Multidimensional Analysis of Quality of Life in Patients with Chronic Non-Cancer Pain and Short- and Long-Term Intrathecal Analgesic Therapy.

Background: Intrathecal drug delivery (IDD) is part of the fourth analgesic step. Evidence on the quality of life of patients with refractory chronic non-cancer pain (CNCP) using these devices and their long-term outcomes is scarce. This study aims to evaluate patients with IDD to assess their HRQoL. Additionally, the study seeks to understand the patients' satisfaction with the treatment and changes in pain magnitude over time. Methods: Adult patients with CNCP and intrathecal drug delivery systems (IDDS) were included. The study population was divided into two groups: less than and more than 15 years of treatment. HRQoL was analyzed using validated questionnaires. Pain reduction was assessed using the visual analog scale (VAS), and treatment satisfaction was evaluated using the Patient Global Impression of Improvement scale. Results: The results indicate a poor HRQoL in IDD patients, with better scores in the group with ≥15 years of treatment. Pain reduction was similar in both groups, and patients reported a positive satisfaction level with the treatment. Conclusions: HRQoL in CNCP patients is severely affected. Long-term IDD patients have a similar or even better HRQoL in some respects compared to those with shorter follow-ups. IDD patients experienced pain reduction, with most feeling better or much better.

The Effects of Positive Versus Negative Self-Talk on Vertical Jump in Soccer Players: The Moderating Role of Need for Cognition.

The current study analyzed the effects of positive versus negative self-talk on physical performance in soccer players from a multiprocess approach. We operationalized the process distinction using the need-for-cognition (NC) construct. Thus, NC was measured and self-talk (i.e., positive vs. negative) was manipulated between participants (i.e., 126 soccer players, age 18 years or older, who were competing in national, regional, or local competitions). Physical performance was assessed by a vertical-jump test. According to hypothesis, regression analyses indicated that positive versus negative self-talk influenced physical performance to a greater extent for high-NC individuals than for low-NC individuals. Specifically, among high-NC soccer players, relative to baseline, positive self-talk produced greater physical performance in the vertical-jump test than negative self-talk. In contrast, among low-NC soccer players, no difference was found between positive and negative self-talk on physical performance. These results supported the moderating role of NC.

The interplay between self-talk and body posture on physical performance: Analyzing a moderated serial multiple mediation model.

Prior research has shown that non-verbal behavior (e.g., overt head movements) can moderate the effects of positive and negative self-talk on physical performance. In the current studies, we aimed to extend existing research on self-talk by examining a different non-verbal behavior (i.e., body posture), as well as specifying some conditions under which body posture can interact with self-talk on physical performance from the Self-Validation Theory perspective. Most importantly, we proposed and tested a moderated serial multiple mediation model. In Studies 1 and 2, self-talk (i.e., positive vs. negative) and body posture (i.e., upright vs. slumped) were manipulated between participants. In Study 1, soccer players performed slalom and dribbling tests. In Study 2, athletes performed a push-up test. We hypothesized and found that positive (vs. negative) self-talk influenced physical performance to a greater extent for participants in the upright posture (i.e., validating) condition than for participants in the slumped posture (i.e., invalidating) condition. Furthermore, Study 3 was designed to analyze a moderated serial multiple mediation model. In this third study, self-talk was positive, body posture was manipulated, and the meaning of body posture was measured as a moderator. Results supported the proposed model, identifying the perceived validity of self-statements (i.e., the self-validation mechanism) and self-efficacy as serial mediators. That is, the meaning (i.e., validity-invalidity) moderated the effects of body posture on athletes' physical performance in a pull-up test, through the indirect effects of the perceived validity of self-statements and self-efficacy. Implications for self-talk research and application are discussed.

High-frequency spinal cord stimulation as rescue therapy for chronic pain patients with failure of conventional spinal cord stimulation.

BACKGROUND: This study aims to evaluate the efficacy of 10-kHz high-frequency (HF10) devices as a rescue treatment in patients with failure of conventional spinal cord stimulation (SCS) therapy for chronic pain without the need to change the spinal hardware. METHODS: In this real-world prospective study, patients with neuropathic pain treated with conventional tonic SCS in whom the therapy had failed, either during the trial phase or after a period of optimal functioning, were recruited throughout 2 years for HF10-SCS therapy. Data on analgesia, functionality, analgesics use and treatment safety were collected 12 months after treatment. RESULTS: Eleven of the 18 (61%) patients included in the study were successfully rescued with HF10-SCS. Of them, 5 out of 12 (45%) were in the trial phase and six out of six (100%) had previously functioning implants. A significant improvement in low-back and limb pain was obtained (p = 0.003 and p = 0.0001, respectively). Treatment success was significantly associated with gender (p = 0.037), weight (p = 0.014), body mass index (BMI) (p = 0.007) and time of rescue (p = 0.015). A linear regression test confirmed a significant association between treatment failure and BMI and gender (p = 0.004). CONCLUSIONS: Our results suggest that analgesic rescue with HF10-SCS is an effective therapeutic option for non-responders to conventional SCS, although obesity might be a limiting factor for treatment success. Nevertheless, more comprehensive studies are needed to corroborate our findings. SIGNIFICANCE: This study shows that high-frequency stimulation may be useful in patients with failure of conventional tonic stimulation for chronic pain, both in the trial phase and in previously implanted subjects. The novelty of this study lies in the use of the implanted epidural electrodes, which avoids the need for further surgery. The results in terms of pain control and recovery of functionality are satisfactory. In addition, variables such as male gender and high body mass index could be predictors of therapy failure.

Long-Term Effectiveness and Tolerability of Pain Treatment with Tapentadol Prolonged Release.

BACKGROUND: The central analgesic tapentadol prolonged release (PR) has proven effective and generally well tolerated in a broad range of chronic pain conditions. Long-term data of its use are still scarce. OBJECTIVES: To evaluate long-term effectiveness, tolerability, and safety of tapentadol PR in patients with severe chronic osteoarthritis (OA) knee pain or low back pain (LBP) who responded to tapentadol in 1 of 4 preceding 12-week phase 3b clinical trials. STUDY DESIGN: Open-label, uncontrolled, observational extension study of up to 72 weeks. SETTING: Fourteen centers in Spain. Protocol approval by the reference ethics committee for all the participating centers. METHODS: Eligible patients started the extension trial on the tapentadol PR dosage optimized for them in the preceding trial; dose adjustments were permitted throughout the extension. Treatment effectiveness outcomes included changes in pain intensity, sleep, state of health, quality of life, patient and clinician global impression of change, and patients' satisfaction with treatment. Patients with OA knee pain also answered the Western Ontario and McMaster Universities OA index, and patients with LBP with a possible neuropathic pain component completed neuropathic pain-related questionnaires. RESULTS: Eighty-three patients were enrolled: 40 with OA knee pain, 43 with LBP. The full analysis set consisted of 81 patients. Mean pain intensity remained relatively stable over the 72-week extension period with mean increases from baseline of 0.44 (95% confidence interval [CI], -0.1,1.0; Numeric Rating Scale) for all patients, 0.2 (95% CI, -0.5, 0.9) for patients with OA, and 0.68 (95% CI, -0.2, 1.6) for patients with LBP. State of health and quality of life baseline ratings were maintained; overall impression of change was "improved." Most patients (88.9%) reported at least good treatment satisfaction at the end of treatment. Mean daily tapentadol PR doses slightly increased from 313.3 ± 139.5 mg at baseline to 315.7 ± 140.1 mg at end of study. Uptitration was required for 8.4% of the patients, 4.8% had a dose reduction during the trial. Adverse events considered probably/likely or certainly related to tapentadol PR treatment by the investigator were documented for 18.1% of all patients, most commonly constipation (7.2%). Seven patients (8.4%) experienced adverse events leading to premature discontinuation. LIMITATIONS: An open-label design, stable concomitant analgesics (World Health Organization step I), and dose adjustments were allowed during the study. All patients had benefitted from tapentadol PR in preceding trials. CONCLUSIONS: Sustained pain relief and quality of life for up to 72 treatment weeks under relatively stable dosing, as well as the good safety profile, indicate the usefulness of tapentadol PR for patients who suffer from severe chronic OA knee pain and LBP with limited risk for tolerance development.

A meta-cognitive approach to doping in sports: The effects of thought validation on attitudes related to doping.

To better understand doping-related attitude change, it is important to consider not only the amount of thinking (i.e., elaboration) done by message recipients, but also the favourability of their thoughts in response to the proposal, as well as the perceived validity in their thoughts. The main goal of the present study was to analyse the effects of a meta-cognitive process (i.e., thought validation) on attitudes related to doping. Thus, we randomly assigned participants to read a message either against or in favour of legalising several doping behaviours. Participants listed their thoughts regarding the proposal and indicated the perceived validity in their thoughts, then reported their attitudes. As hypothesised, the message against legalisation elicited more unfavourable thoughts and attitudes than the message in favour of legalisation. Most relevantly, the effects of the message direction on attitudes were greater for participants with higher (vs. lower) levels of thought validity. Furthermore, consistent with the thought validation process, results revealed that thought favourability was a better predictor of attitudes for participants with higher (vs. lower) perceived thought validity, indicating that perceiving one's thoughts as valid plays an important role in persuasion. These findings provide novel insights for research and interventions regarding doping in sports.

Trait aggressiveness predicting aggressive behavior: The moderating role of meta-cognitive certainty.

Research on aggression has benefitted from using individual-difference measures to predict aggressive behavior. Research on meta-cognition has recently identified that the predictive utility of individual-difference inventories can be improved by considering the certainty with which people hold their self-views. Merging these two frameworks, the present research examines whether assessing certainty in trait aggressiveness improves its ability to predict aggressive outcomes. Across two studies, participants reported their level of trait physical aggressiveness and the certainty with which they held their responses to the scale (predictor variables). Aggressive behavioral intentions (Study 1 and 2) and actual aggressive behavior (Study 2) were used as dependent measures. As hypothesized, results indicated that certainty moderated the effects of individual-differences in aggressiveness on both aggressive outcomes. Therefore, considering the certainty with which people hold their relevant traits can be useful for understanding aggression, and also for predicting the consistency between personality and behavior.

Oral pregabalin for postoperative pain relief after third molar extraction: a randomized controlled clinical trial.

OBJECTIVES: The aim of this randomized controlled clinical trial was to evaluate the efficacy and safety of pregabalin administered pre- and postoperatively in patients with pain and swelling due to the surgical removal of impacted lower third molars. MATERIALS AND METHODS: The final study sample comprised 60 volunteers (23 males and 37 females). Group 1 (n = 30) received 75 mg oral pregabalin 1 h before surgery and 1 h after surgery. Group 2 (n = 30) served as a control group and received no pregabalin. Both groups were administered with 650 mg paracetamol every 8 h for 2 days. Postoperative pain intensity and swelling were measured using a visual analog scale (VAS); pain relief experienced was reported using a four-point verbal rating scale (VRS); the rescue medication requirement, adverse effects, and global impression of the medication were also recorded. RESULTS: No significant difference in pain intensity (VAS) was observed between the groups. However, fewer rescue medication tablets were needed by pregabalin-treated patients than by controls (p = 0.021). The frequency and intensity of adverse effects were significantly higher in pregabalin-treated patients (p < 0.001), although no serious adverse events occurred. No significant difference in the degree of swelling was observed in any measurement except that from mandibular angle to lip junction, which showed lesser inflammation in the pregabalin group at 24 h post-surgery (p = 0.011). The global opinion on the medication received was more positive in the pregabalin group (p = 0.042). CONCLUSIONS: The administration of pregabalin reduces the requirement for rescue medication after third molar surgery and results in a more constant pain level, with fewer peaks of pain intensity. CLINICAL RELEVANCE: These findings suggest that pregabalin may be useful to control acute postoperative pain. Adverse effects are known to be reduced at the low pregabalin dose used in our study.

Effectiveness of pregabalin as monotherapy or combination therapy for neuropathic pain in patients unresponsive to previous treatments in a Spanish primary care setting.

BACKGROUND AND OBJECTIVE: Patients from a previous study of neuropathic pain (NP) in the Spanish primary care setting still had symptoms despite treatment. Subsequently, patients were treated as prescribed by their physician and followed up for 3 months. Since pregabalin has been shown to be effective in NP, including refractory cases, the objective of this study was to assess the effectiveness of pregabalin therapy in patients with NP refractory to previous treatments. METHODS: This was a post hoc analysis of pregabalin-naïve NP patients treated with pregabalin in a 3-month follow-up observational multicenter study to assess symptoms and satisfaction with treatment. Patients were evaluated with the Douleur Neuropathique en 4 questions (DN4), the Brief Pain Inventory (BPI) and the Treatment Satisfaction for Medication Questionnaire (SATMED-Q) overall satisfaction domain. RESULTS: 1,670 patients (mean age 58 years, 59 % women), previously untreated or treated with ≥1 drug other than pregabalin, were treated with pregabalin (37 % on monotherapy). At 3 months, pain intensity and its interference with activities decreased by half (p < 0.0001), while the number of days with no or mild pain increased by a mean of 4.5 days (p < 0.0001). Treatment satisfaction increased twofold (p < 0.0001). Patients with a shorter history of pain and those with neuralgia and peripheral nerve compression syndrome (PCS) as etiologies had the highest proportion on monotherapy and showed the greatest improvements in pain-related parameters in their respective group categories. CONCLUSION: Treatment with pregabalin (as monotherapy or combination therapy) provides benefits in pain and treatment satisfaction in patients with NP, including refractory cases. Shorter disease progression and neuralgia and PCS etiologies are favorable factors for pregabalin treatment response.