Safety analysis of percutaneous needle electrolysis: a study of needle composition, morphology, and electrical resistance.

BACKGROUND: Percutaneous needle electrolysis (PNE) consists of a galvanic current combined with the insertion of a solid needle into the tissues of the musculoskeletal system. The application of a galvanic current through a needle can alter the morphology and composition during treatment application. This procedure may also provoke a localized temperature increase. AIM: The aim was to evaluate the safety of the PNE procedure by analyzing possible alterations of the needles employed. METHODS: Physio Invasiva® and AguPunt EPI® brand needles, commonly used for the application of this technique, were analyzed in response to three different treatment protocols. Temperature changes were evaluated with the needles immersed in a test tube containing Ringer's solution, and electrical resistance was evaluated with a multimeter. The morphology of the needles, pre- and post-treatment, was examined with a scanning electron microscope (FEI Quanta 600), and the composition of the needles was evaluated using RX diffusion with Oxford Instruments software. RESULTS: Ringer's solution contained in the test tubes examined did not present temperature changes. No changes were observed in the needles under investigation with respect to electrical resistance, morphology, or composition with a protocol applying 3-mA intensity for 3 s and three applications. However, important morphological alterations were observed that affected needle composition after 50 applications (at 3 mA for 3 s). CONCLUSION: PNE, applied according to conventional protocols, appeared to be safe and athermal, and did not provoke a loss of metal particles or modify the morphology of the needles used when studied in vitro.

Residual strain effects in needle-induced cavitation.

Needle-induced cavitation (NIC) locally probes the elastic and fracture properties of soft materials, such as gels and biological tissues. Current NIC protocols tend to overestimate properties when compared to traditional techniques. New NIC methods are needed in order to address this issue. NIC measurements consist of two distinct processes, namely (1) the needle insertion process and (2) the cavitation process. The cavitation process is hypothesized to be highly dependent on the initial needle insertion process due to the influence of residual strain below the needle. Retracting the needle before pressurization to a state in which a cylindrical, tube-like fracture is left below the needle tip is experimentally demonstrated to reduce the impact of residual strain on NIC. Verification of the critical cavitation pressure equation in this new geometry is necessary before implementing this retraction NIC protocol. Complementary modeling shows that the change in initial geometry has little effect on the critical cavitation pressure. Together, these measurements demonstrate that needle retraction is a viable experimental protocol for reducing the influence of residual strain, thus enabling the confident measurement of local elastic and fracture properties in soft gels and tissues.

Fabrication, Physicochemical Characterization, and Performance Evaluation of Biodegradable Polymeric Microneedle Patch System for Enhanced Transcutaneous Flux of High Molecular Weight Therapeutics.

A revolutionary paradigm shift is being observed currently, towards the use of therapeutic biologics for disease management. The present research was focused on designing an efficient dosage form for transdermal delivery of α-choriogonadotropin (high molecular weight biologic), through biodegradable polymeric microneedles. Polyvinylpyrrolidone-based biodegradable microneedle arrays loaded with high molecular weight polypeptide, α-choriogonadotropin, were fabricated for its systemic delivery via transdermal route. Varied process and formulation parameters were optimized for fabricating microneedle array, which in turn was expected to temporally rupture the stratum corneum layer of the skin, acting as a major barrier to drug delivery through transdermal route. The developed polymeric microneedles were optimized on the basis of quality attributes like mechanical strength, axial strength, insertion ratio, and insertion force analysis. The optimized polymeric microneedle arrays were characterized for in vitro drug release studies, ex vivo drug permeation studies, skin resealing studies, and in vivo pharmacokinetic studies. Results depicted that fabricated polymeric microneedle arrays with mechanical strength of above 5 N and good insertion ratio exhibited similar systemic bioavailability of α-choriogonadotropin in comparison to marketed subcutaneous injection formulation of α-choriogonadotropin. Thus, it was ultimately concluded that the designed drug delivery system can serve as an efficient tool for systemic delivery of therapeutic biologics, with an added benefit of overcoming the limitations of parenteral delivery, achieving better patient acceptability and compliance.

Evidence and expert opinions: Dry needling versus acupuncture (II) : The American Alliance for Professional Acupuncture Safety (AAPAS) White Paper 2016.

In the United States and other Western countries, dry needling has been a topic in academic and legal fields. This White Paper is to provide the authoritative information of dry needling versus acupuncture to academic scholars, healthcare professionals, administrators, policymakers, and the general public by providing the authoritative evidence and expertise regarding critical issues of dry needling and reaching a consensus. We conclude that Dr. Travell, Dr. Gunn, Dr. Baldry and others who have promoted dry needling by simply rebranding (1) acupuncture as dry needling and (2) acupuncture points as trigger points (dry needling points). Dry needling simply using English biomedical terms (especially using "fascia" hypothesis) in replace of their equivalent Chinese medical terms. Dry needling is an over-simplified version of acupuncture derived from traditional Chinese acupuncture except for emphasis on biomedical language when treating neuromuscularskeletal pain (dry needling promoters redefined it as "myofascial pain"). Trigger points belong to the category of Ashi acupuncture points in traditional Chinese acupuncture, and they are not a new discovery. By applying acupuncture points, dry needling is actually trigger point acupuncture, an invasive therapy (a surgical procedure) instead of manual therapy. Dr. Travell admitted to the general public that dry needling is acupuncture, and acupuncture professionals practice dry needling as acupuncture therapy and there are several criteria in acupuncture profession to locate trigger points as acupuncture points. Among acupuncture schools, dry needling practitioners emphasize acupuncture's local responses while other acupuncturists pay attention to the responses of both local, distal, and whole body responses. For patients' safety, dry needling practitioners should meet standards required for licensed acupuncturists and physicians.

["Sham Needle"--Design and Application of A Double-blind Placebo Needle Assembly].

The blind study design, particularly the double-blind study design is a very important method for diminishing placebo effect and reducing bias in clinical medical trial. Enlightened by Streitberger's and Park's sham needle design, the authors of the present paper introduce a newly designed sham needle device (Yan's sham-needle) for controlled double-blind trials of acupuncture. This sham needle device consists of needle, tube and base. The bottom of the tube is completely sealed and it can never arouse any invasive stimulation on the subject's skin when the sham needle is downward pressed on the body surface. Meanwhile, this sham device is filled with sponge which is able to simulate soft tissues of the acupoint area. By combining words suggestions or hints before trials and the same shape as verum device, this sham-needle device reduces the risk of blind-breaking and makes it possible to conduct controlled double-blind trials. Primary practice showed that this device may provide a new and practical tool for researching the placebo effect of acupuncture therapy.

[Design and application of silver needle-knife].

A silver needle-knife which has the dual function of silver needle and needle-knife is designed. The main components of this silver needle-knife are approximately 50% silver and approximately 50% nichrome. The silver needle-knife is composed of five parts, including needle-knife tail, spiral handle; steering handle, needle-knife body and needle-knife edge. It converges the advantages of needle-knife and silver needle, which can cut loose of diseased tissue and peel adhesion of lesions, but also be heated with moxa cone and thermal therapeutic instrument, and connect with electroacupuncture apparatus. It has the function of warming channel and removing coldness, dispelling wind and eliminating dampness, resolving spasm and relieving pain, dredging the channel and so on. Due to the spiral handle and the steering handle, the operation is easier, which reduces the blindness of cutting and increase the safety. It is mainly used for soft tissue injury, rheumatism and rheumatoid arthritis, as well as degenerative diseases of spine and joint, and it has obvious efficacy on some internal medical diseases.

[From manual workshop to international standard maker: exploration on production standard of acupuncture needle by Chengjiang acupuncture school].

ABSTRACT The exploration course on production standard of acupuncture needle by Chengjiang acupuncture school is reviewed in this paper. After new China was established, acupuncture needle standard was unified by Mr. CHENG Dan-an, which guided Suzhou Hua Erfang (predecessor of Suzhou Medical Supplies Factory) to make the quality standards and testing methods of acupuncture needle and improved the production process to make the modern acupuncture needle. Based on this, Suzhou Medical Supplies Factory followed the time development pace, ac tively introduced new technology, carried out technological innovation, and constantly improved the level of production technology, as a result, it gradually developed into one of the world's largest acupuncture needle production suppliers. Meanwhile, after establishing China's first national standard on acupuncture needle (GB 2024-1980), the Suzhou Medical Supplies Factory took the lead to draft "ISO) 17218:2014 the disposable use asepsis acupuncture needle", which was officially published as an international standard. The Suzhou Medical Supplies Factory developed from a manual workshop to an international standard maker.

[Academic origin of round magnetic needle and standardization operation].

The origin and development of round magnetic needle was explored, and the structure of round magnetic needle was introduced in detail, including the handle, the body and the tip of the needle. The clinical opera tion of round magnetic needle were standardized from the aspects of the methods of holding needle, manipulation skill, tapping position, strength of manipulation, application scope and matters needing attention, which laid foundation for the popularization and application of round magnetic needle.

Examination of surface conditions and other physical properties of commonly used stainless steel acupuncture needles.

OBJECTIVES: The present work examined the surface conditions and various other physical properties of sterilised single-use stainless steel acupuncture needles from two of the most popular brands widely used in many countries. METHODS: Scanning electron microscope (SEM) images were taken for 10 randomly chosen needles from each brand. Further SEM images were taken after each of these needles underwent a standard manipulation with an acupuncture needling practice gel. A comparison of forces and torques during the needling process was also carried out. RESULTS: The SEM images revealed significant surface irregularities and inconsistencies at the needle tips, especially for needles from one of the two brands. Metallic lumps and small, loosely attached pieces of material were observed on the surfaces of some needles. Some of the lumps and pieces of material seen on the needle surfaces disappeared after the acupuncture manipulation. If these needles had been used on patients, the metallic lumps and small pieces of material could have been deposited in human tissues, which could have caused adverse events such as dermatitis. Malformed needle tips might also cause other adverse effects including bleeding, haematoma/bruising, or strong pain during needling. An off-centre needle tip could result in the needle altering its direction during insertion and consequently failing to reach the intended acupuncture point or damaging adjacent tissues. CONCLUSIONS: These findings highlight the need for improved quality control of acupuncture needles, with a view to further enhancing the safety and comfort of acupuncture users.

MRI evaluation of metal acupuncture needles.

OBJECTIVE: To evaluate the MR compatibility of three metal acupuncture needles (a standard stainless steel needle, a gold needle and an austenitic stainless steel needle) by comparing their imaging artefacts, radiofrequency heating effects and ease of operation. METHODS: The MRI artefacts of the three metal needles were first evaluated by placing them in an agar gel phantom and performing MRI of the phantom. The increase in temperature during MRI was recorded using an MR-compatible fibreoptic thermometer. MRI of acupuncture at SP6 was performed using the MR-compatible gold needle and the austenitic stainless steel needle. RESULTS: The standard stainless steel acupuncture needle produced large imaging artefacts on MRI. The gold needle was superior for MRI but not rigid enough for some clinical applications such as scalp acupuncture. The austenitic stainless steel needle is non-ferromagnetic and compatible with MRI. None of these acupuncture needles introduced radiofrequency heating during MRI. CONCLUSIONS: The evaluation of MR compatibility showed that gold and austenitic stainless steel needles are MR-compatible and therefore can be used for MRI of acupuncture.

A randomized, controlled trial of acupuncture self-needling as maintenance therapy for cancer-related fatigue after therapist-delivered acupuncture.

BACKGROUND: Maintenance acupuncture is advocated by clinicians after successful clinic-based acupuncture. We aimed to assess the effectiveness of maintenance acupuncture in the management of cancer-related fatigue (CRF); treatment delivered by therapists or self-acupuncture/self-needling was compared with no maintenance treatment. METHODS: Breast cancer patients who participated in a randomized trial of acupuncture for CRF management (reported elsewhere) were re-randomized to receive an additional four acupuncturist-delivered weekly sessions; four self-administered weekly acupuncture sessions (self-needling); or no acupuncture. Primary outcome was general fatigue (Multidimensional Fatigue Inventory). Mood, quality of life and safety were also assessed. RESULTS: In total, 197 patients were re-randomized, with 65 to therapist-delivered sessions, 67 to self-acupuncture/self-needling and 65 to no further acupuncture. Primary outcome scores were equivalent between the therapist-delivered acupuncture and self-acupuncture (P > 0.05). A non-significant trend in improving fatigue was observed at the end of 4 weeks in the combined acupuncture arms (P = 0.07). There was no impact on mood or quality of life of the further acupuncture sessions at 18 weeks beyond the improvement observed in initial trial. CONCLUSION: Self-acupuncture is an acceptable, feasible and safe maintenance treatment for patients with CRF. However, overall, maintenance acupuncture did not yield important improvements beyond those observed after an initial clinic-based course of acupuncture. TRIAL REGISTRATION NUMBER: NCT00957112.

[Experience and discussion on the national standard Standardized Manipulation of Acupuncture and Moxibustion. Part 8: Intradermal Needle].

Standardized Manipulation of Acupuncture and Moxibustion Part 8: Intradermal Needle was compiled with the following principles. The compiling standard, technical features and clinic manipulations of intradermal needle were taken as the basic principle for compiling. Literature research, expert survey and clinic practice verification were applied as the drafting methods. The key issues were focused on the relationship between standardization and individualization, normalization and effectiveness, qualification and quantification. And the postural selection, reinforcing and reducing manipulations, fixing materials and embedding duration involved in intradermal needling were emphasized particularly. At the same time, details and the future way of thinking of intradermal needle were expounded in this article as well.

[Elucidation of the national standard for Standardized Manipulation of Acupuncture and Moxibustion, Part VII: Skin needle].

The importance of standardization, the main content and important cautions in the Standardized Manipulation of Acupuncture and Moxibustion, Part VII: Skin Needle are introduced briefly in this paper. It standardizes the stimulation intensity, the tapped needling location, the course of treatment and the interval between treatments. It elucidates the key points, the difficulty and the important cautions in clinical practices. In order to promote the standardization and its implementation, it also states the experiences of establishing the national standard of acupuncture and moxibustion manipulations.

Double needle technique: an alternative method for performing difficult sacroiliac joint injections.

The sacroiliac joint (SIJ) is a common source of low back pain. The most appropriate method of confirming SIJ pain is to inject local anesthesia into the joint to find out if the pain decreases. Unfortunately, although the SIJ is a large joint, it can be difficult to enter due to the complex nature of the joint and variations in anatomy. In my experience a double needle technique for sacroiliac joint injection can increase the chances of accurate injection into the SIJ in difficult cases. After obtaining appropriate fluoroscopic images, the tip of the needle is advanced into the SIJ. Once the tip of the needle is correctly placed, its position is checked under continuous fluoroscopy while moving the C-arm in the right and left oblique directions (dynamic fluoroscopy). On dynamic fluoroscopy the tip of the needle should remain within the joint line and not appear to be on the bone. If the tip of the needle appears to be on the bone a new joint line will need to be identified (the most translucent area through the joint) by dynamic fluoroscopy and another needle advanced into the newly identified joint line. Dynamic fluoroscopy is repeated again to confirm that the tip of the second needle remains within the joint line. Once both needles are in place contrast dye is injected through the needle that is most likely to be in the SIJ. If the contrast dye spread is not satisfactory then it is injected through the other needle. I have used this technique in 10 patients and found it very helpful in accurately performing SIJ injection which can at times be challenging.

Fluoroscopically guided transforaminal epidural dry needling for lumbar spinal stenosis using a specially designed needle.

BACKGROUND: This report describes the methodological approach and clinical application of a minimally invasive intervention to treat lumbar spinal stenosis (LSS). METHODS: Thirty-four patients with LSS underwent fluoroscopically guided transforaminal epidural dry needling using a specially designed flexed Round Needle. The needle was inserted 8-12 cm lateral to the midline at the level of the stenosis and advanced to a position between the anterior side of the facet joint and pedicle up to the outer-third of the pedicle. The needle was advanced medially and backed laterally within a few millimetres along the canal side of the inferior articular process between the facet joint and pedicle. The procedure was completed when a marked reduction in resistance was felt at the tip of the needle. The procedure was performed bilaterally at the level of the stenosis. RESULTS: The average follow-up period was 12.9 +/- 1.1 months. The visual analogue scale (VAS) pain score was reduced from 7.3 +/- 2.0 to 4.6 +/- 2.5 points, the Oswestry Disability Index (ODI) score decreased from 41.4 +/- 17.2 to 25.5 +/- 12.6% and the average self-rated improvement was 52.6 +/- 33.1%. The VAS scores indicated that 14 (41.2%) patients reported a "good" to "excellent" treatment response, while 11 (32.4%) had a "good" to "excellent" treatment response on the ODI and 22 (64.7%) had a "good" to "excellent" treatment response on the self-rated improvement scale. CONCLUSIONS: These results suggest that fluoroscopically guided transforaminal epidural dry needling is effective for managing LSS.

Developing and validating a sham cupping device.

OBJECTIVES: The aims of this study were to develop a sham cupping device and to validate its use as a placebo control for healthy volunteers. METHODS: A sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup. We enrolled 34 healthy participants to evaluate the validity of the sham cupping device as a placebo control. The participants were informed that they would receive either real or sham cupping and were asked which treatment they thought they had received. Other sensations and adverse events related to cupping therapy were investigated. RESULTS: 17 patients received real cupping therapy and 17 received sham cupping. The two groups felt similar sensations. There was a tendency for subjects to feel that real cupping created a stronger sensation than sham cupping (48.9±21.4 vs 33.3±20.3 on a 100mm visual analogue scale). There were only mild to moderate adverse events observed in both groups. CONCLUSION: We developed a new sham cupping device that seems to provide a credible control for real cupping therapy by producing little or no negative pressure. This conclusion was supported by a pilot study, but more rigorous research is warranted regarding the use of this device.