scholarly journals Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin

2021 ◽  
Vol 24 (6) ◽  
pp. 453-463
Keyword(s):  
Neuropathic Pain ◽  
Treatment Options ◽  
High Concentration ◽  
Medical Outcomes ◽  
Open Label ◽  
Peripheral Neuropathic Pain ◽  
Patient Reported ◽  
Single Intervention ◽  
Outcomes Study ◽  
Eq Vas

BACKGROUND: Peripheral neuropathic pain (PNP) is a complex, subjective experience affecting both physical and psychological aspects of functioning. Assessing patient-reported outcomes (PROs) beyond pain relief is important and aligns with the recommendations of IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials). Moreover, PRO data are key to clinical decision-making when evaluating treatment options. However, direct comparisons between such options are scarce. High-concentration capsaicin 179 mg (8% w/w) cutaneous patch (HCCP) is applied to the skin at minimum intervals of 90 days under physician supervision; alternative recommended treatments for PNP are mostly orally administered on a daily basis. The ELEVATE study directly compared HCCP with pregabalin and found noninferior efficacy of HCCP to pregabalin in relieving pain after 8 weeks, with a significantly faster onset of action and fewer systemic side effects. OBJECTIVES: The objective of this analysis was to compare PRO outcomes defined as secondary objectives of the ELEVATE study after a single intervention with HCCP to daily oral pregabalin for 8 weeks. STUDY DESIGN: ELEVATE was an open-label, randomized (1:1) multicenter study. SETTING: The study included 92 sites in 22 countries in Europe and Asia. METHODS: Five hundred fifty-nine non-diabetic patients with PNP received a single intervention with HCCP (n = 282; 1-4 patches at baseline) or oral daily pregabalin (n = 277; 150-600 mg, 8 weeks). At baseline (Day 0) and Week 8, patients completed the following PROs in addition to the regular pain assessments: Patient Global Impression of Change (PGIC), Medical Outcomes Study Cognitive Functioning scale (MOS-Cog), Medical Outcomes Study Sleep scale (MOS-Sleep), Treatment Satisfaction Questionnaire for Medication (TSQM), and EuroQol 5-Dimensions 5-levels (EQ-5D-5L) Utility Index (EQ-UI) and Visual Analog Scale (EQ-VAS). RESULTS: At Week 8, 76% and 75.9% of patients on HCCP and pregabalin, respectively, reported to be very much/much/minimally improved on the PGIC. HCCP application was associated with significant improvements from baseline vs. pregabalin in MOS-Cog (mean difference: 4.28 [95% CI: 2.90-5.66]; P < 0.001), EQ-VAS (3.11 [0.30-5.92]; P = 0.030), and TSQM global satisfaction (6.74 [2.29-11.20]; P = 0.029), particularly the side-effects dimension (21.23 [17.55-24.94]; P < 0.0001). No significant differences in improvements were noted for the MOS-Sleep, TSQM convenience, and EQ-UI. LIMITATIONS: The ELEVATE study has an open-label design, with only one comparator (pregabalin); it was limited to 8 weeks. The sample size was determined for the primary endpoint. CONCLUSIONS: A single intervention with HCCP showed benefits vs. daily pregabalin at Week 8 on several PROs. While HCCP has been approved in the United States for PNP treatment in diabetic and PHN patients, these observations provide information on how patients perceive the effects of distinct PNP treatments. They are complementing already existing knowledge on efficacy and safety of different treatment options with data on patient preferences and may help identify the appropriate treatment option in dialogue with the patients and shared decision-making. IRB Approval: At the time of the study, the trial was approved either nationally or at site level. All approvals were granted prior to the initiation of the trial. A list of Ethics Committees that approved the trial is included as a supplemental file. Clinical Trial Registration Number: NCT01713426. KEY WORDS: Capsaicin; comparative study; ELEVATE study; neuropathic pain; pain; pain measurement; patient outcome assessment; pregabalin

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

Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain

2011 ◽  
Vol 93 (2) ◽  
pp. 187-197 ◽  
Author(s):  
Lynn R. Webster ◽  
John F. Peppin ◽  
Frederick T. Murphy ◽  
Biao Lu ◽  
Jeffrey K. Tobias ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Open Label ◽  
Peripheral Neuropathic Pain ◽  
Open Label Study ◽  
Label Study

scholarly journals Prevalence of Neuropathic Pain and Patient-Reported Outcomes in Korean Adults with Chronic Low Back Pain Resulting from Neuropathic Low Back Pain

2017 ◽  
Vol 11 (6) ◽  
pp. 917-927 ◽  
Author(s):  
Jin-Hwan Kim ◽  
Jae Taek Hong ◽  
Chong-Suh Lee ◽  
Keun-Su Kim ◽  
Kyung-Soo Suk ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Low Back Pain ◽  
Back Pain ◽  
Linear Regression ◽  
Chronic Low Back Pain ◽  
Patient Reported Outcomes ◽  
Functional Disability ◽  
Low Back ◽  
Patient Reported ◽  
Eq Vas

<sec><title>Study Design</title><p>A noninterventional, multicenter, cross-sectional study.</p></sec><sec><title>Purpose</title><p>We investigated the prevalence of neuropathic pain (NP) and patient-reported outcomes (PROs) of the quality of life (QoL) and functional disability in Korean adults with chronic low back pain (CLBP).</p></sec><sec><title>Overview of Literature</title><p>Among patients with CLBP, 20%–55% had NP.</p></sec><sec><title>Methods</title><p>Patients older than 20 years with CLBP lasting for longer than three months, with a visual analog scale (VAS) pain score higher than four, and with pain medications being used for at least four weeks before enrollment were recruited from 27 general hospitals between December 2014 and May 2015. Medical chart reviews were performed to collect demographic/clinical features and diagnosis of NP (douleur neuropathique 4, DN4). The QoL (EuroQoL 5-dimension, EQ-5D; EQ-VAS) and functional disability (Quebec Back Pain Disability Scale, QBPDS) were determined through patient surveys. Multiple linear regression analyses were performed to compare PROs between the NP (DN4≥4) and non-NP (DN4&lt;4) groups.</p></sec><sec><title>Results</title><p>A total of 1,200 patients (females: 65.7%; mean age: 63.4±13.0 years) were enrolled. The mean scores of EQ-5D, EQ-VAS, and QBPDS were 0.5±0.3, 55.7±19.4, and 40.4±21.1, respectively. Among all patients, 492 (41.0%; 95% confidence interval, 38.2%–43.8%) suffered from NP. The prevalence of NP was higher in male patients (46.8%; <italic>p</italic>&lt;0.01), in patients who had pain based on radiological and neurological findings (59.0%; <italic>p</italic>&lt;0.01), and in patients who had severe pain (49.0%; <italic>p</italic>&lt;0.01). There were significant mean differences in EQ-5D (NP group vs. non-NP group: 0.4±0.3 vs. 0.5±0.3; <italic>p</italic>&lt;0.01) and QBPDS (NP group vs. non-NP group: 45.8±21.2 vs. 36.3±20.2; <italic>p</italic>&lt;0.01) scores. In the multiple linear regression, patients with NP showed lower EQ-5D (β=−0.1; <italic>p</italic>&lt;0.01) and higher QBPDS (β=7.0; <italic>p</italic>&lt;0.01) scores than those without NP.</p></sec><sec><title>Conclusions</title><p>NP was highly prevalent in Korean patients with CLBP. Patients with CLBP having NP had a lower QoL and more severe dysfunction than those without NP. To enhance the QoL and functional status of patients with CLBP, this study highlights the importance of appropriately diagnosing and treating NP.</p></sec>

scholarly journals Evidence for Dietary Agmatine Sulfate Effectiveness in Neuropathies Associated with Painful Small Fiber Neuropathy. A Pilot Open-Label Consecutive Case Series Study

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 576 ◽  
Author(s):  
Michael L. Rosenberg ◽  
Vahid Tohidi ◽  
Karna Sherwood ◽  
Sujoy Gayen ◽  
Rosina Medel ◽  
...  
Keyword(s):  
Neuropathic Pain ◽  
Pain Intensity ◽  
Treatment Options ◽  
Case Series ◽  
Small Fiber Neuropathy ◽  
Consecutive Case ◽  
Open Label ◽  
Small Fiber ◽  
Case Series Study ◽  
Series Study

Peripheral neuropathies associated with painful small fiber neuropathy (SFN) are complex conditions, resistant to treatment with conventional medications. Previous clinical studies strongly support the use of dietary agmatine as a safe and effective treatment for neuropathic pain. Based on this evidence, we conducted an open-label consecutive case series study to evaluate the effectiveness of agmatine in neuropathies associated with painful SFN (Study Registry: ClinicalTrials.gov, System Identifier: NCT01524666). Participants diagnosed with painful SFN and autonomic dysfunctions were treated with 2.67 g/day agmatine sulfate (AgmaSet® capsules containing G-Agmatine® brand of agmatine sulfate) for a period of 2 months. Before the beginning (baseline) and at the end of the treatment period, participants answered the established 12-item neuropathic pain questionnaire specifically developed to distinguish symptoms associated with neuropathy and to quantify their severity. Secondary outcomes included other treatment options and a safety assessment. Twelve patients were recruited, and 11 patients—8 diagnosed with diabetic neuropathy, two with idiopathic neuropathy and one with inflammatory neuropathy—completed the study. All patients showed improvement in neuropathic pain to a varied extent. The average decrease in pain intensity was 26.0 rating points, corresponding to a 46.4% reduction in overall pain (p < 0.00001). The results suggest that dietary agmatine sulfate has a significant effect in reducing neuropathic pain intensity associated with painful SFN resistant to treatment with conventional neuropathic pain medications. Larger randomized placebo-controlled studies are expected to establish agmatine sulfate as a preferred treatment.

Investigating high-concentration 8% capsaicin patch in chronic cancer-treatment related peripheral neuropathic pain.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 208-208 ◽  
Author(s):  
Sabrina Ramnarine ◽  
Barry Laird ◽  
Linda J Williams ◽  
Marie T Fallon
Keyword(s):  
Neuropathic Pain ◽  
Cancer Treatment ◽  
Short Form ◽  
Depression Score ◽  
Post Treatment ◽  
Pain Severity ◽  
High Concentration ◽  
Peripheral Neuropathic Pain ◽  
Clinically Significant

208 Background: Cancer-treatment related peripheral neuropathic pain is a challenging clinical problem as current interventions have limited efficacy and significant toxicities. This study aims to examine the analgesic effect of high-concentration 8% capsaicin patch in this cohort of patients. Methods: A single arm study was conducted. Patients with long-term peripheral neuropathic pain received a single application of 8% transdermal capsaicin patch to the affected area (chest wall, hands or feet). Assessments at baseline, 4 weeks and 12 weeks post-treatment included: Brief Pain Inventory (BPI) short form (pain severity and interference with function); Hospital Anxiety and Depression Scale (HADS). The primary efficacy measure was a clinically significant improvement in pain (≥ 30% reduction in total BPI score (responders) from baseline to 4 weeks and 12 weeks). Secondary efficacy measures assessed worst pain, function and associated changes in mood. Results: 19 patients, median age 61.5 all had peripheral neuropathic pain for a median of 2 years (IQR 1-3) following treatment for various types of cancer: gynecological (n = 2), breast (n = 6), colorectal (n = 8), multiple myeloma (n = 2) or other (n = 1). At 4 weeks, 37% (7/19) patients showed a clinically significant improvement in pain (≥ 30%). Of the 7 responders, 5 had > 50% reduction in pain. 16% (3/19) suggested a partial improvement (mean 17%). Of the patients reassessed at 12 weeks, 50% (7/14) were responders with all patients exhibiting a reduction in: worst pain score, -1.3 (95% CI: -2.5, -0.06; p = 0.04), interference with function, -10.9 (95% CI: -21.5, -0.4; p = 0.04) and HADS depression score, -1.7 (95% CI: -3.4, 0.02; p = 0.05). Total HADS score correlated with total BPI at 4 weeks (r = 0.68) and 12 weeks (r = 0.70). HADS depression score also correlated with BPI at 12 weeks (r = 0.73). All correlations were significant (p < 0.01). Conclusions: In patients with chronic, resistant, cancer-treatment related peripheral neuropathic pain, high-concentration 8% capsaicin patch may provide some benefit in pain severity, function and mood with the effect continuing at 12 weeks post-treatment. This may warrant further long-term follow up in a larger cohort.

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