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

An international panel including patients, clinicians, researchers, acupuncture and surgery trialists, statisticians, and experts in clinical epidemiology and methodology have developed new guidance for randomised controlled trials in acupuncture. It addresses the most prevalent and critical concerns of current acupuncture trials and will help funding agencies, trial registers, and journal editors to evaluate the relevance, importance, and quality of submitted trial proposals and completed trials

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“…Example 2: A pragmatic acupuncture randomised controlled for the management of chronic low back in older adults 57 …”

Section: Fine Tuning the Flexibility Of Intervention And Comparatormentioning

confidence: 99%

How to design high quality acupuncture trials—a consensus informed by evidence

Zhang

Jiao

Witt

et al. 2022

BMJ

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“…To assess fidelity, we will determine the proportion of patients who are treated in a manner consistent with the manualized intervention and treatment fidelity parameters determined by consensus of acupuncture experts. We expect treatment fidelity measures will include: the dose (minimum number of needles, minimum points treated, minimum duration of needle retention time), and the delivery (was the intervention delivered as planned or cut short due to ED flow) [57] . Acupuncture documentation will be reviewed of all acupuncture participants and to assess manual fidelity.…”

Section: Method/designmentioning

confidence: 99%

“…We expect treatment fidelity measures will include: the dose (minimum number of needles, minimum points treated, minimum duration of needle retention time), and the delivery (was the intervention delivered as planned or cut short due to ED flow). [57] Acupuncture documentation will be reviewed of all acupuncture participants and to assess manual fidelity. Additionally, the review will evaluate the proportion of cases when acupuncturists treated the patient "off manual" and their reasoning, as well as assess whether minimum standards for number of needles used, points treated, and needle retention time were met.…”

Section: Secondary Objectivesmentioning

confidence: 99%

Acupuncture in the emergency department for pain management

et al. 2022

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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 opioidsparing 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.

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“…54 The process of forming a consensus-based intervention protocol, sometimes called manualization, 54–56 describes one such adaptation that seeks to strike a balance between standardization and flexibility in acupuncture research 55 for trials on depression, 57 stroke 58,59 and chronic pain. 54,56,60,61 The Delphi process, developed by the RAND Corporation, is widely used for convergence of expert opinion within certain topic areas. 62 It is part of the development of research protocols and manuals 63 and typically involves a formal process of using questionnaires to gather information from experts, summarizing areas of consensus and reviewing with experts one or more times until consensus is obtained.…”

Section: Modified Delphi Processmentioning

confidence: 99%

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

Nielsen

Olson²,

Quesada

et al. 2022

Acupunct Med

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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).

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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

Cited by 12 publications

References 58 publications

How to design high quality acupuncture trials—a consensus informed by evidence

How to design high quality acupuncture trials—a consensus informed by evidence

Acupuncture in the emergency department for pain management

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

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