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

Li, Jinling; Liu, Cun‐Zhi; Zhang, Na; Yan, Chao-Qun; Tu, Jian‐Feng; Wang, Yu; Qi, You-Sheng; Liu, Junhong; Wang, Xu

doi:10.1186/s13063-020-04908-9

Cited by 6 publications

(3 citation statements)

References 53 publications

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“…However, the mechanism behind it was unelucidated. 20,21 It could also be possible that the effect of sham acupuncture was regression to the mean because we did not have a waiting list control. However, the previous study testing the effect of acupuncture on TTH showed that it was unlikely to be only an effect of regression to the mean, in which participants in the waiting list control group had a response rate of 4%.…”

Section: Discussionmentioning

confidence: 99%

Acupuncture for Patients With Chronic Tension-Type Headache

et al. 2022

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Background and Objectives:Whether acupuncture is effective for chronic tension-type headache (CTTH) is inconclusive. We aimed to examine the effectiveness of acupuncture with a follow-up period of 32 weeks.Methods:We conducted a randomized controlled trial, and 218 participants who were diagnosed with CTTH were recruited from June 2017 to September 2020. The participants in the intervention group received 20 sessions of true acupuncture (TA group) over 8 weeks. The acupuncture treatments were standardized across participants, and each acupuncture site was needled to achieve deqi sensation. Each treatment session lasted 30 minutes. The participants in the control group received the same sessions and treatment frequency of superficial acupuncture (SA group)—defined as a type of sham control by avoiding deqi sensation at each acupuncture site. The main outcome was the responder rate at 16 weeks after randomization (week 16) and was followed up at week 32. A responder was defined as a participant who reported at least a 50% reduction in the monthly number of headache days (MHDs).Results:Our study included 218 participants (mean age: 43.1 years, mean disease duration: 130 months, MHDs: 21.5 days). The responder rate was 68.2% in the TA group (n=110) versus 48.1% in the SA group (n=108) at week 16 (odds ratio, 2.65; 95%CI, 1.5 to 4.77; p<0.001); and it was 68.2% in the TA group versus 50% in the SA group at week 32 (odds ratio, 2.4; 95%CI, 1.36 to 4.3; p<0.001). The reduction in MHDs was 13.1±9.8 days in the TA group versus 8.8±9.6 days in the SA group at week 16 (mean difference, 4.3 days; 95%CI, 2.0 to 6.5; p<0.001), and the reduction was 14±10.5 days in the TA group versus 9.5±9.3 days in the SA group at week 32 (mean difference, 4.5 days; 95%CI, 2.1 to 6.8; p<0.001). Four mild adverse events were reported; three in the TA group versus one in the SA group.Conclusion:The 8-week TA treatment was effective for the prophylaxis of CTTH. Further studies might focus on the cost-effectiveness of the treatment.TrialRegistration Information: ClinicalTrials.gov: NCT03133884 (https://clinicaltrials.gov/ct2/show/NCT03133884)Classification of Evidence:This study provides Class I evidence that acupuncture (achieving deqi sensation) reduces mean headache days (per month) in patients with chronic tension-type headache.

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Section: Discussionmentioning

confidence: 99%

Acupuncture for Patients With Chronic Tension-Type Headache

et al. 2022

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“…Patients will then be randomized into the control arm or the intervention arm. Considering previous studies [ 15 , 16 ], patients who have received TCM treatment within 1 week prior to the trial will be subject to a 2-week washout period, counting from their last TCM treatment date. They will be requested to stop any form of acupuncture before beginning the trial.…”

Section: Methodsmentioning

confidence: 99%

Heat and Acupuncture to Manage Osteoarthritis of the Knee (HARMOKnee): Protocol for an Effectiveness-Implementation Hybrid Randomized Controlled Trial

Tan,

Tan

et al. 2024

JMIR Res Protoc

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Background Knee osteoarthritis (KOA) is one of most prevalent and fastest-growing causes of pain, impaired mobility, and poor quality of life in the rapidly aging population worldwide. There is a lack of high-quality evidence on the efficacy of traditional Chinese medicine (TCM), particularly acupuncture, and a lack of KOA practice guidelines that are tailored to unique population demographics and tropical climates. Objective Our HARMOKnee (Heat and Acupuncture to Manage Osteoarthritis of the Knee) trial aims to address these gaps by evaluating the short- and medium-term clinical and cost-effectiveness of acupuncture with heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, we aim to inform evidence-based practice for patients with KOA to facilitate the large-scale implementation of a comprehensive and holistic model of care that harmonizes elements of Western medicine and TCM. We hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone. Methods A multicenter, pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomized controlled trial will be conducted. We intend to recruit 100 patients with KOA randomized to either the control arm (standard care only) or intervention arm (acupuncture with heat therapy, in addition to standard care). The inclusion criteria are being a community ambulator and having primary KOA, excluding patients with secondary arthritis or previous knee replacements. The primary outcome measure is the Knee Osteoarthritis Outcome Score at 6 weeks. Secondary outcome measures include psychological, physical, quality of life, satisfaction, and global outcome measures at 6, 12, and 26 weeks. A mixed method approach through an embedded process evaluation will facilitate large-scale implementation. An economic evaluation will be performed to assess financial sustainability. Results Patient enrollment has been ongoing since August 2022. The recruitment process is anticipated to conclude by July 2024, and the findings will be analyzed and publicized as they are obtained. As of November 6, 2023, our patient enrollment stands at 65 individuals. Conclusions The findings of our HARMOKnee study will contribute substantial evidence to the current body of literature regarding the effectiveness of acupuncture treatment for KOA. Additionally, we aim to facilitate the creation of standardized national guidelines for evidence-based practice that are specifically tailored to our unique population demographics. Furthermore, we seek to promote the adoption and integration of acupuncture and heat therapy into existing treatment models. Trial Registration ClinicalTrials.gov NCT05507619; https://clinicaltrials.gov/study/NCT05507619 International Registered Report Identifier (IRRID) DERR1-10.2196/54352

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“…This randomized controlled neuroimaging trial was approved by the ethic committee of Dongzhimen Hospital in Beijing University of Chinese Medicine (DZMEC-KY-2017-53-02), preregistered in Chinese Clinical Trial Registry (ChiCTR1900025807), 42 and conducted in accordance with the Declaration of Helsinki. Because of the coronavirus pandemic, the second stage of the intended crossover design was not continued for the participants.…”

Section: Methodsmentioning

confidence: 99%