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Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.

ABSTRACT: INTRODUCTION:Doin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare. METHODS AND ANALYSIS:This multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-effectiveness of acupuncture with Doin therapy. A total of 124 patients (with a neck pain duration of 6?months or longer and a Numeric Rating Scale ?5)?will be recruited at five Korean medicine hospitals. Patients will be randomly allocated to acupuncture with Doin therapy (n=62) and acupuncture alone (n=62) for 5?weeks of treatment. This study will be carried out with outcome assessor and statistician blinding. The primary outcome measure will consist of improvement in neck pain using the Visual Analogue Scale at 6 weeks. The secondary outcomes including measures of pain, functional disability, health-related quality of life and economic evaluation will be conducted at 6 weeks, and 3, 6, 9 and 12 months after treatment ETHICS AND DISSEMINATION: The project is approved by the Institutional Review Board (IRB) of the Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong. Dissemination will occur after the findings from this study are published in other peer reviewed journals. TRIAL REGISTRATION NUMBERS:NCT03558178; KCT0003068; Pre-results.

SUBMITTER: Lee SH

PROVIDER: S-EPMC6530377 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.

Lee Sook-Hyun SH Lee Jinho J Lee Yoon Jae YJ Kim Me-Riong MR Cho Jae Heung JH Kim Koh-Woon KW Ha In-Hyuk IH

BMJ open 20190510 5

<h4>Introduction</h4>Doin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare.<h4>Methods and analysis</h4>This multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-eff ...[more]

PMID: 31079083

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Project description:IntroductionChronic neck pain is a challenging condition to treat in clinical practice and has a considerable impact on quality of life and disability. According to the theory of traditional Chinese medicine, acupoints and tender points may become sensitised when the body is in a diseased state. Stimulation of such sensitive points may lead to disease improvement and improved clinical efficacy. This study aims to evaluate the efficacy and safety of needling at sensitive acupoints in providing pain relief, improvement of cervical vertebral function and quality of life in patients with chronic neck pain.Methods and analysisThis multicentre, randomised controlled, explanatory and parallel clinical trial will include 716 patients with chronic neck pain. Study participants will be randomly assigned in a 1:1:1:1 ratio to four treatment groups: the highly sensitive acupoints group, low/non-sensitive acupoints group, sham acupuncture group and waiting-list control group. The primary outcome will be the change in the visual analogue scale score for neck pain from baseline to 4 weeks. Secondary outcomes will be the Northwick Park Neck Pain Questionnaire and McGill pain questionnaire, 12-item Short-Form health survey, Neck Disability Index, changes in the pressure pain threshold, range of cervical motion, Self-Rating Anxiety Scale, Self-Rating Depression Scale and adverse events before treatment, post-treatment, and at 4, 8, 12, 16 and 20 weeks post-treatment. The intention-to-treat approach will be used in the statistical analysis. Group comparisons will be undertaken using χ2 tests for categorical characteristics, and analysis of variance for continuous variables to analyse whether acupuncture in the highly sensitive acupoints group achieves better treatment outcomes than in each of the other three groups.Ethics and disseminationEthical approval of this study has been granted by the local Institutional Review Board (ID: 2017 KL-038). The outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration numberChiCTR1800016371; Pre-results.

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: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.

Project description:BACKGROUND: Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). METHODS/DESIGN: Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary variables, we will record the changes in diurnal pain intensity on a visual analogue scale (VAS), nocturnal pain intensity on the VAS, doses of non-steroid anti-inflammatory drugs (NSAIDs) taken during the study period, credibility scale for the treatment, degree of improvement perceived by the patient and degree of improvement perceived by the evaluator. A follow up examination will be made at 3, 6 and 12 months after the study period has ended. Two types of population will be considered for analysis: per protocol and per intention to treat. DISCUSSION: The discussion will take into account the limitations of the study, together with considerations such as the choice of a simple, safe method to treat this shoulder complaint, the choice of the control group, and the blinding of the patients, evaluators and those responsible for carrying out the final analysis.

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Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.

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Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.

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