Cross-cultural adaptation of the Korean Synkinesis Assessment Questionnaire: A validation study.

Objective: The Synkinesis Assessment Questionnaire (SAQ) is a reliable tool to assess synkinesis symptoms; however, it is yet to be validated in Korea. Thus, this study aimed to translate and validate the Korean SAQ. Methods: This validation study was set in a clinic in Seoul, Korea, that provides general integrative medicine services. A total of 100 participants with facial palsy were enrolled. Participants completed the SAQ, House-Brackmann grade (HB grade), Sunnybrook Facial Grading System (SB), and Facial Disability Index (FDI). The forward-backward translation method was followed. Of the 100 participants, 31 underwent a second assessment for test-retest reliability. Internal consistency and test-retest reliability were evaluated using Cronbach's alpha coefficient. The construct validity of the Korean version of the SAQ was tested using Spearman's rank correlation coefficient. Results: The internal consistency score for the SAQ was 0.789, and the test-retest reliability score was 0.787. According to Spearman's rank correlation coefficient, the SAQ correlations to the synkinesis subdomain of SB score, total SB score, HB grade, and physical function domain in the FDI score were 0.366 (p < .001), -0.386 (p < .001), 0.315 (p = .001), and -0.269 (p = .007), respectively. All values were statistically significant. Conclusions: The Korean SAQ is a valid and reliable tool used to evaluate synkinesis in patients with facial palsy. Level of Evidence: Level 3.

Clinical effect and safety of thread embedding acupuncture on facial nerve palsy sequelae: A retrospective observational study.

The purpose of this study was to investigate the clinical effect and safety of thread embedding acupuncture (TEA) in patients with facial nerve palsy sequelae. This was a retrospective observational study on 82 patients treated with TEA from January 2021 to May 2022. The Facial Disability Index (FDI) reported by patients and Sunnybrook Facial Grading System scores assessed by clinical practitioners were used to evaluate the intensity of facial movements, functional problems, and psychosocial status. One-way repeated measure analysis of variance showed that the Sunnybrook Facial Grading System scores improved significantly following the 2nd to 6th TEA treatments (Txs). FDI scores also showed significant increases except for the 4th Tx. Additionally, the physical scores improved significantly among the subscales of FDI, but the social/well-being scores did not. There were no reported serious adverse events or adverse events requiring medical Tx. TEA is a safe Tx that has a clinically cumulative effect, in terms of patient-oriented self-assessment of functional problems and objective facial movements, for treating facial nerve palsy sequelae.

Clinical use of thread embedding acupuncture for facial nerve palsy: A web-based survey.

Although thread embedding acupuncture (TEA) is widely used for facial nerve palsy (FNP) in Korea, it lacks clinical evidence. Therefore, a large-scale and long-term clinical trial is needed. It is necessary to standardize and optimize TEA treatment for clinical study. Hence, we collected information about how TEA in the facial region is performed in clinical practice using a web-based survey. A questionnaire was developed consisting of 22 essential items and 30 optional items including demographic characteristics, purpose of TEA, adverse events (AE), direct medical cost, required time, and current state of TEA treatment on FNP. The questionnaire was sent via e-mail to 23,910 traditional Korean medicine doctors (TKMD). A total of 427 respondents answered the questionnaire. The most common response for the purpose for TEA was cosmetic, followed by musculoskeletal disease and nervous system disease. The most common AE that resolved without medical treatment was bruising (90.4%). The most common AE that required medical treatment was dimple (30.5). Many respondents commonly used TEA for the sequelae of FNP (71.8%). The most frequent sequelae of FNP for which TEA was used as contracture around the mouth (75.3%). The most preferred treatment method was insertion of 6-10 monofilament threads using a 29-gauge needle at intervals of 2.2 ± 1.59 weeks in the sequelae period. The results of this survey can be used to standardize and optimize the procedure of TEA for FNP for further clinical research.

A spadework for integrative medicine based critical pathways for facial palsy: Web-based survey from traditional Korean medicine doctors.

Patients affected with facial palsy consult both traditional Korean medicine doctors and conventional medicine doctors. Considering that the optimal approach varies depending on the progress of the disease, there is a need for facial palsy management through integrated medical care. However, no critical pathway has been developed to manage facial palsy from an integrated medical perspective. The aims of this study were to (a) explore treatment utilization status and awareness for facial palsy; (b) understand possible traditional Korean medicine modalities; and (c) suggest interventions to be included in integrated medical service for treating facial palsy. Regarding existing papers in relevant field, draft of questionnaire was firstly established. Eight-person development committee was comprised and reviewed the draft and modified the items of questionnaire. As an independent committee, the authors of present study have rechecked the validity and reliability of modified items of questionnaire. A questionnaire was developed comprising 21 items, including demographic characteristics, clinical statement, recognition, and demands and directions to improve the quality of newly developing critical pathways. Using the services of the Association of Korean Medicine and Medistream, the questionnaire was sent via a web-based survey to traditional Korean medicine doctors. A total of 1017 valid questionnaires were collected from traditional Korean medicine doctors. Of the total doctors who responded, over 75% stated that they utilized integrated medical systems in various forms. Acupuncture, herbal medicine, and thermal therapy were presented as key traditional Korean medicine treatments to be included in the critical pathway for the establishment of integrated medical services. Conversely, corticosteroids, antivirals, and blood sugar management were chosen to be critical among conventional medical treatments. Considering the responses collected in the present study and the progressive nature of facial palsy, various interventions in both conventional and traditional Korean medicine services need to be included in relevant critical pathways. If the critical pathway developed based on the present study is established, relevant clinical practice guidelines could be made available in an integrated medical system.

Thread Embedding Acupuncture for Temporomandibular Disorder: Protocol for a Pilot Randomized Controlled Trial.

Background: Temporomandibular disorder (TMD) affects multiple tissues of the temporomandibular joint complex and manifests as orofacial pain and functional disturbance. While thread embedding acupuncture (TEA) is used for the treatment of TMD in clinical practice, sufficient clinical evidence is lacking. This pilot trial will explore the feasibility of a confirmatory randomized controlled trial (RCT) by considering the efficacy, safety, and cost-effectiveness of TEA to address pain, function, and quality of life in patients with TMD. Methods: This randomized, assessor-blinded, controlled trial will include two parallel arms. Thirty patients with TMD and temporomandibular joint pain more severe than 40 mm on the 100-mm visual analog scale (VAS) and aged 19-70 years will be recruited and randomly allocated to either TEA or usual care groups. The TEA group will receive treatment at 14 predefined acupoints once weekly for 4 weeks. The usual care group will receive physical therapy consisting of transcutaneous electrical nerve stimulation and infrared therapy. The average VAS score over the last week for temporomandibular pain after four sessions will be assessed as the primary outcome. Furthermore, maximum pain VAS, vertical opening movement, Graded Chronic Pain version 2, Jaw Functional Limitation Scale 20, Patient Global Impression of Change, Korean version of Beck's Depression Index, Short Form-12 Health Survey, EuroQol 5-Dimension 5-level, treatment expectation, rescue medication consumption, adverse events, and medical costs for economic evaluation will be measured and analyzed as secondary outcomes during four follow-up visits and after the termination of all sessions. Conclusion: The results of this trial will help evaluate the feasibility of a confirmatory RCT considering efficacy, safety, and cost-effectiveness and verify the effect size required to determine an appropriate sample size. Trial Registration Number: KCT0007421.

Appraising the safety and reporting quality of thread-embedding acupuncture: a protocol for a systematic review and meta-analysis.

INTRODUCTION: Thread-embedding acupuncture (TEA) is a special type of acupuncture treatment in which medical threads are inserted into subcutaneous tissues or muscles at therapeutic points. TEA is a medical practice that combines acupuncture and medical threads. As such, it is necessary to evaluate the safety of TEA. This systematic review and meta-analysis aimed to assess the safety of TEA and reporting quality of studies regarding TEA. METHODS AND ANALYSIS: The systematic review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and the Cochrane Handbook for Systematic Reviews of Interventions. Searching strategies will be systemically conducted using the following databases from their inception date to September 2022: MEDLINE, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), CiNii, J-STAGE, Korean Medical Database, Korean Studies Information Service System (KISS), ScienceON and Oriental Medicine Advanced Searching Integrated System (OASIS). The search strategies will be adjusted for each database as appropriate. The risk of bias will be assessed using the McMaster tool to identify the quality of harm assessment and reporting in study reports (McHarm). A meta-analysis will be used to synthesise the frequency and incidence of adverse events. ETHICS AND DISSEMINATION: No ethical approval and consent is required for this systematic review. The results of this systematic review will be disseminated through peer-reviewed publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022297123.

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.

Acupuncture for lateral epicondylitis: A prisma-compliant protocol for a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Acupuncture has been widely used for relieving pain associated with musculoskeletal disorders, such as lateral epicondylitis. Although the effect of acupuncture on pain has been demonstrated in previous reviews, it is still under debate. This study is aimed at evaluating the efficacy of acupuncture to treat lateral epicondylitis and establishing the evidence systematically. METHODS: Nine databases will be searched from their inception to May 2020 without language or publication status restrictions, including 3 English databases (MEDLINE, Embase, the Cochrane Central Register of Controlled Trials), 5 Korean databases (Korean Medical Database, KoreaMed, Korean Studies Information Service System, Research Information Service System, Oriental Medicine Advanced Searching Integrated System), and 1 Chinese database (China Knowledge Network Database). Only randomized controlled trials will be included. Pain intensity will be considered as the primary outcome. Secondary outcomes will include the grip strength, total effective rate, and adverse events. Two independent researchers will perform the study selection, data extraction, and quality assessment. The methodological quality of the identified studies will be assessed using the Cochrane Collaboration's risk-of-bias tool. In the meta-analysis, continuous data will be expressed as mean and 95% confidence interval, and dichotomous data will be expressed as risk ratio and 95% confidence interval. RESULTS: The results of this study will be submitted to a peer-reviewed journal for publication. CONCLUSION: The results of this study would provide the evidence of whether acupuncture is effective for lateral epicondylitis. REGISTRATION NUMBER: PROSPERO CRD42020186824.

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 efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell's palsy: A protocol for a patient-assessor blinded, randomized, controlled, parallel clinical trial.

BACKGROUND: The sequelae of Bell's palsy cause critical problem in facial appearance, as well as social and psychological problems in the patient's life. The aim of the present study is to establish clinical evidence of thread-embedding acupuncture (TEA) in the treatment of sequelae of Bell's palsy. METHOD/DESIGN: This is a patient-assessor blinded, randomized, sham-controlled trial with two parallel arms. Fifty-six patients aged 19-65 years, who have experienced sequelae of Bell's palsy for >3 months, will be recruited and screened using the eligibility criteria. After screening, they will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive TEA or STEA treatment on ten predefined acupoints once a week for 8 weeks. Additionally, both groups will receive the same acupuncture treatment twice a week for 8 weeks as a concurrent treatment. Changes in the Facial Disability Index over 8 weeks will be assessed as the primary outcome. Furthermore, the House-Brackmann Grade, Facial Nerve Grading System 2.0, Sunnybrook Facial Grading System, facial stiffness score, lip mobility score, and treatment satisfaction score will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4 and 8 weeks after screening. DISCUSSION: The results from this trial will help establish clinical evidence regarding the efficacy and safety of TEA in the treatment of patients with sequelae of Bell's palsy. TRIAL REGISTRATION NUMBER: KCT0002557 (Clinical Research Information Service of the Republic of Korea).

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).

Cupping for hypertension: a systematic review.

The objective of this review is to assess the clinical evidence for or against cupping as a treatment for hypertension. We searched the literature using 15 databases from their inception to 30 June 2009, without language restrictions. We included all clinical trials (CTs) of cupping to treat hypertension in human patients. Risk of bias was assessed using the Cochrane criteria. Two CTs met all inclusion criteria. One RCT (randomized CT) assessed the effectiveness of dry cupping on changes in cerebral vascular function compared with drug therapy. Their results suggested significant effect in favor of cupping on vascular compliance and degree of vascular filling. One uncontrolled observational study (UOS) tested wet cupping for acute hypertension and found that a one-time treatment reduced blood pressure. In conclusion, the evidence is not significantly convincing to suggest cupping is effective for treating hypertension. Further research is required to investigate whether it generates any specific effects for that condition.