I am a
Home I AM A Search Login

Human Studies

Share this

The Impact of Surgical Amputation and Valproic Acid on Pain and Functional Trajectory: Results from the Veterans Integrated Pain Evaluation Research (VIPER) Randomized, Double-Blinded Placebo-Controlled Trial.

To determine if the perioperative administration of valproic acid reduces the incidence of chronic pain three months after amputation or revision surgery.

Learn More >

Spouse and Patient Beliefs and Perceptions About Chronic Pain: Effects on Couple Interactions and Patient Pain Behavior.

Patient beliefs and perceptions about the causes and meaning of their chronic pain are related to their psychosocial functioning. Beliefs and perceptions about chronic pain held by spouses may also be related to patient functioning. We used a laboratory procedure to evaluate whether spouse beliefs about and perceptions of chronic pain were related to spouse negative responses toward patients with chronic low back pain during a conflictual discussion and to their attributions about patient pain behavior during a subsequent pain-induction task. Patients (n = 71) and their spouses (n = 71) participated in a 10-minute discussion followed by the patient undergoing a 10-minute structured pain behavior task. Findings were that a) spouse perceptions that patient's pain was a mystery were significantly related to greater patient perceived spouse critical/invalidating responses toward the patient during the discussion; and b) spouse perceptions that patient's pain was a mystery were related to internal and negative attributions spouses made while observing patients display pain behaviors during the structured pain behavior task. Inasmuch as both spouse critical/invalidating speech toward patients and negative attributions regarding the cause of patient behavior are related to poor patient functioning, spouse uncertainty about the source and potential legitimacy of their partner's pain may play crucial roles in affecting patient well-being. PERSPECTIVE: Spouse beliefs about and perceptions of patient chronic pain were related to spouse behavior toward patients during a discussion and to attributions explaining patient pain during physical activity. If spouse confusion and doubt about patient pain is related to negative behavior and attributions, then modifying these perceptions may be a fundamental intervention target.

Learn More >

Mindfulness-oriented recovery enhancement reduces opioid misuse risk via analgesic and positive psychological mechanisms: A randomized controlled trial.

Despite the heightened urgency of the current prescription opioid crisis, few psychotherapies have been evaluated for chronic pain patients receiving long-term opioid analgesics. Current psychological pain treatments focus primarily on ameliorating negative affective processes, yet basic science suggests that risk for opioid misuse is linked with a dearth of positive affect. Interventions that modulate positive psychological processes may produce therapeutic benefits among patients with opioid-treated chronic pain. The aim of this study was to conduct a theory-driven mechanistic analysis of proximal outcome data from a Stage 2 randomized controlled trial of Mindfulness-Oriented Recovery Enhancement (MORE), an integrative intervention designed to promote positive psychological health.

Learn More >

The role of sleep quality on the relationship between posttraumatic stress symptoms and pain in women.

Pain frequently co-occurs with elevated posttraumatic stress symptoms (PTSS); women are at elevated risk for their co-occurrence. PTSS and pain are associated with poor sleep quality; yet, little research has examined how sleep impacts their co-occurrence. The current study examines the indirect role of sleep on the relationship between PTSS and pain. A community sample of 182 women completed psychometrically-sound questionnaires assessing PTSS, sleep quality, pain characteristics, depression and anxiety symptoms, and anxiety sensitivity. We examined how sleep quality impacted associations among PTSS and pain intensity and pain interference, while controlling for key psychological factors. Greater PTSS was associated with worse pain interference, and poor sleep quality had a significant indirect effect on this relationship. Sleep may represent a modifiable behavioral mechanism that contributes to the mutual maintenance of PTSS and pain in women. Future research is needed to further clarify the role of sleep quality in their co-occurrence.

Learn More >

Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine.

Sustained pain freedom is an important attribute of acute migraine therapies for patients and physicians. Here we report efficacy of the centrally penetrant, highly selective, 5-HT agonist lasmiditan on sustained pain freedom and other outcomes at 24 and 48 hours post-dose.

Learn More >

Additive Duloxetine for Cancer-related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08).

Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.

Learn More >

Onset of action of naldemedine in the treatment of opioid-induced constipation in patients with chronic noncancer pain: results from 2 randomized, placebocontrolled, phase 3 trials.

Opioid-induced constipation (OIC) is a common side effect of chronic opioid therapy. Previously, naldemedine, a peripherally acting ì-opioid receptor antagonist demonstrated efficacy in the treatment of OIC. In this exploratory analysis, the onset of action of naldemedine was evaluated in 2 identically designed phase 3, randomized, placebo-controlled trials. Proportion of patients experiencing a spontaneous bowel movement (SBM) within 24 hours of treatment initiation, time from initial dose to first SBM and weekly SBM frequency were assessed. Naldemedine was associated with significant increases in the proportion of patients experiencing an SBM at 4, 8, 12, and 24 hours after the initial dose compared with placebo (all P<0.0001). Within 24 hours in both studies, statistically significantly (P<0.0001) more patients treated with naldemedine compared with placebo experienced an SBM (61.2% vs. 28.3% and 56.5% vs. 33.6%, respectively). Median times to first SBM were significantly shorter in the naldemedine group versus placebo (COMPOSE-1, 16.1 vs. 46.7 hours; COMPOSE- 2, 18.3 vs 45.9 hours; P<0.0001). Naldemedine was also associated with significant increases in weekly SBM frequency versus placebo within 1 week (P<0.001). Most common treatment-emergent adverse event (TEAE) were gastrointestinal-related (abdominal pain, diarrhea, and nausea). TEAEs were reported most frequently on day 1, followed by a decrease from days 2-7. Naldemedine had a timely onset of effect, and gastrointestinal AEs largely resolved within the first week. These findings should assist clinicians counseling patients with chronic noncancer pain on expectations when initiating naldemedine for OIC. ClinicalTrials.gov Registration: NCT01965158 and NCT01993940This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Learn More >

Concurrent and lagged associations of prescription opioid use with pain and negative affect in the daily lives of chronic pain patients.

Prescribed opioids for chronic pain management contribute significantly to the opioid crisis. There is a need to understand the real-world benefits that, despite risks, lead chronic pain patients to persist in opioid use. Negative reinforcement models of addiction posit that individuals use substances to reduce aversive states but have seldom been applied to prescribed opioids. Using ecological momentary assessment, we examined reciprocal associations between opioid use and physical pain, for which opioids are prescribed, and negative affect (NA), for which they are not.

Learn More >

Levcromakalim, an Adenosine Triphosphate-Sensitive Potassium Channel Opener, Dilates Extracerebral but not Cerebral Arteries.

ATP-sensitive potassium (K ) channel opener levcromakalim induces migraine attacks in migraine patients. Underlying mechanisms responsible for headache and migraine induction after levcromakalim infusion are unknown.

Learn More >

Feasibility of a Hybrid Web-Based and In-Person Self-management Intervention Aimed at Preventing Acute to Chronic Pain Transition After Major Lower Extremity Trauma (iPACT-E-Trauma): A Pilot Randomized Controlled Trial.

1) To assess the feasibility of research methods to test a self-management intervention aimed at preventing acute to chronic pain transition in patients with major lower extremity trauma (iPACT-E-Trauma) and 2) to evaluate its potential effects at three and six months postinjury. Design. A pilot randomized controlled trial (RCT) with two parallel groups.

Learn More >

Search