Background: Recently, Korean Medicine treatment with pharmacopuncture therapy (PPT) has been increasingly used in clinical practice to improve symptoms in patients with lumbar spinal stenosis (LSS). The aim of this study is to evaluate the effectiveness and safety of PPT in addition to conventional Korean Medicine treatment (CKMT) for the treatment of patients with LSS, compared with CKMT alone. Methods: This study is designed as a pragmatic, randomized, two-armed, parallel, stratified (by sex), controlled pilot trial. Forty patients diagnosed with LSS will be randomly allocated to the PPT + CKMT group or the CKMT group. Patients in the two groups will receive treatment two times weekly for 5 weeks. The primary outcome will be the mean change in the 100-mm visual analog scale score from the baseline to the end of treatment (week 5). The secondary outcomes will include the clinically important difference, Zurich Claudication Questionnaire score, self-reported walking capacity, Modified-Modified Schober test, EuroQol 5-dimension 5-level questionnaire, and Patients' Global Impression of Change. Adverse events will be assessed at each visit. Discussion: The results of this study will provide meaningful data to evaluate the add-on effect and safety of PPT in the medical care of patients with LSS.
Gold thread therapy (GTT) continuously stimulates acupoints and is used to treat chronic conditions/diseases such as chronic lumbar pain. During the procedure gold thread is embedded into the skin and although gold thread is medically pure, GTT is an irreversible treatment where there is limited evidence on its safety. Here, we report a case of a 79-year-old woman being treated for low back pain who developed side effects following moving cupping therapy at a site of GTT (performed in the 1970s). Adverse reactions causing radiating pain persisted more than at least 9 days following moving cupping therapy. The symptoms of pain were evaluated using the numerical rating scale, and changes in tenderness and the state of bruising was recorded. Low back pain improved but the radiating low leg pain did not improve. This case highlights the need for caution when performing moving cupping therapy where GTT has been previously performed.
This study aimed to analyze the status of adverse events (AEs) in the treatment of musculoskeletal conditions/ diseases using thread embedding acupuncture (TEA). Five electronic databases were searched to retrieve data on clinical studies published in the last 5 years (2016 to 2021). Of the 151 studies retrieved, 22 studies analyzed AEs and were selected for this review. There were no AEs reported in 6 studies (27.3%); of the remaining 16 studies, 4 studies (18.2%) reported AEs that were not related to TEA. The most common AEs reported in the Chinese studies were redness of skin with/without swelling and tingling sensation, and in the Korean studies they were stiffness, a foreign body sensation, and bruising. The percentage of patients with AE experience was 5.1% in the Chinese studies and 19.9% in the Korean studies. The discrepancies between the findings in the Chinese and Korean studies may be attribute to differences in the diameter of needles, thread materials, TEA treatment procedure, and evaluation methods for AEs. Most of the reported AEs were of a mild status and did not last for a long time. However, further research on the clinical course after TEA treatment is needed.
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