Successful outcome with oral sirolimus treatment for complicated lymphatic malformations: a retrospective multicenter cohort study.

Purpose: Sirolimus has emerged as a safe and effective treatment for complicated lymphatic malformations (LMs). We aim to prove the effectiveness and safety of sirolimus as a therapeutic option for patients with complicated LMs. Methods: Fifty-eight patients with complicated LMs treated with sirolimus for at least 6 months at multicenter between July 2018 and January 2023 were enrolled. All patients were administered oral sirolimus starting at 0.8 mg/m2 every 12 hours, with target serum concentration levels of 8-15 ng/mL. Evaluation for clinical symptoms and LMs volume on MRI were reviewed to assess treatment response and toxicities. Evaluation of disease response was divided into 3 values: complete response, partial response (significant, moderate, and modest), and progressive disease. Results: The median age at the initiation of sirolimus treatment was 6.0 years (range, 1 month-26.7 years). The median duration of treatment was 2.0 years (range, 6 months-4.4 years). The most common lesions were head and neck (25 of 58, 43.1%). Forty-six patients (79.3%) demonstrated a reduction in LMs volume on MRI or improvement of clinical symptoms including 2 complete responses. The young age group and the patients who underwent few prior therapies showed better responses. None of the patients had toxicities attributable to sirolimus with a Common Terminology Criteria for Adverse Events grade of ≥3. Conclusion: Oral sirolimus treatment brought a successful outcome without severe adverse effects. It could be the first-line therapy, especially for the young age group of complicated LMs, and an additional option for refractory lesions that did not respond to conventional treatment.

Optimal timing for inguinal hernia repair in premature infants: surgical issues for inguinal hernia in premature infants.

Purpose: We analyzed the timing of inguinal hernia repair in premature infants in the neonatal intensive care unit (NICU) considering recurrence, incarceration, and other complications. Methods: In this multicenter retrospective review, premature infants (<37 weeks) in the NICU diagnosed with inguinal hernia between 2017 and 2021 were segregated into 2 groups based on the timing of inguinal hernia repair. Results: Of 149 patients, 109 (73.2%) underwent inguinal hernia repair in the NICU and 40 (26.8%) after discharge. Preoperative incarceration did not differ, but complications with recurrence and postoperative respiratory insufficiency were higher in the NICU group (11.0% vs. 0%, P = 0.029; 22.0% vs. 5.0%, P = 0.01). Multivariate analysis showed that the significant factors affecting recurrence were preoperative ventilator dependence and body weight of <3,000 g at the time of surgery (odds ratio [OR], 16.89; 95% confidence interval [CI], 3.45-82.69; P < 0.01 and OR, 9.97; 95% CI, 1.03-95.92; P = 0.04). Conclusion: Our results suggest that when premature infants are diagnosed with inguinal hernia in the NICU, inguinal hernia repair after discharge may decrease the odds of recurrence and postoperative respiratory insufficiency. In patients who have difficulty delaying surgery, it is thought that surgery should be performed carefully in a ventilator preoperatively or weighed <3,000 g at the time of surgery.

Omental infarction diagnosed by computed tomography, missed with ultrasonography: A case report.

BACKGROUND: Omental infarction (OI) is a surgical abdominal disease that is not common in adults and is very rare in children. Similar to various acute abdominal pain diseases including appendicitis, diagnosis was previously achieved by diagnostic laparotomy but more recently, ultrasonography or computed tomography (CT) examination has been used. CASE SUMMARY: A 6-year-old healthy boy with no specific medical history visited the emergency room with right lower abdominal pain. He underwent abdominal ultrasonography by a radiologist to rule out acute appendicitis. He was discharged with no significant sonographic finding and symptom relief. However, the symptoms persisted for 2 more days and an outpatient visit was made. An outpatient abdominal CT was used to make a diagnosis of OI. After laparoscopic operation, his symptoms resolved. CONCLUSION: In children's acute abdominal pain, imaging studies should be performed for appendicitis and OI.

Laparoscopic cholecystectomy in a swine model using a novel near-infrared fluorescent IV dye (BL-760).

BACKGROUND AND OBJECTIVES: Bile duct injury during laparoscopic cholecystectomy has an incidence rate of 1%-2% and commonly appears under conditions of severe inflammation, adhesion, or unexpected anatomical variations. Despite the difficulties and rising concerns of identifying bile duct during surgeries, surgeons do not have a specific modality to identify bile duct except intraoperative cholangiography. While no biliary-specific fluorescent dye exists for clinical use, our team has previously described the development of a preclinical biliary-specific dye, BL-760. Here, we present our study of laparoscopic cholecystectomy using the fluorescent dye in a swine model. STUDY DESIGN/MATERIALS AND METHODS: With an approval from Institutional Animal Care and Use Committee, two 20-25 kg swine underwent laparoscopic abdominal surgery using a Food and Drug Administration-cleared fluorescent laparoscopic system. Images of the liver and gallbladder were taken both before and after intravenous injection of the novel fluorescent dye. The dye was dosed at 60 µg/kg and injected via the ear vein. The amount of time taken to visualize fluorescence in the biliary tract was measured. Fluorescent signal was observed after injection, and target-to-background ratio (TBR) of the biliary tract to surrounding cystic artery and liver parenchyma was measured. RESULTS: Biliary tract visualization under fluorescent laparoscopy was achieved within 5 min after the dye injection without any adverse effects. Cystic duct and extrahepatic duct were clearly visualized and identified with TBR values of 2.19 and 2.32, respectively, whereas no fluorescent signal was detected in liver. Cystic duct and artery were successfully ligated by an endoscopic clip applier with the visual assistance of highlighted biliary tract images. Laparoscopic cholecystectomy was completed within 30 min in each case without any complications. CONCLUSIONS: BL-760 is a novel preclinical fluorescent dye useful for intraoperative identification and visualization of biliary tract. Such fluorescent dye that is exclusively metabolized by liver and rapidly excreted into biliary tract would be beneficial for all types of hepato-biliary surgeries. With the validation of additional preclinical data, this novel dye has potential to be a valuable tool to prevent any iatrogenic biliary injuries and/or bile leaks during laparoscopic abdominal and liver surgeries.

Efficacy and safety of autologous adipose tissue-derived stem cell therapy for children with refractory Crohn's complex fistula: a Phase IV clinical study.

PURPOSE: Autologous adipose tissue-derived stem cells (ASCs) have been proposed for patients with refractory Crohn disease, but research is lacking in pediatric patients. This Phase IV study evaluated the efficacy and safety of ASCs in children with refractory Crohn's fistulae. METHODS: Patients with a refractory Crohn's fistula who did not have conventional therapy for more than 3 months or with a recurrent complex Crohn's fistula were included. All patients were at least 14 years old. Patients with infection, poor condition, or active Crohn disease with a disease activity index of 450 and above were excluded. Five patients were treated with ASCs from 2014 to 2015 in Asan Medical Center. ASC administration was adjusted according to fistula size (1 mL per cm2). We evaluated the efficacy and safety 8 weeks after injection and followed patients for 6 months. RESULTS: Fistulae were healed in 4 patients by 8 weeks after ASC injection. Of these 4 patients, 1 had complete fistula closure and sustainability after 6 months. The other 3 with healing effects had less than 50% fistula closure by 6 months. None of these 4 patients have persistent fistulae. One patient had no healing effect, and seton ligation was performed 8 months after ASC injection. There were no adverse effects related to ASC administration. CONCLUSION: ASC therapy is a simple and well-tolerated therapeutic option for children with refractory Crohn's complex fistulae. Complete closure was well-sustained. However, more data from a larger number of patients are needed.

Perforation on the superior side of duodenum is a risk factor of laparoscopic primary repair for duodenal ulcer perforation.

PURPOSE: Primary repair is the standard surgical method for treating duodenal ulcer perforations, with very good results usually anticipated because of the simplicity of the associated surgical techniques. Therefore, this study aimed to analyze the risk factors that affect laparoscopic primary repair outcomes for duodenal ulcer perforation. METHODS: Between June 2010 and June 2020, 124 patients who underwent laparoscopic primary repair for duodenal ulcer perforations were reviewed. Early surgical outcomes were evaluated and risk factors for postoperative complications were assessed. RESULTS: All surgeries were performed laparoscopically without open conversion. Multivariate analysis showed that the elderly (over 70 years), and perforations that needed more than 2 stitches for closure were risk factors for overall postoperative complications. Perforations that needed more than 2 stitches and perforations on the superior side of the duodenum were major risk factors for severe postoperative complications. Severe postoperative complications occurred in 6 of the patients, and 1 of them died of multiorgan failure. CONCLUSION: Based on our results, we suggest that laparoscopic primary repair can be safely performed in duodenal ulcer perforation. However, more careful surgery and postoperative care are needed to improve the surgical outcomes of patients who need more than 2 stitches to close their perforation or who have perforations on the superior side of the duodenum.

Effects of sirolimus in the treatment of unresectable infantile hemangioma and vascular malformations in children: A single-center experience.

OBJECTIVE: Recently, sirolimus has emerged as a safe and effective treatment modality for unresectable vascular lesions. In the present study, we investigated the effectiveness and safety of sirolimus from our early experience with patients with unresectable vascular anomalies. METHODS: The medical records and radiologic images of all patients with unresectable vascular anomalies treated with sirolimus at our center from January 2018 to November 2019 were retrospectively reviewed. All patients were administered oral doses of sirolimus 0.8 mg/m2 every 12 hours as the initial dose, followed by maintenance of a target serum concentration (5-10 ng/mL) with therapeutic drug monitoring. RESULTS: Six patients with unresectable vascular anomalies were treated with sirolimus for ≥10 months. Their median age at the initiation of sirolimus treatment was 17 months (range, 8-67 months). The median duration of treatment was 13 months (range, 10-16 months). One patient had a good response, four had an intermediate response, and one had no response to sirolimus therapy. None of the patients had discontinued sirolimus therapy because of adverse effects. CONCLUSIONS: Sirolimus can be used effectively and safely for patients with unresectable vascular anomalies. However, further prospective studies are warranted to evaluate the long-term effects of sirolimus and clarify the indications for early intervention.

The Advantages of Indocyanine Green Fluorescence Imaging in Detecting and Treating Pediatric Hepatoblastoma: A Preliminary Experience.

Background: Currently, indocyanine green (ICG) fluorescence imaging enables radical surgical resection in hepatoblastoma (HB) and has beneficial uses; however, its usage in pediatric patients is still limited. Methods: From 2015 to 2019, 17 hepatoblastoma patients underwent 22 fluorescence-guided surgery using ICG. ICG (0.3 mg/kg) was intravenously injected 24-48 h before the operation. With ICG/NIR camera, intraoperative identification of biological structures and demarcation of mass were conducted. Results: ICG fluorescence-guided surgery was performed for hepatoblastoma in 22 cases: 16, 1, and 2 cases underwent anatomic resection, partial hepatectomy, and liver transplantation, respectively. Six patients accompanied lung metastasis at the time of surgery, and two patients underwent lung surgery using ICG. The median interval from ICG injection to surgery was 38.3 h (range, 20.5-50.3 h). The median tumor size was 36.5 mm (range, 2-132 mm). According to the pathologic finding, the median safety margin was secured for 6 mm (range, 0-11 mm) and there was no residual finding at the liver at the follow-up computed tomography (CT). Conclusions: ICG fluorescence imaging in children with HB was feasible and safe for tumor demarcation and enhancing the accuracy of radical tumor resection.

Living donor liver retransplantation for primary non-function of liver graft following multivisceral transplantation in a pediatric patient.

Multivisceral organ transplantation (MVOT) includes transplantation of three or more abdominal organs, generally including the small bowel, duodenum, stomach, liver, pancreas, and colon. We here presented the detailed procedures of repeat living donor liver transplantation for primary non-function of the first liver graft following MVOT in a pediatric patient. A 6-year-old girl with chronic intestinal pseudo-obstruction underwent MVOT with 5-year-old donor organs. However, the primary non-function of the liver graft developed, and an emergency living donor liver transplantation operation using a left lateral section graft was performed on the third day after MVOT. The donor was the patient's father. Portal flow interruption induced ischemic congestion of the whole small bowel, thus we used a series of porto- caval shunt to reduce the risk of ischemic splanchnic congestion during recipient hepatectomy and graft implantation. Other surgical procedures were the same as the standardized procedures for left liver graft implantation. The graft-recipient weight ratio was 2.15. The patient was managed conservatively for 3 months and discharged in an improved condition at 4 months after MVOT. She finally passed away at 22 months after MVOT. We think that our experience will be helpful for surgeons to cope with portal vein clamping-associated splanchnic congestion during liver transplantation and other abdominal surgeries.

Effect of everolimus rescue therapy for acute cellular rejection following pediatric living donor liver transplantation: Report of one case.

Acute cellular rejection (ACR) after pediatric living donor liver transplantation (LDLT) is often curable with steroid pulse therapy, but a few pediatric patients show steroid-resistant ACR, which is difficult to control. We report the effect of everolimus as a rescue therapy for ACR in a case of pediatric LDLT. The patient was a 11-year-old girl who was admitted due to subacute liver failure of unknown cause. LDLT operation using a modified right liver graft from her mother was performed. The graft-recipient weight ratio was 1.30. The explant liver showed massive hepatic necrosis. The patient recovered uneventfully with immunosuppression using tacrolimus and low-dose steroid. However, at postoperative day (POD) 20, the liver enzyme levels began to increase. The first liver biopsy taken at POD 25 showed moderate ACR with rejection activity index (RAI) score of 7. At that time, steroid pulse therapy was performed, but the patient did not respond and the liver enzyme levels increased further. The second liver biopsy taken at POD 40 showed moderate ACR with RAI score of 7. At this time, everolimus was administered, and soon after that, liver enzyme levels had gradually improved. Currently, the patient is doing well for 44 months to date without any abnormal findings. The maintenance target trough concentrations were tacrolimus 5 ng/ml and everolimus 3 ng/ml. Our case demonstrated the effect of rescue therapy using everolimus for ACR following pediatric LDLT. Further studies are needed to assess the role of everolimus in pediatric liver transplant recipients suffering from ACR.

Living-donor liver transplantation with inferior vena cava replacement in an infant recipient with advanced hepatoblastoma.

Replacement of the inferior vena cava (IVC) after concurrent resection of hepatoblastoma-containing liver and retrohepatic IVC is regarded as a feasible option for pediatric living-donor liver transplantation (LDLT). This technique makes the extent of resection of LDLT comparable to that of deceased-donor liver transplantation (DDLT). We present one case of pediatric LDLT with IVC homograft replacement for advanced hepatoblastoma. The patient was a 10-kg 18-month-old girl suffering from large multiple hepatoblastomas, which were partially regressed by neoadjuvant chemotherapy. Because the tumors had invaded the retrohepatic IVC, there was a high risk of residual tumor cells at the IVC if it was preserved. Thus, we decided to replace the IVC during the LDLT operation. After a cold-stored fresh iliac vein homograft was prepared, we performed LDLT using her mother's left lateral section liver graft. A 4-cm-long common iliac vein homograft was attached to the liver graft at the back table. The left lateral-section graft with IVC attachment was implanted using the standard procedures like those of DDLT. We also did portal vein graft interposition. The patient recovered uneventfully and has been undergoing scheduled adjuvant chemotherapy to date. This is our second case of IVC homograft replacement for pediatric LDLT. In pediatric recipients, various vein homografts, such as iliac vein, IVC, and other large veins, can be used depending on the body size of the recipient and availability of vein homografts.

Living donor liver transplantation with total pancreatectomy and portal vein homograft replacement in a pediatric patient with advanced pancreatoblastoma.

Pancreatoblastoma is a malignant exocrine pancreatic tumor that is usually present in childhood. We herein present one case of pediatric living donor liver transplantation (LDLT) combined with spleen-preserving regional total pancreatectomy and portal vein homograft interposition in a 4-year-old boy with advanced pancreatoblastoma invading the portal and superior mesenteric veins. The size of the pancreatoblastoma was gradually reduced along systemic chemotherapy, thus we decided to perform surgery to remove it completely. A cold-stored fresh iliac vein homograft was prepared. Initially, a spleen-preserving distal pancreatectomy was performed. Thereafter, a completion regional total pancreatectomy was performed under superior mesenteric vein-vena cava bypass. A left liver graft from his mother was implanted according to the standardized procedures with portal vein interposition. This patient recovered uneventfully and is currently undergoing scheduled adjuvant chemotherapy. To our knowledge, this is the world-second case of pediatric LDLT for advanced pancreatoblastoma. Availability of fresh vein homografts is helpful to expand the indication of pediatric LDLT.

How to safely perform laparoscopic liver resection for children: A case series of 19 patients.

PURPOSE: The purpose of this study was to determine the feasibility and outcome of laparoscopic hepatectomy in pediatric patients with liver tumors and introduce surgical techniques to minimize complications. METHODS: This was a retrospective study of 19 patients less than the age of 18 years old who underwent LLR for liver tumors between November 2005 and May 2017. RESULTS: Ten females and nine males with a median age of 26 months and a median body weight of 14.7 kg were enrolled. Diseases of these patients were hepatoblastoma, neuroblastoma, biliary atresia, and liver abscess. The numbers of resected hepatic segments were more than two in thirteen patients and one in six patients. One patient required conversion to laparotomy to control bleeding caused by injury to the left hepatic vein. Nine patients received transfusions perioperatively. Median duration of operation was 230 min, and median postoperative hospital stay was 7.0 days. There was no postoperative complication. Only one patient showed nonhepatic recurrence of neuroblastoma which caused mortality. CONCLUSIONS: LLR for benign and malignant liver tumors showed acceptable amount of bleeding and low complication rate. Therefore, LLR would be a safe and feasible option for liver tumors in children with proper technical efforts and selection of patients. LEVEL OF EVIDENCE: Level III.

Suggested Indications for Enucleation of Solid Pseudopapillary Neoplasms in Pediatric Patients.

Background: Solid pseudopapillary neoplasms (SPNs) are rare, low-grade, malignant neoplasms that can occur in pediatric patients. Although complete resection of the tumor is the principle treatment, SPN enucleation (EN) has been reported to be effective in children. This study aimed to examine the feasibility and safety of EN by comparing it with conventional pancreatectomy (CP), and to present the indications for its use in pediatric patients. Methods: We retrospectively reviewed the medical records of 66 patients who underwent surgery for SPN at our institution from October 1992 to April 2018. Surgical methods, postoperative complications, hospital stay, and recurrence were compared. Results: Of the 66 patients, 15 (22.7%) were treated with EN and 51 (77.3%) were treated with CP. The mean duration of EN operation was 262 min (±145 min) and of CP was 345 min (±195 min). There was no statistically significant difference between the two methods (P = 0.13). To objectively compare the mass size between patients, we introduced a tumor size/intraperitoneal width ratio, which also revealed no significant difference between the 2 surgery groups (P = 0.21). The EN group had one case of recurrence at the resection site. The complications observed were fluid collection, splenic infarctions, hematomas, pancreatic fistulas, portal vein thromboses, and chylous drainage, among which pancreatic fistulas were the most frequent followed by moderate-severe fistulas in the EN group (P < 0.001). The mean postoperative fasting time (EN 17.0 ± 8.7 days vs. CP 5.1 ± 3.3 days, P < 0.001) and mean hospital stay (EN 23.4 ± 10.0 days vs. CP 13.2 ± 6.5 days, P = 0.002) showed statistically significant differences. Conclusion: Compared with CP treatment, EN of SPNs in children has the disadvantages of prolonged fasting times and hospital stays to recover from moderate pancreatic fistulas. However, if appropriate indications are applied, EN can be considered a safe and effective surgical procedure for children.

Therapeutic effect of trans-drain administration of antibiotics in patients showing intractable pancreatic leak-associated pus drainage after pancreaticoduodenectomy.

BACKGROUNDS/AIMS: To cope with intractable pus drainage from persistent pancreatic leak after pancreaticoduodenectomy (PD), we have empirically performed local administration of high-concentration antibiotics cocktail solution into abdominal drains. The purpose of this study was to assess its therapeutic effect in patients showing intractable pus drainage after PD. METHODS: The study group was 10 patients who underwent trans-drain administration of high-concentration antibiotics cocktail solution. Another 10 patients were selected through propensity score matching for the control group. Their medical records were retrospectively reviewed with focus on comparison of pancreatic fistula (PF)-associated clinical sequences. RESULTS: Postoperative PF of grade B and C occurred in 7 and 3 patients in the study group and 9 and 1 patient in the control group, respectively (p=0.58). In the study group, a mean of 1.8 sessions of antibiotics cocktail solution (imipenem 500 mg and vancomycin 500 mg dissolved in 20 ml of normal saline) was administered. Two patients showed procedure-associated febrile episodes that were spontaneously controlled within 48 hours. At 2-4 days after the first-session of antibiotics administration, pus-like drain discharge turned to be serous with significantly decreased amount. The study group showed shortened postoperative hospital stay comparing to the control group (25.2±4.6 vs. 31.8±5.6 days, p=0.011). In both groups, no patient received radiological or surgical intervention due to PF-associated complications. CONCLUSIONS: The results of our study demonstrated that trans-drain administration of antibiotics could be an effective therapeutic option for pancreaticojejunostomy leak-associated infection. Further validation of our result is necessary in large patient populations from multiple centers.

Gallstone ileus inducing obstructive jaundice at the afferent loop of Roux-en-Y hepaticojejunostomy after bile duct cancer surgery: a case report.

The diagnosis of gallstone ileus is occasionally challenging due to the variability of its presentation. We herein present a very rare case of gallstone ileus inducing obstructive jaundice at the afferent loop of Roux-en-Y hepaticojejunostomy after 10 years of bile duct cancer surgery. We describe the case of a 74-year-old Korean woman with obstructive jaundice, treated conservatively. She showed severely impaired liver function test and obstructive jaundice. The computed tomography (CT) scan led to a diagnosis of very rare type of gallstones ileus at the afferent jejunal loop. Since the clinical manifestation was improved, we decided to observe her closely. On the next follow-up CT scan, the gallstone disappeared with mild distension of the afferent bowel loop, implicating spontaneous passage of the gallstone. She recovered and returned to normal life after 10 days of initiation of clinical manifestations. We presume that the gallstone may enter the afferent jejunal loop through the hepaticojejunostomy and later increase in size. The presence of narrow tract of intestine may facilitate the incidence of gallstone ileus. It appears to be the first report on this rare type of gallstone ileus inducing obstructive jaundice.

Acupuncture for chronic low back pain: a multicenter, randomized, patient-assessor blind, sham-controlled clinical trial.

STUDY DESIGN: Multicenter, randomized, patient-assessor blind, sham-controlled clinical trial. OBJECTIVE: To investigate the efficacy of acupuncture treatment with individualized setting for reduction of bothersomeness in participants with chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: Low back pain is one of the main reasons of disability among adults of working age. Acupuncture is known as an effective treatment of cLBP, but it remains unclear whether acupuncture is superior to placebo. METHODS: One hundred thirty adults aged 18 to 65 years with nonspecific LBP lasting for at least last 3 months prior to the trial participated in the study from 3 Korean medical hospitals. Participants received individualized real acupuncture treatments or sham acupuncture treatments for more than 6 weeks (twice a week) from Korean Medicine doctors. Primary outcome was change of visual analogue scale (VAS) score for bothersomeness of cLBP. Secondary outcomes included VAS score for pain intensity and questionnaires including Oswestry Disability Index, general health status (Short Form-36), and Beck Depression Inventory (BDI). RESULTS: There were no baseline differences observed between the 2 groups, except in the Oswestry Disability Index. One hundred sixteen participants finished the treatments and 3- and 6-month follow-ups, with 14 subjects dropping out. Significant difference in VAS score for bothersomeness and pain intensity score of cLBP has been found between the 2 groups (P < 0.05) at the primary end point (8 wk). In addition, those 2 scores improved continuously until 3-month follow-up (P = 0.011, P = 0.005, respectively). Oswestry Disability Index, the Beck Depression Inventory, and Short Form-36 scores were also improved in both groups without group difference. CONCLUSION: This randomized sham-controlled trial suggests that acupuncture treatment shows better effect on the reduction of the bothersomeness and pain intensity than sham control in participants with cLBP.

Efficacy of a 0.1% capsaicin hydrogel patch for myofascial neck pain: a double-blinded randomized trial.

OBJECTIVE: The objective of this study was to evaluate the efficacy of a hydrogel patch containing capsaicin 0.1% compared with a placebo hydrogel patch without capsaicin to treat chronic myofascial neck pain. DESIGN: The study was designed as a double-blinded randomized controlled trial. Setting. The study was set at Kyung-hee University Hospital at Gangdong, Korea. SUBJECTS: Sixty-one participants between 18 and 65 years with at least 3 months duration of neck pain and a clinical presentation of myofascial pain syndrome were enrolled in the study from September 1 to November 20, 2010. Interventions. Participants received capsaicin 0.1% hydrogel patches or control hydrogel patches without capsaicin according to the randomization scheme. All participants were instructed to apply one patch to each side of the neck and shoulder girdle overlying the point of maximal pain for 12 hours daily during the duration of the 4-week study. OUTCOME MEASURES: Each participant completed five surveys at baseline, at 2 weeks after the start of treatments, and at the conclusion of the 4-week study. The primary outcome measure was visual analog scale (VAS). Other outcome measures included the Neck Disability Index (NDI), Beck's Depression inventory (BDI), Short Form 36 Korean version, and Euroqol 5-D. RESULTS: Fifty-seven patients completed the study. The mean VAS, NDI, and BDI scores were significantly decreased at 2 and 4 weeks after the start of the intervention in both groups. There was no significant difference between the two groups in any of the outcome measures. CONCLUSIONS: Future research may help to discern specific effects of capsaicin, trigger point stimulation by application of the patch, and the placebo effect.