Effectiveness of Acupotomy Combined with Epidural Steroid Injection for Lumbosacral Radiculopathy: A Randomized Controlled Pragmatic Pilot Study.

Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

Acupotomy in Korean Medicine Doctors: A Preliminary Survey on Experiences, Perceptions, and Clinical Usage Status.

Acupotomy is a widely used medical intervention in traditional East Asian medicine, and efforts are being made to improve its effectiveness and safety. As a first step toward establishing more standardized procedural guidelines, a survey was conducted to explore the current clinical practice status and perceived adverse events (AEs) by Korean Medicine (KM) practitioners. The survey was developed via expert consensus and included information on clinical usage, perception, and the AEs experienced. The largest acupotomy society in Korea, which consists of 185 KM doctors, participated in an online survey conducted in September 2021. Of the 185 KM doctors, 107 (57.8%) responded. Musculoskeletal and connective tissue diseases accounted for 80.8% of suggested indications by KM doctors. Regarding the detailed procedure, there were considerable discrepancies between KM doctors. The most frequent acupotomy-related AEs observed by KM practitioners were bruises (77.3%), fatigue (57.7%), pain (51.8%), and hematoma (51.8%). Only 1.8% of the respondents answered that they had experienced severe AEs. Survey respondents answered that the use of imaging devices during acupotomy and the development of clinical practice guidelines are the most necessary policy requirements for promoting the use and ensuring the safety of acupotomy. To the best of our knowledge, this study marks the initial exploration into the KM physicians' clinical usage status, AEs experienced, and their requests for standardized guidelines and expanded health insurance coverage concerning acupotomy. Further research should include qualitative studies to assess patient experience and prospective observational studies to examine the effects of operator skills and treatment modalities on AEs and adherence.

Positive short term effects of an integrative korean medicine treatment package for low back pain caused by motor vehicle accidents: A retrospective chart review of real - world practice data.

Backgrounds No standard treatment exist for reducing symptoms related to sequelae of motor vehicle accidents (MVAs). In Korea, comprehensive Korean Medicine (KM) treatment that includes botanical drugs (herbal medicine), acupuncture, pharmacopuncture, tuina, moxibustion, and cupping is covered by automobile insurance and increasingly used to help alleviate such pain. This study aimed to analyze real-world data and to evaluate the effectiveness and safety of comprehensive KM treatment for low back pain caused by MVAs. Methods We conducted a retrospective chart review of patients who received KM treatment during hospitalization. Records that lacked follow-up outcome assessments were excluded. The Verbal Numerical Rating Scale (VNRS), the Korean version of the Oswestry Disability Index (K-ODI) and the Korean version of the Roland-Morris Disability Questionnaire (K-RMDQ) were evaluated at admission and discharge. Adverse events were also analyzed. A paired t-test was used to identify the effectiveness of KM treatment. Results A total of 50 patients, 30 males and 20 females, were included in the analysis. The mean age of the patients was 40.72 ± 13.31 years and the average treatment period was 7.22 ± 3.84 days. After treatment, VNRS, K-ODI and K-RMDQ were significantly improved (p < 0.001). There was a decrease from 5.06 ± 1.60 to 3.40 ± 1.81 in VNRS, 33.38 ± 16.88 to 24.54 ± 13.63 in K-ODI, and 6.84 ± 6.27 to 4.14 ± 4.38 in K-RMDQ. During this period, a total of two adverse events were reported. Discussion Although this retrospective chart review looked into the short term effects only, comprehensive KM treatment might be an effective and safe therapeutic option to reduce acute low back pain especially after MVA. Prospective research data is needed to support this hypothesis.

Safety of acupotomy in a real-world setting: A prospective pilot and feasibility study.

OBJECTIVE: Acupotomy is a modern acupuncture method that includes modern surgical methods. Since acupotomy is relatively more invasive than filiform acupuncture treatment, it is important to establish the safety profile of this practice. To justify further large-scale prospective observational studies, this preliminary study was performed to assess the feasibility of the approach and investigate the safety profile and factors potentially associated with adverse events (AEs). METHODS: This was a prospective pilot study that assessed the feasibility of a large-scale forthcoming safety study on acupotomy treatment in a real-world setting. The feasibility (call response rate, drop-out rate, response rate for each variable and recruitment per month) and safety profile (incidence, type, severity and causality of AEs, and factors potentially associated with AEs) were measured. RESULTS: A total of 28 participants joined the study from January to May 2018. A follow-up assessment was achieved in 258 (1185 treatment points) out of 261 sessions (1214 treatment points). The response rate via telephone on the day after treatment was 87.3%. There were 8 systemic AEs in all the sessions (8/258; 3.11%) and 27 local AEs on the total points treated (27/1185; 2.28%). Severe AEs did not occur. Total AE and local AE occurrence were associated with blade width and the number of needle stimulations per treatment point. CONCLUSION: The findings suggest that it could be feasible to analyze the safety of acupotomy in a real-world setting. Moreover, the primary data on some relevant AEs could be determined. We are planning large-scale prospective studies based on these findings. TRIAL REGISTRATION: Clinical Research Information Service (CRIS) KCT0002849 (https://cris.nih.go.kr/cris/search/detailSearch.do/11487).

A comparative study of a nerve block therapy with and without a deeply inserted acupotomy applied to hyeopcheok points for lumbosacral radiculopathy: Safety, effectiveness, cost-effectiveness (a randomized controlled, two-arm, parallel study, pilot study, assessor-blind).

INTRODUCTION: The prevalence of lumbosacral radiculopathy is estimated to be approximately 3% to 5% in patient populations. Lumbosacral radiculopathy is largely caused by a complex interaction between biomechanical and biochemical factors. Nerve block therapy (NBT) mainly treats lumbosacral radiculopathy by improving the biochemical factors, whereas acupotomy mainly focuses on improving the biomechanical factors. Therefore, it is thought that synergistic effects may be obtained for the treatment of lumbosacral radiculopathy when both NBT and acupotomy are combined. However, no study in China and Korea, where acupotomy is majorly provided, has reported the effects of such a combination treatment. Therefore, this study aimed to evaluate the safety, effectiveness, and cost-effectiveness of the concurrent use of a deeply inserted acupotomy and NBT for the treatment of lumbosacral radiculopathy. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded, randomized controlled trial, which will include 50 patients with lumbosacral radiculopathy. After patients voluntarily agree to participate in the study, they will be screened, and will undergo necessary examinations and tests according to the protocol. Those who satisfy the selection criteria will be randomly assigned to either the NBT + acupotomy or NBT groups in a 1:1 ratio. Both groups will undergo 2 NBTs once every 2 weeks from 1 week after the screening test. The treatment group will receive additional acupotomy twice a week for 4 weeks. The primary endpoint is the Oswestry Disability Index, whereas the secondary endpoints are the Numeral Rating Scale, European Quality of Life 5-dimension, McGill pain Questionnaire, Roland-Morris Disability Questionnaire, safety assessment, and economic feasibility evaluation. The measurements will be made at 0, 2, 4, and 8 weeks. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS20OISE0085). We intend to submit the results of the trial to a peer-reviewed journal and/or conferences.

Using magnetic resonance imaging to measure the depth of acupotomy points in the lumbar spine: A retrospective study.

BACKGROUND: The acupotomy is an acupuncture device recently used to stimulate lumbar vertebrae such as transverse processes (TPs) and facet joints (FJs). However, there are many organs, nerves, and blood vessels, which can lead to side effects if the needle misses the treatment target. Therefore, information regarding appropriate insertion depths, which is currently lacking, could facilitate its safe use. We retrospectively investigated the depth from the skin to the TP and FJ of the lumbar vertebrae, using magnetic resonance imaging (MRI). METHODS: This retrospective chart review was conducted at a single medical centre in Korea. From 55,129 patient records, 158 subjects were selected. Perpendicular depth from the skin to the left and right TPs and FJs was measured using T1-weighted sagittal plane MRI. Depth differences between the left and right sides were evaluated using the paired t-test and analysis of covariance (body mass index [BMI] as a covariate). The influence of BMI on depth at each location was evaluated by simple linear regression analysis. RESULTS: The mean age was 43.2 years and mean BMI was 23.6 kg/m2. The depth from skin to the TPs or FJs was unaffected by age, sex, or side. Mean depths (cm) were as follows: (TPs) L1 = 4.5, L2 = 4.9, L3 = 5.3, L4 = 5.7, L5 = 5.9; (FJs) L12 = 3.8, L23 = 4.0, L34 = 4.4, L45 = 4.6, L5S1 = 4.6. Depth was highly correlated with BMI at each location. CONCLUSION: The depth of TPs and FJs adjusted for BMI can safely and effectively be used for treatment via various invasive interventions, including acupotomy treatment, in the lumbar region.

Acupotomy treatment for finger joint contracture after immobilization: Case report.

INTRODUCTION: Contractures frequently occur in the finger joints after immobilization. This report describes the effect of acupotomy treatment in patients with joint contracture due to immobilization of the finger joints. PATIENT CONCERNS AND CLINICAL FINDINGS: Case 1 was of a 39-year-old male patient who had flexion limitation of the left thumb and difficulty in grasping. Case 2 was of a 41-year-old female patient who had flexion limitation of the right index finger and difficulty in typing. Stiffness occurred after tendon repair surgery and cast immobilization in both cases. In Case 1, the patient had limited flexion movement of the first metacarpophalangeal and interphalangeal joints after 5 weeks of immobilization of the left thumb in a cast. In Case 2, the patient had limited flexion movement after 3 weeks of immobilization of the second proximal interphalangeal joint of the left hand in a cast. DIAGNOSIS, INTERVENTIONS, AND OUTCOMES: We diagnosed both patients with finger joint contracture due to immobilization. Conservative treatment for approximately 4 weeks did not lead to improvement in either patient. Acupotomy is the key treatment for improving movement in Korean Medicine. Therefore, acupotomy was performed, and joint stiffness markedly improved without adverse events. Both patients reported that the daily use of the damaged fingers became comfortable. CONCLUSION: We found that acupotomy may be effective for finger joint contracture due to improper immobilization. We suggest it as a simple and safe treatment for joint contracture.

Gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo-Controlled Double-Blind Clinical Trial.

BACKGROUND: Gyejigachulbutang (GUI-ZHI-JIA-SHU-FU-TANG, GCB) is an herbal formula widely prescribed in traditional East Asian medicine practice for arthritis and muscle pain. We evaluated the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA). METHODS: Eighty patients with KOA were randomly assigned to the GCB group or the placebo group in a 1 : 1 ratio in two Korean medicine hospitals. Patients took GCB or placebo three times a day for 4 weeks. Primary outcome was the change in the visual analogue scale (VAS) score for knee pain from baseline to 4th week. Secondary outcomes were the change in the VAS score from baseline to 2nd week and 8th week, Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC), European Quality of Life Five Dimensions questionnaire (EQ-5D), and safety. RESULTS: There was no significant difference between the compared indicators of the GCB and placebo groups. However, in subgroup analysis, GCB was effective for subjects with a BMI lower than 25 kg/m2. The dose of pain medication was significantly lower in the GCB group than in the placebo group after four weeks (p=0.016). There were no serious adverse events in the GCB group. CONCLUSIONS: GCB was not effective in primary outcome analysis. In exploratory subgroup analysis, GCB might be effective for individuals with BMI lower than 25 kg/m2 for the treatment of degenerative KOA. GCB may also help reduce the consumption of pain medication. Furthermore, research is required for our hypothesis. This trial is registered with KCT0003024.

Improved grip myotonia in a patient with myotonic dystrophy type 1 following electroacupuncture therapy: A CARE-compliant case report.

RATIONALE: Myotonic dystrophy type 1 (DM1) is an autosomal-dominant disorder associated with a short life expectancy and various symptoms, including grip myotonia. Even though grip myotonia decreases quality of life, activities of daily living (ADLs), and work performance, very few interventions provide symptomatic relief. PATIENT CONCERNS: In this case report, we present a patient with DM1 and gradually worsening grip myotonia. A 35-year-old woman developed grip myotonia at age 27. She had no underlying diseases or family history of relevant conditions, including DM1. She was unresponsive to medication for several years. DIAGNOSIS: Her symptoms gradually worsened, and she was finally diagnosed with DM1 via genetic, neurologic, and laboratory testing in a tertiary hospital at age 32. She tried several medication therapies; however, she stopped medication at age 34 due a perceived poor response and several adverse events. INTERVENTION: At the age of 35, she underwent 29 sessions (10 minutes per session) of electroacupuncture therapy on TE9 acupuncture point with 120 Hz electrical stimulation over 3 months. OUTCOMES: After 3 months, relaxation time after maximal voluntary isometric contraction decreased from 59 to 2 seconds with treatment. Her Michigan Hand Outcomes Questionnaire score improved (total score, 66.6-75.9; ADL sub-score, 59.7-73.6; function sub-score, 70-90; satisfaction sub-score, 75-91.7). Her Measure Yourself Medical Outcome Profile 2 score also improved from 4.33 to 2. There were no serious adverse events. LESSONS: Electroacupuncture is a potential treatment modality and produced an immediate antimyotonic effect, and cumulative long-term treatment effect, in a patient with DM1 and grip myotonia. Other notable treatment outcomes included improving relaxation time, hand function, ADLs, and overall satisfaction. Electroacupuncture is a potential treatment modality for patients with DM1 and grip myotonia. Further prospective clinical studies are warranted to confirm this hypothesis.

Ephedrae Herba in combination with herbal medicine (Zhizichi decoction and Phellodendri Cortex) for weight reduction: a case series.

BACKGROUNDS: Ephedrae Herba is widely used to treat obesity. There is a concern for adverse events (AEs) using it and we need to develop strategies to attenuate it without its effectiveness for weight-reducing potential. We investigated the effects of a combination of Ephedra Herba with Zhizichi decoction and Phellodendri Cortex (Anmyungambi (AMGB) decoction) in reducing the incidence of Ephedra Herba-related AEs. METHODS: We performed a retrospective chart review from a clinical case series of patients visiting the Jaonmi Korean Medicine Clinic (Seoul, Korea). The inclusion criteria was patients who were prescribed AMGB decoction, (containing Ephedrae Herba, Phellodendri Cortex, and Zhizichi decoction [Gardeniae Fructus, and Glycine Semen Preparata] in different proportions) for weight reduction. Exclusion of Phellodendri Cortex in the original AMGB preparation was allowed; conventional medications, acupuncture, and dietary supplements were not allowed. The primary outcome was absolute weight loss at the end of treatment. RESULTS: Twenty-seven patients (6 men and 21 women), aged 18-75 years (mean age, 42.6 ± 11.1 years) and the average treatment duration was 39.4 days. Absolute weight loss at the end of treatment was 4.49 ± 2.40 kg. Fifteen patients lost more than 5% weight (55.6%). Treatment >45 days resulted in significantly greater weight loss compared to treatment <30 days (p < 0.001). Not severe AEs were reported in 16 patients including constipation, fatigue, etc. CONCLUSION: A combination of Ephedra Herba with Zhizichi decoction and Phellodendri Cortex may be a safe and effective treatment for weight reduction in obese and overweight patients.

Clinical Efficacy and Safety of Miniscalpel-Needle Treatment for Tension-Type Headache: A Systematic Review and Meta-Analysis.

OBJECTIVE: To investigate the clinical efficacy and safety of miniscalpel-needle (MSN) treatment for tension-type headache (TTH). METHOD: Seven medical databases were searched to identify randomized controlled trials (RCTs) evaluating the effect and safety of MSN treatment. All articles published up to November 15, 2018 were retrieved. A meta-analysis was conducted for the included studies, and the risk of bias was assessed. Primary outcomes were visual analogue scale (VAS) or numeric rating scale (NRS) score. Secondary outcomes were clinical effective rates including total effective rate (TER), markedly effective rate (MER), and totally cured rate (TCR) determined by improvement in clinical symptoms or VAS scores, the frequency of adverse events (AEs) that occurred during the study, and participant quality of life (QOL). RESULTS: Seven RCTs involving 724 participants were included. MSN treatment showed significantly higher MER and TCR [relative risk (RR) 1.27, 95% confidence interval (CI) 1.01 to 1.61; RR 1.31, 95% CI 1.09 to 1.57, respectively], but not TER (RR 1.03, 95% CI 0.96 to 1.10) compared to acupuncture. MSN treatment plus conventional treatment showed significant lower VAS and higher TER, MER, and TCR (mean difference -3.54, 95% CI -3.80 to -3.28; RR 1.14, 95% CI 1.06 to 1.23; RR 2.31, 95% CI 1.50 to 3.58; RR 3.01, 95% CI 2.25 to 4.02, respectively) compared to conventional treatment. CONCLUSIONS: According to current evidence, MSN treatment as a monotherapy or as an adjunctive treatment to other existing treatments might have benefits on treating TTH. However, since the number and the sample size of studies included were both small and the methodological quality was poor, the findings of this review should be interpreted with great caution, and our confidence in the results is low. A high quality RCT using objective outcomes should be performed on this topic.

Acupotomy for the treatment of lumbar spinal stenosis: A systematic review and meta-analysis.

BACKGROUND: Lumbar spinal stenosis (LSS) is caused by neural compression due to narrowing of the lumbar spinal canal or neural foramen. Surgical intervention is a standard treatment for LSS; however, the steep increase in the surgical rate, post-operative complications, and comparatively low long-term satisfaction are considered to be limitations of this surgical approach. Conversely, acupotomy is a minimally invasive technique that combines the effects of conventional acupuncture with micro-incision, which may offer an alternative to surgery for the treatment of LSS. This review was conducted to investigate and critically review the current evidence on the efficacy and safety of acupotomy for LSS. METHODS: Eleven databases were searched from their respective inception dates to December 28, 2018. Randomized controlled trials (RCTs) comparing acupotomy and wait-list, sham treatment, or active controls were included. The quality of the included studies was assessed using risk-of-bias tool. RESULTS: Seven RCTs were included in this review and meta-analysis. The methodological quality of the included studies was generally poor. The acupotomy treatment group was associated with significantly lower visual analogue scale scores (range 0∼10) (5 RCTs; mean difference [MD] -1.55, 95% confidence interval [CIs] -2.60 to -0.50; I = 94%) and higher Japanese Orthopedic Association Score (3 RCTs; MD 4.70, 95% CI 3.73 to 5.68; I = 0%) compared to the active control group. In subgroup analysis based on the type of active controls, acupotomy retained significant benefits over lumbar traction and acupuncture, as well as over lumbar traction, spinal decompression, and acupuncture. Safety data were reported in only 1 study, and no adverse events occurred in either the acupotomy or the acupuncture control group. CONCLUSION: According to current evidence, acupotomy might be beneficial for treating LSS. Acupotomy showed consistent superiority over lumbar traction, but the results were mixed in comparisons with other interventions, such as spinal decompression and acupuncture. However, the findings should be interpreted cautiously, given the poor methodological quality of the included studies, and potential small-study effects. Further larger, high-quality, rigorous RCTs should be conducted on this topic and rigorous reporting of acupotomy procedures and safety data should be encouraged.

Clinical effectiveness and safety of acupotomy: An overview of systematic reviews.

BACKGROUND AND PURPOSE: Acupotomy is a modern type of acupuncture that uses a blade-needle combined with a flat surgical scalpel at its tip. This study was conducted to summarize and critically evaluate the current evidence on acupotomy. MATERIALS AND METHODS: All relevant studies up to February 19, 2019, were included, through comprehensive searches in 11 electronic databases without language restrictions. RESULTS: Eleven systematic reviews (SRs) comprising of 69 randomized controlled trials were included, and the methodological quality was medium-to-high in AMSTAR. All the included studies reviewed musculoskeletal disorders and reported a significantly higher total effective and cure rates in the acupotomy group for frozen shoulder, cervical spondylosis, third lumbar vertebrae transverse process syndrome, trigger finger, knee osteoarthritis, and lumbar spinal stenosis, compared to the other active control groups. CONCLUSION: Acupotomy showed promising results for some musculoskeletal disorders; however, additional high-quality evidence is required to make clinical recommendations regarding this procedure.

Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial.

BACKGROUND: Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. METHODS: This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. DISCUSSION: This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0003024 . Registered on 25 July 2018.

Efficacy of acupotomy for cerebral palsy: A systematic review and meta-analysis.

BACKGROUND: In children, cerebral palsy (CP) is one of the most common causes of irreversible neurological sequelae. Acupotomy, a modernized acupuncture form combining the effects of microsurgery and conventional acupuncture, may show specific benefits in the treatment of CP, especially with respect to spasticity. The aim of this review was to evaluate the efficacy of acupotomy for CP. METHODS: Eleven databases were comprehensively searched from their inception dates to November 27, 2018. Randomized controlled trials (RCTs) or quasi-RCTs evaluating acupotomy as a monotherapy or as adjunctive therapy to rehabilitation treatment for CP were included. The methodological quality of included studies was assessed using the risk of bias tool. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. Meta-analysis was performed, and the pooled data were presented as mean difference (MD) with 95% confidence interval (CI) for continuous outcomes and as risk ratio (RR) with 95% CI for dichotomous outcomes. RESULTS: Eight studies involving 530 participants were included. In 1 study, acupotomy was associated with significantly higher total effective rate (TER) compared with Bobath (P < .01). Acupotomy combined with rehabilitation was associated with significantly higher TER (RR 1.24, 95% CI 1.01-1.52, I = 77%) and gross motor function measure score (MD 12.62, 95% CI 11.75-13.49, I = 54%), and significantly lower muscle tone of gastrocnemius measured by the Ashworth scale or the modified Ashworth scale (MD -0.97, 95% CI -1.07 to -0.88, I = 0%) compared with rehabilitation alone. No studies reported the incidence of adverse events. The methodological quality of the included studies and quality of evidence for the main finding were generally low. CONCLUSION: Current evidence shows that acupotomy as a monotherapy or as adjunctive therapy to rehabilitation treatment might have benefits in the treatment of CP. However, due to the small number of studies included, the lack of sample size, poor methodological qualities, and low quality of evidence, the findings of this review should be interpreted with caution. Larger and more rigorous, high-quality RCTs should be performed on this topic. PROSPERO REGISTRATION NUMBER: CRD42018105891.

Acupotomy for the treatment of lumbar spinal stenosis: A protocol for a systematic review and meta-analysis.

INTRODUCTION: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of acupotomy for the treatment of lumbar spinal stenosis. METHODS AND ANALYSIS: The following electronic databases will be searched until December 2018 without language or publication status restrictions: five English databases, that is Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Allied and Complementary Medicine Database (AMED), and Cumulative Index to Nursing and Allied Health Literature (CINAHL); three Korean databases, that is Oriental Medicine Advanced Searching Integrated System (OASIS), Research Information Service System (RISS), and Korea Citation Index (KCI); and three Chinese databases, that is China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP. Any clinical, randomized controlled trials using acupotomy for lumbar spinal stenosis treatment will be included. Changes in the degrees of pain and function will be assessed as primary outcomes. The total effective rate, changes in quality of life, adverse events, and amount of rescue medication used will be evaluated as secondary outcomes. Two independent researchers will perform study selection, data extraction, and risk of bias assessment. If applicable, a meta-analysis will be performed using RevMan version 5.3, with the results expressed as risk ratios or mean differences with 95% confidence intervals. According to a heterogeneity test or the number of studies included, fixed effects or random effects model will be used. The risk of bias tool from the Cochrane group will be used to evaluate the methodological quality of the included studies. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data will not be included in this study. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018116567.

Herbal medicine for acute management and rehabilitation of traumatic brain injury: A protocol for a systematic review.

BACKGROUND: This systematic review protocol describes the methods that will be used to evaluate the efficacy and safety of herbal medicine in treating traumatic brain injury. METHODS AND ANALYSIS: The following electronic databases will be searched up to December 2018 without language or publication status restrictions: Medline, EMBASE, the Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database, and Cumulative Index to Nursing and Allied Health Literature. We will also search Korean, Chinese, and Japanese databases. Any randomized controlled trials related to herbal medicine for traumatic brain injury will be included. The functional outcome, consciousness state, morbidity, and mortality will be assessed as primary outcomes. The quality of life, adverse events, and total effective rate will be evaluated as secondary outcomes. Two researchers will independently perform the study selection, data extraction, assessment of study quality, and evaluation of the quality of evidence for the main findings. Data synthesis and analysis will be performed using RevMan version 5.3. The results will be expressed as a risk ratio for the binary outcome and as the mean difference or standardized mean difference for a continuous outcome. We will synthesize the data by either fixed effects or random effects model according to a heterogeneity test or the number of studies included in the meta-analysis. The methodological quality of the included studies will be evaluated using the Cochrane Collaboration's risk of bias tool. The quality of evidence for each main outcome will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach. ETHICS AND DISSEMINATION: Ethical approval is not required because individual patient data are not included. The findings of this systematic review will be disseminated through a peer-reviewed publication or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018116559.

Current Usage of Terminologies Related to Acupotomy: A Literature Research and Standardization Suggestion.

OBJECTIVE: investigate the current usage of terminologies related to acupotomy through systematic search and analyze the pros and cons of each for proposing a standard terminology. METHODS: Seven medical journal databases were searched including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, KoreaMed, and Korean studies Information Service System using 10 candidate terminologies as searching terms. All studies published from their inception to July 26, 2017 were collected. Articles were included if the title stated one of the 10 candidate terminologies consistent with the definition of acupotomy. Priorly established frequency and consistency of each candidate terminology from medical databases were calculated and evaluated. Moreover, the pros and cons of each were analyzed to propose a standard terminology. RESULTS: A total of 112 studies in English databases, 1,129 studies in Chinese database, and 44 studies in Korean databases were included. The most frequently used terminologies were needle knife (35.71%), acupotomy (48.54%) and acupotomy (90.90%) in English, Chinese and Korean database, respectively. Overall, acupotomy and needle knife were the most frequently used. Others like acupotomology, needle scalpel, miniscalpel acupuncture and miniscalpel needle were used within 10% of the total searched literature. Acupotome, stiletto needle, sword like needle, and Xiaozhendao were rarely used. Acupotomy had the advantages of high frequency and consistency but lacked representativeness. Needle knife also showed a high frequency, but the consistency was poor. Though miniscalpel acupuncture and miniscule needle were used less frequently, they had advantages of inclusiveness and clarity. CONCLUSION: A debate for standardization of the terminology is necessary. This preliminary research can provide a basic outline for the standardization consensus process, and we believe it is noteworthy to discuss miniscalpel needle and miniscalpel acupuncture along with acupotomy and needle knife on the subject.

Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles: Study protocol.

BACKGROUND: Despite the wide usage of miniscalpel-needles (MSNs), information about MSN treatment-related adverse events (AEs) is insufficient. As the definition of AE might vary among physicians, without an exact definition for pain and hemorrhage, it is difficult to provide accurate information about AEs in MSN treatment to physicians, researchers, and patients. The aim of our study is to reach a consensus about the items and definitions of AEs that should be included in the survey form for prospective observational multicenter studies to record MSN treatment-related AEs. We will especially focus on obtaining a consensus on the definition of pain and hemorrhage caused by MSN treatment. METHODS: Our study protocol is composed of 6 steps. First, we will identify the aim of the study. Next, we will conduct a systematic review to investigate MSN treatment-related AEs reported till date in Korea. Third, we will conduct a pilot observational prospective single-center study on AEs in MSN treatment. We will develop a standardized case report form to record MSN treatment-related AEs, including the causality, severity, and details of the MSN procedure at every site. Next, based on the pilot study, the Delphi study questionnaire will be developed by a panel composed of 13 physicians. The Delphi study will have 4 rounds with open questions and 4-point Likert-scale closed questions. Through these rounds, we will develop a consensus about the items and definitions of AEs that should be included in the survey form for future multicenter studies about MSN treatment-related AEs. Following this, a face-to-face consensus meeting will be held for a final agreement of survey form. The final survey form will then be approved by the related academic society for dissemination. DISCUSSION: The aim of this protocol is to develop a survey form for future prospective observational multicenter studies on MSN treatment-related AEs. This protocol will present the research methodology for developing a survey form, which will improve consistency and reliability between MSN treatment studies. We believe that this protocol can evaluate the safety of MSN treatment. TRIAL REGISTRATION: Clinical Research Information Service: KCT0002849.

Effects of Wonli Acupuncture Procedure in Patients with LSS: A Clinical, Retrospective Study.

Background. Lumbar spinal stenosis (LSS) is a disease with increasing prevalence due to prolongation of average life span. Despite various treatment methods, many limitations remain unsolved. Objective. We are reporting cases of patients who have been treated with Wonli Acupuncture, a method of treating LSS by directly approaching the intervertebral foramen and interlaminar space with acupuncture needles different from those used in original acupuncture. Methods. A total of 82 patients with LSS were treated with Wonli Acupuncture, and out of those, 47 patients without exclusion criteria were selected for the following research. We compared the pretreatment VAS and ODI scores based on 1-year follow-up measurements. Results. The ODI value dropped by 15.3 ± 24.8 on average (from 35.2 ± 19.9 at the baseline to 19.8 ± 20.6 at the reading) (P < 0.01) and the average VAS also dropped by 19.2 ± 37.2 (from 60.7 ± 23.1 at baseline to 41.5 ± 31.9 at the reading) (P < 0.01). Conclusions. Wonli Acupuncture was found to have clinical efficacy for lumbar spinal stenosis.