Efficacy of Electroacupuncture Therapy in Patients With Postherpetic Neuralgia: Study Protocol for a Multicentre, Randomized, Controlled, Assessor-Blinded Trial.
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SUBMITTER: Hu H
PROVIDER: S-EPMC8175774 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe chronic neuropathic pain associated with postherpetic neuralgia (PHN) can last for several months or even many years, seriously affecting the affected person's work, sleep, mood, and daily life activities. In generaly, current treatments for PHN are at best limited and unsatisfactory, and adverse reactions are common, especially in elderly patients. Electroacupuncture (EA) is widely used clinically to manage painful diseases, but there remains a lack of evidence to support the effectiveness of EA on PHN. This study is designed to assess the efficacy and safety of EA on PHN, and to provide evidence-based medical evidence for EA treatment of PHN.MethodsThis multicenter, prospective, randomized controlled trial will recruit 448 patients with PHN at seven clinical centers. Multicenter stratified variable block randomization will be used, and the eligible patients will be randomly allocated in a ratio of 1:1 to the EA group or sham EA group. The EA group will receive 4 weeks of EA treatment, given as 30-min treatment sessions, once daily, 5 times per week, for a total of 20 treatments; the sham EA group will receive sham EA treatment under the same conditions.Planned outcomesThe primary outcome measure is the 11-point Numeric Rating Scale pain score at week 4. The secondary outcome measures, including mechanical pain threshold, pain area of PHN, average number of pain episodes, the short-form McGill Pain Questionnaire 2, Zoster Brief Pain Inventory, the Depression, Anxiety, and Positive Outlook Scale, Patient Global Impression of Change, safety of EA, and use of concomitant medications, among others. The primary analysis of the outcomes will be the mixed-effect model with repeated measurement between groups on an intent-to-treat population.Trial registrationClinicaltrials.gov identifier: NCT04560361. Registered 23 September 2020 ( https://clinicaltrials.gov/ct2/show/NCT04560361?term=NCT04560361&draw=2&rank=1 ).
| S-EPMC8586289 | biostudies-literature
Project description:IntroductionA considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.Methods and analysisThis is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.Ethics and disseminationEthical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.Trial registration numberKCT0003235.
| S-EPMC7202710 | biostudies-literature
Project description:BACKGROUND:Postherpetic neuralgia (PHN) is one of the most common types of chronic neuropathic pain, which seriously affects quality of the life because of pain severity and poor response to the currently available treatments. The main strategies for PHN management are medication and invasive interventional therapies; however, these approaches have many adverse effects, so it is important to find another effective and safe treatment for PHN. METHODS:A single-center, single-blind randomized clinical trial will evaluate 98 study participants randomized in a 1:1 ratio into control and experimental groups. The control group will receive conventional treatment including medication therapy and invasive interventional therapy. The experimental group will receive extracorporeal shockwave therapy (ESWT) in addition to conventional therapy. The primary outcome is pain intensity assessed on a visual analogue scale (VAS); the secondary outcomes are the following: quality of life assessed by the 36-Item Short-Form Health Survey (SF-36), psychological state for anxiety and depression measured by the Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS), and sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Assessors blinded to the randomization will collect data during the intervention period at baseline and weeks 1, 4, and 12. The plasma levels of tumor necrosis factor-? and interleukin-6 will be assessed before and after ESWT to explore the biochemical mechanisms of ESWT in the treatment of PHN. DISCUSSION:This randomized controlled trial will evaluate the effectiveness and safety of ESWT in patients with PHN and thus will provide clinical evidence for its use in the management of PHN and explore the potential biochemical mechanisms of this treatment. TRIAL REGISTRATION:www.ChiCTR.org.cn , identifier: ChiCTR1900025828. Registered on 10 September 2019.
| S-EPMC7346340 | biostudies-literature
Project description:IntroductionSeveral systematic reviews and meta-analysis indicate that acupuncture and related therapies may be a valuable adjunctive technique to pharmacological interventions for pain management of postherpetic neuralgia (PHN). However, the robustness of the results of these studies has not been evaluated. The aim of this proposed umbrella review is to provide more reliable evidence of the effectiveness of acupuncture therapy for PHN based on medical references for healthcare decision makers.Methods and analysisPubMed, EMBASE, The Cochrane Library, Web of Science, Chinese BioMedical Literature Database, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure and Wan fang Database will be used to retrieve reviews. The time of publication will be limited from inception to March 2021. Two reviewers will screen all retrieved articles independently to identify their eligibility and extract the data. The quality will be assessed independently by two trained reviewers using Assessment of Multiple Systematic Reviews-2 for methodological quality, Risk of Bias in Systematic Review for level of bias, Preferred Reporting Items for Systematic Reviews and Meta-Analysis for reporting quality and Grading of Recommendations Assessment, Development and Evaluation for the quality of evidence. Any disagreements will be settled by discussion or the involvement of a third reviewer.Ethics and disseminationThe protocol of this review does not require ethical approval because the research will be based on publicly available data. The findings will be disseminated through publication in peer-reviewed international journals or presentation in academic conference.Prospero registration numberCRD42020173341.Reporting checklistPRISMA-P, 2015.
| S-EPMC8144037 | biostudies-literature
Project description:IntroductionCranioplasty is a common surgery in neurosurgery department. However, restoring the integrity of skull brings many challenges to surgeons, and the selection of ideal implant materials is throughout the history of cranioplasty. Although titanium mesh was still preferred by many neurosurgeons in cranial reconstruction, the new polyetheretherketone (PEEK) material, for example, is gaining popularity for craniofacial reconstruction today. There remain limited data that compare the outcome of PEEK cranioplasty and titanium mesh cranioplasty. It is necessary to conduct a study to compare outcome of different materials for cranioplasty.Methods/designIn this multicentre, assessor-blinded, randomised controlled study, we will randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty. Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on), the defect size is over 25?cm2, and they need to agree to participate in this trial. Instead of standard examinations, the enrolled patients receive neurological, motor, cognitive function and cerebral hemodynamics examinations as well as cosmetic evaluation. The procedures are repeated 3, 6 months after cranioplasty. The primary outcome, defined as infection or implant exposure after surgery, is the implant failure rate within 6 months. Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.Ethics and disseminationThis trial protocol has been approved by Biomedical Research Ethics Committee of West China Hospital of Sichuan University. All patients will be fully informed the implant materials, potential complications after surgery, responsibilities during the trial, and they will sign the informed consent before joining in this trial. If the patient's cognitive function is impaired, the patient's next of kin would be carefully informed. The results will be disseminated through academic conferences, student theses and will be published in a peer-reviewed journal.Trail registration numberChiCTR1900024625; Pre-results.
| S-EPMC6924701 | biostudies-literature
Project description:IntroductionPostherpetic neuralgia (PHN) is one of the most common complications following herpes zoster. Clinical trials indicate that acupuncture could reduce pain and discomfort among patients with PHN. This protocol aims to describe how to accumulate the current evidence on the efficacy and safety of acupuncture for treating PHN.Methods and analysisThis systematic review will electronically search multiple databases including the Cochrane Skin Group Trials Register, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Chinese Biomedical Literature Database (CBM), the Chinese Medical Current Content (CMCC) and the China National Knowledge Infrastructure (CNKI), and will hand search a list of medical journals as a supplement. Any clinical randomised controlled trials related to acupuncture for treating PHN will be included. Outcomes will include pain intensity, global impression, quality of life, safety and costs. By screening the titles, abstracts and full texts, two reviewers will independently select studies, extract data, and assess study quality. Meta-analysis of randomised controlled trials will be conducted using Revman 5.1 software. The results will be presented as risk ratio for dichotomous data, and standardised or weighted mean difference for continuous data.Ethics and disseminationThis systematic review does not need ethical approval because there are no data used in our study that are linked to individual patient data. Also, the findings will be disseminated through a peer-review publication or conference presentation.Trial registration numberPROSPERO registration number: CRD42014009555.
| S-EPMC4244400 | biostudies-literature
Project description:BackgroundInsomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.MethodsPeople with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.ResultsTwenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks' follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.ConclusionsElectroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registrationClinical Research Information Service, KCT0002162 . Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016).
| S-EPMC8932204 | biostudies-literature
Project description:BackgroundDiabetic peripheral neuropathy (DPN) is the most common complication of type 2 diabetes mellitus (T2DM); its diagnosis and treatment are based on symptomatic improvement. However, as pharmacological therapy causes multiple adverse effects, the implementation of acupunctural techniques, such as electroacupuncture (EA) has been suggested as an alternative treatment. Nonetheless, there is a lack of scientific evidence, and its mechanisms are still unclear. We present the design and methodology of a new clinical randomized trial, that investigates the effectiveness of EA for the treatment of DPN.MethodsThis study is a four-armed, randomized, controlled, multicenter clinical trial (20-week intervention period, plus 12 weeks of follow-up after concluding intervention). A total of 48 T2DM patients with clinical signs and symptoms of DPN; and electrophysiological signs in the Nerve Conduction Study (NCS); will be treated by acupuncture specialists in outpatient units in Mexico City. Patients will be randomized in a 1:1 ratio to one of the following four groups: (a) short fibre DPN with EA, (b) short fibre DPN with sham EA, (c) axonal DPN with EA and (d) axonal DPN with sham EA treatment. The intervention will consist of 32 sessions, 20 min each, per patient over two cycles of intervention of 8 weeks each and a mid-term rest period of 4 weeks. The primary outcome will be NCS parameters, and secondary outcomes will include DPN-related symptoms and pain by Michigan Neuropathy Screening Instrument (MNSI), Michigan Diabetic Neuropathy Score (MDNS), Dolour Neuropatique Score (DN-4), Semmes-Westein monofilament, Numerical Rating Scale (NRS) for pain assessment, and the 36-item Short Form Health Survey (SF-36). To measure quality of life and improve oxidative stress, the inflammatory response; and genetic expression; will be analysed at the beginning and at the end of treatment.DiscussionThis study will be conducted to compare the efficacy of EA versus sham EA combined with conventional diabetic and neuropathic treatments if needed. EA may improve NCS, neuropathic pain and symptoms, oxidative stress, inflammatory response, and genetic expression, and it could be considered a potential coadjutant treatment for the management of DPN with a possible remyelinating effect.Trial registrationClinicalTrials.gov. NCT05521737 Registered on 30 August 2022. International Clinical Trials Registry Platform (ICTRP) ISRCTN97391213 Registered on 26 September 2022 [2b].
| S-EPMC10868023 | biostudies-literature
Project description:BackgroundPostherpetic neuralgia (PHN) is the most common sequela of herpes zoster, and the efficacy of the treatment regimens recommended in the guidelines is not entirely reliable. Acupuncture and moxibustion are widely used complementary alternative therapies that have a positive effect on the treatment of PHN. However, there are various forms of acupuncture and moxibustion, and there are differences in efficacy between the different forms.MethodsThe retrieval work of randomised controlled trials (RCTs) of acupuncture for PHN in English databases (including PubMed, Cochrane Library, Embase, Web of Science) and Chinese databases (including China National Knowledge Infrastructure (CNKI), WeiPu database, WanFang database, and China Biomedical Literature Database) were conducted from the time of database creation to June 2022. Literature screening, data extraction, and evaluation of risk of bias for the included studies were carried out independently by two researchers, and data analysis was performed using Stata 14.2 software.ResultsA total of 30 RCTs including 2138 patients with PHN were included. In terms of pain improvement, acupoint embedding + Western medicine group, bloodletting-cupping group, and bloodletting-cupping + Western medicine group ranked top. In terms of total efficiency, acupuncture + Western medicine group, bloodletting-cupping + Western medicine group, and acupoint embedding group ranked top. There were no statistically significant differences in the incidence of adverse events between treatment regimens.ConclusionsIn a comprehensive comparison of the outcome indicators of 14 different treatment regimens, we considered acupoint injection + Western medicine and bloodletting-cupping + Western medicine to be the best combinations for the treatment of PHN. Due to the limitations of the study, the above conclusions still need to be validated in further multi-centre, large-sample prospective randomised controlled clinical trials.
| S-EPMC9586726 | biostudies-literature
Project description:BackgroundPoststroke aphasia (PSA) is a disabling condition that decreases the quality of life, and the duration of the disease harms the quality of life of PSA patients. Acupuncture has been widely employed for PSA. There is some evidence for the immediate treatment efficacy of acupuncture for PSA; however, long-term results after acupuncture may be poorer.MethodsThis is a multicentre, randomized, blinded, nonacupoint (NA) acupuncture controlled, multimodal neuroimaging clinical trial. A total of 48 subjects with subacute PSA will be randomly assigned to an acupoint group or an NA control group. The acupoint group will receive acupuncture with normal needling at DU20, EX-HN1, HT5, GB39, EX-HN12, EX-HN13, and CV23. The NA control group will receive acupuncture in locations not corresponding to acupuncture points as sham acupoints. Both groups will receive identical speech and language therapy thrice a week for four weeks. The primary outcome will be the change in the aphasia quotient (AQ) score measured by the Western Aphasia Battery (WAB) test during the 12th week after randomization. Participants will be blindly assessed at prerandomization (baseline) and 4 weeks, 12 weeks, and 24 weeks after randomization. The secondary outcomes include the Boston Diagnostic Aphasia Examination (BDAE) score, the Disease Prognosis Scale score for ischaemic stroke, etc. Magnetic resonance imaging (MRI) and electroencephalogram (EEG) will also be performed at 4-time intervals as secondary outcomes. All scores and image evaluations will be taken at the same point as the linguistic evaluation. The multilevel evaluation technique will be used to assess the long-term efficacy of acupuncture therapy. MRI scans and EEG will be used to assess acupuncture-related neuroplasticity changes. Discussion. The results from our trial will help to supply evidence for the long-term acupuncture effects for PSA over a long follow-up period. It will provide valuable information for future studies in the field of PSA treatment. The trial was registered at the Chinese Clinical Trial Registry on 16 March 2020 (ChiCTR2000030879).
| S-EPMC7895559 | biostudies-literature