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Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Postoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited. METHODS:A randomized, sham-controlled, patient- and- assessor-blind trial is designed to evaluate the efficacy and safety of acupuncture in managing postoperative pain following abdominal surgery of gynecological diseases. Patients who are eligible for laparotomy with a midline incision for gynecological neoplasia, including ovarian mass, uterine mass, and cervical lesions, will be recruited. Seventy-two participants will be randomly allocated to an acupuncture or non-invasive sham control in a 1:1 ratio. Treatment will be done within 2 h before operation, upon arrival to the ward and once daily for 5 days. The Pain Numerical Rating Scale (NRS) on the first 5 days during hospitalization will be the primary outcome and will be analyzed using the area-under-the-curve (AUC) method. The secondary outcome measures include frequency of rescue analgesic use during hospital stay, cumulative morphine consumption; quality of recovery as measured by time to recovery variables and the Quality of Recovery-9 (QoR-9); quality of life as measured by the Short Form-6 dimension (SF-6D) and EuroQol-5 Dimension-5 Level (EQ-5D-5 L). The incremental cost-effectiveness ratio of acupuncture vs sham acupuncture will be calculated. DISCUSSION:This study protocol provides an example of integrative medicine practice in a hospital setting for the management of postoperative pain using acupuncture treatment. The acupuncture treatment protocol, if proven to be effective, can be implemented in routine settings to play a role in postoperative pain management for patients who have undergone abdominal surgery for gynecological diseases. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT02851186 . Registered on 19 July 2016.

SUBMITTER: Lam WL

PROVIDER: S-EPMC5755011 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial.

Lam Wing Lok WL Yeung Wing Fai WF Wong Mei Kuen MK Cheung Chi Wai CW Chan Karen Kar Loen KKL Ngan Hextan Yuen Sheung HYS Wong Carlos King Ho CKH Chen Hai Yong HY Lao Lixing L

Trials 20180104 1

<h4>Background</h4>Postoperative pain is a major complaint following abdominal surgery for gynecological diseases. Effective postoperative pain control after abdominal surgery is particularly important for patient recovery, mobility, and satisfaction. Acupuncture has been commonly used for pain management. However, its efficacy in postoperative pain control is inconclusive and health economic evaluation is limited.<h4>Methods</h4>A randomized, sham-controlled, patient- and- assessor-blind trial ...[more]

PMID: 29301556

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Project description:BackgroundPostoperative delirium is common in elderly patients following major surgery. This study aimed to assess the effect of transcutaneous electrical acupoint stimulation combined with auricular acupressure on the incidence of postoperative delirium among older patients undergoing major abdominal surgery.MethodsIn this single-center, randomized controlled clinical trial, 210 patients aged 65 years or older undergoing major abdominal surgery were randomized to receive either intervention treatment (transcutaneous electrical acupoint stimulation started at 30 min before anesthesia until the end of the surgery, followed by intermittent auricular acupressure in the first three postoperative days; n = 105) or standard care (n = 105). The primary outcome was the incidence of delirium at the first seven postoperative days or until hospitalization depended on which came first. Secondary outcomes included delirium severity, opioid consumption, postoperative pain score, sleep quality, length of postoperative hospital stay, and postoperative 30-day complications. Enrollment was from April 2019 to March 2020, with follow-up ending in April 2020.ResultsAll of the 210 randomized patients [median age, 69.5 years, 142 (67.6%) male] completed the trial. The incidence of postoperative delirium was significantly reduced in patients received intervention treatment (19/105 (18.1%) vs. 8/105 (7.6%), difference, -10.5% [95% CI, -1.5% to -19.4%]; hazard ratio, 0.41 [95% CI, 0.18 to 0.95]; P= 0.023). Patients in the control group had a higher postoperative Memorial Delirium Assessment Scale (4 vs. 3; difference, -1; 95% CI, -1 to 0; P = 0.014) and a greater increase in Pittsburgh Sleep Quality Index score from baseline to postoperative day three (2.5 vs. 2.0; difference, -1; 95% CI, -2 to -1; P < 0.001) than patients in the intervention group. No significant difference was observed as of other secondary outcomes.ConclusionIn elderly patients undergoing major abdominal surgery, transcutaneous electrical acupoint stimulation combined with auricular acupressure reduced the incidence of postoperative in-hospital delirium compared with standard care. A multicenter, randomized clinical trial with a larger sample size is necessary to verify these findings.Clinical trial registration[https://clinicaltrials.gov], identifier [NCT03726073].

Project description:IntroductionThis review aims to evaluate the effectiveness and safety of acupuncture for patients with postoperative pain after laparoscopic surgery.Methods and analysisWe will search the following databases from their inception to October 2014: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), three Chinese databases (China National Knowledge Infrastructure (CNKI), the Chongqing VIP Chinese Science and Technology Periodical Database (VIP) and the Wanfang database), one Japanese database (Japan Science and Technology Information Aggregator, Electronic (J-STAGE)) and eight Korean databases (Korean Association of Medical Journal Edition, Korean Medical Database, Korean Studies Information Service System, National Discovery for Science Leaders, Database Periodical Information Academic, Korean National Assembly Digital Library, Oriental Medicine Advanced Searching Integrated System and Korean Traditional Knowledge Portal). All randomised controlled trials of acupuncture for postoperative pain after laparoscopic surgery will be considered for inclusion. The risk of bias and reporting quality will be assessed using the Cochrane risk of bias tool, the Consolidated Standards of Reporting Trials (CONSORT) and the revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The risk ratio for dichotomous data and mean difference or standard mean difference for continuous data will be calculated with 95% CIs.DisseminationThe results of this review will be disseminated through peer-reviewed publication or conference presentation. Our findings will summarise the current evidence of acupuncture to treat postoperative pain after laparoscopic surgery, and may provide important guidance for acupuncture usage after laparoscopic surgery for clinicians and patients.Trial registration numberPROSPERO 2014: CRD42014010825.

Project description:ImportanceThe opioid crisis creates challenges for cancer pain management. Acupuncture confers clinical benefits for chronic nonmalignant pain, but its effectiveness in cancer survivors remains uncertain.ObjectiveTo determine the effectiveness of electroacupuncture or auricular acupuncture for chronic musculoskeletal pain in cancer survivors.Design, setting, and participantsThe Personalized Electroacupuncture vs Auricular Acupuncture Comparative Effectiveness (PEACE) trial is a randomized clinical trial that was conducted from March 2017 to October 2019 (follow-up completed April 2020) across an urban academic cancer center and 5 suburban sites in New York and New Jersey. Study statisticians were blinded to treatment assignments. The 360 adults included in the study had a prior cancer diagnosis but no current evidence of disease, reported musculoskeletal pain for at least 3 months, and self-reported pain intensity on the Brief Pain Inventory (BPI) ranging from 0 (no pain) to 10 (worst pain imaginable).InterventionsPatients were randomized 2:2:1 to electroacupuncture (n = 145), auricular acupuncture (n = 143), or usual care (n = 72). Intervention groups received 10 weekly sessions of electroacupuncture or auricular acupuncture. Ten acupuncture sessions were offered to the usual care group from weeks 12 through 24.Main outcomes and measuresThe primary outcome was change in average pain severity score on the BPI from baseline to week 12. Using a gatekeeping multiple-comparison procedure, electroacupuncture and auricular acupuncture were compared with usual care using a linear mixed model. Noninferiority of auricular acupuncture to electroacupuncture was tested if both interventions were superior to usual care.ResultsAmong 360 cancer survivors (mean [SD] age, 62.1 [12.7] years; mean [SD] baseline BPI score, 5.2 [1.7] points; 251 [69.7%] women; and 88 [24.4%] non-White), 340 (94.4%) completed the primary end point. Compared with usual care, electroacupuncture reduced pain severity by 1.9 points (97.5% CI, 1.4-2.4 points; P < .001) and auricular acupuncture reduced by 1.6 points (97.5% CI, 1.0-2.1 points; P < .001) from baseline to week 12. Noninferiority of auricular acupuncture to electroacupuncture was not demonstrated. Adverse events were mild; 15 of 143 (10.5%) patients receiving auricular acupuncture and 1 of 145 (0.7%) patients receiving electroacupuncture discontinued treatments due to adverse events (P < .001).Conclusions and relevanceIn this randomized clinical trial among cancer survivors with chronic musculoskeletal pain, electroacupuncture and auricular acupuncture produced greater pain reduction than usual care. However, auricular acupuncture did not demonstrate noninferiority to electroacupuncture, and patients receiving it had more adverse events.Trial registrationClinicalTrials.gov Identifier: NCT02979574.

Project description:BackgroundEvidence for the efficacy and safety of electroacupuncture (EA) on gastrointestinal function recovery after gynecological surgery is unclear.ObjectiveThis meta-analysis aimed to evaluate the effects of EA on recovery of postoperative gastrointestinal function for patients receiving gynecological surgery. Data sources: PubMed, Cochrane Central Register of Controlled Trials (CINAHL), Embase, China National Knowledge Infrastructure (CNKI), Weipu (CQVIP), and Wanfang databases were systematically searched from the inception dates to May 30, 2020, for relevant randomized controlled trials (RCTs). Study selection: RCTs that evaluated EA for postoperative gastrointestinal function directly related to gynecological surgery in adults aged 18 years or over. Data extraction and synthesis: paired reviewer independently extracted the data and assessed study quality. Standardized mean differences (SMD) were calculated as the effect measure from a random effects model. Main outcomes and measures: time to first flatus (TFF), time to bowel sounds recovery (TBS), and time to first defecation (TFD) were recorded as primary outcomes; postoperative nausea and vomiting (PONV), motilin (MTL), gastrin (GAS), pH value of gastric mucosa (pHi), gastric mucosal partial pressure of carbon dioxide (PgCO2), vasoactive intestinal peptide (VIP), and adverse event were reported as secondary outcomes.ResultsWe included eighteen RCTs (1117 participants). Our findings suggested that compared to the control group (CG), electroacupuncture group (EG) showed significant effects on TFF (SMD = -0.98, 95% CI: [-1.28, -0.68], P < 0.00001, I 2 = 69%), TBS (SMD = -0.98, 95% CI: [-1.84, -0.12], P=0.03, I 2 = 92%), and TFD (SMD = -1.23, 95% CI: [-1.59, -0.88], P < 0.0001, I 2 = 0%). Moreover, the incidence of PONV at postoperative 6 h (OR = 0.42, 95% CI: [0.27, 0.64], P < 0.0001, I 2 = 0%) and 24 h (OR = 0.46, 95% CI: [0.32, 0.68], P < 0.0001, I 2 = 0%) was lower in the EG than that in the CG, whereas no significant difference in ratio of PONV at postoperative 48 h (OR = 0.55, 95% CI: [0.20, 1.51], P=0.25, I 2 = 0%) was detected between the two groups. Meanwhile, there was a significant effect in favor of EA on the level of MTL at postoperative 6 h (SMD = -0.93, 95% CI: [-1.36, -0.61], P < 0.0001, I 2 = 21%), while no significant effect was observed at postoperative 24 h (SMD = -0.43, 95% CI: [-0.89, 0.02], P=0.06, I 2 = 69%) in the EG when compared to the CG. Additionally, a large significant effect on decreasing PgCO2 was found in the EG in comparison to the CG, but no significant effect in favor of EA on GAS, VIP, or pHi was observed. It was reported that there was one participant with pain at the needling sites and bruising, and three participants withdrew because they were not intolerant to EA.ConclusionsEA could be a promising strategy for the prevention and treatment of gastrointestinal dysfunction after gynecological surgery, including shortening TFF and TFD, TBS, regulating MTL, and decreasing the ratio of PONV within postoperative 24h. The effects on MTL and PONV varied with different intervention points, and EA used at 30 min prior to surgery might be recommended. However, the evidence quality ranged from low to very low, and large-scale and high-quality RCTs were warranted.

Project description:BackgroundDepression accompanying chronic pain (CP) is one of the most common comorbid psychiatric disorders. This study aimed to investigate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) combined with electroacupuncture at Baihui (GV20) and Yintang (GV29) acupoints compared with citalopram.MethodsSixty patients with depression and pain comorbidity were enrolled in a prospective 8-week, single-blind, randomized controlled trial. Participants were randomly assigned to receive either taVNS combined with electroacupuncture treatment (taVNS: 8 weeks, 3 sessions per week; electroacupuncture: 8 weeks, twice per day, no drugs) or citalopram treatment (8 weeks, 40 mg/day). The primary outcome was Montgomery-Åsberg Depression Rating Scale (MADRS). The secondary endpoints were evaluated using the McGill Pain Questionnaire (SF-MPQ), self-reported 36-Item Short Form Survey (SF-36), Pittsburgh Sleep Quality Index (PSQI), Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Scale (HAMA).ResultsBoth the taVNS combined with electroacupuncture and citalopram groups had significant reductions in depressive and pain symptoms, as indicated by the decrease in MARDS and SF-MPQ scores. Regarding the analgesic effect, the pain intensity score of the SF-MPQ showed a larger reduction with citalopram than with taVNS combined with electroacupuncture at 6 weeks (P = 0.036). The reduction in the BP score of the SF-36 was higher at week 4 (P = 0.000), with no significant difference observed at week 8 (P = 0.1110). This result indicated that the pain intensity can be improved rapidly with citalopram compared with taVNS combined with electroacupuncture. Similarly, the comparison of PSQI scores at 4, 6, and 8 weeks indicates that there was no significant difference between groups, except in the use of sleeping medications. At week 6, higher medication use was found in the citalopram group than in the taVNS combined with electroacupuncture group (P = 0.049).ConclusionIn summary, compared with citalopram, taVNS combined with electroacupuncture produces similar positive effects on depressive and pain symptoms in patients with depression and chronic pain, which last for at least 8 weeks.

Project description:Expression of Concern: Medical Acupuncture issues an Expression of Concern pertaining to a published article in the October 2021 issue of the journal entitled, "Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project," by Brian Lee James, John Welch, and Clint Williamson. (Med Acupunct 33(5):2021.349-352; doi: 10.1089/acu.2021.0007) The journal has received communications from several sources raising significant concerns regarding the claims made in this article as they pertain to the self-administration of Battlefield Acupuncture and patient self-use of acupuncture needles. Each communication states that acupuncture needles are considered FDA-approved medical equipment and are not intended for patient self-administration. An official inquiry with the authors' institution has been launched by the editors and publisher of the journal. Such an inquiry may be a protracted process but the journal will update this notice once a resolution has been reached. Objective: There has been little research on self-administration of auricular acupuncture by patients. This study was conducted to assess the safety and feasibility of self-administration of Battlefield Acupuncture (BFA) with semipermanent needles at intervals of 2 weeks over a timeperiod of 6 months. Materials and Methods: This study was conducted at the Chillicothe Veterans Affairs Medical Center, Chillicothe, OH, USA, and its satellite Community-Based Outpatient Clinics in Ohio. The participants were 12 healthy veteran volunteers (10 males and 2 females) who previously had repeated good responses to BFA administration by a provider. Outcomes of treatment-emergent adverse events and subjective perception of pain relief, compared with provider-administered BFA, were collected telephonically every 2 weeks for 6 months. Results: No treatment-emergent adverse events were reported by any participant over a 6-month time period. Of 12 participants,10 (83%) were able to perform BFA on themselves reliably after a didactic session. Pain relief from self-administration experienced by participants was comparable to that experienced when administered by a provider. Conclusions: In this small pilot study, self-administration of BFA was safe and effective for individuals who had previously received repeated benefit from provider-administered BFA. The contents do not represent the views of the U.S. Department of Veterans Affairs or the United States Government. This research is registered at ClinicalTrials.gov as NCT #: NCT04208659.

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Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial.

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Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial.

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