic insulinomas<2 cm by EUS-RFA, focusing on safety and efficacy. The clinical course of patients with pancreatic insulinoma treated by EUS-RFA at 2 tertiary referral centers was analyzed. Between November 2017 and December 2020, 7 patients were included (6 women; mean age, 66 years). EUS-RFA was feasible in all patients with immediate hypoglycemia relief after only 1 single treatment session; 6 of 7 achieved complete response by cross-sectional imaging and remained asymptomatic (median follow-up, 21 months; range, 3-38). Three patients had minor adverse events. One elderly patient developed a large retrogastric collection 15 days after treatment and died 1 month after EUS-RFA. Management of pancreatic neuroendocrine tumors<2 cm by EUS-RFA seems to be effective with an acceptable safety profile. However, further evidence focusing on long-term survival and recurrence is needed.

Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial.

Objective:To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP).Methods:Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation.Results:Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective.Conclusion:To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed.Trial registration number:NCT01439412 (ClinicalTrials.gov).

Comparing Between the Effects of Dry Needling and Shock Wave in the Treatment of Trapezius Myofascial Pain

Introduction: Musculoskeletal disorders are important causes of pain. Trigger points are one of the common reasons for myofascial pain. This study aimed to compare a single session of dry needling versus a single session of shock wave therapy on the level of pain and Range of Motion (ROM) in the people with Myofascial Pain Syndrome (MPS) of the upper trapezius muscle. Materials and Methods: Sixteen men with active trigger points of upper trapezius muscle were voluntarily attended in this study. They were randomly assigned into two groups. The patients were under a single session treatment of either dry needling or shock wave therapy. Level of pain (by Visual Analog Scale [VAS]) and active ROM of neck lateral flexion (by goniometer) were evaluated once before the treatment and immediately after the intervention. Results: The VAS scores and the neck ROMs were substantially improved at both groups of study immediately after the treatment (P&lt;0.012). However, there were no significant differences between the two groups of interventions in terms of the VAS and ROM scores (P&gt;0.05). Conclusion: Both dry needling and shock wave therapy can improve neck pain and ROM in patients with active trigger points in the upper trapezius muscle.

Comparative metabolomic study of high-flux hemodialysis and high volume online hemodiafiltration in the removal of uremic toxins using 1H NMR spectroscopy

Uremic toxins (UTs) accumulate in the circulation of patients with chronic kidney disease (CKD). High volume hemodiafiltration (HDF) improves clearance of low and medium molecular weight UTs compared to HD. The present study is a post-hoc analysis comparing the metabolomic profile in serum from patients under high flux HD (hf-HD) and HDF in HDFIT, a multicentric randomized controlled trial (RCTs). Per protocol, serum samples were collected pre- and post- dialysis treatments at randomization (baseline) and at the end of the follow up (6 months) and stored in a biorepository. Random (pre- and post-dialysis) samples from nine patients in study arm were selected at baseline and at the end of the follow up. To compare the samples, 26 possibly matching metabolites were identified by a t-test among the four groups using 1H nuclear magnetic resonance (NMR). To evaluate the comparison between the modalities is a single treatment session, the clearance rates (CRs) of each metabolite were calculated based on pre-dialysis and post-dialysis samples. In addition, to evaluate to effect of UT removal during the trial follow up period, the pre-dialysis metabolite concentrations at the baseline and at 6 months were compared among the two arms of the study. There was no significant difference between in the single session CRs of metabolites when hf-HD and HDF were compared. On the other hand, the comparison between baseline and 6-month (long-term evolution) led to the identification of 16 metabolites that differentiated the hf-HD and the HDF evolutions. Most of these 16 metabolites are involved in several important metabolic pathways, such as metabolism of phenylalanine and biosynthesis of phenylalanine, tyrosine, and tryptophan, which are related to UTs and cardiovascular disease development. Although no difference was observed between hf-HD and HDF samples before and after a single session, concentrations of CKD-relevant metabolites and associated pathologies were stable in the HDF samples, but not in the hf-HD samples, over the six-month period, suggesting that HDF enhances long-term stability.

Single-Session Treatment of Patients with Symptomatic Iliocaval and Iliofemoral Deep Vein Thrombosis: Technical Results of a Prospective Pilot Study

PurposeTo investigate the short-term results of single-session treatment of iliocaval and iliofemoral DVT using a single thrombectomy device. Materials and MethodsThis prospective pilot study analyzed patients with acute iliocaval or iliofemoral DVT treated in a single session using the JETi thrombectomy system. All analyses were performed on an intention-to-treat basis. The cohort consisted of 53 limbs in 47 patients (27 women), with a mean age of 57 years (range, 16–88 years). The primary safety and efficacy endpoints were freedom from major adverse events (MAEs) and reestablishment of unobstructed flow in a single session, respectively. ResultsThe mean duration of symptoms was 8.5 days ± SD 9.2, with 10 patients (11 limbs, 21.3%) presenting with a symptom duration of >14 days. Twelve (25.5%) patients had thrombosis of the inferior vena cava and the iliofemoral segments. During the index procedure, unobstructed flow was reestablished in 47 of 53 (88.6%) limbs in 41 of 47 (87.2%) patients (primary endpoint) with no MAEs through 30 days. Overall, unobstructed flow was restored in 50 of 53 (94.3%) limbs and in 44 of 47 (93.6%) patients. ConclusionsSuccessful single-session treatment of patients with acute iliocaval and iliofemoral DVT is feasible with a high rate of efficacy and a low rate of adverse events. Such patients may be treated on an outpatient basis.