scholarly journals An Assessment of Clinically Important Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Diabetic Peripheral Neuropathic Pain

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
James Marcus ◽  
Kathryn Lasch ◽  
Yin Wan ◽  
Mei Yang ◽  
Ching Hsu ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Rating Scale ◽  
Roc Curves ◽  
Brief Pain Inventory ◽  
Pain Severity ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Intensity Rating ◽  
Global Impression Of Change ◽  
Post Hoc

Objectives. Using patient global impression of change (PGIC) as an anchor, an approximately 30% reduction on an 11-point numeric pain intensity rating scale (PI-NRS) is considered a clinically important difference (CID) in pain. Our objective was to define the CID for another pain measure, the worst pain severity (WPS) item of the modified Brief Pain Inventory (m-BPI). Methods. In this post hoc analysis of a double-blind, placebo-controlled, phase 2 study, 452 randomized patients with diabetic peripheral neuropathic pain (DPNP) were followed over 5 weeks, with m-BPI data collected weekly and PGIC at treatment conclusion. Receiver operating characteristic (ROC) curves (via logistic regression) were used to determine the changes in the m-BPI-WPS score that best predicted ordinal clinical improvement thresholds (i.e., “minimally improved” or better) on the PGIC. Results. Similar to the PI-NRS, a change of −3 (raw) or −33.3% from the baseline on the m-BPI-WPS optimized prediction for the “much improved” or better PGIC threshold and represents a CID. There was a high correspondence between observed and predicted PGIC categories at each PGIC threshold (ROC AUCs were 0.78–0.82). Conclusions. Worst pain on the m-BPI may be used to assess clinically important improvements in DPNP studies. Findings require validation in larger studies.

scholarly journals Review of Efficacy and Safety of Duloxetine 40 to 60 mg Once Daily in Patients with Diabetic Peripheral Neuropathic Pain

2012 ◽  
Vol 2012 ◽  
pp. 1-12 ◽  
Author(s):  
Vladimir Skljarevski ◽  
Elijah P. Frakes ◽  
Doron Sagman ◽  
Sarah Lipsius ◽  
Alexandra N. Heinloth ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Brief Pain Inventory ◽  
Primary Outcome Measure ◽  
Pain Severity ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Once Daily

We summarize efficacy and safety findings from 4 double-blind, placebo-controlled, 12-week studies and 1 open-label, uncontrolled, 34-week maintenance-of-effect (MOE) study that examine duloxetine 40 and 60 mg once daily (QD) in patients with diabetic peripheral neuropathic pain (DPNP). In all placebo-controlled studies, duloxetine showed significantly (P≤.01) greater reduction in pain severity (weekly mean of 24-hour average pain severity ratings, primary outcome measure) compared with placebo. In all placebo-controlled studies, duloxetine showed significantly (P≤.05) greater improvement on brief pain inventory-Interference ratings. Patient global impression of improvement ratings were superior to placebo (P≤.01) for duloxetine patients in all placebo-controlled studies. Response rates (based on 30% pain reduction) ranged from 57% to 68% for duloxetine and from 35% to 47% for placebo and were statistically significantly different (P≤.01) between treatment groups in 3 out of 4 studies. The open-label study showed maintenance of analgesic effect of duloxetine in DPNP. In the duloxetine groups, 4.3% to 14.9% of patients discontinued because of adverse events (placebo groups: 2.6% to 7.4%). Most commonly reported treatment-emergent adverse events were nausea, somnolence, and headache. Duloxetine 40 and 60 mg QD was efficacious and well tolerated in the management of DPNP.

scholarly journals Differential response to scrambler therapy by neuropathic pain phenotypes

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Young Gi Min ◽  
Hyun Seok Baek ◽  
Kyoung-Min Lee ◽  
Yoon-Ho Hong
Keyword(s):  
Neuropathic Pain ◽  
Treatment Outcome ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Brief Pain Inventory ◽  
Differential Response ◽  
Open Label ◽  
Numerical Rating ◽  
Scrambler Therapy ◽  
Post Hoc

AbstractScrambler therapy is a noninvasive electroanalgesia technique designed to remodulate the pain system. Despite growing evidence of its efficacy in patients with neuropathic pain, little is known about the clinical factors associated with treatment outcome. We conducted a prospective, open-label, single-arm trial to assess the efficacy and safety of scrambler therapy in patients with chronic neuropathic pain of various etiologies. A post-hoc analysis was performed to investigate whether cluster analysis of the Neuropathic Pain Symptom Inventory (NPSI) profiles could identify a subgroup of patients regarding neuropathic pain phenotype and treatment outcome. Scrambler therapy resulted in a significant decrease in the pain numerical rating scale (NRS) score over 2 weeks of treatment (least squares mean of percentage change from baseline, − 15%; 95% CI − 28% to − 2.4%; p < 0.001). The mean score of Brief Pain Inventory (BPI) interference subdimension was also significantly improved (p = 0.022), while the BPI pain composite score was not. Hierarchical clustering based on the NPSI profiles partitioned the patients into 3 clusters with distinct neuropathic pain phenotypes. Linear mixed-effects model analyses revealed differential response to scrambler therapy across clusters (p = 0.003, pain NRS; p = 0.072, BPI interference subdimension). Treatment response to scrambler therapy appears different depending on the neuropathic pain phenotypes, with more favorable outcomes in patients with preferentially paroxysmal pain rather than persistent pain. Further studies are warranted to confirm that capturing neuropathic pain phenotypes can optimize the use of scrambler therapy.

scholarly journals Progressive Response to Repeat Application of Capsaicin 179 mg (8% w/w) Cutaneous Patch in Peripheral Neuropathic Pain: Comprehensive New Analysis and Clinical Implications

Pain Medicine ◽  
2021 ◽  
Author(s):  
Rainer Freynhagen ◽  
Charles Argoff ◽  
Mariëlle Eerdekens ◽  
Sylvia Engelen ◽  
Serge Perrot
Keyword(s):  
Neuropathic Pain ◽  
Pain Intensity ◽  
Brief Pain Inventory ◽  
Initial Response ◽  
Open Label ◽  
Self Assessment ◽  
Peripheral Neuropathic Pain ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Global Impression Of Change

Abstract Objective To investigate efficacy of repeated application of capsaicin 179 mg cutaneous patch in non-responders to the first application. Design Post hoc, as-treated analysis of two prospective trials (STRIDE and PACE) with 52-week follow-up. Blinding Open-label. Setting Multicenter clinical trial. Subjects STRIDE: non-diabetic neuropathic pain; PACE: painful diabetic peripheral neuropathy. Methods Patients were divided according to number of applications needed before ≥30% response on average pain intensity (question 5 of the Brief Pain Inventory [BPI-Q5]). We assessed change from baseline in average pain intensity (BPI-Q5), mean ‘interference with sleep’ score, Patient Global Impression of Change, quality of life (QOL) using EuroQol 5-dimension, and Self-Assessment of Treatment. Results In STRIDE and PACE, respectively, n = 306/313 received capsaicin patch; n = 60/96 had a response after the first application, n = 33/68 after the second, n = 11/43 after the third. Among patients without a ≥ 30% reduction in pain intensity at 3 months, 23.3%/28.1% achieved a ≥ 30% reduction at 6 months, increasing to 33.9%/45.7% at 12 months. Similar results were obtained using a decrease of ≥ 50% as responder definition. Progressive improvements in pain intensity in slower responders reached similar levels as those in early responders at month 12 and were accompanied by improvements in sleep, QOL, and patient satisfaction. Conclusions While some patients with peripheral neuropathic pain experience rapid improvements with a single treatment of capsaicin 179 mg patch, some may require two or three treatments before an initial response is observed. Similar benefits on pain, sleep, and QOL can be achieved in early and late responders.

scholarly journals Short-Term Outcomes of Mirogabalin in Patients with Peripheral Neuropathic Pain: A Retrospective Study

2020 ◽  
Author(s):  
Tomoko Tetsunaga ◽  
Tomonori Tetsunaga ◽  
Keiichiro Nishida ◽  
Haruo Misawa ◽  
Tomoyuki Takigawa ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Adverse Events ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Duration Of Action ◽  
Peripheral Neuropathic Pain ◽  
Long Duration ◽  
Α2δ Subunit ◽  
The Mean ◽  
Post Hoc

Abstract Background: Mirogabalin, which is approved for the treatment of peripheral neuropathic pain in Japan, is a ligand for the α2δ subunit of voltage-gated calcium channels. Both pregabalin and mirogabalin act as nonselective ligands at the α2δ-1 and α2δ-2 subunits. Mirogabalin has a unique binding profile and long duration of action. Pregabalin has been reported to produce intolerable adverse effects in some patients. This study investigated outcomes associated with mirogabalin administration in patients with peripheral neuropathic pain who ceased treatment with pregabalin.Methods: We retrospectively assessed peripheral neuropathic pain using the neuropathic pain screening questionnaire (NeP score) in 187 patients (58 men, 129 women) who were treated with mirogabalin. All patients had switched from pregabalin to mirogabalin due to lack of efficacy or adverse events. Differences in the treatment course (i.e., numeric rating scale (NRS) scores) were compared using one-way analysis of variance with Bonferroni post hoc tests.Results: The mean age of the patients was 72.3 years (range, 30–94 years), and the mean duration of disease was 37 months (range, 3–252 months). After treatment with mirogabalin for 1 week, NRS scores significantly decreased compared with baseline and continued to decrease over time. After 8 weeks, NRS scores improved by ³30% from baseline in 113 patients (69.3%). Twenty-four patients (12.8%) stopped mirogabalin treatment due to adverse events. Somnolence (26.7%), dizziness (12.3%), edema (5.9%), and weight gain (0.5%) were noted as adverse events of mirogabalin.Conclusions: The results of this investigation indicate that mirogabalin is safe and effective for reducing peripheral neuropathic pain.

scholarly journals Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Malin E. Carmland ◽  
Melissa Kreutzfeldt ◽  
Jakob V. Holbech ◽  
Niels T. Andersen ◽  
Troels S. Jensen ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Negative Impact ◽  
Mean Value ◽  
Primary Objective ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Average Pain ◽  
Related Quality ◽  
Change In The Mean ◽  
Global Impression Of Change

Abstract Background Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide is a sodium-channel blocker that is efficacious in animal models of neuropathic pain. In humans, its effect in neuropathic pain is inconclusive, based on inconsistent results and very large placebo responses. Previous trials have not used patient stratification or looked for predictors for response. Methods This study will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 2, proof-of-concept, phenotype-stratified study. The study will enroll 108 patients with peripheral neuropathic pain who will be randomized to a 12-week treatment with lacosamide or placebo up to 400 mg/day in a 2:1 ratio. The primary objective is to compare the change in the mean value of the patients’ daily ratings of average pain intensity from baseline to the last week of treatment in patients with and without the irritable nociceptor phenotype in the per-protocol population. A supportive objective is to compare the effect of lacosamide with that of placebo in the two phenotypes. Secondary and tertiary outcomes include the Patient Global Impression of Change, pain relief, presence of 30% and 50% pain reduction, sleep disturbance, depression, and anxiety. Discussion We will examine the concept of individualized therapy based on phenotyping, and expect that this study will provide important information on the usefulness of lacosamide in the treatment of peripheral neuropathic pain. Trial registration ClinicalTrials.gov, NCT03777956. Registered on 18 December 2018.

Prospective Evaluation of Intra-Articular Dextrose Prolotherapy for Treatment of Osteoarthritis in Dogs

2017 ◽  
Vol 53 (3) ◽  
pp. 135-142 ◽  
Author(s):  
J. Matthew Sherwood ◽  
James K. Roush ◽  
Laura J. Armbrust ◽  
Walter C. Renberg
Keyword(s):  
Power Analysis ◽  
Brief Pain Inventory ◽  
Pain Severity ◽  
Prospective Evaluation ◽  
Inclusion Criteria ◽  
Double Blind ◽  
Future Studies ◽  
Treatment Groups ◽  
Prospective Pilot Study ◽  
Post Hoc

ABSTRACT The objective of this study was to evaluate intra-articular dextrose prolotherapy for osteoarthritis of the elbow or stifle in dogs in a randomized, double-blind, placebo-controlled, prospective pilot study. Seventeen dogs were evaluated with 10 meeting inclusion criteria for this study. Evaluations included orthopedic exam, visual lameness scoring, Canine Brief Pain Inventory (CBPI), goniometry, kinetic gait analysis, and radiography. Initial lameness score, age, body weight, duration of lameness, and CBPI scores did not differ between groups. Change in CBPI pain severity score in the prolotherapy group from wk 6–12 was significantly less improved than in the placebo group, with no other significant differences in pain severity or pain interference scores between groups. Range of motion and radiographic scores did not differ between groups at any time. Mean kinetic forces improved in prolotherapy dogs but were not significantly different between treatment groups at any time. Although easily performed and well-tolerated, there were no statistically significant benefits of dextrose prolotherapy for treatment of osteoarthritis of the elbow and stifle in dogs. Post hoc power analysis of these sample means and standard deviations found that 29–106 animals per group would be necessary to demonstrate significant differences in kinetic forces, providing useful guidance for future studies.

scholarly journals Efficacy and Safety of 0.625% and 1.25% Capsaicin Patch in Peripheral Neuropathic Pain: Multi-Center, Randomized, and Semi-Double Blind Controlled Study

2017 ◽  
Vol 2 (20;2) ◽  
pp. 27-35
Author(s):  
PyungBok Lee
Keyword(s):  
Neuropathic Pain ◽  
Peripheral Neuropathy ◽  
College Teaching ◽  
Small Sample ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
High Concentration ◽  
Double Blind ◽  
Peripheral Neuropathic Pain ◽  
Topical Capsaicin

Background: Topical capsaicin therapy may be of benefit in providing pain relief in patients with peripheral neuropathy. Objectives: To investigate the efficacy and safety of 0.625% (50 µg/cm2 ) and 1.25% (100 µg/cm2 ) capsaicin patches (CPs) compared to conventional 0.075% capsaicin cream or placebo patches in patients suffering from peripheral neuropathy. Study Design: Early Phase II, multi-center, randomized, semi-double-blind, and placebocontrolled clinical trial. Setting: Two medical college teaching hospitals. Methods: Sixty patients were randomized to the 0.625% CP, 1.25% CP, placebo-controlled patch, or 0.075% capsaicin cream. The primary efficacy endpoint was the mean difference in the change of daily numerical rating scale (NRS) pain score. Secondary endpoints included values for the Daily Sleep Interference Scale, the percentage of patients achieving a ≥ 30% or ≥ 50% reduction in pain, and data for Global Impression Change (GIC) and EQ-5D. Results: Patients treated with the 0.625% CP and 0.075% capsaicin cream showed statistically significant improvements in pain after 6-weeks of test drug application. Daily sleep disorder scores were improved only for those patients applying the 0.075% capsaicin cream. For patient-derived GIC scores, the majority (11 of 12) of patients in the 0.625% CP group reported that their pain was improved. For the safety evaluation, 2 severe adverse events were reported for the 0.075% capsaicin cream group only. Repetitive patch application was related to minor skin problems such as a burning sensation, erythema, pruritus, and vesicles in 28 patients (46.67%). Limitations: The small sample size and relatively high dropout rates. Conclusion: Our data indicate that the 0.625% CP may prove to be an effective and safe alternative with which to treat patients with peripheral neuropathy and could replace the high concentration (8%) CP. Further studies are now needed to definitively establish efficacy. Key words: Capsaicin, patch, CP, topical capsaicin, neuropathic pain, peripheral neuropathic pain, PNP, high concentration CP

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