Pain
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Randomized Controlled Trial
Emotional awareness and expression therapy, cognitive-behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial.
Patients with fibromyalgia (FM) experience increased lifetime levels of psychosocial adversity, trauma, and emotional conflict. To address these risk factors, we developed emotion awareness and expression therapy (EAET) and tested its benefits against an active control condition, FM education, and the field's gold standard intervention for FM, cognitive behavioral therapy (CBT) for symptom management. Adults with FM (N = 230) formed 40 treatment groups, which were randomized to EAET, CBT, or education and given 8, 90-minute sessions. ⋯ Emotional awareness and expression therapy did not differ from CBT on the primary or most secondary outcomes, but compared to CBT, EAET led to significantly lower FM symptoms (d = 0.35) and widespread pain (d = 0.37) and a higher percentage of patients achieving 50% pain reduction (22.5% vs 8.3%). In summary, an intervention targeting emotional awareness and expression related to psychosocial adversity and conflict was well received, more effective than a basic educational intervention, and had some advantages over CBT on pain. We conclude that EAET should be considered as an additional treatment option for FM.
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Randomized Controlled Trial
Placebo effects of a sham opioid solution: a randomized controlled study in patients with chronic low back pain.
This study tested the experimental placebo effect in a group of chronic pain patients. Forty-eight patients having chronic back pain participated in a randomized clinical trial that tested the efficacy of a sham opioid solution (NaCl) compared with an alleged neutral, completely inactive solution (NaCl). We shaped the placebo effect by 2 interventions: verbal instruction and conditioning. ⋯ The inactive solution (NaCl), when presented as an effective treatment (sham "opioid" solution), induced placebo analgesia as evident in lower ratings of the patients' clinical back pain (F(3.12,144.21) = 25.05, P < 0.001), acute pain ratings (F(1.99,87.40) = 18.12, P < 0.01), and time needed to complete a series of daily activities exercises (F(1,44) = 8.51, P < 0.01) as well as increased functional capacity (F(1,44.00) = 19.42, P < 0.001). The 2 manipulations (instruction and conditioning) changed pain expectations, and they were maintained in both sham opioid groups. The results suggest that it may be clinically useful to explicitly integrate placebo analgesia responses into pain management.
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Randomized Controlled Trial
Longitudinal change in parent and child functioning after internet-delivered cognitive-behavioral therapy for chronic pain.
Theoretical models of pediatric chronic pain propose longitudinal associations between children's pain experiences and parent and family factors. A large body of cross-sectional research supports these models, demonstrating that greater parent distress and maladaptive parenting behaviors are associated with greater child disability. Family-based cognitive-behavioral therapy interventions have been developed for youth with chronic pain which aim to improve child disability and reduce maladaptive parenting behaviors. ⋯ These findings indicate that parent distress may increase the risk of poor response to psychological pain treatment among youth with chronic pain. At present, parent distress is not routinely targeted in psychological interventions for pediatric chronic pain. Research is needed to determine optimal strategies for targeting parent and family factors in the treatment of pediatric chronic pain.
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of neublastin in painful lumbosacral radiculopathy: a randomized, double-blinded, placebo-controlled phase 2 trial using Bayesian adaptive design (the SPRINT trial).
Neublastin (BG00010) is a first-in-class, glial cell-derived neurotrophic factor shown in preclinical studies and an early clinical trial to have potential for the treatment of neuropathic pain. SPRINT was a phase 2, multicenter, double-blinded, placebo-controlled study to evaluate efficacy/safety of 5 neublastin doses (50, 150, 400, 800, and 1200 μg/kg) administered as an intravenous injection 3 times/week for 1 week in patients with chronic painful lumbosacral radiculopathy, utilizing Bayesian response-adaptive study design. Primary endpoint was change from baseline in mean 24-hour average general pain intensity over a 5-day period (week 1) after the last dose, analyzed using a Bayesian normal dynamic linear model. ⋯ The most common adverse event in all neublastin dose groups was pruritus (79% vs 10% with placebo). There was no dose-response relationship with respect to primary/secondary efficacy outcomes or incidence of pruritus, despite dose-proportional increases in serum neublastin concentrations. In conclusion, while this study showed some evidence of pain relief with neublastin, particularly at the lowest dose, there was no clear dose-response relationship for pain reduction or the most common adverse event of pruritus.
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Randomized Controlled Trial
Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial.
Chronic low back pain (LBP) is a common condition, usually with the involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first phase II, randomized, double-blind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate-to-severe chronic LBP with and without neuropathic pain component. ⋯ Those patients reaching the target doses had an acceptable tolerability profile. The incidence rate of most frequently reported treatment-emergent adverse events during maintenance phase was ≤10%. Although further optimizing the titration scheme to the optimal dose for individual patients is essential, cebranopadol is a new drug candidate with a novel mechanistic approach for potential chronic LBP treatment.