BackgroundSciatica is a relatively frequent illness that easily becomes a chronic and relapsing condition. Although numerous systematic reviews have analyzed various therapies for sciatica, the validity of their included studies is limited. Considering the limitations of conventional treatment options for sciatica, acupuncture is a possible option; however, evidence supporting its efficacy and mechanism in patients with sciatica is lacking. The aim of this proposed protocol is to investigate the effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica.Methods/designThis study is a randomized, patient-assessor blind, two-arm, parallel, non-penetrating, sham-controlled clinical trial. Eligible participants will include adults (aged 19–70 years old) with a clinical diagnosis of chronic sciatica (40 mm or more of a 100-mm visual analog scale (VAS) for bothersomeness) blinded to the treatment received. Patients will be randomly allocated into the acupuncture treatment group (manual acupuncture plus electroacupuncture (EA), n = 34) or the sham acupuncture control group (sham acupuncture plus placebo EA without electrical stimulation, n = 34). Groups will receive treatment twice a week for a total of eight sessions over 4 weeks. Functional magnetic resonance imaging will be implemented at baseline and endpoint to investigate the mechanism of acupuncture. The primary outcome measure is the VAS for bothersomeness and secondary outcomes include the VAS for pain intensity, Oswestry Disability Index, EuroQol 5-Dimension, Coping Strategy Questionnaire, Beck’s Depression Inventory, and State-Trait Anxiety Inventory. Adverse events will be assessed at every visit.DiscussionThe results of this trial (which will be available in 2020) should provide important clinical evidence for the effect of acupuncture and demonstrate how acupuncture can be helpful for the treatment of chronic sciatica.Trial registrationClinicalTrials.gov, ID: NCT03350789. Registered on 15 November 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3164-8) contains supplementary material, which is available to authorized users.
Objective: The aim of this study was to examine the effect of acupuncture on obesity-related parameters with regard to metabolomics. Methods: This two-arm parallel, patient- and assessor-blind, sham-controlled randomized clinical trial included 120 obese participants. Participants were randomized into two groups. The treatment group received a combined intervention of manual acupuncture (MA) plus electroacupuncture (EA), while the control group received a combination of sham acupuncture interventions consisting of sham MA plus sham EA for 6 weeks. The serum lipid levels were measured as the primary outcome measure and anthropometric parameters and serum metabolic profiles including amino acids and carnitines were measured as secondary outcome measures. Results: The serum lipid levels and anthropometric measurements did not significantly differ between groups, while body weight, body mass index (BMI), and waist circumference were improved within each group and the level of high-density lipoprotein cholesterol increased over time in the treatment group. There were no significant differences in amino acid levels between groups, while certain carnitine (C2, C4, C6, and l-carnitine) levels were significantly increased ( p < 0.05) in the treatment group compared to the control group. Conclusion: In summary, 6 weeks of acupuncture treatment did not affect anthropometric and serum metabolic parameters, with the exception of certain carnitines, when compared to sham acupuncture. The observation of increased carnitine levels in the acupuncture group could result in potential long-term benefits to obese individuals. Additional studies are needed to investigate the long-term effects of acupuncture on lipid metabolism and the underlying mechanism of action. Trial registration number: This study is registered at ClinicalTrials.gov (NCT02066090).
Objectives This study was designed to investigate the effects of wet cupping on Wisu (BL12) in non-acute low back pain patients. Methods We recruited 30 participants for this study. Fifteen patients were randomly assigned to the Wisu (BL21) treatment group (WT group) and 15 were assigned to the non-acupoint treatment group (NT group). Both groups were treated with the pricking-cupping bloodletting method three times. Values at baseline and follow-up were analyzed by Wilcoxon signed rank test and the differences between the two groups were determined by Wilcoxon rank sum test. p-values less than 0.05 were considered significant. The primary outcome was the visual analogue scale (VAS), and secondary outcomes were the Oswestry disability index (ODI), Rolland-Morris disability questionnaire (RMDQ), Euroqol-5 dimension questionnaire (EQ-5D) and finger-to-ground distance (FTGD). These outcomes were measured on the day of first treatment before the procedure and on follow-up 7 days after the last treatment. Results Significant changes were identified in the VAS for pain and ODI in each group after wet cupping treatment on Wisu (p<0.05). However, no significant changes were found between groups. Meanwhile, RMDQ and EQ-5D were significantly decreased only in the NT group (p<0.05) without any differences between groups. FTGD was decreased in both groups, but not significantly. Conclusions Wet cupping with both Wisu treatment and non-acupoint had significant effects on non-acute low back pain, although there were no differences between the two groups. A large-scale study is needed to identify the effect of wet cupping on Wisu.
Objectives This study is aimed to identify and evaluate the already developed clinical practice guidelines (CPGs) of temporomandibular disorders (TMD) and contribute to making decisions in developing Korean medicine CPG of TMD. Methods We searched electronic database and selected CPGs of TMD according to the inclusion and exclusion criteria. Then, we made appraisal of selected CPGs by using AGREE II (Appraisal of Guidelines for Research & Evaluation II). Results Four CPGs are included and appraised with AGREE II. Among 6 domains of AGREE II, all CPGs failed to score over 60% in four domains. Only one CPG mentioned acupuncture as an adjunctive treatment for myofascial TMD. Conclusions It is difficult to indicate that included CPGs are with sufficient quality to recommend and it appears not to be appropriate to apply these already developed CPGs in Korean medicine clinical fields. Therefore, developing a new Korean medicine clinical practice guideline of TMD is required.
Objectives Our goal was to review literatures on tool-based manipulation for musculoskeletal diseases with emphasis on guasha and IASTM (Instrument Assisted Soft Tissue Manipulation) by searching foreign and domestic controlled trials. Methods We found literatures published up to August 2016 in electronic databases (OASIS, KoreaMed, KMbase, NDSL, RISS, KISS, MEDLINE/PubMed, EMBASE, Cochrane Central Register of Controlled Trials) without any limitations on language.Results 17 studies were included in the review. 13 out of 17 articles were published within this decade. VAS was the main evaluation tool for most of the articles (14 out of 17). 10 studies showed statistically significant difference between the experimental group and the control group. In terms of materials used for treatment, 6 out of 17 studies used stainless steel. Considering anatomical locations for treatment, trunk area was treated the most, accounting for 7 out of 17 studies. Conclusions Our results show that recently, research on tool-based manipulation treatments for musculoskeletal diseases are actively being performed. Diseases of the vertebral column were the main target for tool-based manipulation treatments, and stainless steel was the most popular and safe material used. Further research should be performed for more accurate data. (J Korean Med Rehabil 2016;26(4):57-65)
Background: Cupping therapy is a common practice in Korean medicine. Despite developments in this clinical and research area, the current knowledge is insufficient to identify the effects of cupping therapy on obesity. We aimed to assess the effects and safety of cupping therapy on obesity by performing a systematic review and meta-analysis of the effects of cupping therapy.Methods: A systematic search of databases was conducted, including MEDLINE/PubMed, EMBASE,
Objectives The purpose of this study is to improve the accessibility of Korean medicine by standardizing managements, improving quality of medical services, and reducing medical costs in ankle sprain by develop clinical pathway (CP). Methods The development of CP in this study is based on clinical practice guideline (CPG) for ankle sprain, and aims to maximize the quality of treatment, such as reducing treatment time and medical costs, and increasing patient satisfaction through standardized pathway. The CP was revised after consultation and review by the advisory committee. The advisory committee is consisted of a stakeholder group applying the CP.Results In previous research studies, there were no Korean medicine CP studies on ankle sprain. Based on CPG for ankle sprain and analysis of medical records, 6 types of time task matrix type CP (for Korean medicine doctors, medical assistant, patients) and 4 types of algorithm type CP (for Korean medicine clinics, Korean medicine hospitals, and cooperative practicing hospitals, public medical centers) were derived as a result. Conclusions Ankle sprain CP is expected to not only increase patient satisfaction and maximize the quality of treatment, but also reduce the financial burden of health insurance by reducing medical costs.
Background: Lumbar herniated nucleus pulposus (L-HNP) is a condition in which fibroblasts escape due to degenerative changes or external forces in the intervertebral disc, causing neurological symptoms by compressing the dura mater or nerve root. Objectives: The purpose of this study is to analyze and compare the effectiveness, economic feasibility, and safety of using an integrated medical service critical pathway (CP) in L-HNP patients. Methods: This single-center prospective observational study will be performed at Kyung Hee University Medicine Hospital and Kyung Hee University Korean Medicine Hospital. The inclusion criteria are a diagnosis of L-HNP on magnetic resonance imaging or computed tomography scans, age under 80 years, a visual analog scale score of 7 or higher for either lower back pain or lower extremity pain. The included 102 participants will be classified into 6 groups (n = 17 in each group): CP application with conservative treatment; CP application with open discectomy; CP application with intrabody fusion; conservative treatment without CP application; open discectomy without CP application; and interbody fusion without CP application. We will collect data on the visual analog scale, ODI, SF-36, and EQ-5D-3L scores; number of admission days; medical staff satisfaction; patients health service satisfaction; waiting time for consultations; use of pain relievers; and CP application and completion rates. Conclusion: In future, this study is expected to serve as a basis for follow-up studies on the development and application of CPs in integrated medical services for various diseases, including lumbar herniated nucleus pulposus.
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