Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study.

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.

Fluoroscopy-guided high-intensity focused ultrasound ablation of the lumbar medial branch nerves: dose escalation study and comparison with radiofrequency ablation in a porcine model.

BACKGROUND: Radiofrequency ablation (RFA) is a common method for alleviating chronic back pain by targeting and ablating of facet joint sensory nerves. High-intensity focused ultrasound (HIFU) is an emerging, non-invasive, image-guided technology capable of providing thermal tissue ablation. While HIFU shows promise as a potentially superior option for ablating sensory nerves, its efficacy needs validation and comparison with existing methods. METHODS: Nine adult pigs underwent fluoroscopy-guided HIFU ablation of eight lumbar medial branch nerves, with varying acoustic energy levels: 1000 (N=3), 1500 (N=3), or 2000 (N=3) joules (J). An additional three animals underwent standard RFA (two 90 s long lesions at 80°C) of the same eight nerves. Following 2 days of neurobehavioral observation, all 12 animals were sacrificed. The targeted tissue was excised and subjected to macropathology and micropathology, with a primary focus on the medial branch nerves. RESULTS: The percentage of ablated nerves with HIFU was 71%, 86%, and 96% for 1000 J, 1500 J, and 2000 J, respectively. In contrast, RFA achieved a 50% ablation rate. No significant adverse events occurred during the procedure or follow-up period. CONCLUSIONS: These findings suggest that HIFU may be more effective than RFA in inducing thermal necrosis of the nerve.

Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Clinical Pilot Study.

OBJECTIVE: To investigate the safety and feasibility of a fluoroscopy-guided, high-intensity focused ultrasound system for zygapophyseal joint denervation as a treatment for chronic low back pain. METHODS: The clinical pilot study was performed on 10 participants diagnosed with lumbar zygapophyseal joint syndrome. Each participant had a documented positive response to a diagnostic block or a previous, clinically beneficial radiofrequency ablation. For a descriptive study, the primary outcome was the safety question. All device- or procedure-related adverse events were collected. Secondary outcome variables included the average numeric rating scale for pain, the Roland-Morris Disability Questionnaire, the Brief Pain Inventory, the Patient Global Impression of Change, the morphine equivalent dose, and the finding of the neurological examination. RESULTS: All participants tolerated the procedure well with no significant device- or procedure-related adverse events; there was one episode of transient pain during the procedure. The average numeric rating scale score for pain decreased from 6.2 at baseline to 2.1 (n = 10) after 1 month, 4.9 (n = 9) after 3 months, 3.0 (n = 8) after 6 months, and 3.0 (n = 6) after 12 months. The ratio of participants who were considered a treatment success was 90% at 1 month, 50% at 3 months, 60% at 6 months, and 40% at 12 months. CONCLUSIONS: The first clinical pilot study using a noninvasive, fluoroscopy-guided, high-intensity focused ultrasound lumbar zygapophyseal neurotomy resulted in no significant device- or procedure-related adverse events and achieved clinical success comparable with that of routine radiofrequency ablation.

A Retrospective Cohort Study of Healthcare Utilization Associated with Paravertebral Blocks for Chronic Pain Management in Ontario.

Background: Injections, particularly paravertebral blocks (PVBs), are frequently performed procedures in Ontario, Canada, for the management of chronic pain, despite limited evidence and risk of complications. Aim: This study examines usage patterns of PVBs to evaluate their effects on healthcare utilization and opioid prescribing. Methods: A retrospective cohort study in Ontario using administrative data. Ontario residents receiving their initial PVBs between July 1, 2013 and March 31, 2018 were included. Changes in use of other interventions, physician visits, and opioids were compared to the 12-month periods before and after index PVBs. Data use was authorized under section 45 of Ontario's Personal Health Information Protection Act. Results: 47,723 patients received their initial PVBs in the study period. The rate of index PVBs increased from 1.61 per 10,000 population (2013) to 2.26 per 10,000 (2018). Initial PVBs were performed most commonly by family physicians (N = 25,042), followed by anesthesiologists (N = 14,195). 23,386 patients (49%) received 1 to 9 repeat PVBs in the 12 months after index PVB; 12,474 patients (26.15%) received 10 or more. Use of other nonimage guided interventional pain procedures per patient (mean±SD) increased from 2.19 ± 9.35 to 31.68 ± 52.26 in the year before and after index PVB. Relevant physician visits per patient (mean±SD) also increased from 2.92 ± 3.61 to 9.64 ± 11.77. Mean opioid dosing did not change significantly between the year before and the year after index PVB. Conclusion: PVBs are associated with increases in healthcare utilization and no change in opioid use patterns.

Contexte: Les injections, en particulier les blocs paravertébraux (BPV), sont des procédures fréquemment effectuées en Ontario, Canada, pour la prise en charge de la douleur chronique, malgré des données probantes limitées et le risque de complications.Objectif: Cette étude examine les modes d'utilisation des BPV afin d'évaluer leurs effets sur l'utilisation des soins de santé et la prescription d'opioïdes.Méthodes: Étude de cohorte rétrospective utilisant les données administratives en Ontario. Les résidents de l'Ontario ayant reçu leur BPV initial entre le 1er juillet 2013 et le 31 mars 2018 ont été inclus. Les changements dans l'utilisation des autres interventions, les visites aux médecins et les opioïdes ont été comparés 12 mois avant et 12 mois après les BPV de référence. L'utilisation des données a été autorisée en vertu de la Loi sur la protection des renseignements personnels sur la santé de l'Ontario.Résultats: 47 723 patients ont reçu leur BPV initial au cours de la période étudiée. Le taux de BPV est passé de 1,61 pour 10 000 habitants (2013) à 2,26 pour 10 000 (2018). Les BPV de référence étaient effectués le plus souvent par des médecins de famille (N = 25 042), suivis par les anesthésistes (N = 14 195). 23 386 patients (49 %) ont reçu de 1 à 9 BPV répétés dans les 12 mois suivant le BPV de référence ; 12 474 patients (26,15 %) en ont reçu 10 ou plus. L'utilisation d'autres procédures interventionnelles pour la douleur non guidées par l'image par patient (moyenne ± ET) est passée de 2,19 ± 9,35 à 31,68 ± 52,26 l'année précédant et suivant le BPV. Les visites médicales pertinentes par patient (moyenne ± ET) ont également augmenté de 2,92 ± 3,61 à 9,64 ± 11,77. La dose moyenne d'opioïdes n'a pas changé de manière significative entre l'année précédant et suivant le BPV de référence.Conclusion: Les BPV sont associés à une augmentation de l'utilisation des soins de santé et ne sont associés à aucun changement dans les modes d'utilisation des opioïdes.

Tolerability and Feasibility of X-ray Guided Non-Invasive Ablation of the Medial Branch Nerve with Focused Ultrasound: Preliminary Proof of Concept in a Pre-clinical Model.

Four to six million patients a year in the United States suffer from chronic pain caused by facet joint degeneration. Thermal ablation of the affected facet joint's sensory nerve using radiofrequency electrodes is the therapeutic standard of care. High-intensity focused ultrasound (HIFU) is a novel technology enabling image-guided non-invasive thermal ablation of tissue. Six pigs underwent fluoroscopy-guided HIFU of the medial branch nerve and were followed up for 1 wk (two pigs), 1 mo (two pigs) and 3 mo (two pigs). At the end of each follow-up period, the animals were sacrificed, and targeted tissue was excised and evaluated with computed tomography scans as well as by macro- and micropathology. No significant adverse events were recorded during the procedure or follow-up period. All targets were successfully ablated. X-Ray-guided HIFU is a feasible and promising alternative to radiofrequency ablation of the lumbar facet joint sensory nerve.

In vivo measurements of medial branch nerve depth and adjacent osseous structures for ablation of facet-related back pain: Predictors for patient candidacy.

BACKGROUND: Medial branch (MB) targeting during RF ablation for facetogenic back pain is usually performed with flouroscopic guidance yet no specific measurements on the target depth have been published. In order to understand candidacy for other potential ablation methods, we sought to determine the actual MB depth and measurements of adjacent osseous structures. METHODS: CT scans without contrast of the lumbar spine performed in the supine position were retrospectively analyzed in 100 patients. Axial slices less than or equal to 2.5 mm with sagittal and coronal reformations were evaluated. The following distances were measured bilaterally at the L2-L5 levels: The depth from the skin to the MB nerve (anatomic target for RF ablation) at a 15° angulation, the smallest width of the pedicle, and the length, height and width of the transverse process. Age, gender, weight, height, and BMI were correlated with the above measurements. RESULTS: The average distance and 95% CI from skin-to-MB in mm at a 15°angle to the skin increased as the lumbar level increased measuring 64.4 (62.4-66.5) at L2, 72.0 (69.7-74.3) at L3, 79.2 (76.9-81.6) at L4, and 79.1 (76.7-81.5) at L5. The average thickness of the pedicles also increased as the lumbar level increased measuring 9.2 mm at L2 and 16.1 mm at L5. Body weight, lumbar level, and female gender were associated with increased MB depth. Taller stature was associated with more superficial MB depth. We eliminated mild interaction effects between height, weight, and gender by substituting BMI for height and weight without affecting r2. Linear regression revealed the following equation: MB Depth (mm) = 2.2*BMI + 4.9*lumbar vertebral level + 3.6 (if female) - 5.4, which fit the data well (P<0.001, r2 = 0.60). CONCLUSIONS: Our results demonstrate that the MB resides 107 mm or less in depth when measured at a 15° angulation from the skin in > 95% of patients and the distance increases as the lumbar level increases.

Anatomical study of the innervation of posterior knee joint capsule: implication for image-guided intervention.

BACKGROUND AND OBJECTIVES: Peripheral nerve block is an important component of the multimodal analgesia for total knee arthroplasty. Novel interventional techniques of ultrasound-guided nerve block supplying the posterior knee joint capsule require knowledge of the innervation of the posterior capsule. The objectives of this cadaveric study were to determine the course, frequency, and distribution of the articular branches innervating the posterior knee joint capsule and their relationships to anatomical landmarks. METHODS: Fifteen lightly embalmed specimens were meticulously dissected. The origin of articular branches was identified, their frequency recorded, and the course documented in relation to anatomical landmarks. The capsular distribution of articular branches was documented and a frequency map generated. RESULTS: In all specimens, articular branches from the posterior division of the obturator and tibial nerves were found to supply the posterior capsule. Additionally, articular branches from common fibular nerve and sciatic nerve were found in eight (53%) and three (20%) specimens, respectively. The capsular distribution of tibial nerve spanned the entire posterior capsule. The posterior division of obturator nerve supplied the superomedial aspect of the posterior capsule overlapping with the tibial nerve. The superolateral aspect of the posterior capsule was innervated by the tibial nerve and, when present, the common fibular/sciatic nerves. CONCLUSIONS: Frequency map of the course and distribution of the articular branches and their relationship to anatomical landmarks form an anatomical basis for peripheral nerve block approaches that provide analgesia to the posterior knee joint capsule.

Biceps Tendon Sheath Injection: An Anatomical Conundrum.

Objective: Long head biceps tendon peritendinous or sheath injections are routinely administered at or immediately distally to the bicipital groove. The main indication for injection remains the clinical diagnosis or treatment of biceps tendinopathy, although true inflammation of the tendon within the bicipital groove is rare. Because the tendon sheath is merely an extension of the joint cavity, it is plausible to assume that an injection into the sheath would result in intraarticular spread. Surprisingly, such an anatomical tenet has a vague confirmation in the published clinical literature. This experiment was undertaken to investigate patterns of injectate spread when peri-tendon injection at the bicipital groove is performed. Design: An experimental cadaveric study. Setting: An institutional clinical anatomy laboratory. Methods: Twelve ultrasound-guided methylene blue injections of the bicep tendon sheath were performed on cadaver specimens. Dissections and gross examination of staining of the internal joint surfaces were performed. Visual confirmation of the intra- and/or extra-articular spread of the injectate was performed. Results: In 11 specimens, injected contrast was found spreading onto the entire internal joint surface, including glenoid cartilage. One extraarticular injection was attributable to a technical issue. Conclusions: The experiment confirmed continuity of the joint capsule and the biceps tendon sheath. These results suggest a low diagnostic utility of peritendinous injections at the level of the bicep groove. Such injections would likely result in intraarticular deposit of the injectate. Nonetheless, this approach may be utilized as an alternative simplified access to the glenohumeral joint.

Anatomical Study of the Innervation of Anterior Knee Joint Capsule: Implication for Image-Guided Intervention.

BACKGROUND AND OBJECTIVES: The knee joint is the most common site of osteoarthritis. While joint replacement is considered an ultimate solution, radiofrequency denervation may be contemplated in some cases. Radiofrequency ablation requires precise localization of the articular branches innervating the joint capsule. The objective of this cadaveric study was to determine the source, course, relationships, and frequency of articular branches innervating the anterior knee joint capsule. METHODS: Fifteen knees were meticulously dissected. The number and origin of the articular branches were recorded, and their distribution defined by quadrants. Their relationships to anatomical landmarks were identified. RESULTS: The articular branches terminated in 1 of the 4 quadrants with minimal overlap. In all specimens, the superolateral quadrant was innervated by the nerve to vastus lateralis, nerve to vastus intermedius, superior lateral genicular and common fibular nerves; inferolateral by the inferior lateral genicular and recurrent fibular nerves; superomedial by the nerve to vastus medialis, nerve to vastus intermedius and superior medial genicular nerve; and inferomedial by the inferior medial genicular nerve. In 3 specimens, the inferomedial quadrant also received innervation from the infrapatellar branch of saphenous nerve. All articular branches except the nerves to vastus lateralis and medialis course at the periosteal level. CONCLUSIONS: The frequency map of the articular branches provides an anatomical basis for the development of new clinical protocols for knee radiofrequency denervation and perioperative pain management.

Peripheral Nerve Stimulation for Chronic Shoulder Pain: A Proof of Concept Anatomy Study.

OBJECTIVES: Although spinal cord and dorsal root ganglia stimulation may be effective for managing regional pain syndromes, a more targeted approach is perhaps more appealing for discrete anatomical structures. Chronic shoulder pain is a common musculoskeletal problem with significant socioeconomic impact. A peripheral nerve stimulation of the axillary and suprascapular nerves may prove to be effective as a long-term solution for this indication. In anticipation of the future experimental research and clinical utilization, a sound methodology for the lead placement was developed, and its feasibility is tested in a cadaveric study. MATERIALS AND METHODS: Normal anatomy was corroborated with ultrasound scans of live models and cadaver specimens. A step-by-step ultrasound-guided implantation technique was designed. The procedure was completed targeting both the axillary and suprascapular nerves. The accuracy of the lead placement was confirmed by dissections. RESULTS: The implanted devices were found adjacent to the target nerves within 0.5-1 cm distance. CONCLUSIONS: The anatomical dissections confirmed the accuracy of ultrasound-guided placement of the lead. The described method is based on normal anatomy and appeared to be reproducible by following the outlined procedural steps.

Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention.

BACKGROUND AND OBJECTIVES: The purpose of this cadaveric study was to determine the pattern of anterior hip capsule innervation and the associated bony landmarks for image-guided radiofrequency denervation. METHODS: Thirteen hemipelvises were dissected to identify innervation of the anterior hip capsule. The femoral (FN), obturator (ON), and accessory obturator (AON) nerves were traced distally, and branches supplying the anterior capsule documented. The relationships of the branches to bony landmarks potentially visible with ultrasound were identified. RESULTS: The anterior hip capsule received innervation from the FNs and ONs in all specimens and the AON in 7 of 13 specimens. High branches of the FN (originating above the inguinal ligament) were found exclusively in 12 specimens and passed between the anterior inferior iliac spine and the iliopubic eminence. The ONs were innervated exclusively by high branches (proximal to the division), by low branches (from the posterior branch), and by both in 4, 5, and 4 specimens, respectively. The most consistent landmark was the inferomedial acetabulum (radiographic "teardrop"). When present, the AON coursed over the iliopubic eminence before innervating the anterior hip capsule. CONCLUSIONS: Branches of the FNs and ONs consistently provided innervation to the anterior hip capsule. The AON also contributed innervation in many specimens. The relationship of the articular branches from these 3 nerves to the inferomedial acetabulum and the space between the anterior inferior iliac spine and iliopubic eminence may suggest potential sites for radiofrequency ablation.

Using Activity Trackers to Quantify Postpartum Ambulation: A Prospective Observational Study of Ambulation after Regional Anesthesia and Analgesia Interventions.

BACKGROUND: Early postoperative ambulation is associated with enhanced functional recovery, particularly in the postpartum population, but ambulation questionnaires are limited by recall bias. This observational study aims to objectively quantify ambulation after neuraxial anesthesia and analgesia for cesarean delivery and vaginal delivery, respectively, by using activity tracker technology. The hypothesis was that vaginal delivery is associated with greater ambulation during the first 24 h postdelivery, compared to cesarean delivery. METHODS: Parturients having first/second cesarean delivery under spinal anesthesia or first/second vaginal delivery under epidural analgesia between July 2015 and December 2016 were recruited. Patients with significant comorbidities or postpartum complications were excluded, and participants received standard multimodal analgesia. Mothers were fitted with wrist-worn activity trackers immediately postdelivery, and the trackers were recollected 24 h later. Rest and dynamic postpartum pain scores at 2, 6, 12, 18, and 24 h and quality of recovery (QoR-15) at 12 and 24 h were assessed. RESULTS: The study analyzed 173 patients (cesarean delivery: 76; vaginal delivery: 97). Vaginal delivery was associated with greater postpartum ambulation (44%) compared to cesarean delivery, with means ± SD of 1,205 ± 422 and 835 ± 381 steps, respectively, and mean difference (95% CI) of 370 steps (250, 490; P < 0.0001). Although both groups had similar pain scores and opioid consumption (less than 1.0 mg of morphine), vaginal delivery was associated with superior QoR-15 scores, with 9.2 (0.6, 17.8; P = 0.02) and 8.2 (0.1, 16.3; P = 0.045) differences at 12 and 24 h, respectively. CONCLUSIONS: This study objectively demonstrates that vaginal delivery is associated with greater early ambulation and functional recovery compared to cesarean delivery. It also establishes the feasibility of using activity trackers to evaluate early postoperative ambulation after neuraxial anesthesia and analgesia.

Twelve-Month Follow-up of a Randomized Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain.

Objective: This report conveys 12-month outcomes of subjects treated with intradiscal biacuplasty (IDB) and conservative medical management (CMM) for chronic low back pain of discogenic origin, and results for subjects who elected to receive IDB + CMM 6 months after CMM-alone. Methods: Sixty-three subjects were originally randomized to the IDB + CMM group (N = 29) or CMM-alone (N = 34). Six months following continuous CMM-alone treatment, participants in this study group were permitted to "cross-over" to IDB + CMM (N = 25), and followed for an additional 6 months. The original IDB + CMM study subjects were followed for a total of 12 months (N = 22). Results: Pain reduction at 12 months was statistically significant and clinically meaningful in the original IDB + CMM group compared to baseline. Functional and disability outcomes were also improved statistically and clinically. Fifty-five percent of the IDB + CMM patients responded to treatment with a mean VAS reduction of 2.2 points at 12 months. Furthermore, 50% and 64% of subjects reported clinically significant improvements in SF36-PF and in ODI, respectively. There was a 1.7-point reduction (improvement) on a 7-point PGIC scale, and a 0.13-point increase (improvement) in the EQ-5D Health Index. Fifty-percent of cross-over subjects responded to IDB + CMM intervention. Mean outcome scores for cross-over subjects were similar to those of the originally-treated subjects, and functional and disability endpoints were improved statistically and clinically compared to respective baseline values. Conclusions: The study demonstrated long-term clinical effectiveness of IDB + CMM for treating chronic lumbar discogenic pain. Furthermore, the cross-over study subjects experienced similar improvements in pain, function, disability, and satisfaction.

Ultrasound-Guided Superior Hypogastric Plexus Block: A Cadaveric Feasibility Study with Fluoroscopic Confirmation.

Plancarte first described a fluoroscopy-guided superior hypogastric plexus block to manage pelvic pain in 1990. Modifications have since been described using different imaging modalities. Ultrasound-guided approach has been described in a clinical outcome study. However, the accuracy of an ultrasound-guided method has never been validated by alternative imaging. We conducted an experiment aiming to develop ultrasound-guided superior hypogastric plexus block using human cadavers in the supine position. Final needle position and spread of a radiopaque contrast was verified by fluoroscopy, a standard imaging tool. The needle approach to the L5 vertebral body was performed in the short axis as has been recommended. Injection of radiopaque contrast revealed unilateral and cephalad spread to the L5/S1 disk. Additional transabdominal long-axis scanning of the lumbosacral segment was and the needle trajectory was modified to aim for the apex of the L5/S1 disk. Bilateral spread was achieved by strict midline placement of the needle tip and real-time observation of injection. The modified ultrasound-guided technique resulted in a similar spread of injectate as the traditional fluoroscopy-guided technique that in a clinical scenario would offer complete block of the superior hypogastric plexus.

A Prospective, Randomized, Multicenter, Open-label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain.

STUDY DESIGN: This study was a prospective, randomized, crossover, multicenter trial for the evaluation of comparative effectiveness of intradiscal biacuplasty (IDB) versus conventional medical management (CMM) in the treatment of lumbar discogenic pain. OBJECTIVE: The objective was to demonstrate the superiority of IDB over CMM in the treatment of discogenic pain with respect to the primary outcome measure. SUMMARY OF BACKGROUND DATA: Current therapeutic options for the treatment of chronic low back pain of discogenic origin are limited. CMM is often unsatisfactory with regard to the treatment of discogenic pain. IDB offers a minimally invasive treatment that has been demonstrated to be superior to placebo in the past. METHODS: A total of 63 subjects with lumbar discogenic pain diagnosed via provocation discography were randomized to IDB + CMM (n = 29) or CMM-alone (n = 34). At 6 months, patients in the CMM-alone group were eligible for crossover if desired. The primary outcome measure was the change in visual analog scale (VAS) from baseline to 6 months. Secondary outcome measures included treatment "responders," defined as the proportion of subjects with a 2-point or 30% decrease in VAS scores. Other secondary measures included changes from baseline to 6 months in (1) short form (SF) 36-physical functioning, (2) Oswestry Disability Index, (3) Beck Depression Inventory, (4) Patient Global Impression of Change, (5) EQ-5D VAS, and (6) back pain-related medication usage. RESULTS: In the IDB cohort, the mean VAS score reduction exceeded that in the CMM cohort (-2.4 vs. -0.56; P = 0.02), and the proportion of treatment responders was substantially greater (50% vs. 18%). Differences in secondary measures favored IDB. No differences in opioid utilization were noted between groups. CONCLUSION: Superior performance of IDB with respect to all study outcomes suggests that it is a more effective treatment for discogenic pain than CMM-alone. LEVEL OF EVIDENCE: 2.

Bone targeted bipolar cooled radiofrequency ablation in a VX-2 rabbit femoral carcinoma model.

To determine the effect of bipolar cooled radiofrequency ablation (BCRF) on bone and tumour in a lapine pathologic femoral model. Under institutional approval, twelve New Zealand white rabbits received a single femoral injection of VX2 carcinoma cells (day 0). The rabbit femora, (n = 24), were block-randomized into four experimental groups: tumour-bearing radiofrequency ablation (RFA) treated, healthy bone RFA treated, tumour-bearing shams and healthy bone shams (n = 6 per group). 15 min of thermally regulated (65 °C) BCRF was applied at day 14. Pre- and post-treatment MR imaging was performed and repeated at day 28 prior to euthanasia. Histologic evaluation was used to determine treatment effect on tumour and bone tissue. A thirteenth injected rabbit served as a histologic control (no BCRF electrode placement). Large volumes (12.9 ± 5.5 cm(3)) of thermal ablation were achieved. An eight-fold reduction in tumour growth resulted in RFA treated animals compared to tumour-bearing sham controls (p < 0.001). Osteolysis was controlled in the tumour-treated group. Therapeutic effects were best imaged using MR contrast-enhanced SPoiled Gradient Recalled (SPGR) sequences. Osteoclasts and osteoblasts were observed to be sensitive to BCRF but osteocytes were more resilient. A small number of tumour cells within BCRF treated regions appeared viable post treatment. New bone formation was stimulated in the periphery of the targeted BCRF treatment zone. Structurally large VX2 tumour volumes within bone were successfully ablated with BCRF, stimulating new bone formation in the treatment periphery, although viable appearing osteocytes and tumour cells were observed in some treated regions.

Intense focused ultrasound stimulation can safely stimulate inflamed subcutaneous tissue and assess allodynia.

BACKGROUND: Potential peripheral sources of deep pain can require invasive evocative tests for their assessment. Here we perform research whose ultimate goal is development of a non-invasive evocative test for deep painful tissue. METHODS: We used a rat model of inflammation to show that intense focused ultrasound (iFU) differentially stimulates inflamed versus control tissue and can identify allodynia. To do so we applied iFU to inflamed and normal tissue below the skin of rats' hind paws and measured the amount of ultrasound necessary to induce paw withdrawal. RESULTS: iFU of sufficient strength (spatial and temporal average intensities ranged from 100-350 W/cm(2)) caused the rat to withdraw its inflamed paw, while the same iFU applied to the contralateral paw failed to induce withdrawal, with sensitivity and specificity generally greater than 90%. iFU stimulation of normal tissue required twice the amount of ultrasound to generate a withdrawal than did inflamed tissue, thereby assessing allodynia. Finally, we verified in a preliminary way the safety of iFU stimulation with acute histological studies coupled with mathematical simulations. CONCLUSIONS: Given that there exist systems to guide iFU deep to the skin, image-guided iFU may one day allow assessment of patient's deep, peripheral pain generators.