scholarly journals Gabapentin versus Transdermal Fentanyl Matrix for the Alleviation of Chronic Neuropathic Pain of Radicular Origin: A Randomized Blind Multicentered Parallel-Group Noninferiority Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-9
Author(s):  
Chang Ju Hwang ◽  
Jae Hyup Lee ◽  
Jung-Hoon Kim ◽  
Sang Hyuk Min ◽  
Kun-Woo Park ◽  
...  

A number of studies have been published proposing various approaches to the treatment of neuropathic pain; however, to our knowledge, no attempts have been made to compare gabapentin and fentanyl in patients with lumbar radiculopathy. We evaluated the relative efficacy and safety of fentanyl matrix and gabapentin for the treatment of chronic neuropathic pain of radicular origin. The study was designed as a randomized blind multicentered parallel-group noninferiority trial. A total of 108 patients with moderate-to-severe pain (≥4 intensity on an 11-point numeric rating scale) were randomly prescribed either fentanyl matrix or gabapentin over a period of 56 days. In the primary analysis, the noninferiority of fentanyl matrix treatment was evaluated in relation to the efficacy of gabapentin based on the pain intensity difference (PID) at 56 days after the first dose of the drugs. Secondary endpoints included pain relief, improvement in functional status (the Korean-Oswestry Disability Index (K-ODI)), improvement in depressive symptoms (Korean-Beck Depression Index (K-BDI)) between the 28th and 56th day, and adverse events (AEs). Analysis of the primary efficacy endpoint established the noninferiority of fentanyl matrix compared with gabapentin, with no statistically significant difference observed in the PID after 56 days for the two treatment groups. Similarly, analysis of pain relief revealed no significant differences between the groups on days 28 and 56. There was no difference in the K-ODI and K-BDI between the groups during the study period. The overall incidence of at least one AE was similar for fentanyl matrix (67.3%) and gabapentin (69.6%). The most commonly reported AEs for patients treated with fentanyl matrix and gabapentin included dizziness (30.8% vs. 44.6%, respectively), somnolence (26.9% vs. 35.7%), and constipation (15.4% vs. 17.9%). This study demonstrated that the analgesic effect of fentanyl matrix is noninferior in comparison with gabapentin and supports the use of fentanyl matrix as an effective and safe treatment for moderate-to-severe chronic neuropathic pain. This trial is registered with NCT01127100.

2017 ◽  
Vol 3 (1) ◽  
pp. 4-15
Author(s):  
Byung-chul Son ◽  
Jin-gyu Choi ◽  
Sang-woo Ha ◽  
Deog-ryeong Kim

Objective Although deep brain stimulation (DBS) and motor cortex stimulation (MCS) are effective in patients with refractory neuropathic pain, their application is still empirical; there is no consensus on which technique is better. Methods To enhance the success rate of trial stimulation of invasive neuromodulation techniques and identify approapriate stimulation targets in individual patients, we performed a simultaneous trial of thalamic ventralis caudalis (Vc) DBS and MCS in 11 patients with chronic neuropathic pain and assessed the results of the trial stimulation and long-term analgesia. Results Of the 11 patients implanted with both DBS and MCS electrodes, nine (81.8%) had successful trials. Seven of these nine patients (77.8%) responded to MCS, and two (18.2%) responded to Vc DBS. With long-term follow-up (56 ± 27.5 months), the mean numerical rating scale decreased significantly (P < 0.05). The degree of percentage pain relief in the chronic MCS (n = 7) and chronic DBS (n = 2) groups were 34.1% ± 18.2% and 37.5%, respectively, and there was no significant difference (P = 0.807). Five out of the seven MCS patients (71%) and both DBS patients had long-term success with the treatments, defined as >30% pain relief compared with baseline. Conclusions With simultaneous trial of DBS and MCS, we could enhance the success rate of invasive trials. Considering the initial success rate and the less invasive nature of epidural MCS over DBS, we suggest that MCS may be a better, initial means of treatment in chronic intractable neuropathic pain. Further investigations including other subcortical target-associated medial pain pathways are warranted.


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Wei Zhou ◽  
Ruxue Lei ◽  
Chuanyi Zuo ◽  
Yunqing Yue ◽  
Qin Luo ◽  
...  

The aim of this study was to determine whether variation of temperature during moxibustion would generate division of analgesic effect. The moxibustion with different temperatures (37°C, 42°C, 47°C, and 52°C) was applied to ST36 acupoint for 30 minutes in chronic inflammatory or neuropathic pain mice. The analgesic effect was evaluated by thermal hyperalgesia test in chronic inflammatory pain and by mechanical allodynia in neuropathic pain, respectively. The results indicated that interventions of moxibustion with different temperature caused different analgesic effect on either chronic inflammatory induced by injection of complete Freund’s adjuvant (CFA) or neuropathic pain induced by spared nerve injury (SNI). In chronic inflammatory pain, different moxibustion temperature generated different intensity of analgesic effect: the higher the better. In chronic neuropathic pain, stronger analgesic effect was found in moxibustion with temperature 47°C or 52°C other than 37°C and 42°C. However, there is no significant difference displayed between moxibustion temperatures 47°C and 52°C or 37°C and 42°C. It implies that the temperature should be taken into account for moxibustion treatment to chronic inflammatory or neuropathic pain.


2019 ◽  
Vol 44 (6) ◽  
pp. 637-645 ◽  
Author(s):  
Christopher Gilmore ◽  
Brian Ilfeld ◽  
Joshua Rosenow ◽  
Sean Li ◽  
Mehul Desai ◽  
...  

Background and objectivesChronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting fine-wire coiled peripheral nerve stimulation (PNS) leads in proximity to the sciatic and femoral nerves for postamputation pain. A multicenter, double-blinded, randomized, placebo-controlled study collected data on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain following amputation.MethodsTwenty-eight lower extremity amputees with postamputation pain were enrolled. Subjects underwent ultrasound-guided implantation of percutaneous PNS leads and were randomized to receive PNS or placebo for 4 weeks. The placebo group then crossed over and all subjects received PNS for four additional weeks. The primary efficacy endpoint evaluated the proportion of subjects reporting ≥50% pain reduction during weeks 1–4.ResultsA significantly greater proportion of subjects receiving PNS (n=7/12, 58%, p=0.037) demonstrated ≥50% reductions in average postamputation pain during weeks 1–4 compared with subjects receiving placebo (n=2/14, 14%). Two subjects were excluded from efficacy analysis due to eligibility changes. Significantly greater proportions of PNS subjects also reported ≥50% reductions in pain (n=8/12, 67%, p=0.014) and pain interference (n=8/10, 80%, p=0.003) after 8 weeks of therapy compared with subjects receiving placebo (pain: n=2/14, 14%; pain interference: n=2/13, 15%). Prospective follow-up is ongoing; four of five PNS subjects who have completed 12-month follow-up to date reported ≥50% pain relief.ConclusionsThis work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain.Trial registration numberNCT01996254.


2018 ◽  
Vol 5 (1) ◽  
pp. 23 ◽  
Author(s):  
Vincent Bounes, MD ◽  
Jean Louis Ducassé, MD ◽  
Annie Momo Bona, MD ◽  
Florent Battefort, MD ◽  
Charles-Henri Houze-Cerfon, MD ◽  
...  

Objective: To evaluate the efficacy and safety of inhaled morphine delivered in patients experiencing severe acute pain in an emergency setting.Patients and Methods: Patients were eligible for inclusion if they were aged 18 years or older, with a severe acute pain defined by a numerical rating scale (NRS) score of 60/100 or higher. The intervention involved administering a single dose of 0.2 mg/kg morphine nebulized using a Misty-Neb nebulizer system. NRSs were recorded and were repeated at 1, 3, 5, and 10 minute after the end of inhalation (T10). The protocol-defined primary outcome measure was pain relief (defined by an NRS score of 30/100 or lower) at T10. Secondary outcomes included differences between pain scores at baseline and at T10 and incidence of adverse events.Results: A total of 28 patients were included in this study. No patient experienced pain relief 10 minutes after the end of inhalation, and no adverse effects were recorded. Respective initial and final median NRS scores were 80 (70-90) and 70 (60-80), p < 0.0001. Despite achieving statistical significance, the value of this point estimate is less than the 14 NRS difference that was defined a priori as representing a minimum clinically significant difference in pain severity.Conclusion: 0.2 mg/kg nebulized morphine is not effective in managing acute pain in an emergency setting. In spite of the potential advantages of the pulmonary route of administration, opioids should be intravenous prescribed at short fixed intervals to control severe acute pain in an emergency setting.


2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
D. Koethe ◽  
L. Kranaster ◽  
M. Hellmich ◽  
B.M. Nolden ◽  
J. Klosterkoetter

The outcome in treatment of schizophrenia is still not satisfactorily, and using the adjunctive administration of various anticonvulsant drugs adjunctive to antipsychotics has become widely distributed. This study determines the efficacy of oxcarbazepine combined to olanzapine in treatment of schizophrenia in a double-blind, randomized, placebo-controlled, parallel-group, add-on therapy, 7 week study in 54 patients suffering schizophreniform disorder or schizophrenia. Patients were randomized to oxcarbazepine or placebo and titrated up to 1800 mg/ day in week 1 and maintained at that dose for another 6 weeks. Treatment of olanzapine started at week 2 with 5 mg/day. According to weekly improvement in Brief Psychiatric Rating Scale (BPRS), olanzapine dose was maintained constant or escalated in regular steps of 2.5 mg. Main outcome measure was the cumulative olanzapine dose from beginning administration of oxcarbazepine/placebo for a period of 42 days. Comparing treatment of oxcarbazepine and olanzapine with placebo and olanzapine, there was no difference in cumulative olanzapine doses in both groups. in the oxcarbazepine group was not significantly more rescue medication given. A mixed regression model was used to assess time trends in BPRS over the treatment period: the differences in the rate of change of BPRS in the two treatment groups suggested that the scores sank more rapidly in the oxcarbazepine group (p=0.063). Mean post-treatment aggression score also showed no significant difference. Results from this study do not support the use of OXC as an adjunct to atypical antipsychotics in patients with schizophrenia.


2021 ◽  
Vol 41 (1) ◽  
Author(s):  
Kenichi Serizawa ◽  
Haruna Tomizawa-Shinohara ◽  
Shota Miyake ◽  
Kenji Yogo ◽  
Yoshihiro Matsumoto

Abstract Background Neuropathic pain in neuroimmunological disorders refers to pain caused by a lesion or disease of the somatosensory system such as multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD). MS and NMOSD are autoimmune disorders of the central nervous system, and ≥ 50% of patients with these disorders experience chronic neuropathic pain. The currently available medications for the management of neuropathic pain have limited effectiveness in patients with MS and NMOSD, and there is an unmet medical need to identify novel therapies for the management of chronic neuropathic pain in these patients. In this review article, we summarize the role of interleukin-6 (IL-6) in the pathogenesis of MS and NMOSD and the ameliorative effects of anti–IL-6 therapies in mouse models of experimental autoimmune encephalomyelitis (EAE). Main body Intraperitoneal injection of MR16-1, an anti–IL-6 receptor (IL-6R) antibody, reduced mechanical allodynia and spontaneous pain in EAE mice, which was attributed to a reduction in microglial activation and inhibition of the descending pain inhibitory system. The effect of anti–IL-6 therapies in ameliorating neuropathic pain in the clinical setting is controversial; a reduction in pain intensity has been reported with an anti–IL-6 antibody in four studies, namely a case report, a pilot study, a retrospective observational study, and a case series. Pain intensity was evaluated using a numerical rating scale (NRS), with a lower score indicating lesser pain. A reduction in the NRS score was reported in all four studies. However, in two randomized controlled trials of another anti–IL-6R antibody, the change in the visual analog scale pain score was not statistically significantly different when compared with placebo. This was attributed to the low mean pain score at baseline in both the trials and the concomitant use of medications for pain in one of the trials, which may have masked the effects of the anti–IL-6R antibody on neuropathic pain. Conclusion Thus, anti–IL-6 therapies might have a potential to reduce neuropathic pain, but further investigations are warranted to clarify the effect of inhibition of IL-6 signaling on neuropathic pain associated with MS and NMOSD.


2017 ◽  
Vol 12 (2) ◽  
pp. 212-217
Author(s):  
Roy Januardi Irawan

Pencak Silat is a martial art that has a risk of causing micro-trauma due to physical impact. This trauma will stimulate the secretion of prostaglandin, a compound in the body which is a mediator of pain and inflammatory response that promote pain in bruised trauma. Passion fruit contains high level of anti-inflammatory and antioxidant substances. The objective of this study was to understand the effectiveness of passion fruit juice consumption in reducing bruised trauma pain in Pencak Silat athletes of PSHT Belotan Magetan. The research design is a quantitative descriptive with quasi-experimental. The pretest and posttest group of 20 people PSHT Belotan Magetan Pencak Silat athletes with an average age of 13.4 0.94 years were divided into treatment group (K1) and control group (K0) with 10 subjects respectively. Each treatment group (K1) subject was given the juice twice a day for 10 consecutive days. We used paired sample T-test to assess the mean variance of the group. The result showed that there was a decrease of pain intensity in both the treatment group and the control group. The pain intensity difference assessed by a Bourbonnais Rating Scale in the treatment group showed a significant difference with the t value of 7,216 and a probability value of 0,000, while the control group showed t value of 3,000 and probability value of 0,015. There was a decrease in the athletes muscle soreness who were given passion fruit juice twice a day for 10 days. The athletes pain intensity was in middle category.


2021 ◽  
Vol 0 ◽  
pp. 1-3
Author(s):  
Anand Murugesan ◽  
M. S. Raghuraman

Pleural leiomyosarcomas are rare soft-tissue sarcomas. Neuropathic pain associated with such tumours can be quite debilitating. We present the case of a 62-year-old woman with chronic neuropathic pain refractory to pharmacologic interventions in association with recurrent pleural leiomyosarcoma. Pulsed radio-frequency of the stellate ganglion was performed after due consideration and planning as a palliative measure to provide pain relief. The patient was discharged the same day with pain score 0/10 and followed up for 3 years. The unique features of this case report are: (1) Different approach of the treatment modality and (2) longer follow-up.


Cephalalgia ◽  
1999 ◽  
Vol 19 (6) ◽  
pp. 581-588 ◽  

Two-hundred-and-seventy-eight patients with acute migraine attacks with or without aura were treated in 17 centers with 1.8 g lysine acetylsalicylate i.v. (Aspisol®;=1 g acetylsalicylic acid), 6 mg sumatriptan s.c. or placebo using a double-blind, double-dummy, randomized, multicenter parallel group study design. Two-hundred-and-seventy-five of them fulfilled the criteria for efficacy analysis, corresponding to 119 patients treated with lysine acetylsalicylate (L-ASA), 114 with sumatriptan and 42 with placebo injections. Both treatments were highly effective compared to placebo ( p <0.0001) in decreasing headache from severe or moderate to mild or none (verbal rating scale, VRS, placebo=23.8%). Sumatriptan showed a significantly ( p=0.001) better response (91.2%) compared to L-ASA (response 73.9%). Of the patients in the L-ASA-group, 43.7% were pain-free after 2 h; 76.3% after sumatriptan and 14.3% after placebo. It took patients on average 12.6 (L-ASA), 8.2 (sumatriptan), and 19.4 h (placebo) to be able to work again. There was no significant difference between treatment groups in recurrence of headache in responders within 24 h (18.2% L-ASA, 23.1% sumatriptan, 20% placebo). Accompanying symptoms (nausea, vomiting, photophobia, phonophobia, and visual disturbances) improved with both verum treatments to a similar extent. L-ASA was significantly better tolerated than sumatriptan (adverse events L-ASA 7.6%, sumatriptan 37.8%). In conclusion, subcutaneous sumatriptan and lysine acetylsalicylate i.v. are effective treatments for patients suffering from migraine attacks. Sumatriptan is more effective, but resulted in more adverse events.


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