The journal of pain : official journal of the American Pain Society
-
Randomized Controlled Trial Multicenter Study
Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial.
The efficacy and tolerability of oral lacosamide (200, 400, and 600 mg/day) was evaluated in patients with painful diabetic neuropathy in a double-blind, randomized, placebo-controlled trial. The primary target dose to be confirmed was lacosamide 400 mg/day. Efficacy was assessed by changes in pain scale scores from baseline, with changes over the last 4 weeks of the 12-week maintenance period regarded as the primary endpoint. Endpoint reductions in mean pain score were higher with all doses of lacosamide, reaching the level of significance with 400 mg/day (P = .05). Over the treatment period (titration + maintenance), pain relief was significantly higher than placebo with lacosamide 400 (P = .02) and 600 mg/day (P = .03). Lacosamide had an early-onset effect with significant reductions over placebo during the titration period. Nonparametric and mixed-model analysis approaches gave similar results, supporting significant efficacy at 400 mg/day. Secondary criteria such as Patient's Global Impression of Change, responder rates, and pain-free days provided additional support. Adverse events included dizziness, nausea, and headache. Incidence of cognitive and behavioral adverse events was low. This trial suggests that lacosamide has beneficial effects and may be a suitable treatment option for patients with diabetic neuropathic pain. ⋯ This study presents efficacy and safety results of a phase 3, double-blind, placebo-controlled trial of the anticonvulsant drug lacosamide in patients with painful diabetic neuropathy. Lacosamide treatment at a dose of 400 mg/day reduced diabetic neuropathic pain with a favorable safety and tolerability profile that may be suitable for patients with diabetes.
-
Randomized Controlled Trial
L2 spinal nerve-block effects on acute low back pain from osteoporotic vertebral fracture.
Elderly patients with osteoporosis sometimes experience lumbar vertebral fracture and may feel diffuse nonlocalized pain in the back, the lateral portion of the trunk, and the area surrounding the iliac crest. The pattern of sensory innervation of vertebral bodies remains unclear. Some sensory nerves from the L2 and L5 vertebral bodies may enter the paravertebral sympathetic trunks and reach the L2 dorsal root ganglion. Our randomized controlled study was to clarify the effect of L2 spinal nerve block on low back pain originating from acute osteoporotic lumbar vertebral fracture. Patients with low back pain originating from acute L3 or L4 osteoporotic vertebral fractures received a spinal nerve root block (L2 block group, n = 30) or subcutaneous injection (control, n = 30). Both groups received 1.5 mL of 1% lidocaine. The visual analog scale score, Roland Morris Disability Questionnaire, and Short Form questionnaire were examined before and after treatment. In both groups, spinal nerve blocks were significantly effective in alleviating low back pain (P < .05). One hour, 1 week, and 2 weeks after treatment, the visual analog scale score improved more in the L2 block group than in the control group (P < .05). From 1 month to 4 months after treatment, there were no significant differences in the pain scores between groups (P > .05). We conclude that L2 spinal nerve block for acute L3 or L4 osteoporotic vertebral body fracture was effective for 2 weeks, but it had no long-term effects on pain and social function. ⋯ L2 spinal nerve block treatment for L3 or L4 osteoporotic vertebral body fracture was effective. This results suggest that the L2 dorsal root ganglion may innervate the L3 and L4 vertebral bodies in humans. L2 spinal nerve block for lumbar osteoporotic vertebral fracture may be a useful strategy to treat acute low back pain.
-
Randomized Controlled Trial
Effects of intramuscular anesthesia on the expression of primary and referred pain induced by intramuscular injection of hypertonic saline.
Intramuscular injection of hypertonic saline produces pain in the belly of the injected muscle (primary pain) and, often, pain that projects distally (referred pain). While it is known that referred pain can be induced during complete sensory block of the distal site, there is little evidence as to whether the perception of referred pain depends on ongoing input from the primary stimulus. We assessed whether blocking the noxious input following the induction of pain blocks the primary but not the referred pain. A cannula was inserted into the tibialis anterior muscle in 15 subjects (8 male, 7 female). In a quasi-random crossover design conducted over 2 experimental sessions, each subject received a bolus intramuscular injection of .5 mL of 5% hypertonic saline, followed 90 seconds later by either: A) A second bolus injection or; B) An injection of 2 mL lignocaine through the same cannula. Protocol A was followed 60 seconds later by either a sham injection or an injection of lignocaine, while protocol B was followed 60 seconds later by either a sham injection or an injection of hypertonic saline. Subjects mapped the areas of primary and referred pain, and rated the intensities at these sites every 30 seconds until the cessation of pain. In all subjects, the area and intensity of primary pain rapidly disappeared within 7.5 minutes of intramuscular lignocaine injection (P < .02 relative to the nonanesthesia condition). With the exception of 2 subjects, in whom the referred pain continued in the absence of primary pain, the referred pain declined in parallel with local pain: the mean total pain intensity declined by 74% in both regions. We conclude that the maintenance of referred muscle pain usually depends on ongoing noxious inputs from the site of primary muscle pain. ⋯ Referred pain is a significant clinical problem, and commonly occurs with pain originating in muscle but not from skin. It is important to know the primary source of the pain so that treatment can be directed to this site rather to the site of referral.
-
Randomized Controlled Trial
An investigation of the hypoalgesic effects of TENS delivered by a glove electrode.
This randomized, placebo-controlled, blinded study investigated the hypoalgesic effects of high-frequency transcutaneous electrical nerve stimulation (TENS) delivered via a glove electrode compared with standard self-adhesive electrodes. Fifty-six TENS-naïve, healthy individuals (18 to 50 years old; 28 men, 28 women) were randomly allocated to 1 of 4 groups (n = 14 per group): glove electrode; placebo TENS using a glove electrode; standard electrode; and no treatment control. Active TENS (continuous stimulus, 100 Hz, strong but comfortable intensity) was applied to the dominant forearm/hand for 30 minutes. Placebo TENS was applied using a burst stimulus, 100-Hz frequency, 5-second cycle time for 42 seconds, after which the current amplitude was automatically reset to 0 mA. Pressure pain thresholds (PPTs) were recorded from 3 points on the dominant and nondominant upper limbs before and after TENS. Statistical analyses of dominant PPT data using between-within groups ANOVA showed significant differences between groups at all 3 recording points (P = .01). Post hoc Scheffe tests indicated no significant difference between the standard electrode and glove electrode groups. There was a significant hypoalgesic effect in the standard electrode group compared with the control group and between the glove electrode group and both the control and placebo TENS groups. There was no significant interactive effect between time and group at any of the recording points (P > .05). ⋯ This study presents a comparison of the hypoalgesic effects of 2 different types of TENS electrode, a novel glove electrode and standard self-adhesive rectangular electrodes. The glove electrode provides a larger contact area with the skin, thereby stimulating a greater number of nerve fibers. The results show that both electrodes have similar hypoalgesic effects and therefore give the clinician another choice in electrode.
-
Randomized Controlled Trial Multicenter Study
A randomized, double-blind, placebo-controlled trial of a selective COX-2 inhibitor, GW406381, in patients with postherpetic neuralgia.
In this randomized, double-blind, placebo-controlled study, we evaluated the efficacy and safety of GW406381, an investigational selective cyclooxygenase (COX)-2 inhibitor with both peripheral and central actions, in 209 patients with postherpetic neuralgia (PHN). Patients were randomly assigned to GW406381 25 mg or 50 mg or placebo treatments for 3 weeks. The primary efficacy outcome measure was the change in average daily pain intensity score from baseline to the last week of treatment. Both doses of GW406381 produced greater reduction in pain score than placebo, but the treatment difference did not reach statistical significance. It was possible that the 3-week duration was too short, as there was a tendency for increasing separation from placebo over time that did not appear to reach maximum effect by the end of the study for either GW406381 treatment group. Overall, GW406381 was well tolerated in this elderly population. ⋯ To our knowledge, this is the first report of a randomized, controlled clinical trial of a selective or nonselective COX inhibitor in neuropathic pain. The results of this study were inconclusive regarding the clinical relevance of the role of COX-2 in modulation of the symptoms of PHN.