Pain
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Randomized Controlled Trial Multicenter Study
Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy.
A length-dependent neuropathy with pain in the feet is a common complication of diabetes (painful diabetic neuropathy). It was hypothesized that pain may arise from sensitized-hyperactive cutaneous nociceptors, and that this abnormal signaling may be reduced by topical administration of the α(2)-adrenergic agonist, clonidine, to the painful area. This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. ⋯ In subjects with a capsaicin pain rating ⩾2 (0-10, NPRS), the mean decrease in foot pain was 2.6 for active compared to 1.4 for placebo (P=0.01). Topical clonidine gel significantly reduces the level of foot pain in painful diabetic neuropathy subjects with functional (and possibly sensitized) nociceptors in the affected skin as revealed by testing with topical capsaicin. Screening for cutaneous nociceptor function may help distinguish candidates for topical therapy for neuropathic pain.
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Randomized Controlled Trial Multicenter Study
Acupuncture in patients with acute low back pain: a multicentre randomised controlled clinical trial.
Reviews of the efficacy of acupuncture as a treatment for acute low back pain have concluded that there is insufficient evidence for its efficacy and that more research is needed to evaluate it. A multicentre randomized controlled trial was conducted at 4 primary-care centres in Spain to evaluate the effects of acupuncture in patients with acute nonspecific low back pain in the context of primary care. A total of 275 patients with nonspecific acute low back pain (diagnosed by their general practitioner) were recruited and assigned randomly to 4 different groups: conventional treatment either alone or complemented by 5 sessions over a 2-week period of true acupuncture, sham acupuncture, or placebo acupuncture per patient. ⋯ The primary outcome was the reduction in Roland Morris Disability Questionnaire scores of 35% or more after 2weeks' treatment. The patients in the 3 types of acupuncture groups were blinded to the treatments, but those who received conventional treatment alone were not. In the analysis adjusted for the total sample (true acupuncture relative risk 5.04, 95% confidence interval 2.24-11.32; sham acupuncture relative risk 5.02, 95% confidence interval 2.26-11.16; placebo acupuncture relative risk 2.57 95% confidence interval 1.21-5.46), as well as for the subsample of occupationally active patients, all 3 modalities of acupuncture were better than conventional treatment alone, but there was no difference among the 3 acupuncture modalities, which implies that true acupuncture is not better than sham or placebo acupuncture.
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Randomized Controlled Trial
The efficacy of acupuncture in human pain models: a randomized, controlled, double-blinded study.
Acupuncture is frequently used to treat pain, although data supporting the analgesic efficacy from placebo-controlled studies is sparse. In order to get evidence for acupuncture analgesia we performed a study with 2 well-recognized experimental human pain models - the cold-pressor (CP) test and intradermal capsaicin injection. Fifty healthy men were included. ⋯ In addition, there was no placebo response. Attitude towards acupuncture and partial unblinding did not affect the results. We conclude that acupuncture on predefined points has a minor effect on experimental pain in healthy subjects.
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The effect of PF-04457845, a potent and selective fatty acid amide hydrolase-1 (FAAH1) inhibitor, on pain due to osteoarthritis of the knee was investigated in a randomised placebo and active-controlled clinical trial. The trial involved 2 periods (separated by a 2-week washout) consisting of a 1-week wash-in phase followed by 2weeks double-blind treatment. Patients received single-blind placebo throughout the wash-in and washout periods. ⋯ PF-04457845 was well tolerated in osteoarthritis patients, and there was no evidence of cannabinoid-type adverse events. The lack of analgesic effect of FAAH1 inhibition in humans is in contrast to data from animal models. This apparent disconnect between species needs further study.