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Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol.

ABSTRACT: BACKGROUND:Acupuncture therapy is frequently used to treat Knee Osteoarthritis (KOA) in clinic, and usually used local acupoints near the diseased knees as therapeutic targets. Some local acupoints appeared sensitization phenomenon which was called sensitized acupoints, which were regarded as important therapeutic targets to get better therapeutic effect on clinic. Therefore, it is necessary to explore the biological basis of acupoint sensitization. Meanwhile, there is a lack of an analysis of the metabolism for sensitized acupoints in KOA patients. Considering that acupuncture effect could be multi-targeted, omics (such as metabolomics) may be a useful method to reveal the relationship between sensitized acupoints and clinical efficacy of acupuncture. METHODS AND ANALYSIS:This study is a parallel design trial. Thirty KOA patients and 30 healthy volunteers will be recruited in this study. Mechanical pain threshold will be measured by Electron Von frey in order to confirm the highest sensitized acupoints. Then collect tissue fluid from the highest sensitized acupoints by micro dialysis technical, then apply electro-acupuncture method on the highest sensitized acupoints to treat KOA patients, after 20 sessions treatments, measure and collect again. Liquid chromatography-tandem mass spectrometry method will be used to analyze the metabonomics of dialysate. RESULTS:This study will provide a high-quality evidence to reveal the local molecular mechanism of acupuncture sensitized acupoints for patient with KOA. CONCLUSION:This study will provide up-date evidence of whether acupuncture sensitized acupoints have local molecular mechanism for KOA. TRIAL REGISTRATION NUMBER:NCT03599180 (24 Jul. 2018).

SUBMITTER: Li S

PROVIDER: S-EPMC6855587 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol.

Li Sheng S Chai Xiao Ning XN Zuo Chuan Yi CY Lv Peng P Tang Yong Y Tan Hui Juan HJ Liu Li Zhou LZ Yin Hai Yan HY Yu Shu Guang SG

Medicine 20191101 45

<h4>Background</h4>Acupuncture therapy is frequently used to treat Knee Osteoarthritis (KOA) in clinic, and usually used local acupoints near the diseased knees as therapeutic targets. Some local acupoints appeared sensitization phenomenon which was called sensitized acupoints, which were regarded as important therapeutic targets to get better therapeutic effect on clinic. Therefore, it is necessary to explore the biological basis of acupoint sensitization. Meanwhile, there is a lack of an analy ...[more]

PMID: 31702640

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Project description:BackgroundAlthough previous clinical studies suggest possible benefits of acupuncture for knee osteoarthritis (KOA), the value of acupuncture at sensitized points is uncertain. We aimed to preliminarily assess the feasibility of performing a definitive randomized controlled trial to explore the effectiveness of acupuncture for KOA with highly sensitized acupoints.MethodsIn this randomized, single-blind, parallel, pilot trial, 36 participants with KOA were randomly assigned to receive acupuncture at highly sensitized acupoints (high-sensitization group) or at low/non-sensitized points (low/non-sensitization group) by a computer-generated random sequence. Both groups received three treatment sessions per week for four consecutive weeks (12 sessions in total). Assessments were performed at screening and at 4, 8, 12, and 16?weeks after randomization. Primary feasibility outcomes were patient recruitment, retention rate, and adherence to group treatment. Secondary outcomes included the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score from baseline to 16?weeks, the change of Short Form (SF)-12 health survey score, and safety outcomes.ResultsPatient recruitment of 36 patients took 2 months, achieving the recruitment target. Retention rates were similar between the treatment groups, 14 (77.8%) patients in the high-sensitization group completed the 16-week follow-up and compared to 14 (77.8%) patients in low/non-sensitization group, but the result was lower than expected. All patients received at least ten treatment sessions in total. The WOMAC total score and the pain, stiffness, and physical function score in the high-sensitization group were lower or very close to those in the control group at each assessment point. Similar results were observed on quality of life. No adverse events occurred.ConclusionThis trial has presented preliminary data on the feasibility of conducting a large trial to test the effectiveness of acupuncture at sensitized points in KOA patients.Trial registrationClinicalTrials.gov, NCT03008668. Registered on 26 December 2016-retrospectively registered.

Project description:Background Knee osteoarthritis (OA) presented with knee pain and limitation of mobility is common, and it may become a chronic problem resulting in major loss of function, with related impaired activity of daily living. Current traditional therapy for knee OA includes pharmacological treatment and physiotherapy, but the efficacies are limited. An alternative noninvasive treatment low-level laser therapy (LLLT) applied to acupoints is still contradictory and the efficacy needs to be assessed. Methods and Materials We conduct the randomized double-blind control study to investigate the efficacy of a dual-frequency LLLT (combines red light (780?nm) and near-infrared light (830?nm)) in patients suffering knee OA. Participates were randomly assigned into active laser therapy (ALT) and placebo laser therapy (PLT) groups. Subjects in the ALT group were separately treated by laser apparatus at the three acupoints (SP9, SP10, and EX-LE2) on their knee joints under continuous radiation for 15?min at the maximum intensity, three times per week for four weeks. The PLT group used laser apparatus of the same model according to similar procedures without laser light emission. Outcome Measurements including visual analog scale (VAS), pain pressure threshold (PPT), and Lequesne index were used. Results A total of 30 subjects with two-sided knee OA in both groups completed the experiment. Statistically significant decreases were observed in the Lequesne index (5.27?±?3.26 vs. 10.83?±?3.83), conscious VAS 4 weeks after treatment (moving: 2.87?±?1.13 vs. 5.67?±?1.72; resting: 0.33?±?0.62 vs. 2.67?±?1.29), and the increase was noted in PPT (21.23?±?1.82?kg vs. 13.02?±?1.46?kg) in the ALT group compared with the PLT group. Conclusion It appears that the knee OA pain and disability can be decreased after a dual-frequency LLLT applied to acupoints (SP9, SP10, and EX-LE2). The clinical efficacy of LLLT is highly related to the therapeutic settings of the laser apparatus; hence, more clinical trials with diffident parameter settings are needed to be further clarified.

Project description:IntroductionMillions of patients are currently suffering from pain and dysfunction caused by osteoarthritis (OA), and billions of dollars have been invested into treatment. Because there is no effective treatment that can reverse the progression of knee OA, it is important to determine the risk factors that may influence the progression. However, although there are many studies that examine risk factors for progression, there are only a few that specifically focus on the impact of each risk factor for predicting progression of knee OA. This study aimed to develop a cohort of patients with primary knee OA in the Beijing area to establish models that identify the influence of each risk factor on the prediction of knee OA progression.Methods and analysisThis is a prospective, multicentre, hospital-based cohort study. The study population comprises 2000 patients with primary knee OA from the Beijing area. The recruitment and baseline visits started in December 2017 and will finish in November 2018. After baseline visits, the patients will be followed for 3 years or until the occurrence of primary outcomes. Demographic variables will be collected during the baseline visit. Influencing factors including occupational exposures, family history and treatment will be collected at baseline and each follow-up visit. The primary outcome measure is a comprehensive index which will be combined with clinical WOMAC score, imaging K-L grade and clinical outcomes. These data will also be collected at baseline and each follow-up visit.Ethics and disseminationThis study protocol has been approved by Peking University Third Hospital Medical Science Research Ethics Committee. All the eligible participants will give written informed consent. The findings will be published in peer-reviewed journals and presented at national or international conferences. Besides, the results will be disseminated to all participants via the social software 'WeChat'.Trial registration numberChiCTR-ROC-17013790; preresults.

Dataset Information

Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol.

Publications

Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol.

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