Pain
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Multicenter Study
Frequency, Impact, and Predictors of Persistent Pain Following Root Canal Treatment: A National Dental PBRN Study.
Root canal treatment (RCT) is commonly performed surgery and persistent pain is known to occur, but little is known about how these patients are affected by this pain. Although biopsychosocial mechanisms are thought to be associated with the development of such pain, similar to persistent pain after surgery in other body sites, little is known about the baseline predictors for persistent pain. We assessed the frequency of persistent pain 6 months after RCT, measured the impact this pain had on patients, and determined predictive factors for persistent tooth pain in a multicenter prospective cohort study conducted within the National Dental Practice-Based Research Network. ⋯ After adjusting for the type of dental practitioner and patient age, gender, and household income, pain duration over the week before RCT significantly increased the risk of developing persistent pain (odds ratio = 1.19 per 1 day increase in pain duration, 95% confidence interval: 1.07-1.33), whereas optimism about the procedure reduced the risk (odds ratio = 0.39, 95% confidence interval: 0.22-0.67). Our data suggest that persistent pain 6 months after RCT is fairly common, but generally does not have a large impact on those experiencing it. Furthermore, patient age and gender did not predict persistent pain, whereas preoperative pain duration and the patient's expectation did.
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Randomized Controlled Trial Multicenter Study
A phase 3, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ERTM in patients with moderate-to-severe chronic low back pain.
Opioid analgesics are commonly used for the treatment of chronic low back pain (CLBP); however, abuse potential is a major concern. This study used a randomized, double-blind, placebo-controlled, enriched-enrollment randomized-withdrawal study design to evaluate the safety, tolerability, and analgesic efficacy of an abuse-deterrent formulation of extended-release oxycodone, Xtampza ER, in opioid-naive and opioid-experienced adults with moderate-to-severe CLBP. Patients entered an open-label titration phase (N = 740); those who were successfully titrated on Xtampza ER (≥40 to ≤160 mg oxycodone hydrochloride equivalent per day) were randomized to active drug (N = 193) or placebo (N = 196) for 12 weeks. ⋯ There was less rescue medication (acetaminophen) use in the Xtampza ER treatment group than in the placebo group. Xtampza ER had an adverse event profile consistent with other opioids and was well tolerated; no new safety concerns were identified. In conclusion, Xtampza ER resulted in clinically and statistically significant efficacy in patients with CLBP.
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Randomized Controlled Trial Multicenter Study Comparative Study
Randomized, Double-Blind, Comparative-Effectiveness Study Comparing Pulsed Radiofrequency to Steroid Injections for Occipital Neuralgia or Migraine with Occipital Nerve Tenderness.
Occipital neuralgia (ON) is characterized by lancinating pain and tenderness overlying the occipital nerves. Both steroid injections and pulsed radiofrequency (PRF) are used to treat ON, but few clinical trials have evaluated efficacy, and no study has compared treatments. We performed a multicenter, randomized, double-blind, comparative-effectiveness study in 81 participants with ON or migraine with occipital nerve tenderness whose aim was to determine which treatment is superior. ⋯ Comparable benefits favoring PRF were obtained for worst occipital pain through 3 months (mean change from baseline -1.925 ± 3.204 vs -0.541 ± 2.644; P = 0.043), and average overall headache pain through 6 weeks (mean change from baseline -2.738 ± 2.753 vs -1.120 ± 2.1; P = 0.037). Adverse events were similar between groups, and few significant differences were noted for nonpain outcomes. We conclude that although PRF can provide greater pain relief for ON and migraine with occipital nerve tenderness than steroid injections, the superior analgesia may not be accompanied by comparable improvement on other outcome measures.
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Self-compassion is the ability to respond to one's failures, shortcomings, and difficulties with kindness and openness rather than criticism. This study, which might be regarded as a proof-of-concept study, aimed to establish whether self-compassion is associated with expected emotional responses and the likelihood of responding with problem solving, support seeking, distraction, avoidance, rumination, or catastrophizing to unpleasant self-relevant events occurring in 3 social contexts. Sixty chronic pain patients were presented with 6 vignettes describing scenes in which the principal actor transgressed a social contract with negative interpersonal consequences. ⋯ Work-related vignettes were rated as more emotional and more likely to be associated with avoidance, catastrophizing, and rumination and less likelihood of problem solving. The findings suggest that self-compassion warrants further investigation in the chronic pain population both regarding the extent of its influence as a trait and in terms of the potential to enhance chronic pain patients' ability to be self-compassionate, with a view to its therapeutic utility in enhancing psychological well-being and adjustment. Limitations regarding the possible criterion contamination and the generalizability of vignette studies are discussed.
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Randomized Controlled Trial Multicenter Study
A randomized double-blind, placebo- and active-controlled study of T-type calcium channel blocker ABT-639 in diabetic patients with peripheral neuropathic pain.
T-type Cav3.2 calcium channels represent a novel target for neuropathic pain modulation. Preclinical studies with ABT-639, a peripherally acting highly selective T-type Cav3.2 calcium channel blocker, showed dose-dependent reduction of pain in multiple pain models. ABT-639 also demonstrated an acceptable safety profile at single- and multiple-dose levels evaluated in a clinical phase 1 study in healthy volunteers. ⋯ There were no significant safety issues identified with ABT-639. A majority of adverse events were considered mild to moderate in intensity. In conclusion, treatment with the highly selective T-type Cav3.2 calcium channel blocker ABT-639 100 mg twice daily for 6 weeks showed no safety signals that would preclude further investigation but did not reduce neuropathic pain in patients with diabetes (ClinicalTrials.gov identifier: NCT01345045).