Dataset Information

Myofascial acupuncture versus routine acupuncture for mechanical neck pain: a protocol for a multicentre randomised controlled trial.

ABSTRACT:

Introduction

Mechanical neck pain (MNP) is defined as pain in the area of the neck and/or neck-shoulder provoked by body mechanics and which adversely affects physical, psychological and social function. The treatments for MNP are limited. Previous studies and clinical experience have indicated that myofascial acupuncture might be a better treatment option for MNP, but the efficacy is controversial. Therefore, our aim is to compare the efficacy of myofascial acupuncture and routine acupuncture for MNP.

Methods and analysis

The study is a multicentre, prospective randomised clinical trial. Patients will be recruited from four tertiary hospitals in China. A total of 438 participants with MNP will be randomly assigned into two groups, namely the 'Sancai-Tianbu' myofascial acupuncture group and the routine acupuncture group, at a ratio of 1:1. Each group will receive the acupuncture treatment twice a week for 21 days, totalling six sessions. The primary outcome will be the Visual Analogue Scale score. The secondary outcomes will be the Neck Disability Index, the cervical range of motion and the MOS 36-Item Short Form Health Survey. The assessments will be performed at baseline (immediately after allocation), pretreatment (5 min before every treatment), post-treatment (within 10 min after every treatment), postcourse (within 1 day after the course), and at 1, 3 and 6 months after the course. All patients will be included in the intent-to-treat analysis. Repeated-measure analysis of covariance will be used to determine the effects of the intervention on the outcome measures.

Ethics and dissemination

Ethics approval was obtained from China Aerospace Science & Industry Corporation 731 Hospital, with permission number 2022-0204-01. Written informed consent will be obtained from the enrolled patients. Trial results will be disseminated in peer-reviewed publications.

Trial registration number

ChiCTR2200061453.

SUBMITTER: Qiu XH

PROVIDER: S-EPMC10476120 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Myofascial acupuncture versus routine acupuncture for mechanical neck pain: a protocol for a multicentre randomised controlled trial.

Qiu Xing-Hua XH Yang Xing-Yue XY Wang Yu-Yu YY Tian Su-Ling SL Yan Yan-Bin YB Xu An-Ping AP Fu Fei F Wen Feng-Yun FY Yang Yang Y Zhang Yang Y Zhang Yu-Qin YQ Yang Zhi-Wen ZW Xu Chang C Sun Qian-Hui QH Wu Xiao-Ling XL Dai Xing-Ye XY Li Na N Cheng Kai K

BMJ open 20230831 8

<h4>Introduction</h4>Mechanical neck pain (MNP) is defined as pain in the area of the neck and/or neck-shoulder provoked by body mechanics and which adversely affects physical, psychological and social function. The treatments for MNP are limited. Previous studies and clinical experience have indicated that myofascial acupuncture might be a better treatment option for MNP, but the efficacy is controversial. Therefore, our aim is to compare the efficacy of myofascial acupuncture and routine acupu ...[more]

PMID: 37652590

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Project description:BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.

Project description:IntroductionDiscogenic low back pain is a common form of chronic low back pain. In traditional Chinese medicine, combinations of acupuncture and herbal medicine are frequently used to manage this condition. However, evidence for the efficacy of a combined approach remains scarce. To address this gap, we designed a multicentre, randomised controlled trial to compare the effects of the combined use of acupuncture and Chinese herbal medicine, and their separate applications along with non-steroidal anti-inflammatory drugs, in treating discogenic low back pain.Methods and analysisThis is a multicentre, prospective, randomised, four-arm, parallel-controlled trial involving patients with discogenic low back pain. Patients will be randomly divided into four groups (acupuncture combined with herbal medicine, acupuncture, herbal medicine and positive drug control) at a 1:1:1:1 ratio. All patients will undergo a 4-week treatment regimen consisting of acupuncture (active or sham acupuncture) and oral medication (herbal medicine or placebo granules and celecoxib or placebo capsules), as well as a 3-month follow-up assessment. The primary outcome measure will be pain intensity, measured using the Visual Analogue Scale after a 4-week treatment period. Secondary outcome measures will include the lumbar pressure pain threshold, pain-related disability measured using the Oswestry Disability Index, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, 36-Item Short-Form Health Survey and incidence of adverse events. Assuming an SD of 1.8, minimal clinically important difference of 1.5 and a 10% dropout rate, at least 97 participants per group are needed, totalling 388 participants.Ethics and disseminationThe study was approved by the Ethics Committee of Dongzhimen Hospital Affiliated with Beijing University of Chinese Medicine (approval number: 2024DZMEC-083-03) and the other seven participating subcentres. All participants will provide written informed consent. This trial will be conducted in accordance with the principles outlined in the Declaration of Helsinki and its amendments. This work will be disseminated through the publication of peer-reviewed manuscripts.Trial registration numberChiCTR2400082428.

Project description:IntroductionPain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.Methods and analysisWe describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.Ethics and disseminationThe Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.Trial registration numberNCT04095234.

Project description:ObjectiveTo assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura.DesignMulticentre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician.SettingSeven hospitals in China, 5 June 2016 to 15 November 2018.Participants150 acupuncture naive patients with episodic migraine without aura.Interventions20 sessions of manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks.Main outcome measuresChange in migraine days and migraine attacks per four weeks during weeks 1-20 after randomisation compared with baseline (four weeks before randomisation).ResultsAmong 150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham (adjusted difference -1.4, 95% confidence interval -2.4 to -0.3; P=0.005) at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham (adjusted difference -2.1, -2.9 to -1.2; P<0.001) at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham (adjusted difference -1.0, -1.5 to -0.5; P<0.001). No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%; P=0.891).ConclusionsTwenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.Trial registrationClinicaltrials.gov NCT02765581.

Dataset Information

Myofascial acupuncture versus routine acupuncture for mechanical neck pain: a protocol for a multicentre randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Myofascial acupuncture versus routine acupuncture for mechanical neck pain: a protocol for a multicentre randomised controlled trial.

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