Acupuncture for cancer pain: protocol for a pilot pragmatic randomised controlled trial

Abstract

IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023

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“…As an integral part of TCM, acupuncture has been used to treat pain for thousands of years. e complications of acupuncture in the treatment of pain diseases are fewer than those of drug treatment [32]. Wang Limei et al reported that [33] Evidence-Based Complementary and Alternative Medicine pneumothorax, dizziness, pain, needle syncope, infection, and visceral puncture can occur due to improper acupuncture manipulation; however, when doctors master anatomical knowledge, perform acupuncture correctly, and sterilise needles strictly, complications are further reduced.…”

Acupuncture combined with opioids for cancer pain: a pilot pragmatic randomized controlled trial

“…Z2017-184-01) and Royal Melbourne Institute of Technology (RMIT) University Human Research Ethics Committee (reference no 21361) with registration at Chictr.org.cn (identifier ChiCTR1800017023) on 9 July 2018, and the protocol of this pilot trial has been published following peer review. 15…”

“…3 In addition to routine pain management, participants allocated to the acupuncture group were provided acupuncture treatment according to the protocol approved by peer review and published previously. 15 The acupuncture treatments were administered by a licensed acupuncturist with more than 3 years' acupuncture experience in accordance with the guidelines for providing acupuncture treatment for cancer patients, 17 daily for the first 2 days of the trial and once every 2 days for the remainder (days 4/6). The duration of the treatment course was 1 week from the day after patients were enrolled into the study.…”

“…(3) compliance with the schedule of outcome assessments; (4) influence of missing data by comparing the differences of results according to intention-to-treat (ITT) and per-protocol (PP) analyses; and (5) feasibility of the method used for minimization/randomization/allocation by comparing the baseline differences between groups. 15…”

Patient‐centred, self‐administered acupressure for Chinese advanced cancer patients experiencing fatigue and co‐occurring symptoms: A pilot randomised controlled trial

“…Such an individualised approach in acupoint selection is consistent with the emphasis of patient‐centred interventions, which are interventions altered to address the individual needs of care recipients (Lauver et al., 2002). Although individualised protocols are increasingly used in acupuncture trials (Conboy et al., 2016; He et al., 2019; Landgren, Tiberg, & Hallström, 2015), they have not been tested in any self‐administered acupressure studies.…”