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Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial.

ABSTRACT: BACKGROUND:Acupuncture, as one of the promising non-pharmacological interventions, has been proved to be beneficial for patients. However, the magnitude of acupuncture's specific and nonspecific effects, as well as their neurological and psychological determinants, remains unclear. Therefore, this study is designed to examine the acupuncture efficacy, investigate whether the brain mechanisms between the specific and nonspecific effects of acupuncture are different, and to evaluate how psychological factors affect the acupuncture effects. METHODS:This is a randomized, controlled, crossover clinical trial. A total of 60 patients with knee osteoarthritis will receive 4?weeks of acupuncture treatment and 4?weeks of sham acupuncture treatment in a random order separated by a washout period of 2?weeks. The changes in clinical characteristics based on pain-related scales will be assessed to investigate the clinical efficacy of acupuncture. Resting state functional magnetic resonance imaging (fMRI) scans will be used to identify the brain activity changes related to the specific and nonspecific effects of acupuncture. The questionnaires of psychological factors will be used to evaluate patients' psychological properties. Correlation and mediation analyses will be conducted among psychological factors, brain activity changes, and symptoms improvement to explore the neurological and psychological correlates of the acupuncture effects. DISCUSSION:This study will concentrate on distinguishing and clarifying the specific and nonspecific effects of acupuncture. The results of this study may contribute to rationally optimize the acupuncture therapies by flexible application of the specific and nonspecific effects of acupuncture. TRIAL REGISTRATION:Chinese Clinical Trial Registry ChiCTR1900025807 . Registered on 9 September 2019.

SUBMITTER: Li JL

PROVIDER: S-EPMC7706223 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial.

Li Jin-Ling JL Liu Cun-Zhi CZ Zhang Na N Yan Chao-Qun CQ Tu Jian-Feng JF Wang Li-Qiong LQ Qi You-Sheng YS Liu Jun-Hong JH Wang Xu X

Trials 20201130 1

<h4>Background</h4>Acupuncture, as one of the promising non-pharmacological interventions, has been proved to be beneficial for patients. However, the magnitude of acupuncture's specific and nonspecific effects, as well as their neurological and psychological determinants, remains unclear. Therefore, this study is designed to examine the acupuncture efficacy, investigate whether the brain mechanisms between the specific and nonspecific effects of acupuncture are different, and to evaluate how ps ...[more]

PMID: 33256796

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Project description:Background Acupuncture is one of the most popular complementary and alternative treatments for knee osteoarthritis (KOA). There are many methods of acupuncture in the treatment of KOA, and the effects are different. According to our clinical observations and researches, it is found that manual acupuncture (MA), electro-acupuncture (EA), and warm acupuncture (WA) are used more frequently in the treatment of KOA, and the curative effects are satisfactory. However, there is currently a lack of efficacy comparison of efficacy between different acupuncture treatments, as well as a lack of standardized clinical research on the acupuncture treatment of KOA. Therefore, we will carry out a high-quality clinical randomized controlled trial to research the effect laws of MA, EA, and WA on KOA. Methods/design A total of 200 eligible participants with KOA will be randomly assigned to group A, B, C, or D in a ratio of 1:1:1:1. Patients in group A will receive MA, while those in group B, group C, and group D will be treated with EA, WA, and sham acupuncture (SA), respectively. Patients will be treated with acupuncture once a day, 30 min per session, 5 sessions per week for 4 weeks. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes include WOMAC, visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline and weeks 4, 8, and 12 respectively after randomization. Discussion This is a randomized controlled trial. We will observe the clinical effect of MA, EA, and WA on KOA to research the effect laws of these three acupuncture treatments on KOA and set up standardized treatment programs for acupuncture for KOA. Trial registration China Clinical Trials Registry ChiCTR2100049526. Registered on August 2, 2021 Supplementary Information The online version contains supplementary material available at 10.1186/s13063-022-06653-7.

Project description:INTRODUCTION:There is a lack of curative medical treatment for patients with knee osteoarthritis (KOA). Acupuncture represents an important alternative therapy. According to the theory of traditional Chinese medicine and preliminary clinical evidence, the patients' acupoints and tender points may become sensitised when the body suffers from a disease state; stimulation of such sensitive points could lead to a disease improvement. It is thus hypothesised that acupuncture at highly sensitised points on patients with KOA would achieve better treatment outcomes than acupuncture at low/non-sensitised points. Previously, we conducted a pilot trial to prove the feasibility of further investigation. METHODS AND ANALYSIS:A three-arm, parallel, multicentre randomised controlled trial of 666 patients will be conducted at four hospitals of China. Eligible patients with KOA who consent to participate will be randomly assigned to a high-sensitisation group (patients receive acupuncture treatment at high-sensitive points), a low/non-sensitisation group (patients receive acupuncture treatment at low/non-sensitive points) or a waiting-list group (patients receive standard acupuncture treatment after the study is concluded) via a central randomisation system using 1:1:1 ratio. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index total score from baseline to 16 weeks. Outcome assessors and data analysts will be blinded and participants will be asked not to reveal their allocation to assessors. The outcome analyses will be performed both on the intention-to-treat and per-protocol population. The primary analyses will test if acupuncture at highly sensitised points would achieve statistically better treatment outcomes than acupuncture at low/non-sensitised points and no acupuncture (ie, waiting list), respectively. A small number of prespecified subgroup analyses will be conducted. ETHICS AND DISSEMINATION:Ethics approval has been granted by the Bioethics Subcommittee of West China Hospital, Sichuan University: 2017 (Number 228). Results will be expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03299439.

Dataset Information

Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial.

Publications

Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial.

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