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Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial.

ABSTRACT: BACKGROUND:Acupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence. This study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA. METHODS/DESIGN:This is a multi-center three-arm randomized controlled trial. It will enroll 480 participants with KOA in China. Participants will be randomly assigned 1:1:1 to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8?weeks. The primary outcome is the response rate, which is the proportion of patients who achieve the minimal clinically important improvement in pain and function at 8?weeks. The primary outcome will be analyzed using the Z-test with the intention-to-treat set. Secondary outcomes include pain, function, global patient assessment, and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data. DISCUSSION:The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and to enhance the transparency of the trial. The aim of the trial is to provide high-quality evidence on the efficacy of acupuncture for KOA. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03366363 . Registered on 20 November 2017.

SUBMITTER: Tu JF

PROVIDER: S-EPMC6610899 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial.

Tu Jian-Feng JF Yang Jing-Wen JW Wang Li-Qiong LQ Wang Yang Y Li Jin-Ling JL Zhang Na N Lin Lu-Lu LL Yu Zhang-Sheng ZS Liu Cun-Zhi CZ

Trials 20190704 1

<h4>Background</h4>Acupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence. This study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA.<h4>Methods/design</h4>This is a multi-center three-arm randomized controlled trial. It will enroll 480 participants with KOA in China. Participants will be randomly assigned 1:1:1 to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupunct ...[more]

PMID: 31272488

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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:BackgroundInflammation plays a significant role in the pathogenesis of knee osteoarthritis (KOA). Although both electro-acupuncture (EA) and manual acupuncture (MA) are known to influence systemic inflammation, little is known about the potential changes in inflammation as a working mechanism of EA and MA in KOA.MethodsData from the Acupuncture for Knee Osteoarthritis Trial (ATKOA) were used. Serum concentrations of inflammatory factors (tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), IL-6, IL-8, IL-18, IL-4, IL-10, IL-13, IL-15, IL-17, monocyte chemotactic protein-1 (MCP-1), CC-chemokine ligand 5 (CCL5), and cartilage degradation biomarkers (matrix metalloproteinase-1 MMP-1, MMP-3, MMP-13 and cartilage oligomeric matrix protein COMP)) were measured at baseline and after 8 weeks of treatment. Clinical outcomes were valid and reliable self-reported pain and function measures for osteoarthritis using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analogue scale (VAS) at baseline and post-treatment.ResultsBoth 8-weeks EA and MA significantly reduced pro-inflammatory cytokines (TNFα, IL-1β), and cartilage degradation biomarkers (MMP-3, MMP-13) significantly increased the anti-inflammatory cytokine IL-13 compared with pre-treatment (p<0.05). Further, the reduction of TNF-α was more significant in EA when compared to MA (p=0.046). While there was no significant difference between groups in cytokines IL-1β (p=0.102), MMP-3 (p=0.113), MMP-13 (p=0.623) or IL-13 (p=0.935). Moreover, in both EA and MA, the effect of acupuncture on the VAS and WOMAC function scale after 8 weeks is clinically important, although no significant differences were found between groups.ConclusionEight weeks of both EA and MA seem to provide improvement in pain relief and function among individuals with mild to moderate knee OA. This benefit is partly mediated by changes of major inflammatory factors TNF-α, IL-1β and IL-13.Trial registrationControlled-Trials.com Identifier: NCT03274713.

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.

Project description:BackgroundPrimary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care.Methods/designThis is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS).DiscussionThis study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual.Trial registrationClinical Trials.gov NCT02783534 . Registered on 26 May 2016.

Dataset Information

Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial.

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Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial.

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