ABSTRACT
OBJECTIVE: The objective of this study is to investigate safety and effectiveness of a fluoroscopy-guided high-intensity focused ultrasound (HIFU) system for thermal ablation of the lumbar medial branch nerves. METHODS: This dual center prospective cohort study enrolled 30 participants with lumbar zygapophyseal joint syndrome. Each participant previously had a positive response to either a single diagnostic analgesic block or radiofrequency ablation (RFA). The primary effectiveness outcome was individual responder rate, defined as a reduction of two points or more on the pain intensity numerical rating scale without an increase in opioid intake, or a reduction in opioid intake without an increase in pain at 6 months after the intervention. The primary safety outcome was procedure-related or device-related adverse events (AEs). Secondary outcome variables included MRI evidence of tissue ablation, Oswestry Disability Index, 12-Item Short Form Health Survey, Brief Pain Inventory, and Patient Global Impression of Change. RESULTS: The individual responder rate was 89.7% at 2 days, 89.7% at 7 days, 72.4% at 14 days, 82.1% at 30 days, 59.3% at 90 days and 82.6% at 180 days. The average Numeric Rating Scale for pain severity decreased from 7.1 at baseline to 3.0 (N=29) after 2 days, 3.0 (N=29) after 7 days, 3.1 (N=29) after 14 days, 3.2 (N=28) after 30 days, 4.3 (N=27) after 90 days, and 3.3 (N=23) after 180 days. All participants tolerated the procedure well with no significant side effects or complications. CONCLUSIONS: Fluoroscopy-guided HIFU neurotomy achieved clinical responses comparable with RFA, and there were no significant device-related or procedure-related AEs. TRIAL REGISTRATION NUMBER: NCT04129034.
ABSTRACT
BACKGROUND: Various forms of sympathetic chain neurolysis (sympathectomy) have, at one time or another, held promise as effective treatment options for complex regional pain syndrome (CRPS). Complications, such as worsening pain and the development of new pain syndromes, have prevented sympathectomy from emerging as a standard intervention. In an effort to avoid poor outcomes associated with neurolysis, pulsed radiofrequency (PRF) has been proposed as a potential treatment alternative for a number of chronic neuropathic pain states, including some forms of CRPS. METHODS: The present report describes three cases in which patients diagnosed with lower extremity CRPS type I obtained substantial and lasting intervals of pain relief following PRF of the lumbar sympathetic chain. Over a period of four years, 14 fluoroscopically guided procedures using PRF lesioning of the lumbar sympathetic chain at L2, L3 and L4 were performed in three individuals with CRPS type I of the lower limb. Outcome measures included pre- and post-treatment self-reported pain and medication requirements. RESULTS: Substantial pain relief (>50%) was achieved in 91.7% of PRF applications at three months and 83.3% at six months, with some treatments resulting in persistent relief well beyond 12 months. Medication use decreased to a comparable degree, with discontinuation of opiates after all but three treatments. CONCLUSIONS: PRF lesioning of the lumbar sympathetic chain can be an effective treatment for patients with CRPS type I of the lower extremity, with the potential to provide ≥6 months of substantial pain relief.
Subject(s)
Causalgia/therapy , Pulsed Radiofrequency Treatment/methods , Adult , Female , Humans , Male , Middle Aged , Pain Measurement , Treatment OutcomeABSTRACT
INTRODUCTION: Since inception of the alexithymia construct in 1970's, there has been a continuous effort to improve both its theoretical postulates and the clinical utility through development, standardization and validation of assessment scales. OBJECTIVE: The aim of this study was to validate the Serbian translation of the 20-item Toronto Alexithymia Scale (TAS-20) and to propose a new method of translation of scales with a property of temporal stability. METHODS: The scale was expertly translated by bilingual medical professionals and a linguist, and given to a sample of bilingual participants from the general population who completed both the English and the Serbian version of the scale one week apart. RESULTS: The findings showed that the Serbian version of the TAS-20 had a good internal consistency reliability regarding total scale (alpha=0.86), and acceptable reliability of the three factors (alpha=0.71-0.79). CONCLUSION: The analysis confirmed the validity and consistency of the Serbian translation of the scale, with observed weakness of the factorial structure consistent with studies in other languages. The results also showed that the method of utilizing a self-control bilingual subject is a useful alternative to the back-translation method, particularly in cases of linguistically and structurally sensitive scales, or in cases where a larger sample is not available. This method, dubbed as 'forth-translation' could be used to translate psychometric scales measuring properties which have temporal stability over the period of at least several weeks.
