scholarly journals Effectiveness, Safety, and Tolerability of Nabiximols Oromucosal Spray vs Typical Oral Long-Acting Opioid Analgesics in Patients with Severe Neuropathic Back Pain: Analysis of 6-Month Real-World Data from the German Pain e-Registry

Pain Medicine ◽  
2021 ◽  
Author(s):  
Michael A Ueberall ◽  
Carlos Vila Silván ◽  
Ute Essner ◽  
Gerhard H H Mueller-Schwefe
Keyword(s):  
Back Pain ◽  
Propensity Score ◽  
Adverse Events ◽  
Symptom Relief ◽  
Opioid Analgesics ◽  
Real World Data ◽  
Patient Reported ◽  
Scale Scores ◽  
Long Acting ◽  
Matched Data

Abstract Objective To compare the effectiveness, safety, and tolerability of add-on nabiximols (NBX) oromucosal spray vs typical oral long-acting opioid (LAO) analgesics in patients with severe (± chronic) peripheral neuropathic back pain poorly responsive to other treatments. Methods Retrospective analysis of anonymized, propensity score–matched data from the German Pain e-Registry of adult outpatients who initiated NBX or LAO between March 2017 and March 2020. Results Data were analyzed from propensity score–matched patients treated with NBX (n = 655) or LAO (n = 655): mean age ≈51 years; 57% female; mean pain duration ≈2.6 years; chronic pain 61%; severe dysfunctional pain 93%. At 6 months, NBX was noninferior to LAO for overall symptom relief, based on the least-squares mean difference between cohorts in change from baseline in patient-reported, pain-related aggregated nine-item scale scores (−27.84%; 95% confidence interval [CI] −29.71 to −25.96; P < 0.001) and individual pain-related scale scores. Subsequent prespecified superiority analysis of the primary endpoint showed that NBX was superior to LAO: all secondary endpoints measuring symptoms of pain and physical function improved significantly with NBX and LAO, with between-group differences favoring NBX (all P < 0.001). Fewer patients treated with NBX than LAO experienced treatment-related adverse events (25.5% vs 76.0%; P < 0.001) or discontinued treatment because of treatment-related adverse events (7.9% vs 29.3%; P < 0.001). Conclusion Within study limitations (e.g., observational design, all potential biases), add-on NBX was superior to and better tolerated than add-on treatment with typical oral LAO analgesics in patients with neuropathic back pain inadequately controlled by recommended/established systemic therapies.

scholarly journals A Prospective Study Evaluating Intra-Articular Hyaluronic Acid (1 ml) for Ankle Osteoarthritis

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0004
Author(s):  
Alastair Younger ◽  
Kevin Wing ◽  
Andrea Veljkovic ◽  
Murray Penner
Keyword(s):  
Hyaluronic Acid ◽  
Adverse Events ◽  
Pain Score ◽  
Symptom Relief ◽  
Loss Of Function ◽  
Ankle Arthritis ◽  
Variable Effect ◽  
Duration Of Effect ◽  
Patient Reported ◽  
Cortisone Injection

Category: Ankle Arthritis Introduction/Purpose: Early ankle arthritis can result in disabling symptoms and loss of function. However the degree of arthritis may not be severe enough or the symptoms severe enough to merit a fusion or replacement. For other patients they may wish to delay surgery to avoid financial issues with recovery time. Many of these patients have also been treated with NSAIDs, physiotherapy and bracing with variable effect. Stabilized long chain Hyaluronic acid (NASHA) has been used successfully in the knee, and has given a longer duration of effect compared to steroid injection. The purpose of this study was to determine the effect of hyaluronic acid in the ankle for sustainable symptom relief. Methods: A power analysis determined that a minimum of 29 patients would be required to appropriately power the study. A total of 37 adult patients with KL grade II and III ankle arthritis were enrolled in the study at a single institution. Patients recruited via a newspaper advertisement and from the surgical clinics and and screened for standard inclusion and exclusion criteria. The VAS pain preoperatively had to be greater than 30 / 100 mm. Outcomes were recorded at baseline, weeks 6, 12 and 26. The injection was performed after the baseline assessment using 1 ml of Hyaluronic acid NASHA (Q-Med AB, Uppsala, Sweden; DUROLANE 10 mg / mL) with or without local anesthetic to the skin. Outcomes included a VAS from the AOS scale for pain and disability, review of adverse events, physical exam, and use of rescue medication. Results: 35 of 37 patients completed the study. At baseline the VAS pain was 7.2 (SD +/-1.8). At 6 weeks the pain score was 5.4 (+/-2.5) improving by 1.8 points with a 26% improvement. At 12 weeks the pain score was 5.3 (+/-2.7) for a 29% improvement. At week 26 the pain score was 5 (+/- 2.7) for a 32% improvement. 4 adverse events were recorded – one patient reported increased pain after injection. One reported pain and swelling, one reported inflammation, and one pain after injection. Conclusion: This prospective cohort study shows promise for the use of Hyaluronic acid for the treatment of ankle arthritis with relief of symptoms up to 26 weeks after injection. The injection was safe for all 37 patients, although one patient reported pain and dropped out of the study. We would support the use of Hyaluronic acid for the treatment for moderate ankle arthritis. An RCT would be merited based on this study to compare results with placebo or cortisone injection.

scholarly journals P352 A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn’s disease. The Cross Pennine study II

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S372-S373
Author(s):  
M V Lenti ◽  
V Dolby ◽  
T Clark ◽  
V Hall ◽  
S Tattersall ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Propensity Score ◽  
Adverse Events ◽  
Clinical Response ◽  
Real World ◽  
Propensity Score Analysis ◽  
Physician Global Assessment ◽  
Real World Data ◽  
The Difference

Abstract Background The best choice of biological agents after failure to an anti-tumour necrosis factor (TNF)α agent in patients with Crohn’s disease (CD) is yet to be defined. Real-world data dealing with this issue are still emerging. Methods This is a multicentre retrospective study including eight UK hospitals (August 2014-April 2020). We retrospectively collected data of patients treated with ustekinumab. Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Predictors of clinical response were examined, and a propensity score-matched analysis with a cohort of patients treated with vedolizumab was performed. Results Overall, 282 patients (mean age 40±15, F:M ratio 1.7:1) treated with ustekinumab were included. Clinical response or remission was reached by 200/282 patients (70.9%) at 14 weeks, and by 162/259 patients (62.5%) at 52 weeks. The most common reason for discontinuation was either primary failure or loss of response, followed by the occurrence of adverse events and by the need for surgery. The rate of non-adherence was rather low (1.4%). Current smoking (OR 2.48, 95% CI 1.13-5.44; p=0.02), baseline PGA (OR 2.4, 95% CI 1.55-3.69, p<0.001), and use of steroids (OR 2.42, 95% CI 1.26-4.65, p=0.008) were associated with 52-week treatment failure. Overall, 74 adverse events occurred, of which 26 were labelled as serious (8.3 per 100 person-year). After exclusion of patients without anti-TNFα exposure prior to starting ustekinumab or vedolizumab and exclusion of patients previously exposed to vedolizumab or ustekinumab, we analysed 275/282 patients (97.5%) from the ustekinumab cohort and 118/135 patients (87.4%) from the vedolizumab cohort. Propensity score analysis revealed that at 14 weeks, patients treated with ustekinumab were 38% (95% CI 25-50%; p<0.001) more likely to achieve a clinical remission, while at 52 weeks, the difference of 9% (95% CI -15-33%; p=0.462) was not significant. Conclusion Ustekinumab was effective and well tolerated in this real-world cohort. While ustekinumab proved more effective at 14-week follow-up, we found no statistically significant differences in outcomes at 52 weeks.

The use of a chatbot based on artificial intelligence to collect patients reported outcomes in oncology practice. A pilot study with real-world data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19119-e19119
Author(s):  
Munir Murad Junior ◽  
Arthur Nascimento ◽  
Alexandre Fonseca De Castro ◽  
Lilian Paiva ◽  
Amandio S. Fernandes ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Pilot Study ◽  
Adverse Events ◽  
Real World ◽  
Oral Treatment ◽  
Case Series ◽  
Real World Data ◽  
Active Search ◽  
Patient Reported ◽  
Belo Horizonte

e19119 Background: There is growing interest in enhancing symptoms monitoring during routine cancer care using patient-reported outcomes (PROs). The quality of evidence that demonstrates clinical benefits of this type of assistance is also increasing. However, the best method for this approach is evolving and there are many barriers to implement these tools in the real world scenario. We aim to describe a pilot study about a chatbot with artificial intelligence developed to collect PROs and to optimize adherence to systemic cancer treatment. Methods: This is a case series that reports the first patients in a private oncology clinic in Belo Horizonte, Southeast Brazil who consecutively underwent regular conversations with a chatbot based on artificial intelligence. Data was collected from February the 23th to December the 3rd 2019. The virtual assistant interacted with the patient in four different ways, being the first three of these an active search from the chatbot: a) search for adverse events, b) adherence to oral treatment c) screening for depression d) spontaneous patient demand (not an active search). Results: Interaction with the chatbot was offered to 193 patients. A total of 107 patients were included. Of these 74% were female, 55% older than 60 years and 22% had at least 7 years education.194 protocols of treatment were analysed, 66% of these being chemotherapy regimens and 23% hormone therapy. Oral drugs corresponded to 23% of the protocols. The main adverse events reported were fatigue 20%, nausea 13%, pain 11%, diarrhea 10%, lack of appetite 6%. Adverse effects were classified by patients as grade III or IV approximately 24% of the time. For patient safety the system runs a script twice a day to detect any adverse effect and send it to the service attended. A total of 3883 dialogues were initiated, the majority of which (3772) was carried out by the machine. Only 3% of the dialogues were spontaneously initiated by the patients. Once the conversation started, adherence was considerably satisfactory since engagement was 73% for questions about adherence to oral medications and 76% of people reported at least one adverse event. Conclusions: An initial barrier must be surpassed since the chatbot was offered to 193 patients and 86 (44%) did not register for use. Once the contact started, we understand that the use of AI is promising since the engagement rates were very good. It is important to highlight the potential capacity for early identification of symptoms since most dialogues were initiated by the virtual assistant.

scholarly journals Tapentadol prolonged release in patients with chronic low back pain: real-world data from the German Pain eRegistry

2021 ◽  
Author(s):  
Michael A Überall ◽  
Christian Elling ◽  
Christoph Eibl ◽  
Gerhard HH Müller-Schwefe ◽  
Claudia Lefeber ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Chronic Low Back Pain ◽  
Opioid Analgesics ◽  
Prolonged Release ◽  
Low Back ◽  
Real World Data ◽  
Routine Medical Care ◽  
Treatment Responder ◽  
Pain Patients

Aim: Comparison of tapentadol prolonged release (PR) with other oral WHO-III PR opioid analgesics (morphine, oxycodone ± naloxone, hydromorphone) in routine medical care of chronic low back pain. Patients & methods: Noninterventional, retrospective 12-week study using anonymized clinical practice data from the German Pain eRegistry. Six effectiveness, tolerability, and safety criteria were aggregated in a primary composite end point (treatment responder). Propensity scoring matched 2331 datasets per treatment cohort. Results: All six single criteria showed significantly better outcomes for tapentadol PR (all parameters p < 0.001). There were significantly more treatment responders under tapentadol PR (65.7 vs 14.2%; p < 0.001). Conclusion: Tapentadol PR showed significantly better effectiveness and tolerability in severe chronic low back pain unsuccessfully treated with WHO-I/II analgesics compared with the other oral WHO-III PR opioids investigated.

scholarly journals Establishment of Personalized Pain Goals in Oncology Patients to Improve Care and Decrease Costs

2017 ◽  
Vol 13 (3) ◽  
pp. e266-e272 ◽  
Author(s):  
Dylan Zylla ◽  
Amber Larson ◽  
Gladys Chuy ◽  
Lisa Illig ◽  
Adina Peck ◽  
...  
Keyword(s):  
Medication Use ◽  
Opioid Analgesics ◽  
Pain Medication ◽  
Management Information ◽  
Lower Treatment ◽  
Patient Reported ◽  
Pain Intervention ◽  
Long Acting ◽  
Reported Data

Purpose: Cancer-related pain is common, negatively affects quality of life and survival, and often requires treatment with opioid analgesics. Patient-reported data that describe the incidence and severity of pain, medication use, and patient satisfaction with care are lacking. Methods: We analyzed 18 months of outpatient oncology clinic encounters from the electronic medical record to obtain data on pain levels and opioid and nonopioid treatments. In June 2014, we instituted a pain intervention by creating a pain management information handout for patients, educating clinicians on opioid cost-effectiveness, and implementing a nursing protocol to document personalized pain goals (PPGs). Results: Moderate to severe pain was reported in nearly 15% of patient encounters. We observed an increase in the percentage of encounters with a documented PPG of 16% to 71% ( P < .001). On average, PPG was achieved in 84% of patients. Rates of high-cost long-acting opioid prescriptions (oxycodone controlled release and fentanyl patches), as a total of all long-acting opioids, declined from 45% preintervention to 33% postintervention ( P = .005). Conclusion: Our intervention improved rates of PPG documentation and decreased the number of prescriptions for high-cost long-acting opioids. Oncology clinics can implement simple quality improvement methods, such as asking patients about their PPG and educating clinicians about opioid costs, to improve outcomes and lower treatment costs.

Management of Back Pain in Myeloma Patients Using Vertebral Augmentation: A Practical Approach to Elimination of Pain and Improvement of Functional Status

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4713-4713
Author(s):  
Douglas B Yim ◽  
Ajay K. Nooka ◽  
James M Martin ◽  
Sagar Lonial
Keyword(s):  
Back Pain ◽  
Pain Relief ◽  
Functional Status ◽  
Conflicts Of Interest ◽  
Symptom Relief ◽  
Vertebral Compression Fractures ◽  
Vertebral Augmentation ◽  
Compression Fractures ◽  
Post Procedure ◽  
Patient Reported

Abstract Abstract 4713 Background: Management of pain and height restoration in multiple myeloma (MM) patients with vertebral compression fractures remains an important area of symptom management among a group of patients that is living longer through advances in therapeutic approaches. Prior studies demonstrated that pain reduction after vertebral augmentation was associated with reduction in patient-reported symptom relief, but clearly more emphasis is needed in this quarter (Julka A, 2012; Mendoza TR, 2012).We report the multidisciplinary approach adapted at our center to management of back pain in MM patients through early and aggressive intervention. Materials and Methods: Our study evaluated ten consecutive MM patients from a single center with vertebral compression fractures refractory to conservative treatment and treated with vertebral augmentation. Per our protocol, after a thorough review of pre-procedure magnetic resonance imaging (MRI), fluoroscopic examination of the spine was performed. Symptomatic levels were topographically localized by marking the skin. Demographic, clinical, and procedural data on patients were retrospectively analyzed. The primary measure of outcome is pain relief and functional status, as assessed by the pre and post-procedure Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). Paired-Samples T test is used for comparison of pre and post measures of outcome. Results: Ten patients with refractory back pain and 36 levels of vertebral compression by MRI were evaluated for potential cement augmentation. Of these levels, 50% (18 levels) were selected for treatment based on fluoroscopic assisted palpation of the spine eliciting a moderate to severe pain-response. A review of the MRI findings of the treated levels showed the absence of traditional MR signal finding of marrow edema; and had little utility in guiding therapy at the time of exam. 15 levels were treated with kyphoplasty alone and 3 levels by a combination of pediculoplasty and kyphoplasty with no adverse outcomes. All patients experienced significant improvement in pain score as measured by VAS. The mean pre and post-procedure VAS were 6.8 and 1.3 (p=0.000), respectively. All patients experienced significant improvement in there functional ability as measured by their ODI questionnaire. Mean pre and post-procedure ODI were 51.4 and 29.8, (p=0.001), respectively. Conclusion: Solely relying on MRI alone to determine who may benefit from vertebral augmentation and pain relief is not sufficient, and often may preclude patient's potential to gain significant benefit. Careful selection of symptomatic levels may be difficult due to the presence of multilevel MR signal abnormalities, but by utilizing a clinical-based approach and primarily relying on palpation of the spine under direct fluoroscopy, excellent results may be achieved, which is critical to palliative success. Disclosures: No relevant conflicts of interest to declare.

scholarly journals A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena® (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence

2016 ◽  
Vol 32 (3) ◽  
pp. 185-193 ◽  
Author(s):  
Kathleen Gibson ◽  
Lowell Kabnick
Keyword(s):  
Adverse Events ◽  
Venous Insufficiency ◽  
Varicose Veins ◽  
Symptom Relief ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Economic Study ◽  
Patient Reported ◽  
Saphenofemoral Junction

Objectives A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI®] score 30.7 points vs 16.7 points, p = 0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINES-QOL/Sym; p < 0.001]), physician-assessed VCSS, and physician- and patient-assessed appearance compared with placebo. The HASTI score correlated highly with the modified-VEINES-QOL/Sym and Chronic Venous Insufficiency Questionnaire-2 scores (r = 0.7 to > 0.9, p ≤ 0.001). Adverse events included contusion, incision-site hematoma, and limb discomfort. Venous thrombus adverse events were reported as mild and generally resolved without sequelae. Conclusions Varithena provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Adverse events were generally mild and transient. ( www.clinicaltrials.gov [NCT00758420]).

PERCUTANEOUS EPIDURAL NEUROPLASTY (PEN) USING COMBINATION OF HYALURONIDASE AND HYPERTONIC SALINE (NaCl 3%) IN TREATING FAILED BACK SURGERY SYNDROME

2018 ◽  
Vol 1 (1) ◽  
pp. 1
Author(s):  
Wawan Mulyawan ◽  
Yudi Yuwono Wiwoho ◽  
Syaiful Ichwan
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Hypertonic Saline ◽  
Failed Back Surgery Syndrome ◽  
Favourable Outcome ◽  
Lumbar Spine Surgery ◽  
Low Back ◽  
Failed Back Surgery ◽  
Scale Scores

Background: Following surgical treatments for low back pain, lower extremity pain or neurologic symptoms would last or recur, this is defined as failed sack surgery syndrome (FBSS). FBSS usually occurs in 5-40% of these surgical patients. The most common cause is an epidural scar adhesion. Percutaneous epidural neuroplasty is the non-mechanical treatment for this condition. Previously, the use of hyaluronidase and hypertonic saline separately is commonly used for epidurolysis but the combination of hyaluronidase and hypertonic saline 3% has not been explored.Objective: To investigate the two-year outcomes of percutaneous epidural neuroplasty using a combination of hyaluronidase and hypertonic saline 3% in patients with FBSS.Methods: Twelve patients who experience low back pain, with or without radiculopathy, who have underwent lumbar spine surgery previously were assigned to the study. Parameters, such as the visual analogue scale scores for the back (VAS-B) and legs (VAS-L), and the Oswestry disability index (ODI), were recorded and compared between pretreatment, 1 week, 1 month, 3 months, 1 year and 2 years follow-up.Results: For all 12 patients, the postoperative VAS-B, VAS-L, and ODI were significantly different from the preoperative values in all follow-up periods: 1 month, 3 months, 1 year, and 2 years.Conclusion: Based off this study group, percutaneous epidural neuroplasty using a combination of hyaluronidase and hypertonic saline 3% has a favourable outcome in the 2 years follow-up

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