Pain
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Randomized Controlled Trial Clinical Trial
Transdermal clonidine compared to placebo in painful diabetic neuropathy using a two-stage 'enriched enrollment' design.
Because a variety of mechanisms may generate pain in neuropathic pain syndromes, conventional clinical trial methods may fail to identify some potentially useful drugs; a drug affecting just a single mechanism may work in too few patients to yield a statistically significant result for the trial. To test a previous clinical observation that approximately one-quarter of patients with painful diabetic neuropathy appear responsive to clonidine, we conducted a formal clinical trial of transdermal clonidine in painful diabetic neuropathy patients using a 2-stage enriched enrollment design. In the first stage (study 1), 41 patients with painful diabetic neuropathy completed a randomized, 3-period crossover comparison of transdermal clonidine (titrated from 0.1 to 0.3 mg/day) to placebo patches. ⋯ In study II, however, the 12 apparent responders from study I had 20% less pain with clonidine than placebo (95% confidence interval (CI): 4-35% pain reduction; P = 0.015), confirming that their pain was responsive to clonidine. None of the 3 consistent clonidine responders who were tested with the alpha-adrenergic blocker phentolamine had relief of pain, suggesting that clonidine's pain relief is not mediated by a decrease in sympathetic outflow. A post-hoc analysis of many variables suggested that patients who described their pain as sharp and shooting may have a greater likelihood of responding to clonidine.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Comparative Study Clinical Trial
The hypoalgesic effect of imipramine in different human experimental pain models.
In a randomized, placebo-controlled, double-blind, cross-over study, the hypoalgesic effect of a single oral dose of 100 mg imipramine was investigated in 12 healthy volunteers. Test procedures performed before, 3, 6, and 9 h after medication included determination of (1) pain detection and tolerance thresholds to heat and pressure; (2) the thresholds of quadriceps femoris muscle withdrawal reflex to single and repeated electric stimulation of the sural nerve; (3) amplitude of the reflex evoked by 1.5 times the premedication reflex threshold; and (4) continuous pain rating during the cold pressor test. Imipramine significantly increased pain tolerance thresholds to heat (P = 0.03) and pressure (P = 0.01), and both the psychophysical pain tolerance threshold and the reflex threshold to single electric stimulation (P = 0.02 and P = 0.03, respectively). ⋯ Pain detection thresholds to heat and pressure, the amplitude of the reflex to single suprathreshold stimulation, and pain ratings during the cold pressor test were unaltered by imipramine. It is concluded that imipramine has a differential hypoalgesic effect on different human experimental pain tests. This provides new possibilities of assessing the differential effect of different tricyclic antidepressants on different pain modalities and intensities.
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Randomized Controlled Trial Clinical Trial
Pre-emptive lumbar epidural anaesthesia reduces postoperative pain and patient-controlled morphine consumption after lower abdominal surgery.
The present study tested the hypothesis that patients receiving epidural bupivacaine before surgery would require less morphine postoperatively and/or report less intense pain than patients receiving epidural bupivacaine after incision but before the end of surgery. Forty-two patients (ASA class I-III) scheduled for lower abdominal surgery were randomly assigned to 1 of 2 groups of equal size and prospectively studied using a double-blind, placebo-controlled crossover design. Epidural catheters were placed in the T12-L1 or L1-L2 interspaces pre-operatively, the position of the catheter was confirmed with 3% chloroprocaine with epinephrine 1:200,000, and sensory testing was carried out until levels had receded to below T12. ⋯ Postoperative analgesia consisted of patient-controlled (PCA) intravenous morphine. Visual analogue pain scores (VAS) (at rest and after standardized mobilization) did not differ significantly between the 2 groups but McGill Pain Questionnaire (MPQ) pain ratings were significantly lower in group 1 at the 24 and 72 h assessments. Group 1 used significantly less morphine than did group 2 between 12 and 24 h after surgery.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Comparative Study Clinical Trial
Reduction of temporalis exteroceptive suppression by peripheral electrical stimulation in migraine and tension-type headaches.
Inhibition of the second exteroceptive suppression of temporalis muscle activity (ES2) produced by a preceding electrical stimulus applied at the index was studied in patients suffering from migraine without aura (MO), chronic (CTH) or episodic (ETH) tension-type headache. Each patient group comprised of 12 subjects was compared to a group of healthy controls. Mean duration of unconditioned ES2, measured on 10 averaged rectified responses after labial stimulation at a 0.1 Hz frequency, was reduced in CTH only. ⋯ Among 9 ETH patients with normal (> or = 32 msec) unconditioned ES2, 5 had total disappearance of ES2 after a 20 mA index stimulation. These results demonstrate that peripheral conditioning at 20 mA increases the diagnostic sensitivity of ES2 studies. They suggest that the changes observed in tension-type headache are due to hyperexcitability of the reticular nuclei which inhibit the medullary inhibitory interneurons mediating ES2.
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Randomized Controlled Trial Clinical Trial
Brief group cognitive-behavioral intervention for temporomandibular disorders.
Temporomandibular disorders (TMD) are currently viewed as an interrelated set of clinical conditions presenting with signs and symptoms in masticatory and related muscles of the head and neck, and the soft tissue and bony components of the temporomandibular joint. Epidemiologic and clinical studies of TMD confirm its status as a chronic pain problem. In this report we present results from a randomized clinical trial which compared, at 3- and 12-month follow-ups, the effects of usual TMD treatment on TMD pain and related physical and psychological variables with the effects of a cognitive-behavioral (CB) intervention delivered to small groups of patients before usual TMD treatment began. ⋯ Such effects were not observed for depression, somatization, or clinical measures of jaw range of motion. Additionally, as hypothesized, dysfunctional chronic pain patients did not appear to benefit from the brief CB intervention. Intent to treat analyses were also performed to assess generalizability of the results.