Acupuncture Therapy as an Evidence-Based Nonpharmacologic Strategy for Comprehensive Acute Pain Care: The Academic Consortium Pain Task Force White Paper Update.

BACKGROUND: A crisis in pain management persists, as does the epidemic of opioid overdose deaths, addiction, and diversion. Pain medicine is meeting these challenges by returning to its origins: the Bonica model of multidisciplinary pain care. The 2018 Academic Consortium White Paper detailed the historical context and magnitude of the pain crisis and the evidence base for nonpharmacologic strategies. More than 50% of chronic opioid use begins in the acute pain care setting. Acupuncture may be able to reduce this risk. OBJECTIVE: This article updates the evidence base for acupuncture therapy for acute pain with a review of systematic reviews and meta-analyses on postsurgical/perioperative pain with opioid sparing and acute nonsurgical/trauma pain, including acute pain in the emergency department. METHODS: To update reviews cited in the 2018 White Paper, electronic searches were conducted in PubMed, MEDLINE, CINAHL, and the Cochrane Central Register of Controlled Trials for "acupuncture" and "acupuncture therapy" and "acute pain," "surgery," "peri-operative," "trauma," "emergency department," "urgent care," "review(s) ," "systematic review," "meta-analysis," with additional manual review of titles, links, and reference lists. RESULTS: There are 22 systematic reviews, 17 with meta-analyses of acupuncture in acute pain settings, and a review for acute pain in the intensive care unit. There are additional studies of acupuncture in acute pain settings. CONCLUSION: The majority of reviews found acupuncture therapy to be an efficacious strategy for acute pain, with potential to avoid or reduce opioid reliance. Future multicenter trials are needed to clarify the dosage and generalizability of acupuncture for acute pain in the emergency department. With an extremely low risk profile, acupuncture therapy is an important strategy in comprehensive acute pain care.

Individual vs. Group Delivery of Acupuncture Therapy for Chronic Musculoskeletal Pain in Urban Primary Care-a Randomized Trial.

BACKGROUND: Acupuncture has been shown to be effective for the treatment of chronic musculoskeletal back, neck, and osteoarthritis pain. However, access to acupuncture treatment has been limited in medically underserved and low-income populations. OBJECTIVE: Acupuncture therapy delivered in groups could reduce cost and expand access. We compared the effectiveness of group versus individual acupuncture for pain and function among ethnically diverse, low-income primary care patients with chronic musculoskeletal pain. DESIGN: This was a randomized comparative effectiveness non-inferiority trial in 6 Bronx primary care community health centers. Participants with chronic (> 3 months) back, neck, or osteoarthritis pain were randomly assigned to individual or group acupuncture therapy for 12 weeks. PARTICIPANTS: Seven hundred seventy-nine participants were randomized. Mean age was 54.8 years. 35.3% of participants identified as black and 56.9% identified as Latino. Seventy-six percent were Medicaid insured, 60% reported poor/fair health, and 37% were unable to work due to disability. INTERVENTIONS: Participants received weekly acupuncture treatment in either group or individual setting for 12 weeks. MAIN MEASURES: Primary outcome was pain interference on the Brief Pain Inventory at 12 weeks; secondary outcomes were pain severity (BPI), physical and mental well-being (PROMIS-10), and opiate use. Outcome measures were collected at baseline, 12 and 24 weeks. KEY RESULTS: 37.5% of individual arm and 30.3% in group had > 30% improvement in pain interference (d = 7.2%, 95% CI - 0.6%, 15.1%). Non-inferiority of group acupuncture was not demonstrated for the primary outcome assuming a margin of 10%. In the responder analysis of physical well-being, 63.1% of individual participants and 59.5% of group had clinically important improvement at 12 weeks (d = 3.6%, 95% CI - 4.2%, 11.4%). CONCLUSIONS: Both individual and group acupuncture therapy delivered in primary care settings reduced chronic pain and improved physical function at 12 weeks; non-inferiority of group was not shown. TRIAL REGISTRATION: Clinicaltrials.gov # NCT02456727.

Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events.

OBJECTIVE: Auricular acupuncture (AA) and extended auricular therapy (AT) are a part of acupuncture practice shown to benefit patients with pain, anxiety, and other conditions, with cost-effective access enhanced when given in a group setting. Yet there are safety concerns and risks, perhaps unnecessary risks, that attend embedded, indwelling needles applied to the ear as a means of extended AT. METHODS: Electronic searches were conducted in PubMed, MEDLINE, CINAHL and Cochrane Central Register of Controlled Trials (CENTRAL) for "auriculotherapy," "auricular acupuncture" or "auricular acupressure," "safety," "adverse events," "chondritis," and "perichondritis," with additional manual review of titles, links, and reference lists. Individual auricular therapy adverse event (AE) case reports were included, as well as systematic reviews and or meta-analyses if they evaluated AEs associated with AT. RESULTS: Nineteen auricular AE case reports and nine safety reviews of or including auriculotherapy were included. Ten systematic reviews of AT with eight specific reviews of auricular acupressure (AP) were also included. CONCLUSIONS: The primary AE risks is infection, perichondritis, and chondritis stemming from embedded or indwelling needles or potential inadvertent needlesticks from contaminated roaming sharps. Extended AP i.e., application of spheres, preferably seeds (natural, nontoxic botanical Vaccaria seeds) provides clinical benefit without the risks associated with embedded needles. More research is needed to establish if embedded needles at the ear are even necessary or have any advantage over in-session auricular acupuncture for immediate pain relief followed by ear acupressure.

Acupuncture Therapy in a Group Setting for Chronic Pain.

Objective: This project was designed to test the feasibility and effectiveness of acupuncture therapy given in a group setting for chronic pain. Design: Nonrandomized, repeated measures quasi-experimental trial. Setting: Care was delivered in a primary care clinic waiting area after clinic hours. Subjects: Included were primary care patients (≥18 years old) with chronic pain of the neck, back, shoulder, or osteoarthritis of any site of at least three months' duration. Methods: Subjects received eight weekly acupuncture therapy sessions in a group setting. Acupuncture therapy included a combination of palpation, acupuncture needling, Tui na, Gua sha, and auricular treatment. Baseline pain levels were established in a two- to four-week run-in; assessment of the intervention impact on pain intensity, mood, and functional status were made at the end of the treatment period (eight weeks) and 16 weeks after completion of intervention (24 weeks). Results: Of the total 113 participants recruited for the trial, 96 completed the 24-week protocol. We found a statistically and clinically significant decrease in pain severity, pain interference, and depression in our study population. There were no serious adverse events. Conclusions: Acupuncture therapy offered in the group setting was effective in reducing pain severity, pain interference, and depression in patients with chronic neck, back, or shoulder pain or osteoarthritis. Benefit persisted through the 24-week measure despite no additional treatment. This finding has potentially important implications for improving access to effective acupuncture treatment for patients with limited financial resources.

Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials.

Background: The effectiveness of acupuncture for chronic low back pain (cLBP) has not been studied specifically in the 65-and-older population. To inform the validity and generalizability of future acupuncture studies among older adults, we characterized elderly participants' prior experience with and views toward acupuncture and tested for clinical and sociodemographic differences between acupuncture-naïve and non-naïve participants. Methods: Data for this study were collected during the baseline telephone interview from the participants enrolled in the Kaiser Permanente Northern California site of an NIH-funded, multicenter clinical trial of acupuncture for cLBP in older adults. Results: Nearly two-thirds (65.6 %) of participants surveyed reported they had previously received acupuncture treatment with the vast majority seeking acupuncture treatment for pain-related issues (84.8 %). The majority of these participants reported relatively modest levels of exposure to acupuncture with most participants (63.1 %) reporting fewer than 10 treatment sessions over their lifetimes. There were no significant differences in age, sex, race, ethnicity, disability scores, income levels, or pain levels between the acupuncture-naïve and non-naïve groups. Conclusion: Contextual consideration for prior acupuncture utilization rates is warranted and may be higher than expected or previously reported. We found few differences in baseline characteristics between participants who were acupuncture-naïve and those with prior acupuncture experience; thus, future pragmatic clinical trials might relax previous acupuncture-use considerations in their recruitment criteria. For trials focused on acupuncture-naive patients, it may be more feasible to expand the definition of "acupuncture-naive" based on lifetime acupuncture visits or time since last treatment. Trial registration: The protocol was registered at clinicaltrials.gov (#NCT04982315).

Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines.

Background: Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported. Methods: ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity. Results: Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points (M = 13.2, range 2-22), needle retention time (M = 23.5 min, range 4-52), session length (M = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form. Conclusion: To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs. Protocol registration: The protocol of this study is registered at clinicaltrials.gov: NCT04880733.

The effect of sham acupuncture can differ depending on the points needled in knee osteoarthritis: A systematic review and network meta-analysis.

Objective: In sham acupuncture-controlled acupuncture clinical trials, although sham acupuncture techniques are different from those of verum acupuncture, the same acupuncture points are often used for verum and sham acupuncture, raising the question of whether sham acupuncture is an appropriate placebo. We aimed to examine the effects of sham and verum acupuncture according to the points needled (same or different between verum and sham acupuncture) in knee osteoarthritis. Methods: Ten databases were searched to find randomized controlled clinical trials (RCTs) assessing the effects of verum acupuncture with sham acupuncture or waiting lists on knee osteoarthritis. Sham acupuncture was classified as using the same acupuncture points as those in verum acupuncture (SATV) or using sham points (SATS). A frequentist network meta-analysis (NMA) was conducted, and the certainty of evidence was evaluated. Results: A total of 10 RCTs involving 1628 participants were included. Verum acupuncture was significantly superior to SATS but not different from SATV in terms of pain reduction. Additionally, SATV was significantly superior to the waiting list. For physical function, no difference were found between verum acupuncture, SATV, and SATS. The certainty of evidence was low to moderate. Conclusion: For knee osteoarthritis, the pain reduction effect of acupuncture may differ according to the needling points of sham acupuncture, and the control group should be established according to the specific aim of the study design and treatment mechanism.

Utilization of Reimbursed Acupuncture Therapy for Low Back Pain.

Importance: Treating low back pain (LBP) often involves a combination of pharmacologic, nonpharmacologic, and interventional treatments; one approach is acupuncture therapy, which is safe, effective, and cost-effective. How acupuncture is used within pain care regimens for LBP has not been widely studied. Objective: To document trends in reimbursed acupuncture between 2010 and 2019 among a large sample of patients with LBP, focusing on demographic, socioeconomic, and clinical characteristics associated with acupuncture use and the nonpharmacologic, pharmacologic, and interventional treatments used by patients who utilize acupuncture. Design, Setting, and Participants: This cross-sectional study included insurance claims of US adults in a deidentified database. The study sample included patients diagnosed with LBP between 2010 and 2019. Data were analyzed between September 2023 and June 2024. Main Outcomes and Measures: Changes in rates of reimbursed acupuncture utilization between 2010 and 2019, including electroacupuncture use, which involves the electrical stimulation of acupuncture needles. Covariates included age, sex, race and ethnicity, income, educational attainment, region, and a chronic LBP indicator. Secondary analyses tracked other nonpharmacologic treatments (eg, physical therapy, chiropractic care), pharmacologic treatments (eg, opioids, gabapentinoids), and interventional treatments (eg, epidural steroid injections). Results: The total sample included 6 840 497 adults with LBP (mean [SD] age, 54.6 [17.8] years; 3 916 766 female [57.3%]; 802 579 Hispanic [11.7%], 258 087 non-Hispanic Asian [3.8%], 804 975 non-Hispanic Black [11.8%], 4 974 856 non-Hispanic White [72.7%]). Overall, 106 485 (1.6%) had 1 or more acupuncture claim, while 61 503 (0.9%) had 1 or more electroacupuncture claim. The rate of acupuncture utilization increased consistently, from 0.9% in 2010 to 1.6% in 2019; electroacupuncture rates were relatively stable. Patients who were female (male: odds ratio [OR], 0.68; 99% CI, 0.67-0.70), Asian (OR, 3.26; 99% CI, 3.18-3.35), residing in the Pacific region (New England: OR, 0.26; 99% CI, 0.25-0.28), earning incomes of over $100 000 (incomes less than $40 000: OR, 0.59; 99% CI, 0.57-0.61), college educated (high school or less: OR, 0.32; 99% CI, 0.27-0.35), and with chronic LBP (OR, 2.39; 99% CI, 2.35-2.43) were more likely to utilize acupuncture. Acupuncture users were more likely to engage in other nonpharmacologic pain care like physical therapy (39.2%; 99% CI, 38.9%-39.5% vs 29.3%; 99% CI, 29.3%-29.3%) and less likely to utilize prescription drugs, including opioids (41.4%; 99% CI, 41.1%-41.8% vs 52.5%; 99% CI, 52.4%-52.5%), compared with nonusers. Conclusions and Relevance: In this cross-sectional study, we found that acupuncture utilization among patients with LBP was rare but increased over time. Demographic, socioeconomic, and clinical characteristics were associated with acupuncture utilization, and acupuncture users were more likely to utilize other nonpharmacologic treatments and less likely to utilize pharmacologic treatments.

Needling Point Location Used in Sham Acupuncture for Chronic Nonspecific Low Back Pain: A Systematic Review and Network Meta-Analysis.

Importance: When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points. Objective: To assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example. Data sources: Searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023. Study selection: Randomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture-controlled or waiting list-controlled trials on CLBP were included. Data extraction and synthesis: Two researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA). Main outcomes and measures: The primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Ten RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, -0.33; 95% CI, -0.52 to -0.15) and function outcomes (SMD, -0.13; 95% CI, -0.25 to -0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, -0.45; 95% CI, -0.88 to -0.03) and function outcomes (SMD, -0.30; 95% CI, -0.56 to -0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low. Conclusions and relevance: In this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.

Different Outcomes According to Needling Point Location Used in Sham Acupuncture for Cancer-Related Pain: A Systematic Review and Network Meta-Analysis.

Numerous acupuncture studies have been conducted on cancer-related pain; however, its efficacy compared to sham acupuncture remains controversial. We confirmed whether the outcome of acupuncture differs according to the needling points of sham acupuncture for cancer-related pain. We searched 10 databases on 23 May 2023 to screen acupuncture trials using sham acupuncture or waiting list as controls for cancer-related pain. Sham acupuncture was classified into two types, depending on whether the needling was applied at the same locations as verum acupuncture (SATV) or not (SATS). A network meta-analysis (NMA) was performed on the basis of a frequentist approach to assess pain severity. Eight studies (n = 574 participants) were included in the review, seven of which (n = 527 participants) were included in the NMA. The pain severity was not significantly different between SATV and verum acupuncture, but verum acupuncture significantly improved pain severity compared to SATS. The risk of bias affecting the comparisons between the verum and sham acupuncture was generally low. Previous acupuncture trials for cancer-related pain showed differing outcomes of sham and verum acupuncture, depending on the needling points of sham acupuncture. The application of SATV cannot be considered a true placebo, which leads to an underestimation of the efficacy of verum acupuncture.

Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial.

BACKGROUND: Back pain prevalence and burden increase with age; approximately one-third of U.S. adults 65 years of age and older experience lower back pain (LBP). For chronic low back pain (cLBP), typically defined as lasting three months or longer, many treatments for younger adults may be inappropriate for older adults given their greater prevalence of comorbidities with attendant polypharmacy. While acupuncture has been demonstrated to be safe and effective for cLBP in adults overall, few studies of acupuncture have either included or focused on adults ≥65 years old. METHODS: The BackInAction study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial designed to test the effectiveness of acupuncture needling for improving back pain-related disability among 807 older adults ≥65 years old with cLBP. Participants are randomized to standard acupuncture (SA; up to 15 treatment sessions across 12 weeks), enhanced acupuncture (EA; SA during first 12 weeks and up to 6 additional sessions across the following 12 weeks), and usual medical care (UMC) alone. Participants are followed for 12 months with study outcomes assessed monthly with the primary outcome timepoint at 6 months. DISCUSSION: The BackInAction study offers an opportunity to further understand the effectiveness, dose-dependence, and safety of acupuncture in a Medicare population. Additionally, study results may encourage broader adoption of more effective, safer, and more satisfactory options to the continuing over-reliance on opioid- and invasive medical treatments for cLBP among older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.

Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Settings for an Underserved Population: A Feasibility Pilot Study.

Background: Acupuncture and yoga have both been shown to be effective in chronic pain. Underrepresented populations have poorer pain outcomes with less access to effective pain care. Objective: To assess the feasibility of bundling group acupuncture with yoga therapy for chronic neck, back or osteoarthritis pain in safety net settings. Methods: This was a feasibility pilot in Bronx and Harlem primary care community health centers. Participants with chronic neck, back or osteoarthritis pain received acupuncture and yoga therapy over a 10-week period. Participants received 10 weekly acupuncture treatments in group setting; with Yoga therapy sessions beginning immediately following the 3rd session. Primary outcome was pain interference and pain intensity on the Brief Pain Inventory (BPI); Outcomes were measured at baseline, 10-week close of intervention, and 24-week follow-up. Results: 93 patients were determined to be eligible and completed the baseline interview. The majority of participants were non-White and Medicaid recipients. 78 (84%) completed the intervention and 10-week survey, and 58 (62%) completed the 24-week post intervention survey. Participants received an average number of 6.5 acupuncture sessions (out of a possible 10), and 4 yoga sessions (out of a possible 8) over the 10-week intervention. Patients showed statistically significant improvements in pain at the close of the intervention and at a somewhat lesser rate, at 24-weeks post intervention. Challenges included telephone outreach and site coordination integrating acupuncture with yoga therapy. The trial also had to be stopped early due to the COVID-19 pandemic. Conclusions: Bundling acupuncture therapy and yoga therapy is feasible for an underrepresented population with chronic pain in urban community health centers with preliminary indications of acceptability and benefit to participants.

"The Pain Left, I Was Off and Running": A Qualitative Analysis of Group Acupuncture and Yoga Therapy for Chronic Pain in a Low-Income and Ethnically Diverse Population.

Introduction: Chronic pain and the current opioid epidemic are pressing public health concerns, especially in low-income and ethnically diverse communities. Nonpharmacologic therapies that are safe, effective, and acceptable for the treatment of chronic pain conditions may provide a solution for addressing this issue. This qualitative analysis explores the experience of study participants who received combined acupuncture and yoga therapy (YT) to treat chronic pain delivered in a primary care setting. Methods: The group acupuncture with yoga therapy for chronic neck, low back, and osteoarthritic pain trial (GAPYOGA) assessed the feasibility and effectiveness of group acupuncture (GA) combined with YT in a low-income, racial, and ethnically diverse population. Individual in-depth interviews were conducted with a subset of patients in the trial. Nineteen participants were interviewed for qualitative analysis of their experience. Using the immersion and crystallization method, transcribed interviews were analyzed for themes meaningfully representing participant experience. Results: The combined GA and YT resulted in significant pain relief and transformative healing experiences. Three themes emerged from participant narratives: (1) transformative engagement with self in the healing process through pain relief, psychological well-being, and self-efficacy; (2) therapeutic relationship with acupuncture and yoga providers; and (3) fostering relationships with fellow participants in the group. Discussion: In this study of a low-income and ethnically diverse population, the combination of acupuncture and YT was found to alleviate pain, improve function, promote psychological well-being, and engage participants in self-care practices in a transformative healing process-resulting in physical and psychological benefits.

Comparative effectiveness of acupuncture in sham-controlled trials for knee osteoarthritis: A systematic review and network meta-analysis.

Objectives: Although many trials have assessed the effect of acupuncture on knee osteoarthritis (KOA), its efficacy remains controversial. Sham acupuncture techniques are regarded as representative control interventions in acupuncture trials and sometimes incorporate the use of sham devices (base units) to support a non-penetrating needle. To achieve successful blinding, these trials also use acupuncture base units in the verum acupuncture group. Base units are not used in real-world clinical settings. We aimed to assess the effect sizes of verum and sham acupuncture for KOA in sham-controlled trials with or without base units. Methods: A total of 10 electronic databases for randomized controlled trials (RCTs) comparing the efficacy of verum manual acupuncture and sham acupuncture for the treatment of KOA were searched for articles published before April 12, 2022. The primary outcome was pain intensity, and the secondary outcomes included physical function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMDs) with 95% confidence intervals (95% CIs). The risk of bias was assessed using the Cochrane risk of bias tool, and publication bias was evaluated using a funnel plot and Egger's test. The quality of evidence for estimates was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Results: Fifteen RCTs were included. There was generally a low risk of bias except for the difficulty in blinding acupuncture therapists (performance bias). Compared to verum acupuncture in sham-controlled trials using base units, verum acupuncture in sham-controlled trials without base units was more effective for improving pain (SMD -0.56, 95% CI -1.09 to -0.03) and function (SMD -0.73, 95% CI -1.36 to -0.10) in KOA. The quality of evidence for network estimates was moderate to low due to the risk of bias and imprecision. Conclusion: These findings suggest that verum acupuncture in different types of sham-controlled trials has different effect sizes for KOA. Because base units are not used in clinical settings, the results of verum acupuncture in sham-controlled trials with base units need to be interpreted carefully. Systematic review registration: https://www.researchregistry.com/browse-the-registry#registryofsystematicreviewsmeta-analyses/registryofsystematicreviewsmeta-analysesdetails/6269f962606c5e001fd8790c/, identifier reviewregistry1351.

Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process.

PURPOSE: This document describes the consensus process and intervention for a National Institutes of Health (NIH)-funded multi-site feasibility study utilizing acupuncture for ACUte paIn in The EmergencY Department (ACUITY). The acupuncture intervention is designed to be flexible and responsive to the most common Emergency Department (ED) scenarios, including trauma, acute pain of the low back, abdomen and/or musculoskeletal system, renal colic and headache. BACKGROUND: Opioids remain a primary treatment for acute ED pain with attendant risk of adverse effects, addiction liability, diversion and death. Effective/safer options for acute pain are needed. Although acupuncture therapy has shown promise for acute pain in the ED alone or in conjunction with usual care, pragmatic trials are needed to obtain definitive and generalizable evidence. METHODS: An Acupuncture Advisory Panel was convened that included nine acupuncture experts with 5-44 years of experience in practice and 2-16 years of experience in the acute pain care setting. A modified Delphi process was used with provision of a literature review, surveys of our panel members, three online discussions and email discussion as needed. The STandards for Reporting Interventions in Controlled Trials (STRICTA) checklist was used as a guide. RESULTS: A responsive acupuncture intervention was agreed on for ACUITY. Session forms were fashioned in REDCap (Research Electronic Data Capture program to capture essential treatment data, assess fidelity and inform our design for a future pragmatic multi-site randomized controlled trial (RCT) of acupuncture in the ED, and for use by other future researchers. CONCLUSION: Development of a responsive manualization intervention provides the appropriate framework for conducting a future, pragmatic, multi-site, definitive RCT of acupuncture in the ED. TRIAL REGISTRATION NUMBER: NCT04880733 (ClinicalTrials.gov).

Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study.

PURPOSE: Pain accounts for up to 78% of emergency department (ED) patient visits and opioids remain a primary method of treatment despite risks of addiction and adverse effects. While prior acupuncture studies are promising as an alternative opioid-sparing approach to pain reduction, successful conduct of a multi-center pilot study is needed to prepare for a future definitive randomized control trial (RCT). METHODS: Acupuncture in the Emergency Department for Pain Management (ACUITY) is funded by the National Center for Complementary and Integrative Health. The objectives are to: conduct a multi-center feasibility RCT, examine feasibility of data collection, develop/deploy a manualized acupuncture intervention and assess feasibility/implementation (barrier/facilitators) in 3 EDs affiliated with the BraveNet Practice Based Research Network.Adults presenting to a recruiting ED with acute non-emergent pain (e.g., musculoskeletal, back, pelvic, noncardiac chest, abdominal, flank or head) of ≥4 on a 0-10-point Numeric Rating Scale will be eligible. ED participants (n = 165) will be equally randomized to Acupuncture or Usual Care.At pre-, post-, and discharge time-points, patients will self-assess pain and anxiety using the Numeric Rating Scale. Pain, anxiety, post-ED opioid use and adverse events will be assessed at 1 and 4 weeks. Opioid utilization in the ED and discharge prescriptions will be extracted from patients' electronic medical records.Acupuncture recipients will asked to participate in a brief qualitative interview about 3 weeks after their discharge. ED providers and staff will also be interviewed about their general perspectives/experiences related to acupuncture in the ED and implementation of acupuncture in ACUITY. RESULTS: Recruitment began on 5/3/21. As of 12/7/21: 84 patients have enrolled, the responsive acupuncture intervention has been developed and deployed, and 26 qualitative interviews have been conducted. CONCLUSION: Successful conduct of ACUITY will provide the necessary framework for conducting a future, multi-center, definitive RCT of acupuncture in the ED. CLINICAL TRIALSGOV: NCT04880733 https://clinicaltrials.gov/ct2/show/NCT04880733.

Effectiveness of traditional Chinese "gua sha" therapy in patients with chronic neck pain: a randomized controlled trial.

OBJECTIVE: Gua sha is a traditional East Asian healing technique where the body surface is press-stroked with a smooth-edged instrument to intentionally raise therapeutic petechiae. A traditional indication of Gua sha is neck pain; no data from controlled trials exist to support this claim. The researchers aimed to investigate the effectiveness of Gua sha in the symptomatic treatment of chronic neck pain. DESIGN: The study was designed as an open randomized controlled clinical trial. SETTING: The study was set in Kliniken Essen-Mitte, Academic Teaching Hospital of the University Duisburg-Essen, Germany. SUBJECTS: Forty-eight outpatients (58.5±8.0 years; 41 female) with chronic mechanical neck pain were the subjects of the study. INTERVENTION: Patients were randomized into Gua sha (N=24) or control groups (N=24) and followed up for 7 days. Gua sha patients were treated once with Gua sha, while control patients were treated with a local thermal heat pad. OUTCOME MEASURES: Primary outcome was change of neck pain severity after 1 week as assessed by visual analog scale. Secondary outcomes included pain at motion, the neck disability index (NDI) and quality-of-life (Short-Form [36] Health Survey). RESULTS: Neck pain severity after 1 week improved significantly better in the Gua sha group compared with the control group (group difference -29.9 mm, 95% confidence interval: -43.3; -16.6 mm; P<0.001). Significant treatment effects were also found for pain at motion, scores on the NDI, and dimensions of quality-of-life. The treatment was safe and well tolerated. CONCLUSION: Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain. The value of Gua sha in the long-term management of neck pain and related mechanisms remains to be clarified.

Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded Project.

OBJECTIVE: The aim of this article is to describe the consensus process used to develop an acupuncture intervention protocol for an NIH-funded pragmatic randomized controlled trial (PRCT) of acupuncture for the management of chronic low back (cLBP) in older adults (BackInAction). BACKGROUND: CLBP is among leading causes of disability worldwide: almost 33% of US adults 65 and older experience LBP. Acupuncture is effective for cLBP but there is no specific data on older adults. The National Institutes for Health (NIH) funded a PRCT of acupuncture needling for this population. An essential trial milestone was development of a consensus intervention protocol. METHODS: An Acupuncture Advisory Panel (AAP) was formed with nine members: two physician-acupuncturists, six licensed acupuncturists representing diverse work backgrounds, and an acupuncture researcher. We used a modified Delphi process that included provision of acupuncture trial data, survey data describing how each expert treats cLBP, three conference calls, and between-call email discussion. RESULTS: Lively and professional discussions led to a consensus intervention protocol for the BackInAction trial that included steps/staging of care, recommendations for parameters of care session length, number of needle insertion sites, insertion depths, needle retention times, recommended types of needles, both local and distal areas of the body to be treated, acupuncture point options, auricular point options, self-care options, and minimum number of sessions considered ideal. CONCLUSION: Using a modified Delphi process, an expert AAP created a consensus intervention protocol for the PRCT of acupuncture needling for cLBP in patients 65 and older.

Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot.

Objective: To identify factors associated with implementing bundled group acupuncture and yoga therapy (YT) to treat underserved patients with chronic pain in community health center (CHC) settings. This is not an implementation science study, but rather an organized approach for identification of barriers and facilitators to implementing these therapies as a precursor to a future implementation science study. Design: This study was part of a single-arm feasibility trial, which aimed to test the feasibility of bundling GA and YT for chronic pain in CHCs. Treatment outcomes were measured before and after the 10-week intervention period. Implementation feasibility was assessed through weekly research team meetings, weekly yoga provider meetings, monthly acupuncture provider meetings, and weekly provider surveys. Settings: The study was conducted in New York City at two Montefiore Medical Group (MMG) sites in the Bronx, and one Institute for Family Health (IFH) site in Harlem. Subjects: Participants in the feasibility trial were recruited from IFH and MMG sites, and needed to have had lower back, neck, or osteoarthritis pain for >3 months. Implementation stakeholders included the research team, providers of acupuncture and YT, referring providers, and CHC staff. Results: Implementation of these therapies was assessed using the Consolidated Framework for Implementation Research. We identified issues associated with scheduling, treatment fidelity, communication, the three-way disciplinary interaction of acupuncture, yoga, and biomedicine, space adaptation, site-specific logistical and operational requirements, and patient-provider language barriers. Issues varied as to their frequency and resolution difficulty. Conclusions: This feasibility trial identified implementation issues and resolution strategies that could be further explored in future implementation studies. Clinical Trial Registration No.: NCT04296344.