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A placebo-controlled trial of pregabalin and amitriptyline for treatment of painful diabetic peripheral neuropathy (PHrMA FDA 1008-040 2007)

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Authors PHrMA
Unpublished Information reported in a systematic review
Year

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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This reference is based in information provided by a systematic review reporting unpublished data obtained by the authors. This record has been prepared by collaborators of Epistemonikos. POPULATION: Diabetic polyneuropathy (n=169/256) INTERVENTION: Amitriptyline 75 mg (oral) (max daily dose) COMPARISON: Pregabalin

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Effect of coenzyme Q10 on mitochondrial respiratory proteins in trigeminal neuralgia.

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Journal Free radical research
Year 2018
Links Pubmed DOI

This article is included in 1 Systematic review Systematic reviews (1 reference)

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Trigeminal neuralgia (TN) is the neuropathic pain. Mitochondrial dysfunction, increased oxidative stress, and inflammation demonstrated in chronic pain. Carbamazepine (CBZ) is the first-line drug for TN, however, it is still insufficient. Coenzyme Q10 (CoQ10) has been used as the additional supplement for pain therapy. Nonetheless, mitochondrial respiratory proteins, oxidative stress, and inflammation in TN, and the add-on effects of CoQ10 on those defects have never been investigated. CBZ-treated TN-patients, naïve TN-patients, and control subjects were included. CBZ-treated TN-patients were randomised into two subgroups, received either CoQ10 or placebo for 2 months. Pain levels were evaluated, and peripheral blood mononuclear cells were isolated to determine the oxidative stress, mitochondrial oxidative phosphorylation (OXPHOS), peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), and cytokines including TNF-α, IL-1β and IL-18 mRNA expression. Pain scales, oxidative stress, and OXPHOS levels were greater in naïve TN-patients than control, whereas the cytokine profiles were unchanged. Although pain scales were lower in CBZ-treated TN-patients than in naïve TN-patients, oxidative stress, OXPHOS, and cytokine expression profiles were not different. PGC-1α levels found to be increased in CBZ-treated TN patients when compared with the naïve group. CoQ10 supplement in CBZ-treated TN patients reduced pain scale and oxidative stress and increased antioxidants levels when compared with placebo group. However, OXPHOS, PGC-1α, and cytokines were not different between groups. These findings suggest that increased oxidative stress could be potentially involved in the pathogenesis of TN. CoQ10 supplements can reduce oxidative stress, leading to more effective pain reduction in TN patients being treated with CBZ.

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Calcitonin as an Additive to Local Anesthetic and Steroid Injection Using a Modified Coronoid Approach in Trigeminal Neuralgia.

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Authors Elsheikh NA , Amr YM
Journal Pain physician
Year 2016
Links Pubmed

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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BACKGROUND: Pharmacotherapy is the main treatment for management of trigeminal neuralgia. However, many patients become refractory to drugs. OBJECTIVES: The present study aimed to evaluate the effect of adding calcitonin to local anesthetic and methylprednisolone using a modified coronoid approach in management of trigeminal neuralgia pain involving the mandibular and/or maxillary branches. STUDY DESIGN: Randomized double blind clinical trial. SETTING: Hospital outpatient setting. METHODS: Thirty-three patients received maxillary and mandibular blocks by a modified coronoid approach. Patients were allocated into 2 groups. Group 1 received a block with 3 mL of lidocaine 0.5% plus 40 mg of methylprednisolone and another syringe contained 1 mL of 0.9% saline. Group 2 received a block with 3 mL of lidocaine 0.5% plus 40 mg of methylprednisolone and another syringe contained 50 international units of calcitonin. Pain was evaluated by visual analog scale (VAS) before the block (basal), at 2 weeks, one month after the procedure, and monthly for one year. Duration of the effective pain relief of the first block (VAS = 3) was reported. Repeated blockade was allowed for any patient reporting a VAS > 30 mm during one year of follow-up and the number of blocks were reported. Adverse effects were also reported. RESULTS: A significantly longer duration of effective pain relief was noticed in group 2 compared with group 1 (P < 0.0004) while the duration of effective pain relief of the second block in group 1 was 28.5 ± 8.9 weeks. Four patients did not need repeated blocks in group 1 versus 15 in group 2. Six patients received 2 blocks versus 2 patients in each group, respectively. Moreover, 6 patients needed 3 blocks in group1 versus none in group 2. No serious adverse events were reported during or after the interventional procedure. VAS was comparable in both groups (P > 0.05). LIMITATIONS: Small sample size. CONCLUSION: Calcitonin may be a useful additive to local anesthetic and steroid in management of trigeminal neuralgia. Also, a modified coronoid approach for maxillary and mandibular nerve is simple, free of radiation, safe, and may be an effective percutaneous procedure in trigeminal neuralgia. KEY WORDS: Calcitonine, modifed, coronoid approach, trigeminal neuralgia.

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Efficacy of venlafaxine XR for the treatment of pain in patients with spinal cord injury and major depression: a randomized, controlled trial.

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Journal Archives of physical medicine and rehabilitation
Year 2015
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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OBJECTIVES: To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain. DESIGN: Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD. SETTING: Six Departments of Physical Medicine and Rehabilitation in university-based medical schools. PARTICIPANTS: Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain. INTERVENTION: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders. RESULTS: The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites. CONCLUSIONS: Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.

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Treatment of postmastectomy pain with ambulatory continuous paravertebral nerve blocks: a randomized, triple-masked, placebo-controlled study.

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Journal Regional anesthesia and pain medicine
Year 2014
Links Pubmed DOI PubMed Central

This article is included in 2 Systematic reviews Systematic reviews (2 references)

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<b>BACKGROUND: </b>We aimed to determine with this randomized, triple-masked, placebo-controlled study if benefits are afforded by adding a multiple-day, ambulatory, continuous ropivacaine paravertebral nerve block to a single-injection ropivacaine paravertebral block after mastectomy.<b>METHODS: </b>Preoperatively, 60 subjects undergoing unilateral (n = 24) or bilateral (n = 36) mastectomy received either unilateral or bilateral paravertebral perineural catheter(s), respectively, inserted between the third and fourth thoracic transverse process(es). All subjects received an initial bolus of ropivacaine 0.5% (15 mL) via the catheter(s). Subjects were randomized to receive either perineural ropivacaine 0.4% or normal saline using portable infusion pump(s) [5 mL/h basal; 300 mL reservoir(s)]. Subjects remained hospitalized for at least 1 night and were subsequently discharged home where the catheter(s) were removed on postoperative day (POD) 3. Subjects were contacted by telephone on PODs 1, 4, 8, and 28. The primary end point was average pain (scale, 0-10) queried on POD 1.<b>RESULTS: </b>Average pain queried on POD 1 for subjects receiving perineural ropivacaine (n = 30) was a median (interquartile) of 2 (0-3), compared with 4 (1-5) for subjects receiving saline (n = 30; 95% confidence interval difference in medians, -4.0 to -0.3; P = 0.021]. During this same period, subjects receiving ropivacaine experienced a lower severity of breakthrough pain (5 [3-6] vs 7 [5-8]; P = 0.046) as well. As a result, subjects receiving perineural ropivacaine experienced less pain-induced physical and emotional dysfunction, as measured with the Brief Pain Inventory (lower score = less dysfunction): 14 (4-37) versus 57 (8-67) for subjects receiving perineural saline (P = 0.012). For the subscale that measures the degree of interference of pain on 7 domains, such as general activity and relationships, subjects receiving perineural saline reported a median score 10 times higher (more dysfunction) than those receiving ropivacaine (3 [0-24] vs 33 [0-44]; P = 0.035). In contrast, after infusion discontinuation, there were no statistically significant differences detected between treatment groups.<b>CONCLUSIONS: </b>After mastectomy, adding a multiple-day, ambulatory, continuous ropivacaine infusion to a single-injection ropivacaine paravertebral nerve block results in improved analgesia and less functional deficit during the infusion. However, no benefits were identified after infusion discontinuation.

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Pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy: a randomized withdrawal trial.

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Journal The Clinical journal of pain
Year 2014
Links Pubmed DOI

This article is included in 1 Systematic review Systematic reviews (1 reference)

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<b>OBJECTIVES: </b>This study used a randomized withdrawal design to evaluate the efficacy of pregabalin versus placebo for pain relief in patients with painful diabetic peripheral neuropathy inadequately treated by other therapies.<b>METHODS: </b>A total of 665 patients received pregabalin in a 6-week single-blind phase. Two hundred ninety-four patients who achieved a ≥ 30% pain response were randomized to receive pregabalin or placebo in a double-blind phase for a further 13 weeks. The primary endpoint was the change in mean pain score from single-blind baseline to double-blind endpoint for pregabalin versus placebo (last observation carried forward [LOCF]). Secondary endpoints included a baseline observation carried forward (BOCF) analysis of mean pain score; time to loss of pain response; and other assessments of pain, sleep, function, and quality of life (QOL).<b>RESULTS: </b>Pregabalin numerically improved all measures assessed during the single-blind phase. At the end of the double-blind withdrawal phase, there was no significant difference in the primary endpoint of mean pain score (LOCF) between pregabalin and placebo (least squares mean difference, -0.32), although there was a significant difference in the BOCF analysis (least squares mean difference, -0.51). Pregabalin was associated with a significantly longer time to loss of pain response versus placebo during double-blind treatment, and some aspects of sleep and QOL also showed significant improvements with pregabalin.<b>DISCUSSION: </b>This is the first reported placebo-controlled trial of pregabalin in patients with inadequately treated painful diabetic peripheral neuropathy. Although the primary endpoint was not met, pregabalin was associated with clinically relevant improvements versus placebo in this difficult-to-treat population.

Primary study

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A Randomized, Double-Blind, Placebo-Controlled Trial of Duloxetine for the Treatment of Pain in Patients with Multiple Sclerosis.

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Journal Pain practice : the official journal of World Institute of Pain
Year 2014
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Background Patients with multiple sclerosis ( MS) often report neuropathic pain ( NP- MS). The purpose of this study was to assess the efficacy and tolerability of duloxetine as treatment for NP- MS. Methods In this study, 239 adults with NP- MS (duloxetine = 118, placebo = 121) were randomized to duloxetine 60 mg (30 mg for 1 week, then 60 mg for 5 weeks) or placebo once daily for a 6-week acute therapy phase, followed by a 12-week open-label extension phase (duloxetine 30 to 120 mg/day). Eligible patients had MS for ≥ 1 year and a score ≥ 4 on daily average pain intensity ( API) ratings for ≥ 4 of 7 days immediately before randomization. Patients rated API daily on an 11-point numeric scale (0 [no pain] to 10 [worst possible pain]) in an electronic diary. The primary efficacy measure, change in weekly API ratings, was analyzed longitudinally with a mixed-model repeated-measures analysis. Completion, reasons for discontinuation, and treatment-emergent adverse event incidence were compared by Fisher's exact test. Results Duloxetine-treated patients had statistically greater mean improvement in API vs. placebo at Week 6 (−1.83 vs. −1.07, P = 0.001). Treatment completion did not significantly differ between groups. Discontinuation due to adverse events was statistically greater for duloxetine vs. placebo (13.6% vs. 4.1%, P = 0.012). Decreased appetite was reported significantly more often by duloxetine-treated patients (5.9% vs. 0%, P = 0.007). Conclusions This study found analgesic efficacy of duloxetine for NP- MS. Duloxetine is not approved for treatment of this condition. The duloxetine safety profile of this study was consistent with the known profile in other patient populations.

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Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: observation of therapeutic effect from a randomized, double-blind, placebo-controlled trial.

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Authors Zhang H , Lian Y , Ma Y , Chen Y , He C , Xie N , Wu C
Journal The journal of headache and pain
Year 2014
Links Pubmed DOI PubMed Central

This article is included in 11 Systematic reviews Systematic reviews (11 references)

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BACKGROUND: In the majority of cases, trigeminal neuralgia (TN) is a unilateral condition with ultra-short stabbing pain located along one or more branches of the trigeminal nerve. Although prophylactic pharmacological treatment is first choise, considering of insufficient effect or unacceptable side effects, neurosurgical treatment or lesion treatment should be considered. In addition to all these procedures mentioned above, one approach has been based on local intradermal and/or submucosal injections of Botulinum Toxin Type A (BTX-A). METHODS: We conducted a randomized, double-blind, placebo-controlled since November 2012, and adopted local multi-point injection in 84 cases of classical TN with different doses of BTX-A. Eighty four patients were randomized into following groups: placebo (n = 28); BTX-A 25U (n = 27); BTX-A 75U (n = 29). Follow-up visits were conducted every week after the injection, and the overall duration of the study for each patient were 8 weeks to observe the pain severity, efficacy and adverse reactions at endpoint. RESULTS: The visual analogue scale (VAS) scores of 25U and 75U groups reduced significantly compared to placebo as early as week 1, and sustained until week 8 throughout the study. There was no significant difference in VAS between 25U and 75U groups throughout the study. The response rates of 25U group (70.4%) and 75U group (86.2%) were significantly higher than placebo group (32.1%) at week 8, and there was no significant difference between 25U and 75U groups. Evaluation of the Patient Global Impression of Change (PGIC) demonstrated that 66.7% (25U group) and 75.9% (75U group) of the patients reported that their pain symptoms were 'much improved' or 'very much improved' versus 32.1% of the placebo group, and there was also no significant difference between 25U and 75U groups. All adverse reactions were graded as mild or moderate. CONCLUSIONS: BTX-A injection in TN is safe and efficient. It is a useful treatment for refractory TN. Lower dose (25U) and high dose (75U) were similar in efficacy in short-term.

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Efficacy and Safety of Carisbamate in Patients with Diabetic Neuropathy or Postherpetic Neuralgia: Results from 3 Randomized, Double-Blind Placebo-Controlled Trials.

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Journal Pain practice : the official journal of World Institute of Pain
Year 2014
Links Pubmed DOI

This article is included in 1 Systematic review Systematic reviews (1 reference)

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The results of 3 proof-of-concept studies to evaluate carisbamate's efficacy and safety in treating neuropathic pain are presented. In studies 1 (postherpetic neuralgia, n = 91) and 2 (diabetic neuropathy, n = 137), patients received carisbamate 400 mg/day or placebo for 4 weeks and then crossed over to the other treatment for 4 weeks. In study 3 (diabetic neuropathy, higher carisbamate doses), patients (n = 386) were randomized (1:1:1:1) to receive either carisbamate 800 mg/day, 1200 mg/day, pregabalin 300 mg/day or placebo for 15 weeks. Primary efficacy end point was the mean of the last 7 average daily pain scores obtained on days the study drug was taken, for all 3 studies. Least square mean (95% CI) differences between carisbamate and placebo groups on the primary end point were as follows: study 1: -0.512 (-1.32, 0.29) carisbamate 400 mg/day; study 2: -0.307 (-0.94, 0.33) carisbamate 400 mg/day; and study 3: -0.51 (-1.10, 0.08), carisbamate 800 mg/day; -0.55 (-1.13, 0.04), carisbamate 1200 mg/day; and -0.43 (-1.01, 0.15), pregabalin 300 mg/day. Neither carisbamate (all 3 studies) nor pregabalin (study 3) significantly differed from placebo, although multiple secondary end points showed significant improvement in efficacy with carisbamate in studies 1 and 2. Dizziness was the only treatment-emergent adverse event occurring at ≥10% difference in carisbamate groups versus placebo (study 1: 12% vs. 1%; study 3: 14% vs. 4%; study 2: 1% vs. 2%). Carisbamate, although well tolerated, did not demonstrate efficacy in neuropathic pain across these studies, nor did the active comparator pregabalin (study 3).

Primary study

Unclassified

Duloxetine: an effective drug for the treatment of trigeminal neuralgia

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Journal Res J Pharm Biol Chem Sci
Year 2014

This article is included in 1 Systematic review Systematic reviews (1 reference)

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