A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy.

Objective: To assess the durability of treatment over various chronic pain conditions of an emerging, nonprescription electromagnetic neuromodulation device that uses pulsed shortwave therapy. Methods: A 6-month prospective study, involving 240 chronic pain sufferers, 94% of whom reported using pain pills and 98% reported using pain therapies prior to entering the study. Their average baseline pain was 8.2 VAS points before treatment; they had a pain duration of 6.5 years, and they were positive responders to pulsed shortwave therapy in an initial 7-day trial. Prospective assessments were obtained at intervals of 3, 4, and 6 months following a retrospective 7-day assessment. Longitudinal analyses were conducted to determine pain relief trends after the initial 7-day device use. Results: Seven days after initial treatment, the average pain was reduced to 2.9, a 65% pain reduction for the study subjects. At the 6-month measurement, the average pain was 3.3, a 60% pain reduction from baseline. Only 17% of the subjects saw their pain level increase although this new level was still lower than baseline pain. Pain relief translated into improved quality of life and reduced medication use for the majority of the subjects. There were no significant adverse side effects reported over the 6 months of use. Conclusion: Ninety-seven percent of the recruited subjects, all of whom had previously reported clinically significant pain relief using the 7-day PSWT device, sustained this relief for 6 months by using the device on an as-needed basis.

Microneedle fractional radiofrequency treatment of facial photoageing as assessed in a split-face model.

BACKGROUND: A new therapeutic device passes radiofrequency energy through microneedles to targeted tissue. Three-dimensional photography may be useful for evaluating the clinical efficacy of microneedle fractional radiofrequency (MFR) used on the appearance of rhytids and to improve facial laxity. AIM: To evaluate the efficacy and safety of MFR in the treatment of facial photoageing. METHODS: In total, participants with facial photoageing were enrolled in the study. All volunteers were randomized to receive split-face treatments with MFR 2 months apart. The participants self-evaluated at baseline, Days 1-7, and Months 1 and 3 after the final treatment. Objective evaluation was provided by a three-dimensional in vivo imaging system. In addition, skin melanin index, erythema index, immediate reactions, healing times and other adverse effects were evaluated. RESULTS: Compared with the untreated side, the treated side of most participants improved, based on clinical assessments at the 1- and 3-month follow-up visits after treatment. Both objective and participative assessments were satisfactory. The participants demonstrated a decrease of roughness parameter (Sa) value at each follow-up visit. Compared with pretreatment value, Sa decreased significantly at Months 1 and 3 on the treated side (P < 0.05). Minimal and reversible adverse effects and rapid healing were recorded. CONCLUSIONS: MFR appears to be an excellent treatment for photodamaged facial skin in Chinese patients.

Radiofrequency Lesioning Through Deep Brain Stimulation Electrodes in Patients with Generalized Dystonia.

BACKGROUND: Deep brain stimulation (DBS) is an established treatment for generalized dystonia. However, the DBS device is sometimes removed owing to hardware complications. We present 4 cases of generalized dystonia treated with radiofrequency lesioning through DBS electrodes. CASE DESCRIPTION: Four patients, 3 men and 1 woman (age range, 34-44 years), underwent DBS for generalized dystonia and subsequently developed complications, such as infection, necessitating removal of the devices. As stopping the stimulation caused recurrence of uncontrollable symptoms, radiofrequency lesioning was performed through the DBS electrodes under local anesthesia, and the DBS systems were removed under local or generalized anesthesia thereafter. The procedures performed were as follows: 2 patients had bilateral pallidotomy, 1 patient had unilateral pallidotomy, and 1 patient had pallidotomy and ipsilateral thalamotomy. As a result, in 4 patients, the dystonic symptoms did not worsen even after removal of the DBS systems during a follow-up period of 1-12 years. However, 1 patient had a small hemorrhage, and 2 patients showed recurrence of dystonia. CONCLUSIONS: Radiofrequency lesioning with DBS electrodes is feasible in cases of generalized dystonia when the DBS leads have to be removed.

In vivo skin reactions from pulsed-type, bipolar, alternating current radiofrequency treatment using invasive noninsulated electrodes.

BACKGROUND: Bipolar, alternating current radiofrequency (RF) conduction using invasive noninsulated electrodes consecutively generates independent tissue coagulation around each electrode and then, the converged coagulation columns. METHODS: Two pulsed-type RF models at the on-time pulse width/pulse pack of 30 and 40 milliseconds were designed to amplify the early stage of RF-induced tissue reaction using hairless mouse skin in vivo. Then, structural and ultrastructural changes were evaluated in hairless mouse skin samples at baseline and immediately 1 day, 3 days, 7 days, and 14 days after treatment. RESULTS: Immediately after pulsed-RF treatment, a few chrysanthemum-like zones of electrothermal coagulation and hypereosinophilic collagen fibers were found in the dermis and dermo-subcutaneous fat junction. Histochemical staining for periodic acid-Schiff and immunohistochemical staining for type IV collagen revealed marked thickening of basement membranes. Transmission electron microscopy demonstrated that pulsed-RF treatment resulted in higher electron-dense and remarkably thicker lamina densa, as well as increases in anchoring fibrils, compared with untreated control specimens. Furthermore, CD31-positive blood vessels were smaller in size with a slit-like luminal appearance, without excessive damage to endothelial cells. CONCLUSION: Our data indicated that pulse-type, bipolar RF energy induces structural and ultrastructural changes in basement membranes and vascular components in hairless mouse skin.

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.

Effects of Pulsed Versus Conventional Versus Combined Radiofrequency for the Treatment of Trigeminal Neuralgia: A Prospective Study.

BACKGROUND: During radiofrequency bursts of energy are applied to nervous tissue. The clinical advantages of this treatment remain unclear. OBJECTIVES: We compared the effectiveness and pain relief for idiopathic trigeminal neuralgia (TN) after continuous radiofrequency (CRF), pulsed radiofrequency (PRF), and combined continuous and pulsed radiofrequency (CCPRF) treatment of the Gasserian ganglion (GG). STUDY DESIGN: We conducted a randomized prospective study. Forty-three patients were included. Eleven patients were treated with PRF at 42°C for 10 minutes (PRF group), 12 patients received CRF for 270 seconds at 75 °C (CRF group), and 20 patients received PRF for 10 minutes at 42°C followed by CRF for at 60°C for 270 seconds (CCPRF group). SETTING: Assuit University Hospital, Pain and Neurology outpatient clinics. METHODS: Patients were assessed for pain, satisfaction, and consumption of analgesics at baseline and 7 days, one month, 6 months, 12 months, and 24 months after the procedure. The incidence of complications, anesthesia dolorosa, weakness of muscles of mastication, numbness, and technical complications, was evaluated after the procedure. RESULTS: Excellent pain relief was achieved after 6, 12, and 24 months, respectively in 95%, 85%, and 70% of patients with CCPRF; 75%, 75%, and reduced to 50% among patients with CRF; and 82%, reduced to 9.1%, and 0% of patients with PRF. No complications were recorded in 75% of patients in the CCPRF and PRF groups. There was one case of anesthesia dolorosa, 4 cases of masseter muscle weakness, and 5 cases of severe numbness recorded in the CRF group. LIMITATION: There was a small number of patients in each group. CONCLUSION: The best results were observed in the CCPRF group, followed by the CRF group, and then the PRF group.Key words: Pulsed, continuous, radiofrequency, trigeminal neuralgia, Gasserian ganglion.

Bronchial thermoplasty: a non-pharmacological approach.

INTRODUCTION: Asthma is a chronic inflammatory disorder of the airway characterized by the episodic symptoms of breathlessness, wheezes and cough. Even with the use of maximum anti-asthmatic pharmacological treatment sometimes it remains uncontrolled. For such patients, bronchial thermoplasty is the new mode of treatment. OBJECTIVE: To review published article on bronchial thermoplasty. METHODS: We identified 102 English articles on PubMed, and 56 were excluded by the abstract. The remaining articles were retrieved for full-text detailed evaluation by authors, and 28 relevant articles were selected for final review. RESULTS: Bronchial thermoplasty is the radiofrequency ablation of the airway smooth muscle with the help of flexible fiberoptic bronchoscope. It reduces the smooth muscle mass of the bronchial wall and decreases its contractility. CONCLUSION: Bronchial thermoplasty causes improvement in the quality of life, and causes reduction in the emergency room visit and exacerbation due to asthma. Long-term safety has been established by various prospective studies.

Radio frequency-mediated local thermotherapy for destruction of pancreatic tumors using Ni-Au core-shell nanowires.

We present a novel method of radio frequency (RF)-mediated thermotherapy in tumors by remotely heating nickel (Ni)-gold (Au) core-shell nanowires (CSNWs). Ectopic pancreatic tumors were developed in nude mice to evaluate the thermotherapeutic effects on tumor progression. Tumor ablation was produced by RF-mediated thermotherapy via activation of the paramagnetic properties of the Ni-Au CSNWs. Histopathology demonstrated that heat generated by RF irradiation caused significant cellular death with pyknotic nuclei and nuclear fragmentation dispersed throughout the tumors. These preliminary results suggest that thermotherapy ablation induced via RF activation of nanowires provides a potential alternative therapy for cancer treatment.

Clinical Efficacy and Safety of a Monopolar Radiofrequency Device With Comfort Pulse Technology for the Treatment of Facial and Neck Laxity in Men.

The objective of this study was to demonstrate the efficacy and safety of a monopolar radiofrequency treatment for facial and neck laxity in men. Twelve men received one treatment of the face and upper portion of the neck using an RF system with comfort pulsed technology. Standardized photographs were taken at baseline and at 1, 3, and 6 months of follow-up. Study investigators evaluated facial and neck laxity at baseline and all follow-up visits using the Fasil Laxity Scale. Patents and investigators assessed skin texture and overall appearance using the Quartile Improvement Scale. Average improvement in treated areas was statistically significant at 1-month (P<.01), 3-month (P=.02), and 6-month (P=.05) follow-up visits compared with baseline. Investigators rated greatest improvement in skin texture and overall appearance (mild to moderate) at the 3-month follow-up. Patient assessments demonstrated moderate improvement in skin laxity, skin texture, and overall appearance maintained out to 6 months after treatment. A total of 64% of patients were satisfied to very satisfied with treatment at the 6-month follow-up. One RF treatment of the face and neck yielded 20% reduction in facial laxity 1 month after treatment, with maintained improvement out to 6 months (15% reduction).

Thermal analysis of induced damage to the healthy cell during RFA of breast tumor.

Effective pre-clinical computational modeling strategies have been demonstrated in this article to enable risk free clinical application of radiofrequency ablation (RFA) of breast tumor. The present study (a) determines various optimal regulating parameters required for RFA of tumor and (b) introduces an essential clinical monitoring scheme to minimize the extent of damage to the healthy cell during RFA of tumor. The therapeutic capabilities offered by RFA of breast tumor, viz., the rise in local temperature and induced thermal damage have been predicted by integrating the bioheat transfer model, the electric field distribution model and the thermal damage model. The mathematical model has been validated with the experimental results available in the literature. The results revealed that, the effective damage of tumor volume sparing healthy tissue essentially depends on the voltage, the exposure time, the local heat distribution, the tumor stage and the electrode geometric configuration. It has been confirmed that, the assessment of damage front can accurately determine the extent of damage as compared to the thermal front. The study further evaluates the damaged healthy and tumor volumes due to RFA of different stages of breast cancer. The assessment of cell survival and damage fractions discloses the propensity of reappearance/healing of tumor cells after treatment.

Fractional Microneedling Radiofrequency Treatment for Acne-related Post-inflammatory Erythema.

Post-inflammatory erythema is a common result of acne inflammation and is cosmetically unacceptable without effective treatment. Fractional microneedling radiofrequency (FMR) has potential for treatment of post-inflammatory erythema. The aim of this study was to evaluate the efficacy and safety of this treatment. A retrospective chart review was undertaken of 25 patients treated with 2 sessions of radiofrequency at 4-week intervals and 27 patients treated with oral antibiotics and/or topical agents. Efficacy was assessed through an investigator's global assessment of photographs, and the analysis of erythema with image analysis software and photometric devices. Histological changes resulting from the treatment were evaluated by skin biopsy. FMR treatment resulted in significant improvements in erythema with no severe adverse effects. Histological study revealed a reduction in vascular markers and inflammation. FMR is a safe and effective treatment for post-inflammatory erythema, with potential anti-inflammatory and anti-angiogenetic properties.

Treatment of periorbital wrinkles with a novel fractional radiofrequency microneedle system in dark-skinned patients.

BACKGROUND: Periorbital wrinkles as a result of photoaging are a frequent cosmetic concern. Recently, the fractional radiofrequency microneedle system was introduced as a new device for facial rejuvenation, and it has received much recognition for its unique "deep dermal heating with epidermal sparing" feature. OBJECTIVE: The purpose of this study was to examine the clinical efficacy and safety of the system for the treatment of periorbital wrinkles in Korean patients. MATERIALS AND METHODS: Twenty Korean patients (Fitzpatrick skin Type IV-V) with varying degrees of periorbital wrinkles were enrolled in this study. The patients were treated 3 times at 4-week intervals with the system. Changes in periorbital wrinkling were evaluated by 2 independent experts with digital images of the subjects' faces using a 5-point Wrinkle Assessment Scale. At the end of the study, the patients rated their satisfaction with the overall treatment outcome on a numerical scale. RESULTS: All patients completed the treatment regimen and were satisfied with the treatment. Most patients improved according to clinical and photographic assessments performed 6 months after the treatment. Two patients (10%) reported mild hyperpigmentation. CONCLUSION: The system may be an effective and safe treatment option for periorbital wrinkles in dark-skinned Korean patients.

FDA MAUDE data on complications with lasers, light sources, and energy-based devices.

BACKGROUND AND OBJECTIVE: It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. STUDY DESIGN/MATERIALS AND METHODS: We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. RESULTS: Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. CONCLUSION: 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.

Temperature in and around the scapholunate ligament during radiofrequency shrinkage: a cadaver study.

PURPOSE: To investigate whether applied radiofrequency energy (RFE) for shrinkage of the scapholunate interosseus ligament reaches temperatures required for ligament shrinkage while leaving adjacent structures unaffected. METHODS: Standard wrist arthroscopy was performed on 7 pairs of cadaveric limbs with continuous saline irrigation and gravity-assisted outflow through an 18-gauge needle. We subjected 14 scapholunate ligaments to treatment with monopolar (n = 7) or bipolar (n = 7) RFE for ligament shrinkage. Temperature was recorded simultaneously inside the dorsal part of the scapholunate interosseus ligament at a depth of 0.9 ± 0.1 mm and at 6 other sites in and around the wrist because thermal shrinkage starts at 60°C to 65°C. RESULTS: We observed an increase in temperature corresponding to the time of energy application. The highest measured peak temperatures at the scapholunate ligament were 43°C (monopolar) and 32°C (bipolar). Mean temperatures at 30 seconds of application were 29°C ± 7°C (monopolar) and 28°C ± 3°C (bipolar). CONCLUSIONS: Temperatures sufficiently high to induce ligament shrinkage were not reached with either monopolar or bipolar RFE. We did not monitor temperature levels responsible for damage on adjacent cartilage or immediately adjacent capsular tissue in this setting. CLINICAL RELEVANCE: This study suggests that RFE for capsular shrinkage in the wrist is safe but ineffective.

Two-treatment protocol for skin laxity using 90-Watt dynamic monopolar radiofrequency device with real-time impedance intelligence monitoring.

UNLABELLED: Multiple devices are currently on the market that employ radiofrequency to non-invasively treat skin laxity and wrinkle reduction. The study device was a unique monopolar radiofrequency device FDA cleared for the treatment of wrinkles and rhytids. The delivery system allows constant monitoring of the real-time local skin impedance changes, which allows radiofrequency energy to be more uniformly dosed over an entire treatment area. OBJECTIVE: The objective was to validate effectiveness of a modified treatment protocol for a unique monopolar radiofrequency device, which has been engineered with greater power and self-monitoring circuitry. METHODS: Twenty-four female subjects received bilateral monopolar radiofrequency treatments to the mid and lower face from the sub malar region to the submentum. Subjects completed 1 and 3 month follow ups with digital imaging. Skin biopsies (on 4 subjects) and ultrasound measurements (on 12 subjects) were completed. RESULTS: Assessments demonstrated a reduction in skin laxity of 35%, a reduction in fine lines/wrinkles of 42%, and a reduction in the appearance of global photodamage of 33%. Expert photograding demonstrated 92% of subjects showing at least a mild improvement in skin laxity at three months post treatment. 50 MHz ultrasound measurements in 12 subjects showed an increase of 19% in skin density. Histology showed a marked increase in dermal collagen and elastin fibers in two subjects who demonstrated a clinically noticeable reduction in skin laxity and minimal changes in two subjects who demonstrated minimal clinical improvements. There were no significant adverse events reported. CONCLUSION: This modified radiofrequency device and treatment protocol was well tolerated and produced improvements in the appearance of skin laxity and overall anti-aging effects in the majority of subjects. Objective measurements including ultrasound and histology help explain the clinical outcome.

The efficacy in treatment of facial atrophic acne scars in Asians with a fractional radiofrequency microneedle system.

BACKGROUND: Treatment of acne scars remains a challenge to dermatologists. Multiple modalities have been employed with variable results and adverse effects. OBJECTIVE: To determine the efficacy and adverse effects of a fractional radiofrequency microneedle system (FRMS) on acne scars in Asians at 1-, 3- and 6-month follow-up visits after treatment. METHODS: Thirty subjects with atrophic acne scars for more than 6 months were enrolled in the study. All volunteers were treated with a FRMS on affected areas. The subjects were treated for a total number of three treatment sessions at 1-month intervals. Subjective assessments were obtained at baseline, 1, 3 and 6 months after the last treatment session by self-evaluation and two blinded dermatologists. Objective evaluation using an ultraviolet A-light video camera was also performed. In addition, pain scores, immediate reactions, healing times and other adverse effects were evaluated. RESULTS: Twenty-six subjects with skin phototypes III-V completed treatment protocol. The average mean scar age was 7 years (range: 0.5-15 years). At 6-month follow-up visit, the majority of the subjects (42.3%) reported a 26-50% improvement on their acne scars. Percent reduction in scar volume corresponded to clinical evaluation. Adverse reactions of the treatment included pain, immediate oedema/erythema, minimal scabbing and transient pigmentary alteration on treated areas. The average pain score was 5.6 of 10. Worsening of skin texture or new scar formation was not observed in any subjects. CONCLUSION: Fractional radiofrequency microneedle system is a safe and effective device for treating acne scars in Asians with minimal risk of downtime and adverse effects.

Computer modeling of electrical and thermal performance during bipolar pulsed radiofrequency for pain relief.

PURPOSE: Pulsed RF (PRF) is a nonablative technique for treating neuropathic pain. Bipolar PRF application is currently aimed at creating a "strip lesion" to connect the electrode tips; however, the electrical and thermal performance during bipolar PRF is currently unknown. The objective of this paper was to study the temperature and electric field distributions during bipolar PRF. METHODS: The authors developed computer models to study temperature and electric field distributions during bipolar PRF and to assess the possible ablative thermal effect caused by the accumulated temperature spikes, along with any possible electroporation effects caused by the electrical field. The authors also modeled the bipolar ablative mode, known as bipolar Continuous Radiofrequency (CRF), in order to compare both techniques. RESULTS: There were important differences between CRF and PRF in terms of electrical and thermal performance. In bipolar CRF: (1) the initial temperature of the tissue impacts on temperature progress and hence on the thermal lesion dimension; and (2) at 37 °C, 6-min of bipolar CRF creates a strip thermal lesion between the electrodes when these are separated by a distance of up to 20 mm. In bipolar PRF: (1) an interelectrode distance shorter than 5 mm produces thermal damage (i.e., ablative effect) in the intervening tissue after 6 min of bipolar RF; and (2) the possible electroporation effect (electric fields higher than 150 kV m(-1)) would be exclusively circumscribed to a very small zone of tissue around the electrode tip. CONCLUSIONS: The results suggest that (1) the clinical parameters considered to be suitable for bipolar CRF should not necessarily be considered valid for bipolar PRF, and vice versa; and (2) the ablative effect of the CRF mode is mainly due to its much greater level of delivered energy than is the case in PRF, and therefore at same applied energy levels, CRF, and PRF are expected to result in same outcomes in terms of thermal damage zone dimension.