scholarly journals Single-Blind Placebo-Controlled Response Test with Phenytoin 10% Cream in Neuropathic Pain Patients

2018 ◽  
Vol 11 (4) ◽  
pp. 122 ◽  
Author(s):  
David Kopsky ◽  
Jan Keppel Hesselink

Background: Phenytoin cream applied topically has been explored in neuropathic pain conditions. In several case series, phenytoin 5% and 10% cream could reduce pain in a clinically relevant way with a fast onset of action within 30 min, and with positive effects on sleep. Objective: To evaluate a single-blind placebo-controlled response test (SIBRET) for use in clinical practice. Materials and Methods: Patients with localized neuropathic pain, having an equal pain intensity in at least 2 areas (e.g., both feet), and a pain intensity of at least 4 on the 11-point numerical rating scale (NRS), were selected to perform the SIBRET. In one area, placebo cream consisting of the base cream was applied, and on the other area, phenytoin 10% cream was applied with separate hands to avoid contamination. Responders were defined as patients who experienced within 30 min at least 2-points difference as scored on the NRS, between the phenytoin 10% and the placebo cream applied areas, in favor of the former. Responders were subsequently prescribed phenytoin 10% cream. Results: Of the 21 patients, 15 patients (71.45%) were classified as responders. The mean pain reduction after 30 min as measured with the NRS in the phenytoin 10% cream area was 3.3 (SD: 1.3) and in the placebo cream area 1.2 (SD: 1.1). The difference of the mean percentage pain reduction between phenytoin 10% cream and placebo cream was 33.2% (SD: 17.6, p < 0.001). Using a 50% reduction on the NRS as a full response criterion, we could identify 57.1% of responders on phenytoin 10% cream and only 9.5% responders on placebo cream. Conclusions: The SIBRET helps patients and clinicians to quickly identify the appropriate treatment and can thus be seen as an important contributor to the domain of personalized medicine in pain. These results can also be regarded as a proof of principle for the analgesic activity of 10% phenytoin cream.

2018 ◽  
Vol 18 (4) ◽  
pp. 747-753
Author(s):  
Olav Rohof ◽  
Chee Kean Chen

AbstractBackground and aimsThe evidence for interventional treatment of thoracic facet joint pain remains limited. This is partly due to inconsistency of the path of thoracic medial branches and a lower incidence of thoracic facet pain among spine pain patients. The purpose of this study is to evaluate the efficacy of bipolar radiofrequency (RF) neurotomy of medial branches for treating chronic thoracic facet joint pain.MethodsThis is a retrospective record review of all patients diagnosed to have thoracic facet pain with diagnostic block and subsequently treated with bipolar RF neurotomy of medial branch between January 2012 and December 2015. The outcome measures were mean changes in Numeral Rating Scale (NRS) and Pain Disability Index (PDI).ResultsThere were 71 patients with complete data available for analysis. The mean age of the patients was 57.9±11.2 years. The mean duration of pain was 23±10.5 months. The majority of patients (82%) had pain reduction of more than 50% at 12 months after bipolar RF neurotomy. The NRS decreased significantly from baseline of 7.75±1.25 to 2.86±1.53 at 3 months and 2.82±1.29 at 12 months post-procedure (p<0.001.p<0.001, respectively). The PDI improved significantly from 40.92±12.22 to 24.15±9.79,p<0.05). There were no serious adverse effects or complications of the procedure reported in this study.ConclusionsBipolar RF neurotomy of thoracic medial branch is associated with a significant reduction in thoracic facet joint pain. The promising findings from this case series merit further assessment with prospective, randomized controlled trial which will produce a more reliable and accurate finding for its clinical applications.


Medicina ◽  
2020 ◽  
Vol 56 (12) ◽  
pp. 684
Author(s):  
Satoshi Baba ◽  
Ryutaro Shiboi ◽  
Jyunichi Yokosuka ◽  
Yasushi Oshima ◽  
Yuichi Takano ◽  
...  

Background and Objectives: Ossification of the ligamentum flavum (OLF) is a relatively common cause of thoracic myelopathy. Surgical treatment is recommended for patients with myelopathy. Generally, open posterior decompression, with or without fusion, is selected to treat OLF. We performed minimally invasive posterior decompression using a microendoscope and investigated the efficacy of this approach in treating limited type of thoracic OLF. Materials and Methods: Microendoscopic posterior decompression was performed for 19 patients (15 men and four women) with thoracic OLF with myelopathy aged between 35 to 81 years (mean age, 61.9 years). Neurological examination and preoperative magnetic resonance imaging (MRI) and computed tomography (CT) were used to identify the location and morphology of OLF. The surgery was performed using a midline approach or a unilateral paramedian approach depending on whether the surgeon used a combination of a tubular retractor and endoscope. The numerical rating scale (NRS) and modified Japanese Orthopedic Association (mJOA) scores were compared pre- and postoperatively. Perioperative complications and the presence of other spine surgeries before and after thoracic OLF surgery were also investigated. Results: Four midline and 15 unilateral paramedian approaches were performed. The average operative time per level was 99 min, with minor blood loss. Nine patients had a history of cervical or lumbar spine surgery before or after thoracic spine surgery. The mean pre- and postoperative NRS scores were 6.6 and 5.3, respectively. The mean recovery rate as per the mJOA score was 33.1% (mean follow-up period, 17.8 months), the recovery rates were significantly different between patients who underwent thoracic spine surgery alone (50.5%) and patients who underwent additional spine surgeries (13.7%). Regarding adverse events, one patient experienced dural tear, another experienced postoperative hematoma, and one other underwent reoperation for adjacent thoracic stenosis. Conclusion: Microendoscopic posterior decompression was applicable in limited type of thoracic OLF surgery including beak-shaped type and multi vertebral levels. However, whole spine evaluation is important to avoid missing other combined stenoses that may affect outcomes.


2007 ◽  
Vol 35 (7) ◽  
pp. 1180-1187 ◽  
Author(s):  
Brian D. Shannon ◽  
James S. Keene

Background Medial subluxation of the patella is a rare, disabling condition that has iatrogenic and traumatic causation. To date, only open reconstructions have been reported for operative treatment of this condition, but these procedures have a high rate of complications, revisions, and subsequent surgery. This is the first study to present the results of arthroscopic medial retinacular release for treatment of this problem. Hypothesis Arthroscopic release will alleviate painful medial patellar subluxation. Study Design Case series; Level of evidence, 4. Methods Nine knees (7 patients) with painful, recurrent medial subluxation of the patella that occurred spontaneously (2 knees) or after a lateral release (5 knees) or an injury (2 knees) were treated with an arthroscopic medial retinacular release. The retinaculum was released 2 cm medial to the superior pole of the patella down to the anteromedial portal. At a mean follow-up of 2.7 years (range, 1-8 years), all knees were evaluated, and the results were graded according to the Merchant and Mercer rating scale. Results The mean age of the patients was 25 years (range, 15-38 years), and the mean duration of the subluxations before surgery was 28 months (range, 6-48 months). In all 7 patients (9 knees), the medial release relieved their medial subluxation and knee pain, and there were 6 excellent and 3 good results. There were no complications or further realignment surgery needed after this procedure. Conclusion An arthroscopic medial retinacular release will successfully treat painful medial subluxation of the patella.


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.


Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 576 ◽  
Author(s):  
Michael L. Rosenberg ◽  
Vahid Tohidi ◽  
Karna Sherwood ◽  
Sujoy Gayen ◽  
Rosina Medel ◽  
...  

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.


2017 ◽  
Vol 2017 ◽  
pp. 1-17 ◽  
Author(s):  
Stanley K. H. Lam ◽  
Kenneth Dean Reeves ◽  
An-Lin Cheng

Deep nerve hydrodissection uses fluid injection under pressure to purposely separate nerves from areas of suspected fascial compression, which are increasingly viewed as potential perpetuating factors in recalcitrant neuropathic pain/complex regional pain. The usage of 5% dextrose water (D5W) as a primary injectate for hydrodissection, with or without low dose anesthetic, could limit anesthetic-related toxicity. An analgesic effect of 5% dextrose water (D5W) upon perineural injection in patients with chronic neuropathic pain has recently been described. Here we describe ultrasound-guided methods for hydrodissection of deep nerve structures in the upper torso, including the stellate ganglion, brachial plexus, cervical nerve roots, and paravertebral spaces. We retrospectively reviewed the outcomes of 100 hydrodissection treatments in 26 consecutive cases with a neuropathic pain duration of 16±12.2 months and the mean Numeric Pain Rating Scale (NPRS) 0–10 pain level of 8.3±1.3. The mean percentage of analgesia during each treatment session involving D5W injection without anesthetic was 88.1%  ±  9.8%. The pretreatment Numeric Pain Rating Scale score of 8.3±1.3 improved to 1.9±0.9 at 2 months after the last treatment. Patients received 3.8±2.6 treatments over 9.7±7.8 months from the first treatment to the 2-month posttreatment follow-up. Pain improvement exceeded 50% in all cases and 75% in half. Our results confirm the analgesic effect of D5W injection and suggest that hydrodissection using D5W provides cumulative pain reduction.


2012 ◽  
Vol 3 (3) ◽  
pp. 197-197 ◽  
Author(s):  
Marianne Rørbæk ◽  
Lise Ventzel ◽  
Hanne Gottrup

Abstract Background Neuropathic pain is usually treated with antidepressants and anticonvulsant. The use of systemic treatment is, however, limited due to poor tolerability and low efficacy. Qutenza, a topical capsaicin patch (8%), is a relatively new treatment for patients with peripheral neuropathic pain (PNP) conditions. The indication for using topical capsaicin treatment is peripheral neuropathic pain in patients without diabetes. Aim To describe the use of topical capsaicin treatment in a pain clinic in patients with PNP. Methods Case series of patients in a neuropathic pain clinic. Results Since October 2010, 40 patients with PNP with different aetiologies have been treated with topical capsaicin; 14 patients had nerve injuries in feet or lower leg or polyneuropathy, 13 patients had nerve lesions related to fingers, hands or arms, seven patients had pain after thoracotomy, four patients postherpetic neuralgia, and two patients had other lesions. Almost half of the patients (47%) were responders and achieved a decrease in pain intensity as well as increased their quality of life (QoL). Responders received 1–6 treatments with capsaicin. Most responders were found in the post-thoracotomy group, of which 86% had a clinical significant reduction in pain. In the group with injuries to the hands, fingers and arms, 46% experienced a reduction in pain. Only 23% of patients with PNP in the feet and lower leg were responders; these patients had a clinical significant increase in QoL. Conclusion In 40 patients with PNP who were treated with topical capsaicin, we found an increase in QoL and a decrease in mean pain intensity of 3 measured on a VAS scale (0–10) in 47% of the treated patients.


2013 ◽  
Vol 71 (10) ◽  
pp. 757-762 ◽  
Author(s):  
Thiago Cardoso Vale ◽  
Paulo Caramelli ◽  
Francisco Cardoso

Objective To report the clinical and neuroimaging findings in a case series of vascular parkinsonism (VP). Methods Seventeen patients with VP were evaluated with motor, cognitive, and neuroimaging standardized tests and scales. Results All patients had arterial hypertension. Ten patients were male and the mean age of the whole sample was 75.8±10.1 years. The mean age of parkinsonism onset was 72.2±10.0 years. Common clinical features were urinary incontinence (88.2%), lower limb parkinsonism with freezing of gait and falls (82.3%), and pyramidal signs (76.4%). The mean Unified Parkinson’s Disease Rating Scale (UPDRS) and Hoehn-Yahr scores were 72.5±21.6 points and 3.3±0.9 points, respectively. Sixteen (94.1%) patients had freezing of gait and executive dysfunction. Twelve (70.5%) patients had probable vascular dementia. The mean dose of levodopa was 530.9 mg/day. Unresponsiveness to the drug was confirmed by a 6.9 mean point reduction in the UPDRS score after the “practically defined off” test. Conclusion This series provides a profile of VP with predominant lower-limb involvement, freezing of gait and falls, pyramidal signs, executive dysfunction, concomitant vascular dementia, and poor levodopa response.


2014 ◽  
Vol 5 (2) ◽  
pp. 63-71 ◽  
Author(s):  
Heinrich Wernze ◽  
Thomas Herdegen

AbstractObjectiveNo single drug is broadly efficacious in the long-term treatment of fibromyalgia syndrome (FMS). Spironolactone is known to ameliorate mood and tension headache or migraine in women with premenstrual syndrome or clinical signs of hyperandrogenism. In a case series of women with treatment resistant FMS spironolactone was therefore added to their medication, and they were observed for at least 12 months.Methods31 women with treatment-resistant FMS received spironolactone as add-on medication to various pain modulating drugs. 15 women responded to spironolactone and baseline data were compared with assessments over 12–14 months on treatment with spironolactone (ALDACTONE®) in dose range 100–200 mg/day. The efficacy was evaluated by the fibromyalgia impact questionnaire (FIQ) total score and 8 FIQ subtests, a German mood inventory (BSKE-EWL), and further assessments of changes in relevant psychological and physical complaints. 16 women had no effect and stopped the treatment early.ResultsThe subsequent data refer to the 15 responders. The FIQ total score (maximal score = 80) decreased from 56.6 ± 10.0 at baseline to 17.1 ± 11.9 (mean ± SD) 12–14 months later, and pain intensity on an 11 point numeric rating scale (NRS) decreased from 8.8 ± 1.6 to 2.6 ± 1.9 (mean ± SD). Similar changes in FIQ subscores were found for fatigue, morning tiredness, stiffness, anxiety, and depression. Emotional functioning consistently improved: positive mood from 20.0 ± 5.4 to 37.7 ± 5.4 (maximal score = 48), and negative mood from 35.4 ± 5.3 to 10.0 ± 4.4 (maximal score = 60) (each mean ± SD) as well as other mental and physical dysfunctions including non-restorative sleep. All these changes at 4–6 weeks remained on this level for 11–13 months. The drug was well-tolerated and safe, no serious adverse effects were observed. Regular monitoring of serum potassium did not reveal hyperkalemia. All 15 women were able to reduce or discontinue concomitant drugs.ConclusionFifteen of 31 women with otherwise treatment-resistant FMS experienced a number of prolonged beneficial effects from spironolactone on their complex pain-condition.Implications and discussionWe hypothesise that spironolactone affects several central and peripheral neurotransmitter systems such as γ-aminobutyric acid (GABA) activity and dopaminergic transmission. The high rate of non-responsive patients underlines that FMS may represent several subgroups. Pain relief and improvement of associated FHS-symptoms and positive effects on additional diseases or dysfunctions give reasons for marked and sustained improvement in the quality of life.Well-controlled, double-blind, and randomised trials are necessary to confirm our potentially very important observations.


Author(s):  
D. E. Moulin ◽  
D. Palma ◽  
C. Watling ◽  
V. Schulz

ABSTRACT:Objective:To evaluate the role of methadone in the management of intractable neuropathic noncancer pain.Methods:A case series of 50 consecutive noncancer pain patients who were seen at a tertiary care centre and treated with oral methadone for a variety of intractable neuropathic pain states.Results:The mean age was 52.7 years and the mean duration of follow-up was 13.9 months. Post-discectomy nerve root fibrosis, complex regional pain syndrome, peripheral neuropathy and central spinal cord pain syndromes were the most common diagnoses. Over 90% had been treated with one or more tricyclic antidepressants and anticonvulsants and a similar number had received other adjuvant analgesics. All patients had failed treatment with one or more conventional opioid analgesics (mean 2.8) at a mean maximal morphine dose of 384 mg (or equivalents) per day. Twelve patients had failed spinal cord stimulation. Nineteen patients (38%) did not tolerate initial methadone titration or thought their pain was worse on methadone. Five patients (10%) declared initial benefit but required repetitive dose escalation and eventually became non-responders. Twenty-six patients (52%) reported mild (4), moderate (15), marked (6) or complete (1) pain relief and continued on methadone at a mean maintenance dose of 159.8 mg/day for a mean duration of 21.3 months. Fourteen patients (28%) reported improved function on methadone relative to previous treatments.Conclusions:Methadone appears to have unique properties including N-methyl-D-aspartate antagonist activity that may make it especially useful in the management of intractable neuropathic pain. This observation needs to be tested in randomized, controlled trials.


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