A Dual-Mode Multifunctional Pulsed Radio-Frequency Stimulator for Trigeminal Neuralgia Relief and its Animal Model.

This work proposed a programmable pulsed radio-frequency (PRF) stimulator for trigeminal neuralgia (TN) relief on demand. The implantable stimulator is a miniaturized micro-system which integrates a wireless interface circuit, a sensor interface circuit, a PRF pattern generation circuit and a logic controller. The multifunctional stimulator capable of delivering current/voltage stimulation provides the choice of the biphasic sinusoidal, square and patterned waveform for PRF treatment researches. The external handheld device can wirelessly transmit the parameters of frequency, amplitude, pulse duration and repetition rate of the pulse train to the implanted stimulator. While stimulating, the temperature sensor can monitor the operating temperature. The feedback signal is transmitted in medical implanted communication system (MICS). The micro-system is fabricated in a 0.35 µm CMOS process with a chip size of 3.1 × 2.7 mm2. The fabricated chip was mounted on a 2.6 × 2.1 cm2 test board for studying the in vivo efficacy of pain relief by PRF. Animal studies of PRF stimulation and commonly-used medication for trigeminal neuralgia are also demonstrated and the presented results prove that PRF stimulation has greater effectiveness on trigeminal neuralgia relief comparing to the medication. The effectiveness period lasts at least 14 days. The results of neural recording show that the PRF stimulation of trigeminal ganglion (TG) attenuated neuron activities without being severely damaged. Pathology also revealed no lesion found on the stimulated area.

Two Transcutaneous Stimulation Techniques in Shoulder Pain: Transcutaneous Pulsed Radiofrequency (TPRF) versus Transcutaneous Electrical Nerve Stimulation (TENS): A Comparative Pilot Study.

Objective: To compare the safety and efficacy of 2 transcutaneous stimulation techniques, transcutaneous pulsed radiofrequency (TPRF) versus transcutaneous electrical nerve stimulation (TENS), in chronic shoulder tendonitis. Design: A prospective, randomized, and double-blind clinical trial. Setting: Academic pain service of a city hospital. Subjects: Fifty patients with sonography-confirmed shoulder tendonitis. Methods: Fifty patients were randomly allocated into two groups for electrical stimulation treatment with 3-month follow-ups: Group 1 (n=25), TENS and Group 2 (n=25), TPRF. Both groups underwent either treatment for 15 minutes every other day, three times total. Our primary goals were to find any treatment comfort level, adverse event, and changes in Constant-Murley shoulder (CMS) scores. The secondary goals were finding the changes in pain, enjoyment of life, and general activity (PEG) scores. Results: For primary goals, no adverse events were noted throughout this study. No differences were found between groups for treatment tolerability (3.20 + 0.87 vs. 2.16 + 0.75). Statistically significant lower PEG scores were noticeable with the TPRF group after the course (12.73 + 5.79 vs. 24.53 + 10.21, p=0.013). Their statistical significance lasted for 3 months although the difference gap diminished after 1 month. CMS scores were significantly higher in the TPRF group (70.84 + 6.74 vs. 59.56 + 9.49, p=0.007) right after treatment course but the significance did not last. Conclusions: In treating chronic shoulder tendinitis using two transcutaneous stimulation techniques, both TPRF and TENS are safe and effective. TPRF is superior to TENS.

Pulsed radiofrequency stimulation suppresses palmar hyperhidrosis in an animal study.

Objectives: Palmar hyperhidrosis (PH) exhibits excessive and unpredictable sweating. The most effective treatment for permanent cure is the ablation of thoracic sympathetic ganglia innervating hands. However, sympathectomy of T2 sympathetic ganglion by clipping or cauterization causes irreversible nerve damage, and results in a compensatory hyperhidrosis (CH). We herein used the pulsed radiofrequency (PRF) stimulation to reversibly block sympathetic ganglion to treat PH and avoid CH. Material and Methods: A bipolar electrode was implanted into the right T2 sympathetic trunk by endoscopic surgery and PRF was delivered through the electrode. The humidity (%) of right palm was measured to indicate sweating level. Results: Six out of 13 rats (46.2%) that received a 5-min PRF stimulation on the T2 sympathetic trunk showed a decrease in the right palm humidity during the surgery. PRF stimulation significantly reduced humidity from 69.17% ± 0.72% obtained from baseline condition to 66.93% ± 0.69%. The humidity reduction was also observed at 10 min after the PRF stimulation. We further evaluated the effect of PRF stimulation 1 week after surgery and found that the PRF stimuli reduced right hand humidity in 5 out of 8 rats (62.5%). PRF stimulation significantly reduced humidity from 66.11% ± 0.81% obtained from sham operation control to 63.62% ± 0.82%. The percentage of right hand humidity obtained 10 min after PRF stimulation was also reduced to 63.38% ± 0.80%. Anesthetics have no effect on humidity. Conclusions: These results indicate that PRF stimulation of T2 sympathetic trunk reduces palm sweating in rats.

Clinical Effects of Laser Acupuncture plus Chinese Cupping on the Pain and Plasma Cortisol Levels in Patients with Chronic Nonspecific Lower Back Pain: A Randomized Controlled Trial.

OBJECTIVES: Chronic nonspecific lower back pain (LBP) is a common disease. Insufficient data is currently available to conclusively confirm the analgesic effects of laser acupuncture on LBP. This study evaluated the effectiveness of laser acupuncture plus Chinese cupping in LBP treatment. METHODS: Patients with chronic nonspecific LBP were enrolled for a randomized controlled trial and assigned to the laser acupuncture group (laser acupuncture plus Chinese cupping) and control group (sham laser plus Chinese cupping). Laser acupuncture (808 nm; 40 mW; 20 Hz; 15 J/cm2) and Chinese cupping were applied on the Weizhong (BL40) and Ashi acupoints for 5 consecutive days. Plasma cortisol levels were assessed before and after the 5-day treatment session. The visual analog scale (VAS) scores were recorded at baseline and throughout the 5-day treatment session. RESULTS: After the treatment session, the plasma cortisol levels and VAS scores decreased significantly in both groups. In the laser acupuncture group, the VAS scores decreased significantly on days 4 and 5, and an enhanced reduction in VAS scores was observed. CONCLUSION: Laser acupuncture plus Chinese cupping at the Weizhong (BL40) and Ashi acupoints effectively reduced pain and inflammation in chronic nonspecific LBP. This therapy could be a suitable option for LBP treatment in clinical settings.

A dual-mode highly efficient class-E stimulator controlled by a low-Q class-E power amplifier through duty cycle.

This paper presents the design flow of two high-efficiency class-E amplifiers for the implantable electrical stimulation system. The implantable stimulator is a high-Q class-E driver that delivers a sine-wave pulsed radiofrequency (PRF) stimulation, which was verified to have a superior efficacy in pain relief to a square wave. The proposed duty-cycle-controlled class-E PRF driver designed with a high-Q factor has two operational modes that are able to achieve 100% DC-AC conversion, and involves only one switched series inductor and an unchanged parallel capacitor. The measured output amplitude under low-voltage (LV) mode using a 22% duty cycle was 0.98 V with 91% efficiency, and under high-voltage (HV) mode using a 47% duty cycle was 2.95 V with 92% efficiency. These modes were inductively controlled by a duty-cycle detector, which can detect the duty-cycle modulated signal generated from the external complementary low-Q class-E power amplifier (PA). The design methodology of the low-Q inductive interface for a non-50% duty cycle is presented. The experimental results exhibits that the 1.5-V PA that consumes DC power of 14.21 mW was able to deliver a 2.9-V sine wave to a 500 Ω load. The optimal 60% drain efficiency of the system from the PA to the load was obtained at a 10-mm coupling distance.

In situ measurement of tissue impedance using an inductive coupling interface circuit.

In this work, a method of an inductive coupling impedance measurement (ICIM) is proposed for measuring the nerve impedance of a dorsal root ganglion (DRG) under PRF stimulation. ICIM provides a contactless interface for measuring the reflected impedance by an impedance analyzer with a low excitation voltage of 7 mV. The paper develops a calibration procedure involving a 50-Ω reference resistor to calibrate the reflected resistance for measuring resistance of the nerve in the test. A de-embedding technique to build the equivalent transformer circuit model for the ICIM circuit is also presented. A batteryless PRF stimulator with ICIM circuit demonstrated good accuracy for the acute measurement of DRG impedance both in situ and in vivo. Besides, an in vivo animal experiment was conducted to show that the effectiveness of pulsed radiofrequency (PRF) stimulation in relieving pain gradually declined as the impedance of the stimulated nerve increased. The experiment also revealed that the excitation voltage for measuring impedance below 25 mV can prevent the excitation of a nonlinear response of DRG.

Evaluation of the effect of laser acupuncture and cupping with ryodoraku and visual analog scale on low back pain.

The purpose of this study was to evaluate the effect of laser acupuncture (LA) and soft cupping on low back pain. In this study, the subjects were randomly assigned to two groups: active group (real LA and soft cupping) and placebo group (sham laser and soft cupping). Visual analog scale (VAS) and Ryodoraku were used to evaluate the effect of treatment on low back pain in this trial. Laser, 40 mW, wavelength 808 nm, pulse rate 20 Hz, was used to irradiate Weizhong (BL40) and Ashi acupoints for 10 minutes. And the Ryodoraku values were measured 2 times, that is, before and 15 minutes after treatment. The results show that there were significant difference between the first day baseline and the fifth day treatment in VAS in the two groups. Therefore, LA combined with soft cupping or only soft cupping was effective on low back pain. However, the Ryodoraku values of Bladder Meridian of the placebo group have been decreased apparently, and didn't come back to their original values. It means that "cupping" plays the role of "leak or purge" in traditional Chinese medicine (TCM). On the other hand, the Ryodoraku values of Bladder Meridian of the active group have been turned back to almost their original values; "mend or reinforcing" effect is attributed to the laser radiation.

A miniature patient-mount navigation system for assisting needle placement in CT-guided intervention.

BACKGROUND: CT-guided intervention is routinely performed in an iterative fashion that often leads to lengthy operation and high X-ray exposure to patients. To streamline the workflow, we develop a patient-mount navigation system for assisting needle placement in CT-guided interventions. METHODS: The system comprises three components, a miniature patient-mount tracking unit, an auto-registered reference-frame unit and an intuitive image-processing unit. The system is operated like a virtual biplane fluoroscopy with augmented CT reconstructed images to streamline the conventional CT-guided intervention workflow. Surgery efficiency and safety can be increased, while radiation for patients and surgeons can be reduced. Two preclinical validations were conducted to evaluate the technical applicability and accuracy of the system. RESULTS: The results of the rigid physical phantom test showed a machine position error of 1.6 mm and a tilting error of 1.5°. The results of the deformable porcine phantom test showed the operation position error to be 3.6 mm and tilting error to be 2.9°. CONCLUSIONS: We concluded that the accuracy of our system is within the comparable range of the existing navigation systems.

A patient-mount navigated intervention system for spinal diseases and its clinical trial on percutaneous pulsed radiofrequency stimulation of dorsal root ganglion.

STUDY DESIGN: Development of a patient-mount navigated intervention (PaMNI) system for spinal diseases. An in vivo clinical human trial was conducted to validate this system. OBJECTIVE: To verify the feasibility of the PaMNI system with the clinical trial on percutaneous pulsed radiofrequency stimulation of dorsal root ganglion (PRF-DRG). SUMMARY OF BACKGROUND DATA: Two major image guiding techniques, i.e., computed tomography (CT)-guided and fluoro-guided, were used for spinal intervention. The CT-guided technique provides high spatial resolution, and is claimed to be more accurate than the fluoro-guided technique. Nevertheless, the CT-guided intervention usually reaches higher radiograph exposure than the fluoro-guided counterpart. Some navigated intervention systems were developed to reduce the radiation of CT-guided intervention. Nevertheless, these systems were not popularly used due to the longer operation time, a new protocol for surgeons, and the availability of such a system. METHODS: The PaMNI system includes 3 components, i.e., a patient-mount miniature tracking unit, an auto-registered reference frame unit, and a user-friendly image processing unit. The PRF-DRG treatment was conducted to find the clinical feasibility of this system. RESULTS: The in vivo clinical trial showed that the accuracy, visual analog scale evaluation after surgery, and radiograph exposure of the PaMNI-guided technique are comparable to the one of conventional fluoro-guided technique, while the operation time is increased by 5 minutes. CONCLUSION: Combining the virtues of fluoroscopy and CT-guided techniques, our navigation system is operated like a virtual fluoroscopy with augmented CT images. This system elevates the performance of CT-guided intervention and reduces surgeons' radiation exposure risk to a minimum, while keeping low radiation dose to patients like its fluoro-guided counterpart. The clinical trial of PRF-DRG treatment showed the clinical feasibility and efficacy of this system.

A comparison between pulsed radiofrequency and electro-acupuncture for relieving pain in patients with chronic low back pain.

Many treatment options for chronic low back pain are available, including varied forms of electric stimulation. But little is known about the electricity effect between electro-acupuncture and pulsed radiofrequency. The objective of this study is to assess the difference in effectiveness of pain relief between pulsed radiofrequency and electro-acupuncture. Visual analog score (VAS) pain score, the Oswestry disability index (ODI) to measure a patient's permanent functional disability, and Short form 36 (SF-36) which is a survey used in health assessment to determine the cost-effectiveness of a health treatment, were used as rating systems to measure the pain relief and functional improvement effect of pulsed radiofrequency and electro-acupuncture, based on the methodological quality of the randomized controlled trials, the relevance between the study groups, and the consistency of the outcome evaluation. First, the baseline status before therapy shows no age and gender influence in the SF-36 and VAS score but it is significant in the ODI questionnaire. From ANOVA analyses, it is apparent that radiofrequency therapy is a significant improvement over electro-acupuncture therapy after one month. But electro-acupuncture also showed functional improvement in the lumbar spine from the ODI. This study provides sufficient evidence of the superiority of pulsed radiofrequency (PRF) therapy for low back pain relief compared with both electro-acupuncture (EA) therapy and the control group. But the functional improvement of the lumbar spine was proved under EA therapy only. Both therapies are related to electricity effects.

The development and evaluation of the Citizen Telehealth Care service System: case study in Taipei.

Because of the rapid aging population in Taiwan and the trend of fewer children, people are looking into technical solutions for continuous/intermittent monitoring of vital signs in the home setting environment and the interactions between family members. In this study we developed a smart medical services system for managing chronic disease, called Citizen Telemedical Care service System (CTCS). The system integrates biosignal measurement, hypertension risk estimation expert system, clinic appointment service, video communication service, medical assistance referral, health frequency program record, and health/hygiene education. The demo version CTCS is exhibited in the center of INSIGHT opened for visit and trial use. In order to verify the demand and acceptability of the system and services, we have interviewed 251 volunteers with a questionnaire survey with the help from Taipei City Government. The results showed that people have positive expectation about the service program for health care and the capability of home devices. They also expressed high motivation on learning to use the system and to participate in the program. According to the evaluation results, the system is processing a small user test led by Taipei City Government, in order to further verify the acceptability and satisfaction of the system.

Chemical profiling and gene expression profiling during the manufacturing process of Taiwan oolong tea "Oriental Beauty".

Oriental Beauty, which is made from tea leaves infested by the tea green leafhopper (Jacobiasca formosana) in Taiwan, has a unique aroma like ripe fruits and honey. To determine what occurs in the tea leaves during the oolong tea manufacturing process, the gene expression profiles and the chemical profiles were investigated. Tea samples were prepared from Camellia sinensis var. sinensis cv. Chin-shin Dah-pang while the tea leaves were attacked by the insect. The main volatile compounds, such as linalool-oxides, benzyl alcohol, 2-phenylethanol, and 2,6-dimethylocta-3,7-diene-2,6-diol, increased during manufacture. The gene expression profiles during manufacture were analyzed by differential screening between fresh leaves and tea leaves of the first turn over. Many up-regulated transcripts were found to encode various proteins homologous to stress response proteins. Accordingly, the endogenous contents of abscisic acid and raffinose increased during manufacture. Thus the traditional manufacturing method is a unique process that utilizes plant defense responses to elevate the production of volatile compounds and other metabolites.