A Depression and Opioid Pragmatic Trial in Pharmacogenetics (Chronic Pain Trial)
Chronic PainThis study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. All three trials were registered on ClinicalTrials.gov under NCT04445792. In July 2023 each of the three treatment trials was registered under a separate NCT# and NCT04445792 was converted to a screening record per recent guidance on master protocol research programs (MPRPs). This record is specific to the Chronic Pain Trial within the ADOPT-PGx protocol. The Chronic Pain Trial is a prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal.
Group-based Integrative Pain Management
Chronic PainSocioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients.
Optimize Low Back Pain
Low Back PainChronic PainThe objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.
Functional Restoration and Integrative Therapies in Service Members With Neuromusculoskeletal Injury...
Chronic PainThis study will (1) compare the effectiveness of standard rehabilitative pain care with complementary and integrative pain therapies; (2) identify subgroups of patients who do and do not respond to the intervention(s); (3) determine the most effective sequencing of the interventions; and (4) determine factors associated with treatment response that can be implemented to support clinical decision-making.
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Erector Spinae Plane BlockPain Control2 moreInterfascial plane blocks have been developed for analgesia, among which the erector spinae plane (ESP) has gained popularity. The ESP block has been hypothesized to provide truncal analgesia by spread of local anesthetic into the paravertebral space. Recent studies have contested this idea showing unreliability in the spread of the local anesthetic into the paravertebral space.
Implementation of the Hybrid Treatment in Clinical Care. A SCED.
Emotional ProblemChronic PainIn society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. One important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. An important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. Specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. The aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. The treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.
A Depression and Opioid Pragmatic Trial in Pharmacogenetics (DCRI Coordinating Center)
DepressionAcute Pain1 moreThis study is comprised of three separate pharmacogenetic trials grouped into a single protocol due to similarities in the intervention, the hypotheses, and the trial design. The three trials are the Acute Pain Trial, the Chronic Pain Trial, and the Depression Trial. Participants can enroll in only one of the three trials. Each trial is listed individually on clinicaltrials.gov and includes "PRO00104948" within the Unique Protocol ID: PRO00104948_A - Acute Pain Trial - NCT05966129 PRO00104948_B - Chronic Pain Trial - NCT05966142 PRO00104948_C - Depression Trial - NCT05966155 Acute Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided post-surgical opioid therapy (Intervention arm) or standard care and pharmacogenetic testing after 6 months (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain management therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Chronic Pain Trial: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided opioid therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype guided pain therapy improves pain control after surgery in participants who's body processes some pain medicines slower than normal. Depression: A prospective, multicenter, two arm randomized pragmatic trial. Participants meeting eligibility criteria will be randomly assigned to either immediate pharmacogenetic testing and genotype-guided anti-depressant therapy (Intervention arm) or standard care with 6-month delayed pharmacogenetic testing (Control arm). The investigators will test the hypothesis that pharmacogenetic testing and genotype-guided anti-depressant therapy will reduce depression symptoms in participants who's body processes some anti-depressants faster or slower than normal.
Chronic Pain, Opioids, and Anger Treatment
AngerOpioid Use1 moreThe current US opioid epidemic is a pressing public health concern. Links between opioid misuse and mortality are well-known; nearly 70% of all drug overdose deaths in 2017 were attributable to opioids. Given their pain-relieving properties, opioids have been widely used in the chronic pain population who are also susceptible to misuse of these analgesics.. In chronic pain patients with anger, the pain as well as opioid use may be aggravated. For example, suppression of anger has been linked with increased pain sensitivity in experiments, while anger-hostility scores and internalized anger predict pain severity variance and pain intensity, respectively. Anger is also linked with drug use/abuse, including opioids. The goal of this research is to implement a state-of-the-art program for anger regulation in chronic pain patients., Called Cognitive Behavioral Affective Therapy (CBAT), this program is evaluated on multiple measures of anger, sensory versus affective measures of pain, and measures of opioid misuse. CBAT is expected to reduce anger, and thereby produce reduction in pain as well as shift attitudes away from opioid misuse..
One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy...
Traumatic Brain InjuryChronic Pain3 moreMild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.
Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement
ArthroplastyReplacement2 moreThe purpose of the study is to investigate whether a 12-week neuromuscular rehabilitation program (NEMEX-TJR) combined with pain neuroscience education (PNE) provides greater pain relief, improvement in physical function and quality of life than PNE alone in a population of patients with chronic pain after primary total knee arthroplasty. Hypothesis: Rehabilitation involving neuromuscular training and PNE will provide greater pain relief, improved function and improved quality of life compared to PNE alone at the primary endpoint, which is follow-up 12months after the start of the treatment.