Number Of Needle Insertions Research Articles

Overall Reporting Quality of Randomized Controlled Trials of Acupuncture for Knee Osteoarthritis: A Systematic Review.

To evaluate the reporting quality of randomized controlled trials (RCT) of acupuncture for knee osteoarthritis and explore factors associated with the reporting. Eight databases were searched from inception to August 2024 to assess the quality of acupuncture for knee osteoarthritis RCTs based on the CONSORT, the STRICTA, and the CONSORT-Outcomes. We performed regression analyses on pre-specified study characteristics to explore factors associated with reporting quality. One hundred and seventy-four RCTs were evaluated by 69 items from 3 checklists. Seventeen of 37 items on the CONSORT were under-reported (reported in less than 20% of RCTs), and the weakest reported item was why the trial ended or was stopped (0%). Four of 17 items on the STRICTA were under-reported, and the weakest reported item was the number of needle insertions per subject per session (9.2%). Eight of 17 items on the CONSORT-Outcomes were under-reported, and the weakest reported item was identifying any outcomes that were not pre-specified in a trial registry or trial protocol (0.6%). RCT locations include countries other than China, published in English, or funded were more likely to have better reporting. RCTs of acupuncture for knee osteoarthritis need to focus more on reporting details of acupuncture interventions, the reporting of protocol amendment, and the complete reporting of outcome-related content. Journals should encourage authors to adhere strictly to reporting guidelines, which is necessary to improve the quality of reporting, which is very important for Chinese journals.

The risk factors of procedure-related complications after amniocentesis in twin pregnancies: a retrospective analysis

BackgroundThere is an increasing demand for prenatal diagnostic testing in twin pregnancies, however, anecdotally there is a higher incidence of procedure-related complications after amniocentesis than that in singleton pregnancies. There is a paucity of data regarding risk factors of amniocentesis in twin pregnancies.MethodsWomen with twin pregnancies who underwent amniocentesis between January 2016 and December 2020 were enrolled in this retrospective study. Procedure-related complications including spontaneous miscarriage, intrauterine fetal death, spontaneous preterm delivery, preterm premature rupture of membranes, and placental abruption in one or both fetuses after amniocentesis were assessed. Meanwhile, potential risk factors related to amniocentesis including chorionicity, gestational age, conception, number of needle insertions, parity, history of miscarriage, indications, and pregnancy-related complications (pregnancy-induced hypertension and gestational diabetes) were also recorded.ResultsA total of 811 women with twin pregnancies underwent amniocentesis were included, with a procedure-related complications rate of 3.83%. Risk factors associated with increased risk of procedure-related complications after amniocentesis in twin pregnancies were chorionicity (adjusted odds ratio [aOR]: 4.06), gestational age at the procedure (aOR: 2.76), and numbers of needle insertions (aOR: 3.26). In the monochorionic twin pregnancy, hemorrhage during this pregnancy (aOR: 12.01), polyhydramnios (aOR: 5.03), and numbers of needle insertions (aOR: 3.15) were risk factors after amniocentesis. In the dichorionic twin pregnancy, gestational age at the procedure (OR:4.47) affected the risk of procedure-related complications after amniocentesis. In the subgroup of gestational age at the procedure ≤ 24+ 0 weeks, risk factors associated with increased risk of procedure-related complications after amniocentesis in twin pregnancies were chorionicity (aOR: 5.14), and numbers of needle insertions (aOR: 3.76).ConclusionThe procedure-related complications rate is 3.83% in our institution during the study period. The present study has emphasized the significance of certain risk factors for adverse outcome and will be useful in counseling patients with twin pregnancies.

Pain during PICC insertion in preterm infants: the needle is not the only problem

Objective To evaluate whether warm povidone-iodine (PI) application before peripherally inserted central catheter (PICC) placement eased pain related to the procedure in premature infants and reduced the duration of the procedure and the number of attempts. Methods A prospective randomized controlled trial was conducted with infants born before 32 weeks of gestation who required the first placement of the PICC. Skin disinfection was performed with warm PI before the procedure in the warm PI(W-PI) group, whereas PI kept at room temperature was used in the regular PI(R-PI) group. NPASS scores of the infants were evaluated three times: at baseline(T0), during skin preparation(T1), and during needle insertion(T2). Results Fifty-two infants (26 in the W-PI group,26 in the R-PI group) were enrolled in the study. The perinatal and baseline demographic characteristics did not significantly differ between the two groups. While the median NPASS scores at T0 and T2 were similar between the groups, the median T1 score was significantly higher in the R-PI group(p = .019). While the median NPASS scores at T1 and T2 were similar in the R-PI group, there was a significant difference in the W-PI group, with NPASS scores being significantly lower at T1 compared to T2. The results demonstrate that skin disinfection was just as painful as needle insertion in the R-PI group. The duration of the procedure and the number of needle insertions were significantly lower in the W-PI group. Conclusions Before invasive interventions, such as PICC insertion, we recommend warm PI as a part of non-pharmacological pain management.

Descriptions of sham acupuncture in randomised controlled trials: a critical review of the literature

BackgroundSham acupuncture is usually used to assess the specific effects of acupuncture. However, the reporting quality of sham acupuncture remains unclear despite its critical importance in understanding and analyzing the effects of acupuncture. This paper presents a literature review aimed at assessing the quality of reporting of sham acupuncture in randomized controlled trials (RCTs) based on STRICTA 2010 and TIDieR-Placebo.MethodsThree electronic English-language databases (PubMed, MEDLINE and Embase) were searched from inception to March 7, 2022, and RCTs of sham acupuncture were identified. The reporting quality of sham acupuncture was assessed in accordance with the items recommended in STRICTA 2010 and TIDieR-Placebo. The reporting quality of other items related to sham acupuncture apart from items from these two checklists was also captured to further assess the reporting quality of sham acupuncture.ResultsA total of 609 eligible studies were included. For all of the items recommended in STRICTA 2010 and TIDieR-Placebo, 100% of the studies reported a brief name that described the sham acupuncture, 93.9% studies reported the needle type, and 90.0% reported the names of the points used. Other items for which the reporting rates were above 50% included the number, frequency and duration of treatment sessions; needle retention time; and number of needle insertions per subject per session. Overall, 49.4% of the studies revealed the rationale why sham acupuncture was chosen, 39.7% of the studies involving insertion processes reported the depth of insertion, and 37.9% of the studies reported the needle manufacturer. Other items for which the reporting rates were below 30% included practitioner-related information, response sought, evaluation of blinding, intervention mode and environment, assisting tools, and the extent to which the treatment was varied. The items “Modifications”, “How well (planned)” and “How well (actual)” were not reported in any of the analyzed studies.ConclusionsThe overall reporting quality of sham acupuncture in RCTs was suboptimal. Although STRICTA 2010 and TIDieR-Placebo could be beneficial for describing sham acupuncture, neither can offer recommendations specifically for sham acupuncture. There is thus an urgent need to develop specialized guidelines for reporting sham acupuncture in clinical trials.

Development of Provisional Acupuncture Guidelines for Pelvic Pain in Endometriosis Using an e-Delphi Consensus Process.

Introduction: Growing evidence suggests that acupuncture can improve pelvic pain in women with endometriosis. The treatments used in research vary considerably. It remains unclear which treatment could be recommended for clinical practice. This research project aimed at clarifying how acupuncture could be used when treating this condition. Methods: This research comprised two phases: a systematized literature review to extract acupuncture treatment details from published research, and an e-Delphi study to gain knowledge about details as used by expert acupuncturists. Review: Four databases were searched using predefined eligibility criteria. Data were extracted based on the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) criteria. e-Delphi: Purposeful sampling from colleagues and international experts. An open first round gathered qualitative data, analyzed with the Framework method. In rounds 2 and 3, experts rated statements to build group consensus, defined as a rating of ≥5 on a 7-point Likert scale by ≥70% of the experts. The strength of agreement was graded using the median score and interquartile range. Results from the literature review and the e-Delphi were compared using the STRICTA items. Results: The literature review (n = 29 unique studies) found a wide range of treatment details with little agreement. The e-Delphi of international experts (n = 20) resulted in agreement on 94 statements (such as key factors for effectiveness); disagreement on a further 29 (such as acupressure); and absence of consensus on 55 statements (such as the number of needle insertions). A comparison of the review and e-Delphi results found little agreement. Conclusions: Details of acupuncture treatment for endometriosis-related pelvic pain were presented. In the absence of acupuncture guidelines for this condition, the researchers of this e-Delphi recommend using the treatment details on which experts agreed as guidance for good practice. The effectiveness of these guidelines should be evaluated in future research. Study registration: Deutsches Register Klinischer Studien, DRKS00022215, June 30, 2020, retrospectively registered.

Assessment of reporting quality in randomized controlled trials of acupuncture for labor pain.

To evaluate the reporting quality of randomized controlled trials (RCTs) of acupuncture for labor pain, and to explore relevant factors for facilitating reporting transparency and integrity for future RCTs. Eight Chinese and English databases were systematically searched from their inception until August 31, 2021. General characteristics and methodological quality of the included reports were evaluated based on the CONSORT statement and the STRICTA guidelines. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess the agreement of all items between two reviewers. A total of 84 RCTs were included. Based on the CONSORT statement, a positive reporting rate (greater than 80%) was evident for the items "trial design" "participants" "intervention" "outcomes" "numbers analyzed" and "generalizability". The quality of reporting for the items "randomized in the title or abstract" "sample size" "allocation concealment" "implementation" "blinding" "recruitment" "ancillary analyses" "harms" "interpretation" "registration" and "protocol" was poor with positive rates less than 10%. Based on the STRICTA guidelines, the items "extent to which treatment varied" "number of needle insertions per subject per session" and "control or comparator interventions" had poor reporting quality with positive rates of less than 10%. Substantial agreement was observed for most items and excellent agreement for some items. The reporting quality of RCTs of acupuncture for labor pain is suboptimal generally. Rigorous adherence to the CONSORT statement and the STRICTA guidelines should be emphasized in future studies to improve the quality of acupuncture RCT reports.

Robot-Assisted Needle Insertion for CT-Guided Puncture: Experimental Study with a Phantom and Animals.

This study aimed to evaluate the accuracy and safety of robotic CT-guided needle insertion in phantom and animal experiments. A robotic system was developed for CT-guided needle insertion. For the phantom experiment, a specially made phantom containing multiple spherical was used. 15 robotic and manual insertions were conducted, and the accuracy, time, number of needle insertions, and radiation dose were compared between the robotic and manual insertion using Student's t-test. For the animal experiment, 20 robotic needle insertions were attempted toward simulated pulmonary nodules in the swine lung. The accuracy and safety of robotic CT-guided needle insertions were evaluated. In the phantom experiment, the mean accuracies of manual and robotic insertion were 1.8 ± 0.3mm and 1.9 ± 0.2mm. The accuracy of robotic needle insertion had no significant difference with manual needle insertion, but the number of needle insertions and radiation dose of the robotic needle placement significantly decreased compared to manual needle placement. In the animal experiment, the mean accuracy of the robotic needle insertion was 3.8 ± 1.3mm. The time for the whole needle insertion was 14.4 ± 4.8min. The whole robotic needle insertions were safe and only one mild pneumothorax occurred. CT-guided robotic needle insertion showed accuracy comparable to manual needle insertion, but the number of needle insertions, confirmatory scans, and radiation exposure had been reduced significantly. In future, we will further apply the robotic system to clinical experiments.

Specification of interventions and selection of controls in randomized controlled trials of acupuncture: a cross-sectional survey.

Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture. We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment. Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = -0.15, 95% confidence interval: -0.91 to 0.62). Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control.

Ultrasound-assisted spinal anesthesia: A randomized comparison between midline and paramedian approaches

Study objectiveNeuraxial ultrasonography can improve the technical performance of spinal anesthesia. However, there are no data regarding the optimal approach for ultrasound-assisted spinal anesthesia. This study aimed to compare the midline and paramedian approaches for ultrasound-assisted spinal anesthesia in adult orthopedic patients. DesignA single-center, prospective, randomized controlled trial. SettingOperating room. PatientsOne hundred and twelve patients undergoing orthopedic surgery were included. InterventionsPatients were randomized to undergo either the midline or paramedian approach for preprocedural ultrasound-assisted spinal anesthesia. MeasurementsThe primary outcome was the number of needle passes required for successful dural puncture. Secondary outcomes were the number of needle insertions, first pass/attempt success rate, procedural time, and the incidence of periprocedural complications. Main resultsThe median number of needle passes was significantly lower in the paramedian group (1 [IQR, 1–2]) than in the midline group (3 [2–6]; P < 0.001). The paramedian approach showed higher first pass/attempt success rates compared with the midline group (58.9% vs. 21.4%; 91.1% vs. 53.6%; both, P < 0.001). Total procedure times were significantly shorter in the paramedian group than in the midline group (113 [72.5–146.5] vs. 196 [138–298.5] seconds; P < 0.001). The quality of sonographic images was graded as good in 94.6% of paramedian sagittal oblique views and 54.5% of transverse median views. No significant intergroup differences were found in the incidence of periprocedural complications. ConclusionsCompared with the midline approach, the ultrasound-assisted paramedian approach showed improved efficacy in terms of the number of needle manipulations, first pass success rates, and procedural time. These results suggest that the paramedian approach may be more efficient for preprocedural ultrasound-assisted spinal anesthesia. Trial registration numberNCT03491943

Simulation-Based Medical Education and Training Enhance Anesthesia Residents' Proficiency in Erector Spinae Plane Block.

BackgroundAdvances in regional anesthesia and pain management led to the advent of ultrasound-guided fascial plane blocks, which represent a new and promising route for the administration of local anesthetics. Both practical and theoretical knowledge of locoregional anesthesia are therefore becoming fundamental, requiring specific training programs for residents. Simulation-based medical education and training (SBET) has been recently applied to ultrasound-guided regional anesthesia (UGRA) with remarkable results. With this in mind, the anesthesia and intensive care residency program of the University of Milano-Bicocca organized a 4-h regional anesthesia training workshop with the BlockSim® (Accurate Srl, Cesena) simulator. Our study aimed to measure the residents' improvement in terms of reduction in time required to achieve an erector spinae plane (ESP) block.MethodsFifty-two first-year anesthesia residents were exposed to a 4-h training workshop focused on peripheral blocks. The course included an introductory theoretical session held by a locoregional anesthetist expert, a practical training on human models and mannequins using Onvision® (B. Braun, Milano) technologies, and two test performances on the BlockSim simulator. Residents were asked to perform two ESP blocks on the BlockSim: the first without previous practice on the simulator, the second at the end of the course. Trainees were also also asked to complete a self-assessment questionnaire.ResultsThe time needed to achieve the block during the second attempt was significantly shorter (131 [83, 198] vs. 68 [27, 91] s, p < 0.001). We also observed a reduction in the number of needle insertions from 3 [2, 7] to 2 [1, 4] (p = 0.002), and an improvement aiming correctly at the ESP from 30 (58%) to 46 (88%) (p < 0.001). Forty-nine (94%) of the residents reported to have improved their regional anesthesia knowledge, 38 (73%) perceived an improvement in their technical skills and 46 (88%) of the trainees declared to be “satisfied/very satisfied” with the course.ConclusionsA 4-h hands-on course based on SBET may enhance first-year residents' UGRA ability, decrease the number of punctures and time needed to perform the ESP block, and improve the correct aim of the fascia.

To Assess the Technical Feasibility of Ultrasound Lumbar Sympathetic Block with Electrical Stimulation Needle in Out-of-Plane Needle Orientation: A Prospective Interventional Study.

We describe the technical feasibility of a new technique of ultrasound lumbar sympathectomy validated by fluoroscopy. Prospective interventional study. Pain block area. Thirty patients with peripheral arterial disease with pain at rest (numerical rating score [NRS] ≥3) were recruited. In the lateral position, a curved probe (FUJIFILM SonoSite Edge, Bothell, WA, USA, 2-5 MHz) was placed transversely at the iliac crest. An electrical stimulation needle was inserted out of plane, below the lower pole of the kidneys, directed anterior to the vertebral body below. When the needle tip was not visualized, a current of 2.0 A was applied. Patients' quadriceps contractions, ultrasound psoas contractions, and bone contact guided needle placement, which was confirmed on fluoroscopy. Other parameters noted were the number of needle insertions, vertebral level, pain NRS at baseline and at 4 hours, 24 hours, 1 week, and 2 weeks after block, temperature rise, and any other complications. In all patients, the needle tip was correctly placed in one to three attempts. In 73% of patients, the needle tip was at L3. Baseline pain NRS was 8 (interquartile range 7-8), which decreased to 2 (interquartile range 2-3) at 1 week after the procedure, and it was maintained in this range until 2 weeks later. A temperature rise of >2ºC was noted in all patients. Ultrasound lumbar sympathectomy can be performed safely in patients with peripheral arterial disease by an out-of-plane approach in the lateral patient position with an electrical stimulation needle. Before injection of the drug, aspiration of blood should be ruled out in view of the possibility of aortocaval injection.

P–485 A systematic analysis of acupuncture for IVF treatment: how should the HFEA traffic light scale for add-ons rate it?

Abstract Study question How should acupuncture be rated on the Human Fertilisation and Embryology Authority traffic light scheme for IVF add-ons? Summary answer Randomised controlled trials examining the possible effects of acupuncture on IVF success rates are conflicting, and acupuncture should be rated amber. What is known already The use of complementary therapies in assisted reproduction and IVF has become increasingly more commonplace in recent years. Patients seeking to maximise their chances of conception are often interested in purchasing additional treatments (termed ‘add-ons’) to augment their treatment cycle, often at a high price even in the absence of robust underlying evidence. The use of acupuncture is popular due to putative holistic benefits including stress reduction, and the perceived lack of side-effects and minimal invasiveness. The HFEA traffic light system has not yet rated any complementary therapies, even though these are promoted by fertility clinics. Study design, size, duration A systematic review of randomised controlled trials (RCTs) of acupuncture during IVF treatment was conducted. A literature search for acupuncture studies was conducted on the PubMed database and the University College London (UCL) library database. Search terms used were “acupuncture” paired with “IVF”, “in vitro fertilisation”, “assisted reproduction” and “RCT”. Study quality and variance in treatment protocols were assessed, to understand both any evidence and its quality. Statistical analysis was performed using STATA. Participants/materials, setting, methods The UCL library database yielded 403 individual search results and PubMed database yielded 47. Papers were screened and sorted according to the inclusion and exclusion criteria. Inclusion: publication in English, in an English-language journal; RCT; intervention administered during IVF; either pregnancy rate (PR), ongoing/clinical PR or live birth rate (LBR) reported. Exclusion: reviews; not in English; not RCT; above outcomes not reported. Main results and the role of chance After final screening, a total of 34 acupuncture RCTs were included in the review and meta-analysis. The sample sizes of the studies analysed ranged from 44 to 809 (median 162). Only a minority of studies (18%, 6/34) involved blinding of both assessor and participant, while foregoing incorporation of blinding into study design was most common (44%, 15/34 studies). There was little consistency regarding the timing of acupuncture treatment during the IVF protocol across RCTs. A total of 21/34 studies (62%) had a protocol involving acupuncture administration before and after the embryo transfer procedure on the day of transfer. The number of needle insertions during the treatment protocols ranged from 5–13 (mean 8.7). Manual acupuncture only was performed in 8/34 (24%) of studies and 26/34 (76%) utilised electrical stimulation of at least some of the acupuncture needles. Out of 34 RCTs, only 10/34 studies (29%) reported LBR. The meta-analysis included all identified RCTs. The most clinically relevant outcome measure reported in each study found a slight benefit of acupuncture for overall IVF success (OR 1.37, 95% CI 1.13–1.65) however the effect was diluted when only comparing studies reporting LBR (OR 1.14 ,95% CI 0.81–1.61). Limitations, reasons for caution Methodological heterogeneity of acupuncture RCTs in IVF (needling location, stimulation, retention time, repetition and timing) complicates data pooling. Underlying neurophysiological mechanisms of action are still being clarified and may help delineate optimal regimens, potentially tailored to individual causes of infertility. Treatment safety and potential for worse outcomes must be considered. Wider implications of the findings: Complementary therapies are a popular add-on for IVF treatment but assessing them from a robust biomedical perspective is challenging due to issues with study design (including controls), study quality and general attitudes. For acupuncture, future research should arguably focus on biomedical perspectives and shift away from Traditional Chinese Medicine philosophies. Trial registration number Not applicable

Ultrasound-guided needle insertion robotic system for percutaneous puncture.

Ultrasound (US)-guided percutaneous puncture technology can realize real-time, minimally invasive interventional therapy without radiation. The location accuracy of the puncture needle directly determines the precision and safety of the operation. It is a challenge for novices and young surgeons to perform a free-hand puncture guided by the ultrasound images to achieve the desired accuracy. This work aims to develop a robotic system to assist surgeons to perform percutaneous punctures with high precision. An US-guided puncture robot was designed to allow the mounting and control of the needle to achieve localization and insertion. The US probe fitted within the puncture robot was held by a passive arm. Moreover, the puncture robot was calibrated with a novel calibration method to achieve coordinate transformation between the robot and the US image. The system allowed the operators to plan the puncture target and puncture path on US images, and the robot performed needle insertion automatically. Five groups of puncture experiments were performed to verify the validity and accuracy of the proposed robotic system. Assisted by the robotic system, the positioning and orientation accuracies of the needle insertion were 0.9 ± 0.29mm and 0.76 ± 0.34°, respectively. These are improved compared with the results obtained with the free-hand puncture (1.82 ± 0.51mm and 2.79 ± 1.32°, respectively). Moreover, the proposed robotic system can reduce the operation time and number of needle insertions (14.28 ± 3.21s and one needle insertion, respectively), compared with the free-hand puncture (25.14 ± 6.09s and 1.96 ± 0.68 needle insertions, respectively). A robotic system for percutaneous puncture guided by US images was developed and demonstrated. The experimental results indicate that the proposed system is accurate and feasible. It can assist novices and young surgeons to perform the puncture operation with increased accuracy.

Influence of procedural factors on patient procedural pain in relation to diagnostic lumbar puncture.

The aim of this study is to investigate the influence of local anesthetic (LA), operator experience level and needle type on patient procedural pain in relation to diagnostic lumbar puncture (LP). LP was performed with either a 22 gauge traumatic needle (22 TN) or a 22 gauge atraumatic needle (22 ATN). Immediately after LP patients documented a procedural pain score (PPS) on a 10-point Likert scale. Use of LA, needle type, anesthetic time interval (ATI), number of needle insertions and the LP operator experience level were registered. ATI was defined as the time from administration of LA to first needle insertion. 104 patients had the LP procedure performed by 66 physicians (40 novices and 26 experienced physicians). Patients having the procedure performed by novices had a lower PPS of 2.56 if LA was administered compared to a higher PPS of 5.80 if LA was not administered (P = .046). Among experienced physicians there was no difference in PPS regardless of administration of LA. If novices administered LA, patient PPS was equal to patients having the procedure performed by an experienced operator. If novices performed the procedure with a 22 TN PPS decreased with increasing ATI (P = .01). No similar correlation was identified with the 22 ATN. Our study suggests that LP operator experience level, the needle type used and ATI may influence patient PPS. Further studies are necessary for final conclusions. These studies must consider these factors to avoid fault conclusions.

Postneedling Soreness and Tenderness After Different Dosages of Dry Needling of an Active Myofascial Trigger Point in Patients With Neck Pain: A Randomized Controlled Trial

BackgroundPrevious studies in asymptomatic subjects have demonstrated that myofascial trigger point (MTrP) dry needling frequently is associated with postneedling soreness. However, to the authors’ knowledge, there is not any study that performs a detailed description of postneedling soreness characteristics in patients with myofascial pain. This information could help clinicians to make evidence-informed decisions considering the benefits and negative effects of different dry needling dosages. ObjectiveTo (1) compare the prevalence, intensity, and duration of postneedling soreness and tenderness after different dosages of deep dry needling (DDN) and (2) analyze the influence on postneedling soreness of psychological factors and other factors involved in the DDN process Design1-week follow-up, double-blind randomized controlled trial. SettingUniversity community. ParticipantsPatients (n = 120: 34 male; 86 female) aged 18-53 years (median ± interquartile range, 21.0 ± 7.0 years) with active MTrPs in the upper trapezius. InterventionAll patients received DDN in an active MTrP. They were randomly divided into 4 groups: no local twitch responses (LTRs) elicited (control group), 4 LTRs elicited, 6 LTRs elicited, and DDN until no more LTRs were elicited. Main outcome measuresPostneedling soreness and pressure pain threshold were assessed before treatment, during DDN procedure, and every 24 hours during 1 week. ResultsPostneedling soreness showed a significant effect for time (F2,006 = 173.603; P < .001, ηp2 = 0.659) and a significant interaction between group and time (F6,017 = 3.763; P = .001; ηp2 = 0.111). Pressure pain threshold showed a significant effect for time (F2,377 = 16.833; P < .001; ηp2 = 0.127) and a significant interaction between group and time (F7,130 = 2.100; P = .04; ηp2 = 0.052). Psychological factors did not show relevant correlations with the intensity of postneedling soreness. ConclusionsPostneedling soreness is present in most of subjects after DDN of active MTrPs. The groups in which DDN was performed eliciting LTRs exhibited greater post-needling soreness. The number of needle insertions was associated with postneedling soreness but psychological factors did not seem to play a relevant role on its perception. Clinical trial registration numberNCT02190890 Level of EvidenceI

The application of a three-dimensional visualized seed planning and navigation system in 125I seed implantation for pancreatic cancer.

ObjectivesTo evaluate the effectiveness of iodine-125 (125I) seed implantation for pancreatic cancer (PC), and preliminarily evaluate the clinical value of a self-developed three-dimensional (3D) visualized seed planning and navigation system in 125I seed implantation for treatment of PC.Patients and methodsOur team retrospectively reviewed 25 PC patients who underwent 125I seed implantation between December 2010 and November 2016. The patients were divided into two groups: 3D visualization preoperative planning group (12 patients, 13 lesions) and two-dimensional (2D) regular group (13 patients, 14 lesions). We compared and analyzed the parameters of the two groups, such as number of needle insertions, one-time treatment success rate, proportion of added seeds, local control rate, rate of complications, rate of pain relief, and the survival rate and risk factors of the two groups. There was no significant difference in clinical data of the two groups.Results125I seed implantation was performed successfully in all PC patients, with no occurrence of serious complications during and after the procedure. The one-time treatment success rate of 3D group (80%) was higher than that of 2D group (45.5%) (P<0.05), and the proportion of added seed number of 3D group was lower than that of 2D group (P<0.05). The local control rate of 3D group (76.9%) was higher than that of 2D group (35.7%) (P<0.05). The survival rate of 3D group was significantly higher than that of 2D group (P=0.026), and the median survival of 2D group vs 3D group was 5.00 vs 10.80 months. The median survival of all 25 patients was 7.10 months (95% confidence interval: 4.43–9.77). The rate of pain relief was 77.8% (7/9) in 2D group and 88.9% (8/9) in 3D group.ConclusionUltrasound-guided, 3D visualized seed planning and navigation system assisted 125I seed implantation is a safe and effective method for the treatment of PC, with a prolonged survival of patients and better local control of tumor.

458: Amniocentesis in twin pregnancy, does the technique influence the complications?

To compare complications rates after twin gestation amniocentesis, according to sampling technique and number of needle insertions. A retrospective cohort study of all twin gestations that underwent amniocentesis and delivered in a tertiary hospital between 2007 and 2016. Procedure was preformed by elected experienced physicians. Amniocentesis for termination of pregnancy, fetal reduction and monoamniotic twins were excluded. Primary outcome was neonatal complication composite rate within 4 weeks after amniocentesis (late abortion, preterm premature rupture of membranes, hospitalization, fever, chorioamnionitis or seek of medical attention). Secondary outcomes were other pregnancy complications, gestational week at delivery and labor characteristics. Outcomes were compared between single uterine needle insertion advanced through the inter-twin membrane to sample both amniotic sacs, and separate two needle uterine insertions to each amniotic sac. Logistic regression analysis was utilized to adjust results to potential confounders. Overall, 212 women carrying a twin gestation underwent amniocentesis during study period and were found eligible for the study. Of them, 73(34.4%) underwent a single uterine insertion and 139(65.6%) underwent two separate needle insertions. Baseline characteristics did not differ between groups (Table 1). Amniocentesis complication composite rate was 13.7% in the single insertion group and 16.5% in the double insertion group (p=0.587). A single insertion method demonstrated no statistic influence on complication composite rate, after adjustment to potential confounders (OR=1.085 95% CI 0.4-2.9 p=0.871). Of note, multivariate logistic regression demonstrated that gestational age at amniocentesis was associated with increased composite complication rates (OR=1.27 95% CI 1.17-1.39, p<0.001). Other labor characteristics were similar between groups (Table 2). Needle insertion technique in twin gestation amniocentesis was not found to be associated with procedure related complications.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

BackgroundThis study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured.ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%.ConclusionsThe overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.

Assessment of Reporting Quality in Randomised Controlled Trials of Acupuncture for Post-Stroke Rehabilitation Using the Consort Statement and Stricta Guidelines

To evaluate the completeness of reporting of randomised controlled trials (RCTs) of acupuncture for post-stroke rehabilitation in order to provide information to facilitate transparent and more complete reporting of acupuncture RCTs in this field. Multiple databases were searched from their inception through September 2015. Quality of reporting for included papers was assessed against a subset of criteria adapted from the Consolidated Standards for Reporting Trials (CONSORT) 2010 statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Each item was scored 1 if it was reported, or 0 if it was not clearly stated. Descriptive statistical analysis was performed. Cohen's κ-statistics were calculated to assess agreement between the two reviewers. A total of 87 RCTs were included in the full text. Based on CONSORT, good reporting was evident for items ''Randomised' in the title or abstract', 'Participants', 'Statistical methods', 'Recruitment', 'Baseline data', and 'Outcomes and estimation', with positive rates >80%. However, the quality of reporting for the items 'Trial design', 'Outcomes', 'Sample size', 'Allocation concealment', 'Implementation', 'Blinding', 'Flow chart', 'Intent-to-treat analysis', and 'Ancillary analyses' was very poor with positive rates <10%. Based on STRICTA, the items 'Number of needle insertions per subject per session', 'Responses sought', and 'Needle type' had poor reporting with positive rates <50%. Substantial agreement was observed for most items and good agreement was observed for some items. The reporting quality of RCTs in acupuncture for post-stroke rehabilitation is unsatisfactory and needs improvement.

Ultrasound-guided lumbar plexus block in volunteers; a randomized controlled trial

BackgroundThe currently best-established ultrasound-guided lumbar plexus block (LPB) techniques use a paravertebral location of the probe, such as the lumbar ultrasound trident (LUT). However, paravertebral ultrasound scanning can provide inadequate sonographic visibility of the lumbar plexus in some patients. The ultrasound-guided shamrock LPB technique allows real-time sonographic viewing of the lumbar plexus, various anatomical landmarks, advancement of the needle, and spread of local anaesthetic injectate in most patients. We aimed to compare block procedure outcomes, effectiveness, and safety of the shamrock vs LUT. MethodsTwenty healthy men underwent ultrasound-guided shamrock and LUT LPBs (2% lidocaine–adrenaline 20 ml, with 1 ml diluted contrast added) in a blinded randomized crossover study. The primary outcome was block procedure time. Secondary outcomes were procedural discomfort, number of needle insertions, injectate spread assessed with magnetic resonance imaging, sensorimotor effects, and lidocaine pharmacokinetics. ResultsThe shamrock LPB procedure was faster than LUT (238 [sd 74] vs 334 [156] s; P=0.009), more comfortable {numeric rating scale 0–10: 3 [interquartile range (IQR) 2–4] vs 4 [3–6]; P=0.03}, and required fewer needle insertions (2 [IQR 1–3] vs 6 [2–12]; P=0.003). Perineural injectate spread seen with magnetic resonance imaging was similar between the groups and consistent with motor and sensory mapping. Zero/20 (0%) and 1/19 (5%) subjects had epidural spread after shamrock and LUT (P=1.00), respectively. The lidocaine pharmacokinetics were similar between the groups. ConclusionsShamrock was faster, more comfortable, and equally effective compared with LUT. Clinical trial registrationNCT02255591.