The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial
Migraine prevention using different frequencies of transcutaneous occipital nerve stimulation: A randomized controlled trial.
This study's objective was to evaluate the efficacy and tolerability of transcutaneous occipital nerve stimulation (tONS) in patients with migraine, and to explore whether different tONS frequencies influenced treatment effectiveness. This was a randomized, controlled trial of tONS for prevention of migraine. Patients were randomized to 1 of 5 therapeutic groups before treatment for 1 month. ⋯ From baseline to the 1-month treatment period, the tONS group with 100 Hz and topiramate group exhibited significant decreases in headache duration. We conclude that tONS therapy is a new promising approach for migraine prevention. It has infrequent and mild adverse events and may be effective among patients who prefer nonpharmacological treatment.
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Randomized Controlled Trial
Minocycline prevents muscular pain hypersensitivity and cutaneous allodynia produced by repeated intramuscular injections of hypertonic saline in healthy human participants.
Minocycline, a glial suppressor, prevents behavioral hypersensitivities in animal models of peripheral nerve injury. However, clinical trials of minocycline in human studies have produced mixed results. This study addressed 2 questions: can repeated injections of hypertonic saline (HS) in humans induce persistent hypersensitivity? Can pretreatment with minocycline, a tetracycline antibiotic with microglial inhibitory effects, prevent the onset of hypersensitivity? Twenty-seven healthy participants took part in this double-blind, placebo-controlled study, consisting of 6 test sessions across 2 weeks. ⋯ Placebo-treated participants experienced a bilateral 35% alleviation in muscle soreness (P < .0001), with no changes to the prevalence of cold allodynia. In contrast, minocycline-treated participants experienced a bilateral 70% alleviation in muscle soreness (P < .0001), additionally, only 10% of minocycline-treated participants showed cold allodynia. This study showed that repeated injections of HS can induce a hypersensitivity that outlasts the acute response, and the development of this hypersensitivity can be reliably attenuated with minocycline pretreatment.
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Randomized Controlled Trial
Beliefs about pharmaceutical medicines and natural remedies explain individual variation in placebo analgesia.
This study examined whether placebo responses were predicted by a theoretical model of specific and general treatment beliefs. Using a randomized crossover, experimental design (168 healthy individuals) we assessed whether responses to a cold pressor task were influenced by 2 placebo creams described as pharmaceutical versus natural. We assessed whether placebo responses were predicted by pretreatment beliefs about the treatments (placebo) and by beliefs about the pain. ⋯ Treatment necessity beliefs also partially mediated the effects of helplessness on placebo responses. Treatment necessity beliefs for the pharmaceutical placebo were influenced by general pharmaceutical beliefs whereas necessity beliefs for the natural placebo were informed by general background beliefs about holistic treatments. Our findings show that treatment beliefs influence the placebo effect suggesting that they may offer an additional approach for understanding the placebo effect.
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Randomized Controlled Trial Comparative Study
Cost-utility of Group Acceptance and Commitment Therapy for Fibromyalgia versus recommended drugs: An economic analysis alongside a 6-month randomised controlled trial conducted in Spain (EFFIGACT study).
The aim of this study was to analyze the cost utility of a group-based form of acceptance and commitment therapy (GACT) in patients with fibromyalgia (FM) compared with patients receiving recommended pharmacological treatment (RPT) or on a waiting list (WL). The data were derived from a previously published study, a randomized controlled trial that focused on clinical outcomes. Health economic outcomes included health-related quality of life and health care use at baseline and at 6-month follow-up using the EuroQoL and the Client Service Receipt Inventory, respectively. ⋯ Lower direct costs for GACT compared with RPT were due to lower costs from primary care visits and FM-related medications. The incremental cost effectiveness ratios were dominant in the completers' analysis and remained robust in the sensitivity analyses. In conclusion, acceptance and commitment therapy appears to be a cost-effective treatment compared with RPT in patients with FM.
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Randomized Controlled Trial
Trajectory of Improvement in Children and Adolescents with Chronic Migraine: Results from the Cognitive Behavioral Therapy and Amitriptyline Trial.
We compared headache frequency trajectories between clinical trial participants who received cognitive-behavioral therapy (CBT) and amitriptyline (CBT+A) or headache education (HE) and amitriptyline (HE+A) to determine if there was a differential time course of treatment response between the groups. One hundred thirty-five patients (age 10-17 years) diagnosed with chronic migraine participated, attending 8 one-hour one-on-one CBT or HE sessions with a trained psychologist for 8 weekly sessions, 2 sessions at weeks 12 and 16, and a post-treatment visit at week 20. Participants kept daily headache diaries and completed take-home assignments between visits. ⋯ The CBT+A group had greater daily improvement than the HE+A group. A significantly greater proportion of the CBT+A group had a ≥50% reduction in headache days each month, and a significantly greater proportion of the CBT+A group had ≤4 headache days per month in months 3 through 5. Results indicate the trajectory of decrease in headache days is significantly better for patients receiving CBT+A versus HE+A.