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"micro‐needle"
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Musculoskeletal Ultrasound-Guided Micro-Needle-Knife Intervention at the Deep Fascial versus Superficial Fascial Layers in Lateral Epicondylitis Patients: A Randomized Controlled Trial
2026
Lateral epicondylitis (LE) is a prevalent musculoskeletal disorder causing persistent elbow pain and upper-limb dysfunction. While micro-needle-knife (MNK) therapy has shown promise for musculoskeletal pain, its optimal anatomical target and intervention depth remain poorly defined.
70 participants with unilateral lateral epicondylitis (mean age, 39.91±12.41 years; 40 women, 57.1%) were randomized 1:1 to receive musculoskeletal ultrasound (MU)-guided micro-needle-knife intervention targeting either the deep fascial (DF) layer or superficial fascial (SF) layer at two anatomically defined forearm interfaces corresponding to LI10 and TE9. Both groups underwent 12 treatment sessions over 4 weeks. The primary outcomes were Visual Analog Scale (VAS) for pain and Pressure Pain Threshold (PPT) assessed at baseline, week 1, 2, 3, 4, and 8. Secondary outcomes included Pain-Free Grip Strength (PFG) and Mayo Elbow Performance Score (MEPS).
The DF group demonstrated significantly greater and earlier reductions in pain compared with the SF group. At week 1, 42.9% of participants in the DF group achieved mild pain levels (VAS ≤3), compared with 8.6% in the SF group (P < 0.001). The odds of achieving over 50% pain reduction in VAS pain score were higher in the DF group at both week 4 (OR 3.25, 95% CI: 1.72 to 6.19) and week 8 (OR 2.50, 95% CI: 1.67 to 3.75). Improvements in PPT, PFG, and MEPS were consistently greater in the DF group across all post-treatment time points (all P < 0.001). Specifically, the DF group achieved a median VAS reduction of 3 (2, 4) at week 4, which was significantly larger than the 2 (1, 3) observed in the SF group (P < 0.001) and exceeded the established minimal clinically important difference (MCID) of 1.5 points for LE. No serious adverse events were observed.
Over 8-week follow-up period, musculoskeletal ultrasound-guided MNK targeting the deep fascial layer demonstrated superior efficacy and comparable safety to superficial fascial intervention for LE, supporting anatomically targeted, MU-guided fascial interventions as a promising short-term rehabilitation strategy.
ITMCTR2025001055.
Journal Article
Evaluation of the Performance and Safety of a New Micro‐Needle Technology in Comparison With the Classic Needle on the Antiaging Effects of a Biorevitalizing Solution: A Randomized Split Face/Neck Study
2024
Background Skin biorevitalization involves multiple intradermal injections to enhance skin quality, but precise dermal targeting can be challenging due to variations in skin thickness smaller, less painful needles with fewer skin reactions are attractive options. Aims This study evaluates a new Micro‐Needle device's performance and safety in comparison with the classic needle used in skin biorevitalization. Patients/Methods Subjects with facial and neck skin aging were enrolled. Safety outcomes, including immediate and local tolerability, were assessed. Performance outcomes measured skin radiance, wrinkles and photoaging grade, hydration, subepidermal low echogenic band, dermis thickness, and skin elasticity. Both subjects and investigators recorded Global Aesthetic Improvement Scale scores. Results Micro‐Needle injections demonstrated superior performance compared to the classic needle, influenced by the specific skin zones and thickness. Micro‐Needle was superior for skin wrinkles at D49 for periorbital zone and nasolabial folds by −14.5% (p = 0.01) and −15% (p = 0.004), respectively, and for neck by 9.6% (p = 0.0008). The Nanosoft device showed a faster improvement for skin hydration at D42 for the cheek zone (p = 0.04) and at D75 for the neck area (p = 0.01); and for skin radiance at D75 (p = 0.03) and at D120 (p = 0.0098). Ex vivo studies confirmed the Micro‐Needle's accuracy in product placement in the dermis. Adverse events were milder with Micro‐Needle and no serious adverse events occurred. Conclusions Both needles significantly improved skin quality, but Micro‐Needle enhanced the outcomes of skin biorevitalization procedures, particularly in terms of skin wrinkle reduction, elasticity, and overall skin hydration.
Journal Article
Fabrication of Micro-Needle Electrodes for Bio-Signal Recording by a Magnetization-Induced Self-Assembly Method
2016
Micro-needle electrodes (MEs) have attracted more and more attention for monitoring physiological electrical signals, including electrode-skin interface impedance (EII), electromyography (EMG) and electrocardiography (ECG) recording. A magnetization-induced self-assembling method (MSM) was developed to fabricate a microneedle array (MA). A MA coated with Ti/Au film was assembled as a ME. The fracture and insertion properties of ME were tested by experiments. The bio-signal recording performance of the ME was measured and compared with a typical commercial wet electrode (Ag/AgCl electrode). The results show that the MA self-assembled from the magnetic droplet array under the sum of gravitational surface tension and magnetic potential energies. The ME had good toughness and could easily pierce rabbit skin without being broken or buckling. When the compression force applied on the ME was larger than 2 N, ME could stably record EII, which was a lower value than that measured by Ag/AgCl electrodes. EMG signals collected by ME varied along with the contraction of biceps brachii muscle. ME could record static ECG signals with a larger amplitude and dynamic ECG signals with more distinguishable features in comparison with a Ag/AgCl electrode, therefore, ME is an alternative electrode for bio-signal monitoring in some specific situations.
Journal Article
Acupuncture with micro-needle for dry eye disease: A study protocol for a randomized, sham-controlled, clinical trial
by
Xu, Shifen
,
Li, Guancheng
,
Sun, Monica
in
Acuity
,
Acupuncture
,
Acupuncture Therapy - instrumentation
2025
Dry Eye Disease (DED) is a prevalent and significant condition that affects a large number of people. Artificial tears can alleviate the symptoms in patients with mild to moderate dry eyes, but they do not have a long-term effect. Micro-needle is a novel type of acupuncture, with needle tips arrayed on a silicon chip attached to medical plaster, without penetrating the skin. Its effectiveness and efficacy need to be proven clinically.
This is a single-center, randomized, sham-controlled trial. In total, 129 DED patients will be recruited and randomized into three groups: micro-needle, sham, and artificial tears. They will receive four weeks of treatment and undergo follow-up at six and ten weeks. The primary outcome is measured by the Objective Symptoms Scoring Sheet (OSSS). Secondary outcomes include the China Dry Eye Questionnaire (CDEQ), Ocular Surface Disease Index (OSDI), non-invasive tear film break-up time (NIBUT), Schirmer Test I (SIT), Tear Meniscus Height (TMH), and Corneal Fluorescein Staining (CFS).
Questionnaires, including OSSS, CDEQ, and OSDI, will be administered at screening, at the end of week two, and at the conclusion of week four, when treatment is completed. They will also be conducted at follow-up in week six and week ten; OSSS will be taken additionally on day two of the treatment.
Tests of Intraocular Pressure (IOP), Best Corrected Visual Acuity (BCVA), NIBUT, SIT 1, TMH, and CFS are conducted at screening and upon completion of treatment. At week two, NIBUT, SIT 1, TMH, and CFS tests are taken as intermittent measurements.
The trial protocol and informed consent document were reviewed and approved by the Ethics Committee of the Shanghai Municipal Hospital of Traditional Chinese Medicine (Approval Number: 2023SHL-KY-101–01). Prior to enrollment, each potential participant undergoes a structured informed consent process conducted by a trained research coordinator, which includes explaining the trial purpose, design, interventions, benefits, risks, and time commitments; providing sufficient time for participants to review the plain-language written informed consent document; addressing all questions to ensure comprehension; and obtaining signed written consent, with a copy provided to the participant and the original stored in the trial file. To safeguard participant confidentiality, all data are labeled with a unique study ID instead of personal identifiers; paper records are stored in locked cabinets in a restricted-access office, and electronic data are stored on password-protected, encrypted servers accessible only to authorized team members via unique logins; de-identified data are used solely for analysis and reporting, with personal identifiers accessible only to the trial coordinator for enrollment and follow-up and never shared with other parties; and study findings in publications and presentations will be aggregated to prevent individual identification. The findings of this investigation will be disseminated through peer-reviewed publications, and any protocol amendments will be submitted to the ethics committee for re-approval and updated in the trial registry.
ChiCTR2300078187
2023.11.30
China Clinical Trial Registration Center https://www.chictr.org.cn
•\"Study compares micro needle, sham, and artificial tears for treating DED.\"•\"Primary outcome measured by OSSS after 4 weeks of treatment.\"•\"Secondary outcomes include CDEQ, OSDI, NIBUT, SIT, TMH, and CFS.\"•\"Interim measurements and follow-ups at weeks 2, 6, and 10.\"
Journal Article
Fabrication of a Micro-Needle Array Electrode by Thermal Drawing for Bio-Signals Monitoring
by
Chen, Keyun
,
Jiang, Qing
,
Jiang, Lelun
in
Biosensing Techniques - methods
,
Electric Impedance
,
Electrocardiography
2016
A novel micro-needle array electrode (MAE) fabricated by thermal drawing and coated with Ti/Au film was proposed for bio-signals monitoring. A simple and effective setup was employed to form glassy-state poly (lactic-co-glycolic acid) (PLGA) into a micro-needle array (MA) by the thermal drawing method. The MA was composed of 6 × 6 micro-needles with an average height of about 500 μm. Electrode-skin interface impedance (EII) was recorded as the insertion force was applied on the MAE. The insertion process of the MAE was also simulated by the finite element method. Results showed that MAE could insert into skin with a relatively low compression force and maintain stable contact impedance between the MAE and skin. Bio-signals, including electromyography (EMG), electrocardiography (ECG), and electroencephalograph (EEG) were also collected. Test results showed that the MAE could record EMG, ECG, and EEG signals with good fidelity in shape and amplitude in comparison with the commercial Ag/AgCl electrodes, which proves that MAE is an alternative electrode for bio-signals monitoring.
Journal Article
The use of micro-needle arrays to deliver cells for cellular therapies
2020
Cell therapy is used to treat various diseases and to repair injuries. Cell delivery is a crucial process that delivers cells to target sites. Cells must be precisely delivered to a target site and the cells that are delivered must be localized to the target site to repair damaged tissue. For stem cell therapy, the most convenient method of cell delivery involves directly injecting cells into damaged tissue. Other strategies use carriers to transplant stem cells into damaged tissue. These are termed, stem cell delivery systems (SCDSs). Micro-needle arrays are minimally invasive transdermal delivery systems. The devices can pass through the stratum corneum barrier and deliver macromolecules into the skin. They can also access the microcirculation system in the skin. This study fabricates PMMA micro-needle using a two-stage micro-molding method. Cells are seeded on the micro-needle arrays and then transferred into the target tissue. Collagen hydrogel is used as a model biomimetic tissue. Cells are efficiently delivered to regions of interest, collagen hydrogel, by using this system. The delivery rate is about 83.2%. This demonstrates that micro-needle arrays allow very efficient delivery of cells.
Journal Article
Integrating micro-needle jet injection and sustained GLP-1 therapy with structured feeding: a comprehensive strategy for obesity management
2025
Obesity is a global health crisis strongly linked to increased risk of type 2 diabetes, cardiovascular diseases, and other metabolic disorders. Glucagon-like peptide-1 (GLP-1) has emerged as an effective macromolecular therapeutic agent for weight management. This study addressed obesity management from three distinct perspectives: enhancing drug dispersion and bioavailability through a novel drug delivery device, extending drug half-life by developing sustained-release formulations, and sustaining the weight loss through implementation of structured dietary protocols. A new technology, micro-needle jet injection (MNJI) was developed to deliver both standard semaglutide formulations and highly viscous sustained-release formulations, achieving 100% subcutaneous delivery with predictable results. Modulation of MNJI parameters enabled the generation of various dispersion profiles, resulting in higher bioavailability compared to both needle injection (NI) and needle-free jet injection (NFJI). Sustained-release formulations, effectively administered via MNJI, exhibited higher bioavailability than the non-sustained release formulation, and positively impacted weight management efficacy in two distinct ways. First, a single injection achieved the same weight loss as five daily administrations of non-sustained release formulation. Second, a subsequent injection of the sustained-release formulations resulted in a further body weight reduction to 18%, contrasting sharply with the plateau at 13% observed in the standard formulation administered daily (
< 0.05). Finally, dietary management, particularly time-restricted feeding, successfully maintained weight loss at ∼18% below baseline levels. Collectively, the combination of MNJI delivered sustained-release formulations and structured dietary protocols offers a promising and patient-friendly strategy for long-term obesity management, improving both adherence and therapeutic outcomes.
Journal Article
Comparative study between the efficacy of fractional micro-needle radiofrequency and fractional CO2 laser in the treatment of striae distensae
by
Rehab Mohamed Sobhi
,
Mona Abd El Fattah Abd El Wahab
,
Iman Shaarawy Mohamed
in
Carbon dioxide
,
Carbon dioxide lasers
,
Comparative studies
2019
Striae distensae (SD) cause a cosmetic problem to many patients. Recently, fractional micro-needle radiofrequency (FMR) device has been introduced in treatment of SD. Also, fractional CO2 laser has been used as a resurfacing laser technique in the treatment of SD. The aim of our study was to assess and compare between the efficacy of FMR and fractional CO2 laser in treatment of SD. Seventeen female patients with SD were enrolled in this study. Detailed history was taken and dermatological examination was done to determine the type of striae, the location, and measurement of the width of the largest striae on each side. In each patient, one side was randomly assigned to treatment by FMR (area A), and the other side to treatment by fractional CO2 laser (area B). Our results showed that both techniques were effective. A slight better efficacy was encountered with FMR, but the difference was not statistically significant (p = 0.716). The current study concluded that FMR and fractional CO2 laser are almost equally effective in the treatment of SD (rubra and alba). Development of post inflammatory hyper-pigmentation (PIH) was evident with fractional CO2 in contrast with FMR, and the difference was statistically significant (p = 0.001).
Journal Article
The efficacy of electroacupuncture combined with Micro-Needle-Knife for allergic rhinitis: study protocol for a randomized controlled trial
2026
Allergic rhinitis (AR), classified as a hypersensitivity disorder profoundly impairing human quality of life, presents substantial clinical complexities. Among these, the management of moderate-to-severe AR cases constitutes a particularly challenging clinical scenario, which seriously affects their daily life, study, sleep, and mood. The efficacy of conventional treatments for AR remains suboptimal, necessitating an urgent exploration of alternative approaches to identify simpler, more convenient, effective, and cost-efficient therapeutic options for clinical AR management. This trial is designed to rigorously assess the efficacy and safety of electroacupuncture (EA) combined with Micro-Needle-Knife therapy as a novel therapeutic modality for patients with moderate-to-severe allergic rhinitis.
This study protocol is a randomized controlled, patient-assessor-blinded trial. The trial will have a treatment period of 4 weeks and a follow-up period of 3 months. 90 eligible participants will be randomly assigned to the EA combined with Micro-Needle-Knife group and the drug group in a 1:1 ratio. The evaluation of all study parameters will be conducted across five distinct temporal phases: baseline assessment (week 0), two consecutive intervention phases (weeks 2 and 4), and two subsequent follow-up intervals (weeks 8 and 16). The primary outcome is the Total Nasal Symptom Score (TNSS). Secondary outcomes include Total Non-nasal Symptom Score (TNNSS), Rhinitis Quality of Life Questionnaire (RQLQ), serum chemokine Eotaxin, Inter Cellular Adhesion Molecule-1 (ICAM-1), and Eosinophil Cationic Protein (ECP). All adverse events will be evaluated during the trial.
This study will preliminarily evaluate if EA combined with Micro-Needle-Knife is effective and safe in the treatment of AR.
https://clinicaltrials.gov/study/NCT06890260; identifier: NCT06890260.
Journal Article
A needle-type micro-sampling device for collecting nanoliter sap sample from plants
2021
In plant research, measuring the physiological parameters of plants is vital for understanding the behavior and response of plants to changes in the external environment. Plant sap analysis provides an approach for elucidating the physiological condition of plants. However, to facilitate accurate sap analysis, a sampling device capable of collecting sap samples from plants is required. In this paper, a minimally invasive, needle-type micro-sampling device capable of collecting nanoliter (~ 91 nL) quantities of sap from plants is described. The developed micro-sampling system showed great reproducibility (3%) in experiments designed to assess sampling performance. As a proof of concept, sap samples were collected continuously from target plants with the micro-sampling system, and the dynamic changes in potassium ions, plant hormones and sugar levels inside plants were analyzed. The results demonstrated the feasibility of the micro-sampling device and its potential for developing a measurement system for plant research in the future.
Journal Article