Rezum therapy for ≥80-mL benign prostatic enlargement: a large, multicentre cohort study.

OBJECTIVE: To evaluate the efficacy and safety of Rezum therapy in benign prostatic hyperplasia (BPH) patients with prostates ≥80 mL. METHODS: A prospective registry was established at two high-volume Canadian centres. Patients had baseline medical history documented, and uroflowmetry and questionnaire results were recorded over 12 months. RESULTS: Eighty-three patients (median [interquartile range {IQR}] age 69.2 [63.2, 74.8] years) with a prostate size ≥80 mL were included. The median (IQR) prostate volume was 100.0 (88.5, 115.0) mL and 65% had a median lobe. Twenty-one patients had prior urinary retention. The median (IQR) number of injections was 13 (11, 15) and catheterization duration was 9 (7, 14) days. International Prostate Symptom Scores (IPSSs) improved by 24%, 57% and 59% at 1, 3 and 12 months, respectively (P < 0.001). IPSS Quality of Life (QoL) scores improved by 27%, 56% and 70% at these same timepoints (P < 0.001). Maximum urinary flow rate improved by 55% at 3 months (P = 0.002) and 59% at 12 months, and post-void residual urine volume improved by 58% at 3 months (P = 0.006). BPH Impact Index scores improved by 57% at 3 months and 71% at 12 months. International Index of Erectile Function-15 scores improved by 15% at 6 months, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction scores improved by 22.4% at 1 month. Three patients (3.6%) noted reduced/anejaculation. No events of Clavien-Dindo grade III or higher occurred. CONCLUSION: This study demonstrates, for the first time, the safety and efficacy of Rezum therapy in large glands >80 mL. IPSS improved by 59% and IPSS QoL score improved by 70% at 12 months. Objective maximum urinary flow measures improved at 12 months by 59%, while erectile and ejaculatory function remained preserved.

Rezum water vapor therapy for catheter-dependent urinary retention: a real-world Canadian experience.

INTRODUCTION: This analysis reported outcomes of treating catheter-dependent urinary retention with Rezum water vapor therapy. MATERIALS AND METHODS: A prospective registry was established at two high-volume Canadian centers. Patients had baseline medical and benign prostatic hyperplasia (BPH) history documented. The subgroup of patients with refractory, catheter-dependent urinary retention was analyzed. The primary outcome was the proportion of patients who were spontaneously voiding and catheter-free at 6 months. RESULTS: Sixteen patients (age: 68.7 years) with catheter-dependent urinary retention were treated with Rezum. Average prostate volume was 84.4 mL and 75% had median lobe. All patients had at least one recent failed trial without catheter (TWOC) and 87.5% were on BPH oral therapy. Mean number of vapor injections was 14.5. Visibility and bleeding during procedure were assessed using a 5-point scale, and were rated as 1.4 and 1.3, respectively. Anesthesia was either intravenous propofol sedation (n = 13) or self-administered methoxyflurane inhaler (n = 3). Mean catheter duration until first planned TWOC was 28.4 days. Three patients needed catheter replacement due to initial failed TWOC. One patient was lost to follow up, one patient did not return at 1 month, and one patient did not return at 3 months. At 1 month, 13/14 patients were spontaneously voiding and catheter-free. At 3 months, 14/14 patients were spontaneously voiding, and at 6 months, 15/15 patients were spontaneously voiding and catheter-free (1 patient was lost to follow up). CONCLUSIONS: Rezum water vapor therapy can successfully treat catheter-dependent urinary retention after initial failed TWOC in an outpatient setting.

Coccygectomy for refractory coccygodynia: a systematic review and meta-analysis.

PURPOSE: We sought to systematically assess and summarize the available literature on outcomes following coccygectomy for refractory coccygodynia. METHODS: PubMed, Scopus, and Cochrane Library databases were systematically searched in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data concerning patient demographics, validated patient reported outcome measures (PROMs) for pain relief, disability outcomes, complications, and reoperation rates were extracted and analyzed. RESULTS: A total of 21 studies (18 retrospective and 3 prospective) were included in the quantitative analysis. A total of 826 patients (females = 75%) received coccygectomy (720 total and 106 partial) for refractory coccygodynia. Trauma was reported as the most common etiology of coccygodynia (56%; n = 375), followed by idiopathic causes (33%; n = 221). The pooled mean difference (MD) in pain scores from baseline on a 0-10 scale was 5.03 (95% confidence interval [CI]: 4.35 to 6.86) at a 6-12 month follow-up (FU); 5.02 (95% CI: 3.47 to 6.57) at > 12-36 months FU; and 5.41 (95% CI: 4.33 to 6.48) at > 36 months FU. The MCID threshold for pain relief was surpassed at each follow-up. Oswestry Disability Index scores significantly improved postoperatively, with a pooled MD from baseline of - 23.49 (95% CI: - 31.51 to - 15.46), surpassing the MCID threshold. The pooled incidence of complications following coccygectomy was 8% (95% CI: 5% to 12%), the most frequent of which were surgical site infections and wound dehiscence. The pooled incidence of reoperations was 3% (95% CI: 1% to 5%). CONCLUSION: Coccygectomy represents a viable treatment option in patients with refractory coccygodynia.

Differentiating factors of intra-articular injectables have a meaningful impact on knee osteoarthritis outcomes: a network meta-analysis.

PURPOSE: There are a number of developments in intra-articular therapies that have been determined to be differentiating factors within the classes of treatments. This study evaluated the efficacy and safety of intra-articular treatments of primary knee osteoarthritis in the short term (3 months follow-up), using a network meta-analysis design, while taking within-class differentiating factors into consideration. METHODS: A literature search of MEDLINE (through OVID), EMBASE (through OVID), Cochrane Central Register of Controlled Trials for all trials comparing intra-articular therapies was conducted on November 12, 2018. The treatments assessed were high molecular weight and low molecular weight hyaluronic acid injections, extended-release corticosteroids, standard-release corticosteroids, platelet-rich plasma, and saline. A frequentist network meta-analysis was conducted for each outcome. RESULTS: Sixty-four articles (9710 patients) met the inclusion criteria. High molecular weight hyaluronic acid (- 0.53, 95% CI - 0.81 to - 0.25) and PRP (- 0.79, 95% CI - 1.32 to - 0.26) were the only treatments with a confidence interval that lay completely above the MID threshold; however, PRP results varied within sensitivity analyses. For the function analysis, high molecular weight hyaluronic acid (SMD - 0.76, 95% CI - 1.30 to - 0.22) was the only treatment with a confidence interval entirely above the MID. Extended-release corticosteroid demonstrated a possible benefit in functional improvement (SMD - 0.98, 95% CI - 1.79 to - 0.17) compared to that of standard-release corticosteroid (SMD - 0.14, 95% CI - 0.72 to 0.44). CONCLUSION: High molecular weight HA was the only treatment to surpass the MID for both pain and function outcomes. Extended-release corticosteroids may provide additional clinical benefit over standard-release corticosteroids. Platelet-rich plasma demonstrated possibly beneficial results; however, wide confidence intervals and sensitivity analyses made the conclusions of efficacy uncertain. LEVEL OF EVIDENCE: Level 1. Systematic review of level 1 evidence.

Posterior-Based Approaches to Open Reduction Internal Fixation of Bimalleolar and Trimalleolar Fractures: A Systematic Review and Meta-analysis.

Although there is growing evidence supporting posterior-based surgical approaches to open reduction internal fixation (ORIF) of malleolar fractures, the lateral approach still remains the standard of care for this injury. The purpose of this review was to integrate the results of several studies investigating outcomes following posterior-based approaches to the ORIF of malleolar fractures. The literature search was undertaken using PubMed, the Cochrane Library, and Embase. Crude event rates for fracture healing and postoperative complications were calculated. When possible, meta-analyses were conducted to estimate the relative risk of these outcomes between patients treated by posterior-based approaches versus other approaches to ORIF of malleolar fractures. Twenty-two studies were eligible, and 4 studies were included in the meta-analyses. The healing rate was 100% in all patients, regardless of the surgical approach. Overall, 1.26% of patients developed an infection, 0.63% required reoperation, 1.13% experienced aseptic loosening, 5.53% experienced pain after treatment, and 2.52% experienced symptomatic hardware. No malunion or heterotopic ossification was reported in any study. Among patients treated with a posterior-based approach, the most frequently reported complication was infection (2.50%), with lower rates of reoperation and postoperative pain. Patients with trimalleolar fractures experienced slightly poorer outcomes. Patients treated by posterior-based approaches had a significantly increased risk of infection (p = .010) relative to those treated by the lateral approach; patients treated by the lateral approach had a significantly increased risk of pain after surgery (p = .004) and symptomatic hardware (p = .007). This study brought together evidence that posterior-based surgical approaches and non-posterior-based approaches to ORIF are effective in healing malleolar fractures, with significant differences in specific postoperative complications that need to be further explored.

A Survey for End-Stage Ankle Arthritis Treatment: Ankle Arthrodesis Versus Ankle Arthroplasty.

With promising technological advances, ankle arthroplasty has become an alternative to arthrodesis, traditionally the gold standard, for treating end-stage ankle arthritis. We collected knowledge and perceptions on both procedures to determine the need for a patient decision aid for these patients by administering a cross-sectional survey to 103 orthopaedic surgeons. Respondents were predominantly male and 41 to 50 years old. Half of those who stated that they do not perform arthroplasty said this was because they do not have adequate training. Additionally, certain variables were associated with the surgeon's choice of intervention: patient gender, age, body mass index, postoperative activity level, employment type, perceived risk of infection, neurovascular injury or wound complication, risk of developing or pre-existing adjacent arthritis, deformity, malalignment, bone loss or abnormal bone quality, number of prior ankle operations, cause of arthritis, and desire for motion preservation. The majority agreed that they always incorporate patient preferences into their decisions and that a decision aid would be beneficial. This survey revealed that several patient characteristics are influential in the surgeon's preference for either arthroplasty or arthrodesis for end-stage ankle arthritis. Because the majority of surgeons incorporate patient preferences in their decisions and report that a decision aid would be beneficial for informed decision-making in this clinical scenario, this survey identified an unmet need supporting the development of such a tool for these patients.

Combined intra-articular injection of corticosteroid and hyaluronic acid reduces pain compared to hyaluronic acid alone in the treatment of knee osteoarthritis.

PURPOSE: Intra-articular injections of corticosteroid (CS) and hyaluronic acid (HA) have individually demonstrated efficacy for knee osteoarthritis (OA); however, both treatments are limited by the trajectory of symptom relief. The combination of CS and HA in the management of knee OA may provide improved symptomatic relief for patients who are candidates for intra-articular therapies. METHODS: Electronic databases Medline, EMBASE and Cochrane Library were used to identify relevant publications. Randomized controlled trials (RCT) that evaluated intra-articular injections of combined CS and HA in comparison to HA alone were included. Outcomes eligible for meta-analysis were WOMAC pain, WOMAC total, OMERACT-OARSI responder rate, and treatment-related adverse events. Standardized mean differences (SMD) were calculated for continuous outcomes using an inverse variance method and a random-effects model. Odds ratios (OR) were calculated for dichotomous outcomes using the Mantel-Haenszel method and a random-effects model. Heterogeneity was assessed using the I2 statistic. RESULTS: Eight trials (n = 751 patients) were included. Reduction in WOMAC pain scores at 2-4 weeks favoured the combined CS and HA group compared to HA alone [SMD 0.60, 95% CI (0.23, 0.97); p = 0.002, I2 = 75%]. Longer term improvements at 24-26 and 52 weeks WOMAC pain scores also favoured the combined CS and HA group {[SMD 0.25, 95% CI (0.09, 0.41); p = 0.002, I2 = 0%] and [SMD 0.39, 95% CI (0.01, 0.77); p = 0.05, I2 = 0%]} compared to HA alone, respectively. There were no significant differences in WOMAC total scores, OMERACT-OARSI responder rate, or treatment-related adverse events. CONCLUSION: Combined intra-articular injections of CS and HA led to reductions in pain at 2-4, 24-26 and 52 weeks compared to HA injections alone. LEVEL OF EVIDENCE: Level II-meta-analysis.

Interventions for displaced radial head fractures: network meta-analysis of randomized trials.

BACKGROUND: The purpose of this study was to conduct a systematic review of studies comparing treatments for displaced radial head fractures (RHFs) and perform a network meta-analysis of randomized controlled trials (RCTs). METHODS: We searched electronic databases and reviewed the reference lists of included studies and prior systematic reviews. We included RCTs and cohort studies that (1) compared treatments for displaced RHFs in adults and (2) reported a functional outcome or postoperative complications. Data from RCTs were synthesized using a Bayesian network meta-analysis. We compared the proportion of patients categorized as "excellent" or "good" according to the Broberg and Morrey scale and the rate of postoperative complications using odds ratios (OR) with 95% credible intervals (CrI). RESULTS: We included 20 studies (4 RCTs). The evidence from RCTs examined radial head arthroplasty (RHA), open reduction and internal fixation (ORIF) with metal implants (ORIF-M), and ORIF with biodegradable implants (ORIF-B). The network meta-analysis demonstrated that patients treated with an RHA had greater odds of achieving an "excellent" or "good" score compared with ORIF-M (OR, 22.5; 95% CrI, 2.73-299.58) and ORIF-B (OR, 11.83; 95% CrI, 0.58-324.57). For postoperative complications, RHA patients had a lower odds of experiencing a complication than ORIF-M (OR, 0.15; 95% CrI, 0.01-1.81) and ORIF-B (OR, 0.16; 95% CrI, 0.01-3.06) patients. CONCLUSION: The network meta-analysis of RCTs indicated that RHA results in better function and reduced postoperative complications than ORIF-M and ORIF-B over 2 years in the treatment of displaced RHFs.

Comprehensive Examination of Therapies for Pain in Parkinson's Disease: A Systematic Review and Meta-Analysis.

Pain in Parkinson's disease (PD) is a debilitating symptom with a prevalence of 68%, yet is untreated 50% of the time. What is unclear, however, is which treatment is optimal for minimizing pain severity in PD. Thus, the objective of this systematic review and meta-analysis was to investigate the efficacy of a variety of novel, complimentary, and conventional treatments for pain in PD and elucidate which therapy is the most effective. A systematic search was performed using MEDLINE, PsycINFO, Embase, CINAHL, and CENTRAL databases. To identify additional articles, manual searches of reference lists of included trials were also searched. Major neurology conference proceedings occurring between January 2014 and February 2018 were also searched to identify unpublished studies that may be potentially eligible. Twenty-five randomized controlled trials that encompassed medical, surgical, and complementary therapies met our inclusion criteria and exhibited moderate quality evidence. Two reviewers conducted assessments for study eligibility, risk of bias, data extraction, and quality of evidence rating. A conservative random-effects model was used to pool effect estimates of pain severity. The greatest reductions in pain were found with safinamide (Standardized mean difference = -4.83, 95% CI [-5.07 to -4.59], p < 0.0001), followed by cannabinoids and opioids, multidisciplinary team care, catechol-O-methyltransferase inhibitors, and electrical and Chinese therapies. Moderate effects in reducing pain were in pardoprunox and surgery, while the weakest effects were in dopaminergic agonists and miscellaneous therapies. Safinamide is an important adjunct to standard parkinsonian medication for alleviating pain in PD.

Combination radiofrequency ablation and vertebral cement augmentation for spinal metastatic tumors: A systematic review and meta-analysis of safety and treatment outcomes.

Background: The treatment of spine metastases continues to pose a significant clinical challenge, requiring the integration of multiple therapeutic modalities to address the multifactorial aspects of this disease process. Radiofrequency ablation (RFA) and vertebral cement augmentation (VCA) are 2 less invasive modalities compared to open surgery that have emerged as promising strategies, offering the potential for both pain relief and preservation of vertebral stability. The utility of these approaches, however, remains uncertain and subject to ongoing investigation.This systematic review and meta-analysis evaluates the available evidence and synthesize the results of studies that have investigated the combination of RFA and VCA for the treatment of spinal metastases, with the goal of providing a comprehensive and up-to-date assessment of the efficacy and safety of this therapeutic approach. Methods: A literature search was conducted using the electronic databases PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Scopus from their inception to May 4th, 2022 in accordance with PRISMA guidelines. Studies were included if they met the following criteria: 1) spine metastases treated with RFA in combination with VCA, 2) available data on at least one outcome (i.e., pain palliation, complications, local tumor control), 3) prospective or retrospective studies with at least 10 patients, and 4) English language. Meta-analyses were conducted in R (R Foundation for Statistical Computing; Vienna, Austria), using the meta package. Results: In the 25 included studies, a total of 947 patients (females=53.9%) underwent RFA + VCA for spinal metastatic tumors. Out of 1,163 metastatic lesions, the majority were located in the lumbar region (585/1,163 [50.3%]) followed by thoracic (519/1,163 [44.6%]), sacrum (39/1,163 [3.4%]), and cervical (2/1,163 [0.2%]). 48/72 [66.7%] metastatic lesions expanded into the posterior elements. Preoperative pathologic vertebral fractures were identified in 115/176 [65.3%] patients. Between pre-procedure pain scores and postprocedure pain scores, average follow-up (FU) was 4.41±2.87 months. Pain scores improved significantly at a short-term FU (1-6 months), with a pooled mean difference (MD) from baseline of 4.82 (95% CI, 4.48-5.16). The overall local tumor progression (LTP) rate at short-term FU (1-6 months) was 5% (95% CI, 1%-8%), at mid-term FU (6-12 months) was 22% (95% CI, 0%-48%), and at long-term FU (>12 months) was 5% (95% CI, 0%-11%). The pooled incidence of total complications was 1% (95% CI, 0%-1%), the most frequent of which were transient radicular pain and asymptomatic cement extravasation. Conclusions: The findings of this meta-analysis reveal that the implementation of RFA in conjunction with VCA for the treatment of spinal metastatic tumors resulted in a significant short-term reduction of pain, with minimal total complications. The LTP rate was additionally low. The clinical efficacy and safety of this technique are established, although further exploration of the long-term outcomes of RFA+VCA is warranted.

The effect of expandable versus static lordotic interbody implants in minimally invasive spine surgery: patient reported outcomes, sagittal alignment, and restoration of disc height and foraminal height.

Background: Pain and disability due to age-related spinal disorders are increasing due to a more active population placing greater demands on their musculoskeletal system. For patients requiring surgery, spinal fusion is typically indicated. Interbody fusion cages improve fusion rates and restore lordosis, disc height, and foraminal height. Static cages are offered in multiple conformations to account for anatomic variability; however, they have issues related to implant subsidence and loss of lordosis. Expandable cages were developed to address these drawbacks. Methods: Patients treated with either static or expandable transforaminal lumbar interbody fusion devices (ProLift® Expandable Spacer System) for the treatment of spondylolisthesis, degenerative disc disease, spinal stenosis, disc herniation, or degenerative scoliosis at L4-L5 or L5-S1 were chosen from retrospective data. Outcomes included radiographic and spinopelvic changes, patient-reported outcomes, and incidence of non-union and revision surgery. Results: One hundred patients were included (Static: 50; Expandable: 50). Demographics between groups were similar, with some differences in comorbidities and spinal disease diagnosis. Radiographically, changes in disc height, foraminal height, and lordosis were significantly improved in the Expandable group up to 2 years (P<0.001). Improvements in patient reported outcomes were more favorable in the Expandable group. Conclusions: In patients who underwent transforaminal lumbar spinal fusion via minimally invasive surgery, the Expandable device group demonstrated significantly improved radiographic and patient reported outcomes compared to a static cage over 2 years.

Large, Multi-Center, Prospective Registry of Rezum Water Vapor Therapy for Benign Prostatic Hyperplasia.

OBJECTIVE: To illustrate the role of Rezum convective water vapor ablation for treatment of lower urinary tract symptoms secondary to Benign prostatic hyperplasia. METHODS: A prospective registry was established for Rezum therapy in Canada at two high-volume centers. All patients had baseline medical and Benign prostatic hyperplasia history documented, along with uroflowmetry and validated questionnaires up to 12 months post-surgery. RESULTS: 229 patients (mean age 67.3 years), including 83 with prostate volumes ≥80 mL, were treated from April 2019 to December 2020. The mean prostate volume was 71.5 mL (range 20-160 mL) and 55% had a median lobe. The mean number of injections was 11 (range: 4-28) and mean procedural length was 4.8 minutes (range: 1.5-14). The mean duration of postprocedure catheterization was 9.8 days. International Prostate Symptom Scores improved from baseline by 29%, 53%, and 59% at 1, 3, and 12 months, respectively. International Prostate Symptom Scores quality of life improved from baseline by 30%, 50%, and 67% at 1, 3, and 12 months, respectively. Qmax improved by 60% at 3 months and 74% at 12 months. Post-void residual volume improved by 51% and 61% at 3 and 12 months, respectively. No statistically significant changes were seen in International Index of Erectile Function-15 or Male Sexual Health Questionnaire for Ejaculatory Dysfunction scores. No Clavien-Dindo events ≥Grade III occurred. CONCLUSION: Rezum therapy is a safe, effective, and quick outpatient procedure for prostate glands over a wide range of volumes. Clinically significant improvements are seen in all validated questionnaires. Objective maximum flow measures improved, while erectile and ejaculatory function remains preserved.

Management of pain due to cervical multilevel disk bulges and spinal stenosis with a focused vibro-percussion wave treatment: A case report.

A patient presenting with low back pain received 18 treatments of FDA-approved low-frequency vibro-percussion wave stimulation known as Khan Kinetic Treatment (KKT). Following KKT, he demonstrated improvement in pain, function, quality of life, sleep, and trunk range of motion with no adverse events.

Radiofrequency ablation for spinal osteoid osteoma: A systematic review of safety and treatment outcomes.

AIM: We sought to systematically assess and summarize the available literature on the clinical outcomes and complications following radiofrequency ablation (RFA) for painful spinal osteoid osteoma (OO). METHODS: PubMed, Scopus, and CENTRAL databases were searched in accordance with PRISMA guidelines. Studies with available data on safety and clinical outcomes following RFA for spinal OO were included. RESULTS: In the 14 included studies (11 retrospective; 3 prospective), 354 patients underwent RFA for spinal OO. The mean ages ranged from 16.4 to 28 years (Females = 31.3%). Lesion diameters ranged between 3 and 20 mm and were frequently seen in the posterior elements in 211/331 (64%) patients. The mean distance between OO lesions and neural elements ranged between 1.7 and 7.4 mm. The estimated pain reduction on the numerical rating scale was 6.85/10 (95% confidence intervals [95%CI] 4.67-9.04) at a 12-24-month follow-up; and 7.29/10 (95% CI 6.67-7.91) at a >24-month follow-up (range 24-55 months). Protective measures (e.g., epidural air insufflation or neuroprotective sterile water infusion) were used in 43/354 (12.1%) patients. Local tumor progression was seen in 23/354 (6.5%) patients who were then successfully re-treated with RFA or open surgical resection. Grade I-II complications such as temporary limb paresthesia and wound dehiscence were reported in 4/354 (1.1%) patients. No Grade III-V complications were reported. CONCLUSION: RFA demonstrated safety and clinical efficacy in most patients harboring painful spinal OO lesions. However, further prospective studies evaluating these outcomes are warranted.

Percutaneous image-guided cryoablation of spinal metastases: A systematic review.

Percutaneous cryoablation (PCA) is a minimally invasive technique that has been recently used to treat spinal metastases with a paucity of data currently available in the literature. A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Prospective or retrospective studies concerning metastatic spinal neoplasms treated with current generation PCA systems and with available data on safety and clinical outcomes were included. In the 8 included studies (7 retrospective, 1 prospective), a total of 148 patients (females = 63%) underwent spinal PCA. Tumors were located in the cervical (3/109 [2.8%], thoracic (74/109 [68.8%], lumbar (37/109 [33.9%], and sacrococcygeal (17/109 [15.6%] regions. Overall, 187 metastatic spinal lesions were treated. Thermo-protective measures (e.g., carbo-/hydro-dissection, thermocouples) were used in 115/187 [61.5%] procedures. For metastatic spinal tumors, the pooled mean difference (MD) in pain scores from baseline on the 0-10 numeric rating scale was 5.03 (95% confidence interval [CI]: 4.24 to 5.82) at a 1-month follow-up and 4.61 (95% CI: 3.27 to 5.95) at the last reported follow-up (range 24-40 weeks in 3/4 studies). Local tumor control rates ranged widely from 60% to 100% at varying follow-ups. Grade I-II complications were reported in 9/148 [6.1%] patients and grade III-V complications were reported in 3/148 [2.0%]) patients. PCA, as a stand-alone or adjunct modality, may be a viable therapy in appropriately selected patients with painful spinal metastases who were traditionally managed with open surgery and/or radiation therapy.

Can Medical Cannabis Therapies be Cost-Effective in the Non-Surgical Management of Chronic Knee Pain?

INTRODUCTION: Chronic knee pain is a common musculoskeletal condition, which usually leads to decreased quality of life and a substantial financial burden. Various non-surgical treatments have been developed to relieve pain, restore function and delay surgical intervention. Research on the benefits of medical cannabis (MC) is emerging supporting its use for chronic pain conditions. The purpose of this study was to evaluate the cost-effectiveness of MC compared to current non-surgical therapies for chronic knee pain conditions. METHODS: We conducted a cost-utility analysis from a Canadian, single payer perspective and compared various MC therapies (oils, soft gels and dried flowers at different daily doses) to bracing, glucosamine, pharmaceutical-grade chondroitin oral non-steroidal anti-inflammatory drugs (NSAIDs), and opioids. We estimated the quality-adjusted life years (QALYs) gained with each treatment over 1 year and calculated incremental cost-utility ratios (ICURs) using both the mean and median estimates for costs and utilities gained across the range of reported values. The final ICURs were compared to willingness-to-pay (WTP) thresholds of $66 714, $133 428 and $200 141 Canadian dollars (CAD) per QALY gained. RESULTS: Regardless of the estimates used (mean or median), both MC oils and soft gels at both the minimal and maximal recommended daily doses were cost-effective compared to all current knee pain therapies at the lowest WTP threshold. Dried flowers were only cost-effective up to a certain dosage (0.75 and 1 g/day based on mean and median estimates, respectively), but all dosages were cost-effective when the WTP was increased to $133 428/QALY gained. CONCLUSION: Our study showed that MC may be a cost-effective strategy in the management of chronic knee pain; however, the evidence on the medical use of cannabis is limited and predominantly low-quality. Additional trials on MC are definitely needed, specifically in patients with chronic knee pain.

Medical Cannabis for Chronic Noncancer Pain: A Systematic Review of Health Care Recommendations.

Purpose: Medical cannabis for patients with chronic noncancer pain (CNCP) has been the focus of numerous health care recommendations. We conducted a systematic review to identify and summarize the currently available evidence-based recommendations. Methods: We searched MEDLINE, EMBASE, PsycINFO, the Cochrane database of systematic reviews, and websites for clinical guidelines and recommendations. We summarized the type of the publications, developers, approach of health care recommendation development, year and country of publication, and conditions that were addressed. We categorized the direction and strength of each recommendation. Results: We identified 12 eligible publications. Publication years ranged from 2007 to 2019; four (33.3%) of them were published in 2018. Canada ranked first for the number of publications (n = 4, 33.3%). Most (n = 11, 92%) of the included recommendations were based on both a systematic review of the best evidence and expert consensus. All the included publications provided a recommendation supporting medical cannabis for CNCP in general and for the specific conditions of neuropathic pain, chronic pain in people living with Human Immunodeficiency Virus (HIV), and chronic abdominal pain, with detailed information sharing and comprehensive consideration of a patient's own values and preferences. Conclusion: Clinicians can attend to the guidance currently offered, being aware that only weak recommendations are available for medical cannabis in patients with CNCP, as a third- or fourth-line therapy. Detailed discussions with patients regarding the benefits in reducing pain and potential adverse effects are required before its prescription.

Comparing medical cannabis use in 5 US states: a retrospective database study.

BACKGROUND: US states have been adopting their own medical cannabis laws since 1996. There is substantial variability in the medical cannabis programs between states, and these differences have not been thoroughly investigated in the literature. The objective of the study was to compare medical cannabis patient characteristics across five states to identify differences potentially caused by differing policies surrounding condition eligibility. METHODS: We conducted secondary analyses following a retrospective study of a registry database with data from 33 medical cannabis evaluation clinics in the US, owned and operated by CB2 Insights. This study narrowed the dataset to include patients from five states with the largest samples: Massachusetts (n = 27,892), Colorado (n = 16,434), Maine (n = 4591), Connecticut (n = 2643), and Maryland (n = 2403) to conduct an in-depth study of the characteristics of patients accessing medical cannabis in these states, including analysis of variance to compare average ages and number of conditions and chi-squared tests to compare proportions of patient characteristics between states. RESULTS: Average ages varied between the states, with the youngest average in Connecticut (42.2) and the oldest in Massachusetts (47.0). Males represented approximately 60% of the patients with data on gender in each state. The majority of patients in each state had cannabis experience prior to seeking medical certification. Primary medical conditions varied for each state, with chronic pain, anxiety, and back and neck problems topping the list in varying orders for Massachusetts, Maine, and Maryland. Colorado had 78.7% of patients report chronic pain as their primary condition, and 70.4% of patients in Connecticut reported post-traumatic stress disorder as their primary medical condition. CONCLUSION: This study demonstrated the significant impact that policy has on patients' access to medical cannabis in Massachusetts, Colorado, Maine, Connecticut, and Maryland utilizing real-world data. It highlights how qualifications differ between the five states and brings into question the routes through which patients in states with stricter regulations surrounding eligible conditions choose to seek treatment with cannabis. These patients may turn to alternative treatments, or to the illicit or recreational cannabis markets, where permitted.

Pain Relief and Safety Outcomes with Cervical 10 kHz Spinal Cord Stimulation: Systematic Literature Review and Meta-analysis.

BACKGROUND: Chronic pain in head, neck, shoulders and upper limbs is debilitating, and patients usually rely on pain medications or surgery to manage their symptoms. However, given the current opioid epidemic, non-pharmacological interventions that reduce pain, such as spinal cord stimulation (SCS), are needed. The purpose of this study was to review the evidence on paresthesia-free 10 kHz SCS therapy for neck and upper extremity pain. METHODS: Systematic literature search was performed for studies reporting outcomes for cervical 10 kHz SCS using date limits from May 2008 to November 2020. The study results were analyzed and described qualitatively. Additionally, when feasible, meta-analyses of the outcome data, with 95% confidence intervals (CIs), were conducted using both the fixed-effects (FE) and random-effects (RE) models. RESULTS: A total of 15 studies were eligible for inclusion. The proportion of patients who achieved ≥ 50% pain reduction was 83% (95% CI 77-89%) in both the FE and RE models. The proportion of patients who reduced/eliminated their opioid consumption was 39% (95% CI 31-46%) in the FE model and 39% (95% CI 31-48%) in the RE model. Pain or discomfort with the implant, lead migration, and infections were potential risks following cervical SCS. Explant rate was 0.1 (95% CI 0.0-0.2) events per 100 person-months, and no patients in the included studies experienced a neurological complication or paresthesia. CONCLUSION: Findings suggest 10 kHz SCS is a promising, safe, minimally invasive alternative for managing chronic upper limb and neck pain.

Medical cannabis for orthopaedic patients with chronic musculoskeletal pain: does evidence support its use?

The treatment of chronic, non-cancer musculoskeletal pain has become a topic growing interest as it is believed to be one of the reasons for the current opioid epidemic. The medicinal use of cannabis has a long history as a number of active compounds in cannabis have been shown to interact with the body's endocannabinoid system to reduce pain. This position paper provides a history on the evolution of cannabis, the science behind its therapeutic effects, and review of the evidence and current guideline recommendations on its use as a treatment for patients with chronic, non-cancer musculoskeletal pain. Results from systematic reviews have demonstrated a statistically significant reduction in chronic pain conditions with cannabinoids, compared with placebo, although the effects might be considered small and did not reach the minimally important difference. More adverse events were reported in the cannabinoid group than in the placebo group with longer than 2 weeks of treatment. There is a lack of evidence on dependence. With changes to policies, patients' perception has changed to be more positive toward the use of medical cannabis. Current recommendations from North America, Latin America, Europe, Australia and Iran support the use of medical cannabis for chronic, non-cancer pain. Based on the current evidence, it is our position that cannabinoids may be considered as an adjunctive therapy after recommended first- and second-line therapies have failed to provide sufficient efficacy or tolerability. Patients should consider the balance between the desirable and undesirable effects of taking cannabis for chronic pain, and comprehensively consider their own values and preferences, as well as cost-effectiveness factors, based on the information provided by their physician.