KAAACI Allergic Rhinitis Guidelines: Part 2. Update in Non-pharmacological Management.

Allergic rhinitis is the most common chronic disease worldwide. Various upper airway symptoms lower quality of life, and due to the recurrent symptoms, multiple treatments are usually attempted rather than one definitive treatment. There are alternatives to medical (medication-based) and non-medical treatments. A guideline is needed to understand allergic rhinitis and develop an appropriate treatment plan. We have developed guidelines for medical treatment based on previous reports. The current guidelines herein are associated with the "KAAACI Evidence-Based Guidelines for Allergic Rhinitis in Korea, Part 1: Update in pharmacotherapy" in which we aimed to provide evidence-based recommendations for the medical treatment of allergic rhinitis. Part 2 focuses on non-pharmacological management, including allergen-specific immunotherapy, subcutaneous or sublingual immunotherapy, nasal saline irrigation, environmental management strategies, companion animal management, and nasal turbinate surgery. The evidence to support the treatment efficacy, safety, and selection has been systematically reviewed. However, larger controlled studies are needed to elevate the level of evidence to select rational non-medical therapeutic options for patients with allergic rhinitis.

Effectiveness and Safety of Acupotomy on Lumbar Spinal Stenosis: A Pragmatic, Pilot, Randomized Controlled Trial.

Purpose: In Korea, complex treatments such as acupotomy, acupuncture, and physical therapy are performed for lumbar spinal stenosis (LSS). Although there are reports of acupotomy as monotherapy or acupuncture treatment for LSS, pragmatic studies are lacking. Therefore, this study aimed to determine the effectiveness and safety of acupotomy for LSS to provide baseline evidence for a large-scale study. Materials and Methods: This pragmatic randomized controlled pilot study enrolled 34 participants and randomly assigned them to two groups (n=17/group). The intervention was conducted for 8 weeks. Acupotomy plus and usual care groups received acupuncture (17 acupoints) and interferential current therapy (ICT) twice weekly; however, the acupotomy plus group received an additional acupotomy (7 acupoints) for treatment of the usual care group. The primary outcome was measured using visual analog scales (VAS), and secondary outcomes were assessed using the self-rated walking distance, short-form McGill Pain Questionnaire (SF-MPQ), and the Oswestry Disability Index (ODI). Outcome measurements were conducted at baseline and 4, 8, and 12 weeks after the commencement of the intervention. Adverse events were assessed at each visit. Hematological and biochemical examinations were performed at screening and week 8. Results: Overall, 33 of the 34 participants completed the study, and one participant in the usual care group dropped out. In both groups, VAS scores at weeks 4, 8, and 12 significantly improved compared to baseline. Also, self-rated walking distance, SF-MPQ, and ODI scores were significantly improved at weeks 4, 8, and 12 than at baseline. However, there were no significant differences in the time-dependent and group-to-time interactions between the two groups. In addition, no severe adverse reactions were reported, and there were no significant differences in hematological and biochemical results. Conclusion: This study provides baseline data for large-scale studies on the effectiveness and safety of acupotomy in LSS. Clinical Trial Number: KCT0006234.

Efficacy and safety of thread embedding acupuncture for knee osteoarthritis: A randomized controlled pilot trial.

BACKGROUND: Thread embedding acupuncture (TEA) is a widely used clinical procedure for the treatment of musculoskeletal pain. However, few clinical studies have been conducted on the efficacy and safety of TEA for knee osteoarthritis (KOA), and data from randomized controlled trials are lacking. This randomized controlled pilot study aimed to assess the feasibility of conducting large-scale studies on the efficacy and safety of TEA for KOA. METHODS: Forty participants were included in the study and randomly divided into 2 groups (TEA and acupuncture) of 20 each. The intervention period was 6 weeks. The experimental group received TEA once a week (total of 6 sessions) on 14 defined knee areas, and the control group received acupuncture twice a week (total of 12 sessions) on 9 defined acupuncture points. The primary outcome measure was the visual analogue scale score, and the secondary outcome measures were the short-form McGill pain questionnaire, and Western Ontario and McMaster Universities Osteoarthritis Index scores. Participants were assessed prior to the intervention (baseline) and at 3, 6, and 10 weeks (4 weeks after the end of intervention). The adverse effects of TEA and acupuncture were documented. Hematological examination and biochemical tests were performed at the screening and at 6 weeks. RESULTS: Of the 40 participants, 37 completed the study and 3 participants dropped out. Both the TEA and acupuncture groups showed a significant improvement in the visual analogue scale, short-form McGill Pain Questionnaire, and Western Ontario and McMaster Universities Osteoarthritis Index scores in a time-dependent manner. However, there was no significant interaction between group and time. No serious adverse events were reported in the groups, and no clinically significant changes were observed in the hematological and biochemical parameters. CONCLUSION: This pilot study suggests that TEA is a safe and effective procedure for relieving pain in patients with KOA. The results of this study provide basic data and indicate the feasibility of large-scale clinical studies to evaluate the efficacy and safety of TEA for KOA.

Thread embedding acupuncture for herniated intervertebral disc of the lumbar spine: A multicenter, randomized, patient-assessor-blinded, controlled, parallel, clinical trial.

BACKGROUND: and purpose: Although several studies have reported that thread embedding acupuncture (TEA) is effective for lumbar herniated intervertebral disc (LHIVD), the evidence remains limited because previous studies had a high risk of bias. This study aimed to investigate the efficacy and safety of TEA for LHIVD through a rigorously designed trial. MATERIALS AND METHODS: This was a randomized, patient-assessor-blinded, sham-controlled trial. Participants were screened according to eligibility criteria, and 70 patients with LHIVD were randomly allocated to the TEA and sham TEA (STEA) groups in a 1:1 ratio. Both groups received TEA or STEA treatment at 23 acupoints once per week for eight weeks. Changes in low back pain, radiating pain, Oswestry disability index, Roland-Morris disability questionnaire, EuroQol 5-Dimensions 5-Levels, and global perceived effect were measured at baseline and at 4, 8, 12, and 16 weeks after screening and compared between the two groups. RESULTS: TEA showed no significant difference in all outcomes compared to STEA immediately after eight weeks of treatment. After an additional eight weeks of follow-up, TEA showed a more significant effect on the low back pain than STEA (p < 0.05) and showed a better tendency in maintaining or enhancing the improvement of radiating pain, function, and quality of life even after the end of treatment. No serious adverse events were observed. CONCLUSION: TEA is effective in improving low back pain in patients with LHIVD and may help improve function and quality of life, especially in the long term.

Korean Medicine Clinical Practice Guidelines for Lumbar Herniated Intervertebral Disc in Adults: Based on Grading of Recommendations Assessment, Development and Evaluation (GRADE)

A significant number of individuals suffer from low back pain throughout their lifetime, and the medical costs related to low back pain and disc herniation are gradually increasing in Korea. Korean medicine interventions have been used for the treatment of lumbar intervertebral disc herniation. Therefore, we aimed to update the existing Korean medicine clinical practice guidelines for lumbar intervertebral disc herniation. A review of the existing guidelines for clinical treatment and analysis of questionnaires targeting Korean medicine doctors were performed. Subsequently, key questions on the treatment method of Korean medicine used for disc herniation in actual clinical trials were derived, and drafts of recommendations were formed after literature searches using the Grading of Recommendations, Assessment, Development and Evaluation. An expert consensus was reached on the draft through the Delphi method and final recommendations were made through review by the development project team and the monitoring committee. Fifteen recommendations for seven interventions for lumbar disc herniation were derived, along with the grade of recommendation and the level of evidence. The existing Korean medicine clinical practice guidelines for lumbar intervertebral disc herniation have been updated. Continuous updates will be needed through additional research in the future.

Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized, controlled, pilot clinical trial: A study protocol.

INTRODUCTION: Lumbar spinal stenosis (LSS) is a pathological condition that causes a variety of neurological symptoms due to narrowing of the anatomical structures; usually, conservative treatment is recommended, rather than surgical treatment. Acupotomy combines conventional acupuncture with small scalpels; the procedure can be considered minimally invasive, and has recently received considerable attention in clinical practice. Still, there is a lack of data and randomized controlled trials regarding acupotomy related to LSS. Additional studies are necessary, considering the low methodological quality and small size of the study. METHODS AND ANALYSIS: This is a pragmatic, pilot, randomized controlled trial. The trial comprises 8 weeks of treatment, with 16 visits and a 4-week follow-up period. Forty participants diagnosed with LSS will be randomly assigned to either the experimental or control groups; both groups will receive acupuncture and interferential current therapy twice a week for 8 weeks, while the experimental group will receive an additional acupotomy intervention once a week for 8 weeks. The primary outcome will be assessed using the visual analog scale; the secondary outcome will be measured by self-rated walking distance, Oswestry Disability Index, and short-form McGill Pain Questionnaire. Measurements will be obtained prior to the start of the clinical trial, 4 weeks after the interventional procedure, 8 weeks after the procedure, and 4 weeks after the end of the interventional procedure. Blood tests and adverse reactions will be performed to ensure safety of the treatments. CONCLUSION: We expect that this study will provide basic data for future large-scale acupotomy studies regarding LSS.

Efficacy and safety of thread embedding acupuncture combined with acupuncture for chronic low back pain: A randomized, controlled, assessor-blinded, multicenter clinical trial.

BACKGROUND: Low back pain is a very common disease. Many patients with chronic low back pain (CLBP) have been treated by complementary and alternative medicine such as acupuncture (AT) treatment. A type of AT, thread embedding acupuncture (TEA), consists of a thread that can continually stimulate at the AT points and has mechanical and chemical effects. Although TEA was widely used in clinical practice, there was little evidence of its efficacy and safety for CLBP. METHODS: This clinical trial was randomized, controlled, assessor-blinded, two-armed, parallel, and conducted in multiple centers. Four Korean medical institutions recruited 38 outpatients with CLBP. The participants were randomly allocated to a treatment group (TEA combined with AT) or a control group (only AT) in a 1:1 ratio. All participants received conventional AT twice a week for 8 weeks (16 sessions) at 15 AT points (GV3 and bilateral BL23, BL24, BL25, BL26, BL40, BL60, and EX-B5) and the treatment group participants additionally received TEA once a week for 8 weeks (8 sessions) on 10 AT points in the multifidus, spinal erector, and lumbar quadrate muscles. The primary outcome measure of this study was the change of visual analog scale (VAS) from baseline (0 week) to the end of intervention (8 weeks). Secondary outcome measures included clinically relevant improvement (minimal clinically important difference) and 3% to 50% decrease on VAS, disability level (Korean version of Roland and Morris disability questionnaire), quality of life (Korean version of European quality of life 5dimension), global assessment (patient global impression of change), economic analysis, credibility test, and safety assessment. RESULTS: The treatment group showed a significant reduction in VAS scores when compared with the control group (-33.7 ±â€Š25.1 vs -15.6 ±â€Š17.0, P = .013). As for the secondary outcome measures, the treatment group showed significant difference in 50% decrease on VAS and patient global impression of change. There was no serious adverse event associated with TEA and AT. CONCLUSION: This clinical trial documents the efficacy and safety of TEA combined with AT for the management of CLBP.

Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial.

INTRODUCTION: Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients. METHODS AND ANALYSIS: This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment. CONCLUSION: The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis. TRIAL REGISTRATION NUMBER: KCT0004844.

Round Acupuncture for the Treatment of Recurrent Carpal Tunnel Syndrome.

OBJECTIVES: Round Acupuncture having blunt end has developed from acupotomy. This case report is to find out that Round Acupuncture is effective in treating patients with recurrent carpal tunnel syndrome (CTS), which has not improved by steroid injection or acupotomy. METHODS: Round Acupuncture was inserted into the distal fibers of transverse carpal ligament and released toward the proximal fibers. Treatment was performed three times in total. T ingling, numbn ess, night pain and swelling sensation were assessed, and provocative maneuvers were also used. RESULTS: After treat ment, all symptoms completely disappeared and the patient had no recurrence until 3 months after treatment. CONCLUSION: Round Acupuncture co uld be an effective treatment for recurrent CTS.

Acupuncture inhibits reinstatement of intravenous methamphetamine self-administration via gamma aminobutyric acid pathway.

Methamphetamine is one of the widely abused drugs. Nevertheless, there is little predominant therapy for the abuse. In the previous study, acupuncture had shown to attenuate methamphetamine self-administration behavior, and based on, the present study investigated whether acupuncture inhibits the reinstatement of methamphetamine self-administration. As well, a possible neuronal mechanism was investigated. Male Sprague-Dawley rats weighing 270-300 g were trained to intravenously self-administer methamphetamine (0.1 mg/kg) for 3 weeks. Following training, rats who administered stable amount of methamphetamine underwent extinction period of 1 week. Thereafter, priming injection was performed to induce reinstatement, and acupuncture was given immediately before priming. In the second experiment, the selective antagonists of GABAA and GABAB receptors were treated prior to acupuncture to investigate a neuronal mechanism of GABAergic pathway. Acupuncture treatment at HT7, but not at the control acupoint LI5, reduced the active lever responses on the reinstatement session, showing that HT7 suppressed craving for methamphetamine induced by reexposure to the drug during abstinence. And, the effects of acupuncture were blocked by the GABA receptors' antagonists. In addition, HT7 did not influence saline self-administration, indicating that acupuncture effect was selective to the methamphetamine. Results of the present study show that acupuncture at HT7 suppresses reinstatement of methamphetamine self-administration behavior through the GABA receptor system without affecting the normal state. From the results, it may be suggested that acupuncture at HT7 can be a useful option in the treatment of methamphetamine addiction.

Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial.

BACKGROUND: Low back pain is a common symptom and continuous or recurrent pain results in chronic low back pain (CLBP). While many patients with CLBP have tried various treatments, complementary and alternative medicine including acupuncture and herbal medicine is one of the commonly used treatments. Palmijihwang-hwan is a herbal medicine used frequently in clinical practice but there has been no report of the efficacy, safety, or cost-effectiveness analysis of Palmijihwang-hwan for CLBP. METHODS: This study is a randomized, assessor-blinded, multicenter, clinical trial with two parallel groups. Four Korean medicine hospitals will recruit 84 participants and randomly allocate them into the control or treatment group in a 1:1 ratio. The control group will receive acupuncture treatment at 11 local and 4 distal acupuncture points for 20 min twice a week for 6 weeks. The treatment group will receive the same acupuncture treatment as the control group and also take Palmijihwang-hwan for 6 weeks. The primary outcome will be the change in visual analog scale (VAS) score between baseline (visit 1) and completion of the intervention (visit 12), and secondary outcomes will be pain-related clinical relevance (minimal clinical important difference or the proportion of the participants who decrease more than 30, or 50% on VAS), disability (Roland and Morris Disability Questionnaire), quality of life (EuroQol-5D), global assessment (Patient Global Impression of Change), and economic analysis (cost-effectiveness and cost-utility analysis). Additionally, safety will be assessed. DISCUSSION: The results of our study will provide the clinical evidence about the efficacy, safety, and cost-effectiveness analysis of Palmijihwang-hwan for CLBP. There will be a chance to provide multiple subdivided influence of this treatment with various outcome measures, but lack of placebo is our limitation. TRIAL REGISTRATION: Clinical Research Information Service, KCT0002998. Registered on 12 July 2018.

Thread-embedding acupuncture for lumbar herniated intervertebral disc: Protocol for a systematic review and meta-analysis.

BACKGROUND: Lumbar herniated intervertebral disc (LHIVD) is a frequent disease among patients attending Korean medicine hospitals, and it is associated with considerable medical expenses for the patients. Although several recent randomized clinical trials (RCTs) have reported that thread-embedding acupuncture (TEA) has a more favorable therapeutic effect on LHIVD than other types of acupuncture or other treatments, the evidence remains limited because these trials used poor assessment methods and had a high risk of bias. This study aims to evaluate the evidence for the effectiveness and safety of TEA for LHIVD. In this article, we describe our methods and plan for a systematic review. METHODS: We will conduct an electronic search of the following databases from their inception to May 2018: MEDLINE; EMBASE; COCHRANE; China National Knowledge Infrastructure (CNKI) (a Chinese database); CiNii and J-STAGE (Japanese databases); and KoreaMed, Korean Medical Database (KMbase), Korean Studies Information Service System (KISS), National Digital Science Library (NDSL), Korea Institute of Science and Technology Information (KISTI), Oriental Medicine Advanced Searching Integrated System (OASIS). RCTs investigating any type of TEA will be included. The risk of bias in each study will be evaluated using the Cochrane risk of bias tool. Risk ratios or mean differences with 95% confidence intervals will be used to show the effects of TEA if it will be possible to conduct a meta-analysis. Sensitivity analyses will also be conducted in this study. ETHICS AND DISSEMINATION: Ethical approval is not necessary as this paper does not involve patient data. The review will be published in a peer-reviewed journal or presented in a conference. TRIAL REGISTRATION NUMBER: PROSPERO CRD42019133060.

Clinical Manifestations and Risk Factors of Anaphylaxis in Pollen-Food Allergy Syndrome.

PURPOSE: Many studies have reported that pollen-food allergy syndrome (PFAS) can cause anaphylaxis. No comprehensive investigations into anaphylaxis in PFAS have been conducted, however. In this study, we investigated the clinical manifestations and risk factors for anaphylaxis in PFAS in Korean patients with pollinosis. MATERIALS AND METHODS: Data were obtained from a nationwide cross-sectional study that previously reported on PFAS in Korean patients with pollinosis. Data from 273 patients with PFAS were collected, including demographics, list of culprit fruits and vegetables, and clinical manifestations of food allergy. We analyzed 27 anaphylaxis patients and compared them with patients with PFAS with oropharyngeal symptoms only (n=130). RESULTS: The most common cause of anaphylaxis in PFAS was peanut (33.3%), apple (22.2%), walnut (22.2%), pine nut (18.5%), peach (14.8%), and ginseng (14.8%). Anaphylaxis was significantly associated with the strength of sensitization to alder, hazel, willow, poplar, timothy, and ragweed (p<0.05, respectively). Multivariable analysis revealed that the presence of atopic dermatitis [odds ratio (OR), 3.58; 95% confidence interval (CI), 1.25-10.23; p=0.017]; sensitization to hazel (OR, 5.27; 95% CI, 1.79-15.53; p=0.003), timothy (OR, 11.8; 95% CI, 2.70-51.64; p=0.001), or ragweed (OR, 3.18; 95% CI, 1.03-9.87; p=0.045); and the number of culprit foods (OR, 1.25; 95% CI, 1.15-1.37; p<0.001) were related to the development of anaphylaxis in PFAS. CONCLUSION: The most common culprit foods causing anaphylaxis in PFAS were peanut and apple. The presence of atopic dermatitis; sensitization to hazel, timothy, or ragweed; and a greater number of culprit foods were risk factors for anaphylaxis in PFAS.

Clinical research on the efficacy and safety of Bosinji for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A protocol for a multicenter, randomized, controlled equivalence trial.

BACKGROUND: A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes low back pain and radiating pain. The effectiveness of Bosinji, one of the herbal medicines used for low back pain and radiating pain in patient with LHIVD, has been reported in several studies; however, little clinical evidence is available owing to the methodological limitations in previous studies. Hence, the present study aims to establish the clinical evidence regarding the efficacy and safety of Bosinji in improving pain, function, and quality of life in LHIVD patients. METHOD/DESIGN: This is a multicenter, open-label, randomized, controlled, and equivalence trial with 2 parallel arms. A total of 74 patients who have low back pain and radiating pain due to LHIVD will be recruited and randomly allocated to the experimental group and control group. The patients in the experimental group and control group will take 2.5 g of Bosinji granule (1.523 g of Bosinji extract) or Loxonin tablet (60 mg of loxoprofen) 3 times a day for 6 weeks. Additionally, both groups will receive the same acupuncture treatment once a week for 6 weeks as a concurrent treatment. Changes in the 100-mm visual analogue scale (VAS) for low back pain after 6 weeks from baseline will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry disability index (ODI), Roland-Morris disability questionnaire (RMDQ), EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), global perceived effect (GPE), and deficiency syndrome of kidney index (DSKI) will be used to evaluate secondary outcomes. Outcomes will be assessed at baseline and at 3, 6, and 10 weeks after screening. For the safety evaluation, laboratory examinations including complete blood count, liver function test, renal function test, blood coagulation test, inflammation test, and urine analysis will be conducted before and after taking the medications. DISCUSSION: The results of this trial will be used to establish clinical evidence regarding the use of Bosinji with acupuncture treatment in the treatment of patients with LHIVD. TRIAL REGISTRATION NUMBER: NCT03386149 (clinicaltrials.gov) and KCT0002848 (Clinical Research Information Service of the Republic of Korea).

Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial.

BACKGROUND: We investigated the efficacy and safety of thread-embedding acupuncture (TEA) for chronic low back pain (LBP) in a randomized controlled pilot trial with the aim of laying the foundation for a large-scale randomized controlled trial on this topic. METHODS: Forty participants were recruited for this two-arm, assessor-blinded randomized controlled pilot trial. The participants were randomly allocated to a TEA group (experimental group) or an acupuncture group (control group). The TEA group received TEA once every 2 weeks for 8 weeks (four sessions in total), while the acupuncture group received acupuncture twice per week for 8 weeks (16 sessions in total). The primary outcome was the visual analog scale (VAS) score for pain and the secondary outcomes were short-form McGill Pain Questionnaire (SF-MPQ) and Oswestry Disability Index (ODI) scores. Assessments were performed at screening and at 2, 4, 6, 8, and 10 weeks after treatment initiation (the 10-week assessment was conducted at 2 weeks after treatment cessation). RESULTS: Of the 40 participants, 36 completed the study and four dropped out. Both the TEA group and the acupuncture group showed significant improvements in VAS, SF-MPQ, and ODI scores in a time-dependent manner. Furthermore, with regard to ODI, a significant interaction between group and time was observed, with the two groups exhibiting a different pattern of change at 8 weeks according to contrast analysis with Bonferroni's correction. No serious adverse event occurred, and hematological and biochemical test findings were within normal limits. CONCLUSION: This pilot study has provided basic data for a larger clinical trial to demonstrate the efficacy and safety of TEA for chronic LBP. TRIAL REGISTRATION: Clinical Research Information Service of the Korea National Institute of Health, ID: KCT0001819 . Registered on 15 February 2016.

Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis: - A randomized controlled pilot trial.

OBJECTIVES: We investigated the efficacy and safety of miniscalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial. METHODS: Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment). RESULTS: Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. However, there were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits. CONCLUSION: Our results suggest that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial.

BACKGROUND: A lumbar herniated intervertebral disc (LHIVD) is a common problem that usually causes lower back pain and neurological symptoms that manifest as radiating pain. Several studies have reported that thread-embedding acupuncture (TEA) is effective in the treatment of LHIVD. However, these studies were of low quality and there is therefore little clinical evidence for the effectiveness of TEA in this regard. The aim of the present study is to establish the clinical evidence regarding the efficacy and safety of TEA in the treatment of pain, function, and quality of life in patients with LHIVD. The study uses a rigorously designed, full-scale, randomized clinical trial (RCT) protocol. METHOD/DESIGN: This is a multicenter, randomized, patient-assessor blinded, sham-controlled trial with two parallel arms. Seventy patients with LHIVD who have lower back pain more severe than 40 mm on the 100-mm visual analogue scale (VAS), and who are aged 19-70 years, will be recruited and randomly allocated to a TEA group and sham TEA (STEA) group. Both groups will receive treatment on 23 predefined acupoints once a week for eight weeks; needles with the thread removed will be used in the STEA group, while normal TEA will be employed in the TEA group. Changes in the 100-mm VAS for lower back pain after eight weeks will be assessed as the primary outcome. Furthermore, the 100-mm VAS for radiating pain, Oswestry Disability Index, Roland-Morris disability questionnaire, EuroQol 5 Dimensions 5 Levels, and global perceived effect will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4, 8, 12, and 16 weeks after screening. DISCUSSION: The results of this trial will help to establish the clinical evidence regarding TEA in the treatment of patients with LHIVD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03236753 . Registered on August 2, 2017. Clinical Research Information Service of the Republic of Korea, KCT0002439 . Registered on August 1, 2017.

Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain: A study protocol for a randomized, controlled, assessor-blinded, multicenter clinical trial.

BACKGROUND: Back pain is one of the most common diseases, and many patients with recurrent pain seek alternative treatment strategies. Thread embedding acupuncture involves thread insertion at the acupuncture point for continuous physical and chemical stimulation. Although thread embedding is widely used in clinical practice, there is no sound evidence of its efficacy for chronic back pain. We describe the protocol for a randomized controlled trial for investigation of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain. METHODS: This randomized, controlled, assessor-blinded, 2-armed, parallel, multicenter clinical trial will include 38 outpatients with chronic low back pain recruited from 4 traditional Korean Medicine hospitals. The patients will be randomly allocated to a treatment group (conventional acupuncture + thread embedding acupuncture) and a control group (only conventional acupuncture) in a 1:1 ratio. The treatment group patients will receive thread embedding acupuncture treatment at 10 acupuncture points (multifidus muscle, 4 points; spinal erector muscles, four points; lumbar quadrate muscle, 2 points) once a week for 8 weeks (8 sessions). In addition, all patients will receive conventional acupuncture treatment at 14 acupuncture points (GV3, EX-B5, and bilateral BL23, BL24, BL25, BL26, BL40, and BL60) twice a week for 8 weeks (16 sessions). The primary outcome will be the change in the visual analog scale score from visit 1 to visit 16, analyzed by independent t tests, in both groups. The groups will also be compared with regard to the clinical relevance (minimal clinically important difference), quality of life (3-level version of Euroqol-5D), disability level (Roland and Morris Disability Questionnaire), global assessment (patient global impression of change), and safety. Cost data for cost-benefit and cost-effectiveness analyses will be collected. DISCUSSION: Our study results will provide evidence of the efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for the management of chronic low back pain. Even though the assessors will be blinded, the patients will not be blinded to treatment because of the lack of a sham embedding acupuncture group; this is a limitation of our study. TRIAL REGISTRATION: Clinical Research Information Service: KCT0002666.

Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study.

BACKGROUND: Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) in patients with chronic neck pain. METHODS: This seven-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment; NSAIDs; and miniscalpel acupuncture treatment combined with NSAIDs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three sessions of miniscalpel acupuncture over a three-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for three weeks). Primary and secondary outcomes will be measured at weeks 0 (baseline), 1, 2, 3 (primary end point), and 7 (four weeks after treatment completion) using the visual analogue scale and the Neck Disability Index, EuroQol 5-dimension questionnaire, and Patients' Global Impression of Change scale, respectively. Adverse events will also be recorded. DISCUSSION: This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture treatment combined with NSAIDs for chronic neck pain. TRIAL REGISTRATION: Korean Clinical Research Information Service registry, KCT0002258 . Registered on 9 March 2017.

Effects of acupuncture on the anxiety-like behavior induced by withdrawal from chronic morphine use.

OBJECTIVES: In the previous studies, it has been demonstrated that acupuncture treatment was effective on the suppression of withdrawal signs as well as self-administration behavior induced by morphine. Based on, the present study has investigated whether acupuncture could attenuate the anxiety-like behavior induced by withdrawal from chronic morphine treatment. MATERIALS & METHODS: Male Sprague-Dawley rats weighing 270-300g were treated saline or morphine hydrochloride (10mg/kg, s.c.) for 2 weeks. Following abstinence of 5days in home cage, rats were subjected to the measurement of anxiety-like behavior in the elevated plus maze. Bicuculline (1mg/kg, i.p.) and SCH 50911 (2mg/kg, i.p.) were used to investigate the possible mechanism of acupuncture effects focusing on the GABA receptors system. RESULTS: Acupuncture at HT7 increased the time spent in open arms significantly. Also, these effects of acupuncture at HT7 were blocked by GABAA receptor antagonist. CONCLUSION: Results of the present study suggest that acupuncture at HT7 can attenuate anxiety-like behavior induced by withdrawal from chronic morphine treatment through the mediation of GABAA receptor system.