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INTRODUCTION: Epidural steroid injections and epidural blood patches commonly involve the injection of a small amount of radiocontrast media under fluoroscopy to properly identify the target tissue or anatomic space and prevent off-target or intravascular delivery of therapeutic or diagnostic drugs. Iodinated low osmolar non-ionic contrast media is the standard preparation used as it is considered safe and cost-effective, but gadolinium-based preparations have been used as an alternative for patients with an 'iodine'-related or radiocontrast media allergy label to prevent hypersensitivity reactions. The risk of neurotoxic events when gadolinium is inadvertently injected into the intrathecal space has been reported in recent years, raising concerns when gadolinium-based contrast media is used in lieu of iodinated low osmolar non-ionic contrast media. METHODS: A retrospective review was conducted of patients who received gadolinium-based contrast media for procedures with risk of inadvertent intrathecal access from January 1, 2019 to May 1, 2022. Information on patient demographics, allergy label information, and procedure description was documented for all patients who received gadolinium-based contrast media for axial spine procedures (including epidural steroid injections, epidural blood patch procedures, and selective nerve root blocks), and all side effects reported within 1 month of the procedure were recorded. Saved fluoroscopy images of all procedures for which there was concern for possible gadolinium-based contrast media-related side effect were reviewed for evidence of inadvertent intrathecal gadolinium-based contrast media administration. Descriptive statistical analysis was performed using REDCap and IBM SPSS Statistics V.28. RESULTS: We identified 508 patients who received gadolinium-based contrast media during a fluoroscopically guided axial spine procedure. These patients underwent 697 epidural procedures and 23 patients were identified as experiencing an adverse event that could be consistent with possible, probable, or clear signs of exposure to intrathecal gadolinium. Our calculated adverse event rate was 3.3%. Ten patients required additional medical evaluation or treatment. DISCUSSION: Almost all patients in our cohort had an allergy label on their chart that guided the provider to switch to gadolinium-based contrast media, but most were incomplete, ill-defined, or related to allergy to iodine but not iodinated contrast media. Such practice is not recommended based on current guidelines. The current study raises concern regarding the use of gadolinium-based contrast media in axial spine procedures, with the risk of potential severe adverse events, without evidence-based need for avoiding iodinated contrast media.
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International concerns for another pandemic arose after emerging reports of an ongoing outbreak of the monkeypox virus (MPXV) in Europe and the United States in 2022. Severe pain is one of the most distressing complications for patients in the current outbreak, but there is a general paucity of relevant peer-reviewed medical literature from which to draw clear recommendations on appropriate pain therapies. The Centers for Disease Control recently published a letter in July 2022 urging providers to conduct further studies concerning pain management. Thus, a rapid literature search was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of several databases from inception until August 19, 2022, was conducted. All published studies describing pain in patients who tested positive for MPXV with original data and written in English were included. Sixty-nine studies were initially identified for screening. After initial screening, 27 papers were considered for full-text review, and 15 papers met the inclusion criteria. A total of 1043 positive cases were included in this study. Most patients were men. Treatment options proposed by the authors include acetaminophen, ibuprofen, opioids, lidocaine gel, metamizole, and rectal suppositories containing emollients or steroids with oral laxatives for severe anal pain. Although most cases were mild requiring outpatient treatment, a considerable number of patients were admitted due to serious complications. Severe pain was often the reason to seek medical attention and hospital admission for pain control. Analgesic plans included oral and topical analgesia. In severe cases, pain was managed with opioids. To our knowledge, this rapid review is the first study to comprehensively summarize proposed treatments for pain associated with MPXV. Guidelines may be needed to help direct the best management to avoid morbidity in patients, particularly as adjuvants may play a key role but are not commonly utilized in published reports.
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During the last two decades, with the advent of recent technology, peripheral nerve stimulation has become an appealing modality at the forefront of pain management. In this case series, we document the clinical rationale and technical considerations on three of the most challenging cases, refractory to previous interventions, that were treated by our team with an ultrasound-guided percutaneous peripheral nerve stimulator targeting the musculocutaneous, bilateral greater occipital and subcostal nerves. At the 6-month follow-up, all patients experienced greater than 50% relief of baseline pain, with a near-complete resolution of pain exacerbations. Furthermore, to our knowledge, this is the first report of an ultrasound-guided percutaneous technique of a peripheral nerve stimulator targeting the musculocutaneous and subcostal nerves.
Peripheral nerve stimulation is a new tool used in the treatment of peripheral nerve pain. In this study, we share our experience using this technology in three unusual, difficult-to-treat chronic nerve pain presentations, targeting the musculocutaneous, bilateral greater occipital and subcostal nerves. All patients were asked about how pain levels had changed since the peripheral nerve stimulation device had been implanted. In every case, patients reported a decline in their pain level from day one. After 6 months of peripheral nerve stimulator use, all patients reported a greater than 50% pain relief.
Subject(s)
Electric Stimulation Therapy , Neuralgia , Transcutaneous Electric Nerve Stimulation , Humans , Transcutaneous Electric Nerve Stimulation/methods , Neuralgia/diagnostic imaging , Neuralgia/therapy , Electric Stimulation Therapy/methods , Peripheral Nerves/diagnostic imaging , Ultrasonography, Interventional/methodsABSTRACT
Aim: This case report documents the use of peripheral nerve stimulation in the setting of entrapment of the anterior cutaneous branches of the intercostal nerves, with pain rated by the patient as severe during exacerbation episodes. Materials & methods: Under ultrasound guidance, two permanent leads were implanted caudad to cephalad, along and superficial to the lateral aspect of the rectus abdominis, distal to the umbilicus (1 lead per side). Results: At the 6 month follow-up, the patient reported near complete resolution of baseline pain, as well as fewer, sporadic pain exacerbation episodes, rated as mild-to-moderate. Conclusion: This case report suggests that peripheral nerve stimulation might be a valuable treatment option for previously intractable abdominal pain due to entrapment of the anterior cutaneous branches.
Anterior cutaneous nerve entrapment syndrome is a peculiar, a largely disregarded pain condition. Current management algorithms rely mostly on local injections followed by surgical anterior neurectomy. This case report presents a case of longstanding, anterior cutaneous nerve entrapment syndrome, unresponsive to first-line treatment, that was successfully treated with peripheral nerve stimulation technology targeting the anterior cutaneous branches.
Subject(s)
Nerve Compression Syndromes , Neuralgia , Abdominal Pain/therapy , Humans , Intercostal Nerves/diagnostic imaging , Nerve Compression Syndromes/complications , Nerve Compression Syndromes/diagnostic imaging , Nerve Compression Syndromes/therapy , Neuralgia/complications , Ultrasonography, InterventionalABSTRACT
INTRODUCTION: Greater trochanteric pain syndrome may often mimic pain generated from other sources. However, it is most commonly caused by gluteus medius and gluteus minimus tendinopathy or tear. The purpose of this technical report was to: 1) describe the ultrasound-guided fascial plane block technique targeting the superior gluteal nerve in the plane between gluteus medius/gluteus minimus to treat moderate-to-severe, chronic, refractory greater trochanteric pain syndrome; 2) anatomically correlate the procedure with cadaveric dissections demonstrating the structures being imaged and the tissues along the needle trajectory; 3) demonstrate the feasibility of the technique with serial dissection of one cadaveric specimen following injection with color dye. TECHNIQUE DESCRIPTION: The ultrasound-guided fascial plane block targeting the superior gluteal nerve to treat moderate-to-severe, chronic, refractory greater trochanteric pain syndrome has been outlined with supporting ultrasound scans and anatomical dissections. The cadaveric dissections are correlated to the ultrasound scans of a healthy volunteer and provide visualization of the tissues in the needle trajectory. The feasibility study in a cadaveric specimen showed adequate stain of the superior gluteal nerve without spread to the piriformis muscle belly, the sciatic nerve, or the inferior gluteal nerve. CONCLUSIONS: This ultrasound-guided fascial plane block is a feasible option for blocking the superior gluteal nerve without inadvertent involvement of the sciatic and inferior gluteal nerves. Further randomized controlled clinical trials are necessary to assess the clinical efficacy of the gluteus medius/gluteus minimus fascial plane block to treat moderate-to-severe, chronic, refractory greater trochanteric pain syndrome.
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Bursitis , Humans , Correlation of Data , Pain , Ultrasonography, Interventional , CadaverABSTRACT
OBJECTIVES: The purpose of this single center, prospective randomized controlled trial was to compare clinical outcomes between an ultrasound-guided greater occipital nerve block (GONB) at the C2 vertebral level versus landmark-based GONB at the superior nuchal line. METHODS: Patients with occipital neuralgia or cervicogenic headache were randomized to receive either a landmark-based GONB with sham ultrasound at the superior nuchal line or ultrasound-guided GONB at the C2 vertebral level with blinding of patients and data analysis investigators. Clinical outcomes were assessed at 30 minutes, 2 weeks, and 4 weeks postinjection. RESULTS: Thirty-two patients were recruited with 16 participants in each group. Despite randomization, the ultrasound-guided GONB group reported higher numeric rating scale (NRS) scores at baseline. Those in the ultrasound-guided GONB group had a significant decrease in NRS from baseline compared with the landmark-based GONB group at 30 minutes (change of NRS of 4.0 vs. 2.0) and 4-week time points (change of NRS of 2.5 vs. -0.5). Both groups were found to have significant decreases in Headache Impact Test-6. The ultrasound-guided GONB had significant improvements in NRS, severe headache days, and analgesic use at 4 weeks when compared with baseline. No serious adverse events occurred in either group. CONCLUSIONS: Ultrasound-guided GONBs may provide superior pain reduction at 4 weeks when compared with landmark-based GONBs for patients with occipital neuralgia or cervicogenic headache.
Subject(s)
Nerve Block , Neuralgia , Post-Traumatic Headache , Anesthetics, Local , Headache/diagnostic imaging , Headache/therapy , Humans , Ultrasonography, InterventionalABSTRACT
BACKGROUND: During the last decades, platelet-rich plasma has been studied for the treatment of multiple chronic pain conditions, in addition to being employed in the enhancement of healing after tissue injury. OBJECTIVE: To establish a framework for future research regarding the utilization of platelet-rich plasma in the treatment of chronic tissue injuries. METHODS: Preclinical and clinical studies from 2000-2020 relevant to applications of platelet-rich plasma for the treatment of chronic pain conditions were extracted from PubMed and Medline databases. The studies were analyzed on the basis of the study population, type of intervention, method of platelet-rich plasma preparation, the number of treatments administered, the timeframe of injections, and clinical outcomes. RESULTS: Although several preclinical studies and double-blind, randomized trials have shown promising results in the application of platelet-rich plasma for the treatment of multiple chronic pain conditions, various studies have also reported controversial results. Additionally, the methods employed for obtaining the platelet-rich plasma have not been standardized between studies, resulting in different concentrations of blood components between the preparations utilized. Moreover, differences between studies were also found regarding the number of injections administered per treatment. CONCLUSIONS: Future research addressing the utilization of platelet-rich plasma in the treatment of chronic pain conditions should focus on shedding light on the following major questions: a) Is there a dose-effect relation between the platelet count and the clinical efficacy of the preparation?; b) What pathology determinants should be considered when selecting between leukocyte-enriched and leukocyte-depleted concentrates?; c) What is the role of platelet activation methods on the clinical efficacy of platelet-rich plasma?; d) Is there an optimal number of injections and time frame for application of multiple injection treatment cycles?; e) Does the addition of local anesthetics affect the clinical efficacy of platelet-rich plasma?; and f) Is there potential for future platelet-rich plasma applications for the treatment of neuropathic pain of peripheral origin?
Subject(s)
Chronic Pain , Neuralgia , Platelet-Rich Plasma , Chronic Pain/therapy , Humans , Platelet-Rich Plasma/physiology , Randomized Controlled Trials as Topic , Treatment Outcome , Wound Healing/physiologyABSTRACT
This article describes the use of an infiltration between the popliteal artery and capsule of the knee joint (IPACK) to diagnose an entrapment neuropathy of the tibial nerve (TN) in a patient presenting with chronic neuropathic pain in the medial posterior compartment of the left knee, with a previous electromyography showing no evidence of tibial or common peroneal nerve neuropathy. After a positive sciatic nerve block, the patient was evaluated for a TN block, cancelled due to the presence of an abnormal leash of vessels wrapping around the nerve. For this reason, the patient was submitted to a diagnostic IPACK. A negative IPACK suggested that a compression of the TN at the popliteal fossa was the most likely source of the symptoms. After surgical decompression of the TN nerve at the popliteal fossa, the patient's symptoms decreased substantially.
Lay abstract This case report describes the use of an infiltration between the popliteal artery and capsule of the knee joint (IPACK), a technique in which local anesthetic is injected between the popliteal artery and the back side of the knee joint, to diagnose a compression of the tibial nerve (TN) in a patient with chronic knee pain. A female adult patient presented for further evaluation of chronic pain in the inner side of the back of her left knee. A previous electromyography showed no evidence of tibial or common peroneal nerve disease. After a positive diagnostic block of the left sciatic nerve, the patient was evaluated for a left TN block, so as to ascertain whether a compression of this nerve at the back side of the knee could be the origin of the patient's symptoms. During the ultrasound scanning of the TN, a group of abnormal vessels was found wrapping around the nerve, which made it impossible to inject the TN in a safe manner, even with the guidance of ultrasound. For this reason, the patient was instead submitted to a diagnostic left IPACK. A negative IPACK suggested that a compression of the TN at the popliteal fossa, the region behind the knee joint, was the most likely source of the patient's symptoms. After surgical decompression of the TN at the popliteal fossa, the patient's symptoms decreased substantially.
Subject(s)
Arthroplasty, Replacement, Knee , Nerve Block , Humans , Knee Joint/diagnostic imaging , Knee Joint/surgery , Pain, Postoperative , Ultrasonography, InterventionalABSTRACT
ABSTRACT: The primary aim of this randomized clinical trial is to investigate the effects of ultrasound-guided transversus abdominis plane (TAP) vs ultrasound-guided trigger point injections (TPIs) on numerical rating scale pain scores at month 3 follow-up in patients with a chronic abdominal wall pain. The primary outcome measure was the difference in mean numeric rating scale pain scores between the TAP and TPI groups at month 3 in an intent-to-treat (ITT) analysis. A total of 60 patients were randomized 1:1 to receive an ultrasound-guided TAP block (n = 30) or an ultrasound-guided TPI (n = 30). No significant group differences in baseline demographic or clinical characteristics were observed. The mean baseline pain score for the TAP and TPI groups was 5.5 and 4.7, respectively. In the ITT analysis at month 3, the between-group difference in pain scores was 1.7 (95% confidence interval, 0.3-3.0) favoring the TPI group. In a secondary per-protocol analysis, the between-group difference in pain scores was 1.8 (95% confidence interval, 0.4-3.2) favoring the TPI group. For the ITT and per-protocol analyses, the group differences in pain scores were consistent with a medium effect size. The main finding of this randomized clinical trial is that adults with chronic abdominal wall pain who received a TPI reported significantly lower pain scores at month 3 follow-up compared with patients who received a TAP block.
Subject(s)
Abdominal Wall , Abdominal Muscles/diagnostic imaging , Abdominal Wall/diagnostic imaging , Adult , Anesthetics, Local , Double-Blind Method , Humans , Pain, Postoperative , Prospective Studies , Trigger Points , Ultrasonography, InterventionalABSTRACT
Over the last two decades, the clinical applications of diagnostic and interventional ultrasound have expanded rapidly. When analyzing the chest wall and thoracic region, ultrasound has previously been shown to reliably identify chest wall pathologies like rib fracture and slipping rib syndrome, as well as having fundamentally changed perioperative management and patient outcomes after the emergence of point-of-care ultrasound. In addition, ultrasound guidance has recently become more popular for multiple blocks in the field of regional anesthesia and pain medicine. In this technical report, we systematize an ultrasound-guided protocol for counting ribs and thoracic levels for both posterior and anterior approaches, which does not require level confirmation by fluoroscopy. With this protocol, we hope to create an effective educational resource to support physicians from any specialty background as they engage in point-of-care ultrasound applications in the thoracic region.
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Rib Fractures , Thoracic Wall , Humans , Rib Fractures/diagnostic imaging , Ribs/diagnostic imaging , Ultrasonography , Ultrasonography, InterventionalABSTRACT
Bone marrow aspiration (BMA) through the iliac crest is potentially unsafe due to the vicinity of neurovascular structures in the greater sciatic notch. Our objective was to investigate the safety of a recently described BMA technique, specifically a trajectory from the posterior superior iliac spine (PSIS) to the anterior inferior iliac spine (AIIS). We conducted a chart review of 260 patients, analyzing three-dimensional reconstructed computed tomography images of the pelvis and sacrum to validate that this new approach offers a wide safety margin from the greater sciatic notch. Analysis of three-dimensional computed tomography scans demonstrated that the PSIS to AIIS trajectory never crossed the greater sciatic notch. The trajectory was noted to be at least one cm away from the greater sciatic notch in all measurements. The new trajectory entered the PSIS at 25.29 ± 4.34° (left side) and 24.93 ± 4.15° (right side) cephalad from the transverse plane, and 24.58 ± 4.99° (left side) and 24.56 ± 4.67° (right side) lateral from the mid-sagittal plane. The area of bone marrow encountered with the new approach was approximately 22.5 cm2. Utilizing the same CT scans, the trajectory from the traditional approach crossed the greater sciatic notch in all scans, highlighting the potential for violating the greater sciatic notch boundary and damaging important neurovascular structures. Statistically significant sex-related differences were identified in needle trajectory angles for both approaches. We conclude that based on this three-dimensional computed tomography study, a trajectory from the PSIS to the AIIS for BMA may offer a wide safety margin from the greater sciatic notch.
Subject(s)
Bone Marrow , Ilium/diagnostic imaging , Ilium/surgery , Imaging, Three-Dimensional/methods , Tomography, X-Ray Computed/methods , Adolescent , Adult , Aged , Aged, 80 and over , Anatomic Landmarks , Female , Fluoroscopy , Humans , Male , Middle Aged , Radiography, Interventional , Retrospective Studies , SuctionABSTRACT
PURPOSE: Peripheral nerve stimulation (PNS) is a rapidly expanding field within neuromodulation; however, there is limited data on therapeutic efficacy. This study describes the indications and clinical outcomes for patients undergoing PNS for chronic pain states. PATIENTS AND METHODS: This is a retrospective case series of adults undergoing PNS implantation from 2004 to 2017 at an academic medical center. The primary outcomes were changes in numeric rating scale (NRS) pain scores, opioid utilization in oral morphine milligram equivalent (MME), and self-reported patient functioning at 6 months postoperatively. Infectious and device-related complications were also assessed. RESULTS: A total of 72 patients underwent PNS implantation, including 59 patients that received a preceding PNS trial (59/78; 76% progression rate) and 13 that did not receive a PNS trial. The most common indication for stimulation was occipital neuralgia (47%) followed by lower-extremity neuropathies (17%). PNS implantation was associated with 6-month reductions in pain scores (7 [6, 8] baseline vs. 4 [2, 5] 6 months; P < 0.001) and opioid utilization (eg, median 60 [31, 104] vs. 18 [0, 52] MME among those with baseline opioid use; P < 0.001). Median functional improvement was 73% (50%, 88%). Seven patients (10%) suffered a postoperative surgical site infection at a median of 50 (30, 124) days, of which five devices were removed. CONCLUSION: Peripheral nerve stimulation was associated with reduced pain scores, lower opioid utilization, and improved patient function at 6 months. These data support PNS as a potentially effective nonopioid analgesic modality in chronic pain, though prospective multicenter evaluation is warranted to evaluate longer-term outcomes.
Subject(s)
Neuralgia , Transcutaneous Electric Nerve Stimulation , Adult , Humans , Neuralgia/therapy , Peripheral Nerves , Prospective Studies , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Sufentanil is a potent opioid uncommonly used to manage pain and is rarely administered via an intrathecal pain pump system. CASE PRESENTATION: This case illustrates the use of intrathecal sufentanil in a 50-year-old Caucasian man for the management of chronic pain; however, the intrathecal drug delivery system experienced a malfunction which led to 1/100th output of the correct dosage. Interesting aspects of this case report include the uncommon choice of sufentanil use for an intrathecal drug delivery system, as well as the unusual pharmacokinetics of this drug. Specifically, this patient did not experience the major withdrawal that would be expected given significant under dosing of opioid, and this may be explained by the lipophilicity and context-sensitive half-times of sufentanil. CONCLUSIONS: Because of the absence of a clinically significant withdrawal in this case report, clinicians must be aware of relevant pharmacokinetic properties and unusual intrathecal drug delivery system technologies that influence a patient's response when device malfunction occurs.
Subject(s)
Analgesics, Opioid/administration & dosage , Analgesics, Opioid/pharmacokinetics , Equipment Failure , Sufentanil/administration & dosage , Sufentanil/pharmacokinetics , Drug Delivery Systems/instrumentation , Humans , Injections, Spinal/instrumentation , Male , Middle Aged , Pain MeasurementABSTRACT
INTRODUCTION: Radiofrequency ablation (RFA) and spinal cord stimulation (SCS) are 2 common modalities used in management of various pain conditions. RFA generates heat and an electromagnetic field that can theoretically interfere with the functionality and longevity of the SCS device. This is problematic for patients who need RFA and have previously undergone implantation of an SCS device. CASE DESCRIPTION: We present a case highlighting the safe use of bipolar RFA in a patient who had previously undergone implantation of a cervical SCS device. DISCUSSION: We also present device-specific industry guidelines and recommendations for performing RFA in patients following SCS device implantation.
Subject(s)
Catheter Ablation/methods , Combined Modality Therapy/methods , Complex Regional Pain Syndromes/therapy , Pain Management/methods , Spinal Cord Stimulation , Electrodes, Implanted , Humans , Male , Middle Aged , Spinal Cord Stimulation/instrumentationABSTRACT
OBJECTIVE: Spinal cord stimulation (SCS) is an evidence-based therapy for the treatment of refractory pain. Current American College of Graduate Medical Education requirements for pain medicine fellowship graduation include observation of five neuromodulation cases. Matriculating fellows have varying degrees of technical skill, training, and experience. The purpose of this study was to use an innovative skill-based assessment tool using the validated Zwisch scale to evaluate fellow surgical performance during SCS cases. DESIGN: Cross-sectional survey SETTING: Mayo Clinic, Rochester, Minnesota. SUBJECTS: Consultant faculty (10) in the Division of Pain Medicine and pain medicine fellows (5). METHODS: A list of faculty-driven neuromodulation surgical objectives was formed and a rubric was created that focused on technical approach, imaging, epidural access and wound closure. Consultants who perform surgical cases were instructed to use the Zwisch scale as a guide to evaluate fellow surgical performance during a neuromodulation case. Faculty and fellows were surveyed before and after implementation of the tool to determine their satisfaction with use of the skill assessment tool. RESULTS: The consultants reported they were more satisfied, consistent, and efficient with feedback provided to the trainee on every aspect of neuromodulation surgical cases. The improvement was most significant during the fellows' intraoperative skill assessment. The fellows indicated increased satisfaction, improved communication, and increased efficiency of feedback when the tool was utilized. The fellows reported greater intraoperative skill assessment and consistency of feedback provided. CONCLUSIONS: The diverse nature of primary specialty backgrounds observed in pain medicine fellowship training offers a unique opportunity to assess and improve fellow skill and surgical competence in the field of neuromodulation. Both faculty and fellows reported improved satisfaction, consistency and efficiency with feedback provided. Importantly, this pilot project observed that implementation of a skill assessment tool was beneficial for both the faculty and fellow as the feedback received was viewed as strongly beneficial to the educational experience.
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BACKGROUND: Lumbar spinal stenosis (LSS) is a chronic condition that causes low back pain and neurogenic claudication, often resulting in significant limitation of daily activities. In this open-label randomized controlled pilot study, we assessed the safety and feasibility of 4-week novel integrative inpatient treatments for LSS. METHODS: Thirty-six symptomatic LSS patients were randomly and equally allocated to one of the three groups: Mokhuri Chuna treatment 1 (MT1) group, Mokhuri Chuna treatment 2 (MT2) group, or conventional management treatment (CMT) group. MT1 patients were treated with herbal medication, Mokhuri Chuna, and acupuncture, and received daily physician consultation; MT2 patients were treated with Mokhuri Chuna and acupuncture without any herbal medication, and received daily physician consultation; and CMT patients received conventional pain management therapy that included epidural steroid injection, oral NSAID, and muscle relaxant medication, along with daily physiotherapy. The primary outcome of this pilot study was safety as measured by the type and incidence of adverse events (AEs). The secondary outcome measures included VAS score for low back pain and leg pain, Oswestry Disability Index, Oxford Claudication Score (OCS), walking capacity on a 50 m flat track and treadmill, and EuroQol-5D score. Magnetic resonance imaging was also performed up to 6 months after treatment cessation. RESULTS: Thirty-four treated patients were included in the analysis, based on the modified intention-to-treat principle. No serious AEs were observed or reported. Compared to the CMT group, the MT1 and MT2 groups did show significant improvement at 3 and 6 months in various domains, including pain (VAS score for leg and back pain) and function (OCS and treadmill walking). CONCLUSION: These novel multimodal integrative treatments for LSS are both clinically safe and logistically feasible. Larger, adequately powered randomized controlled trials will be necessary to assess comparative efficacy and thoroughly analyze the cost-effectiveness of each treatment approach. CLINICAL TRIAL REGISTRATION NUMBER CRIS: KCT0001218.
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OBJECTIVE: To evaluate the association between smoking and cognitive function in patients with fibromyalgia. PATIENTS AND METHODS: We surveyed 668 patients with fibromyalgia from May 1, 2012 through November 30, 2013 at a major tertiary referral center. Patients were categorized by smoking status. Primary outcome of interest was cognitive function (MASQ questionnaire), and secondary outcomes included fibromyalgia symptom severity (FIQ-R questionnaire), quality of life (SF-36 questionnaire), fatigue (MFI-20 questionnaire), sleep (MOS-sleep scale), anxiety (GAD-7 questionnaire), and depression (PHQ-9 questionnaire). Independent Students' t-tests and χ2 tests were performed for continuous and categorical variables, respectively. Univariate regression analysis identified variables predictive of outcomes, adjusting for age, gender, body mass index, marital status, and educational level. RESULTS: Ninety-four (14.07%) patients self-identified as smokers. There was an association of lower education level, unmarried status, and younger age in smokers compared with nonsmokers. In the adjusted univariate regression analysis, fibromyalgia smokers reported greater perceived total cognitive dysfunction (P=.009) and greater subscale scores of perceived difficulty in language (P=.03), verbal memory (P=.003), visual-spatial memory (P=.02), and attention (P=.04) compared with nonsmokers with fibromyalgia. For secondary outcomes, smokers with fibromyalgia reported greater severity of fibromyalgia-related symptoms (P=.006), worse quality-of-life index in the mental component scale (P=.02), greater sleep problems (P=.01), and increased anxiety (P=.001) compared with nonsmokers who had fibromyalgia. CONCLUSION: In patients with fibromyalgia, smoking is a risk factor for cognitive dysfunction. Moreover, smokers with fibromyalgia were more likely to report increased severity of fibromyalgia symptoms, worse quality of life, more sleep problems, and increased anxiety compared with nonsmokers with fibromyalgia.