Chronic Pain

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

The purpose of this nationwide cross-sectional survey is to determine the prevalence, multidimensional impacts, and associated factors of chronic occupational pain among anesthesiologists and nurse anesthetists in Thailand. Due to the physically demanding nature of anesthesia practice-such as prolonged standing, awkward postures during airway management, and high-stress environments-work-related musculoskeletal disorders are highly prevalent but often underreported. This study aims to collect self-reported data via an anonymous online questionnaire to assess pain severity, specific anatomical locations, economic burdens (including absenteeism and presenteeism), and the overall impact on the health-related quality of life. Ultimately, the findings from this study will help establish a national evidence-based database to improve workplace safety, inform occupational health policies, and enhance the overall well-being of anesthesia providers in Thailand.

To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.

This prospective observational study aims to evaluate whether rebound pain after peripheral nerve block is associated with the development of chronic postsurgical pain following elective total knee arthroplasty. Adult patients undergoing unilateral total knee arthroplasty under spinal anesthesia and receiving a peripheral nerve block as part of routine multimodal analgesia will be included. No additional intervention, drug administration, or biological sampling will be performed beyond standard clinical care. Rebound pain will be assessed during the early postoperative period using pain diaries, numeric rating scale pain scores, and analgesic consumption records. Chronic postsurgical pain and related outcomes will be evaluated at postoperative 3 and 6 months using validated instruments assessing pain severity, neuropathic pain features, psychological status, functional outcomes, and health-related quality of life. The primary outcome is the presence of chronic postsurgical pain at 3 months after surgery. Secondary outcomes include chronic pain at 6 months, pain intensity, neuropathic pain characteristics, opioid consumption, rescue analgesic requirements, sleep disturbance, and quality-of-life measures. The study also aims to explore demographic and clinical factors associated with rebound pain and chronic postsurgical pain.

With vast numbers of active-duty members restricted from their specific duties or deemed unfit for deployment because of low back pain, both the mission of the Department of Defense and overall military workflow can be significantly impacted. More than restriction from duty or being barred from deployment, studies have shown musculoskeletal conditions were among the top reasons for medical disability retirement in the Army and Marine Corps (Niebuhr; Sikorski). Given the significant time, money, and resources invested in training these members, each day of inactivity or disability detrimentally affects the execution of the military's mission. Therefore, precise diagnosis and effective treatment modalities are paramount to foster healing and reduce recovery time. From an operational standpoint, the United States Department of Defense (DoD) is specifically interested in using tailored integrative medicine modalities to manage chronic conditions encountered in the military health system. Not just chronic pain, but polytrauma and the triad of conditions it encompasses; traumatic brain injury and post-traumatic stress disorder combined with chronic pain (Madsen, Kim, Bedard). The DoD's goal is also to decrease opioid prescribing and the addiction and altered state associated with opioids. AT the Nellis Integrative Medicine Clinic, physicians, a chiropractor, and nurses are engaged in the treatment of patients. All personnel are trained in the various modalities available in the clinics. A variety of modalities are utilized in the clinic. This prospective study will evaluate the effectiveness of the many modalities used in the Integrative Medicine Clinic (such as acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies). Most patients receive treatments using multiple modalities. DoD goals align with our experiences in the Integrative Medicine Clinic at Mike O'Callaghan Military Medical Center. Many servicemembers and dependents in our clinic are trying to avoid surgery, or their pain medications - opioid or not - are no longer working. Additionally, many patients are trying to avoid Do Not Fly status caused by pharmacologic approaches. Patient experiences at our IMC also correlate with a study where 80% of people surveyed felt integrative medicine should be routinely offered at all MTFs (Ross). While our patients generally are not on opioids, we have anecdotally noted a reduction or cessation of opioids in several patients. The impacts of such a reduction in opioid usage for military readiness is clear (Madsen).

This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy. Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control. The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.

This project will evaluate the feasibility and acceptability of Empowered Relief (ER) among American Indian adults who are currently receiving or have completed active cancer treatments at Stephenson Cancer Center (SCC). ER is a single-session, Zoom-based, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily practice. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety at 3 and 6 months post-treatment. Because of its brief, didactic nature and Zoom delivery, ER can accommodate large class sizes and may address accessibility disparities among underserved cancer populations. While ER is being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad, it has not been tested in American Indians with cancer.

Chronic musculoskeletal (MSK) pain, which includes spinal pain, osteoarthritis, and fibromyalgia, is a common and costly problem for older adults and is associated with decreased quality of life. In this project, investigators propose to create Reclaim Your Day (RYD), which will consist of 6, 30-min weekly video episodes highlighting patients' inspiring and illustrative experiences living with chronic pain in order to teach current patients with chronic MSK pain how to apply ACT's evidence-based strategies. INvestigators will conduct a pilot RCT (n=100) of older adults with chronic MSK pain. All participants will receive an introductory pain education video. Participants will be randomized to receive either RYD or a comparison intervention (health education videos). Investigators will examine RYD feasibility and acceptability as well as changes over time in outcomes (pain interference, depression, quality of life) and putative mediators.

This is a multicenter prospective study of patients who currently have stably implanted spinal cord simulators. Patients will be randomly assigned to turn on or off their spinal cord stimulators for two week intervals up to six weeks after enrollment, and on the final day of study participation, for one hour intervals, in a multi-crossover design. In a subset of patients we will also perform combined positron emission tomography/magnetic resonance imaging at baseline, week 2 and week 4.

Chronic pain is a prevalent and debilitating condition among Veterans, often accompanied by depression, anxiety, sleep disturbances, and social isolation. Despite the availability of behavioral interventions many Veterans-particularly those with high in-person healthcare utilization-face barriers to accessing non-pharmacological pain management strategies. These barriers include limited clinician availability, geographic constraints, and digital exclusion among older or underserved populations. This study aims to evaluate the feasibility, acceptability, and preliminary impact of My AI Companion, an automated, text/telephone-delivered chatbot designed to support chronic pain self-management among high-utilizing Veterans. The intervention offers a low-barrier approach to promoting symptom tracking, patient activation, and engagement in coping strategies-without requiring Internet access or clinician time.

This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways. Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.

This observational cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Participants with MS and chronic pain will undergo a comprehensive clinical assessment to identify nociceptive, neuropathic, nociplastic, and mixed pain phenotypes. The assessment will include clinical history, pain characteristics and distribution, quantitative sensory testing, pain intensity, disease severity, fatigue, health-related quality of life, and pain catastrophizing. The clinical characteristics of participants with different pain phenotypes will subsequently be compared.

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.

Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disease in which pain remains the most prominent and burdensome symptom from the patient's perspective. Although the introduction of biological and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs) has significantly improved the control of inflammatory activity, an estimated 20-30% of patients continues to experience persistent moderate-to-severe pain despite achieving clinical remission. This discordance between objective inflammatory markers and subjective pain perception reflects an important unmet clinical need and suggests that chronic pain in RA may become partially or fully independent of peripheral inflammation, driven instead by central sensitization and nociplastic mechanisms. The RA-PAIN-AI study is a prospective, observational, case-control study integrating clinical assessment, patient-reported outcome measures, neurophysiological evaluation, and multiomic profiling, analyzed using artificial intelligence (AI)-based methods. Two groups of adult patients with RA are enrolled: a study group of patients with active disease qualifying for biological therapy under the Polish national drug program B.33, and a control group of patients in sustained clinical remission (at least 1.5 years) under biological therapy, without clinically significant chronic pain. All participants undergo clinical assessment, standardized questionnaires, peripheral blood collection at the baseline (Visit 1) and follow-up (Visit 2) visits. Electroencephalography (EEG) is offered as an optional procedure, at the discretion of the investigator. Biological samples are analyzed using advanced multiomic technologies, including whole genome sequencing (genomics), mRNA expression profiling (transcriptomics), and measurement of circulating proteins (secretomics). All clinical, biological, and neurophysiological data are then integrated using AI methods, including dimensionality reduction, clustering, and supervised machine learning, to identify distinct pain-related patient subtypes (endotypes). The primary objective of the study is to identify and characterize clinical, neurophysiological, and multiomic signatures associated with chronic pain in RA. Expected outcomes include identification of biomarkers predictive of chronic pain persistence despite effective anti-inflammatory treatment, improved differentiation between inflammation-driven pain and pain mediated by central nervous system changes, and support for the development of more personalized, mechanism-based treatment strategies in rheumatology. The study is non-interventional: no experimental therapeutic interventions are administered, and all participants continue to receive standard clinical care. All biological analyses are performed ex vivo.

The goal of this clinical trial is to determine whether a sigma-1 receptor PET/MRI scan can help identify the specific nerves responsible for chronic pain. Researchers will use an investigational imaging agent called \[18F\]FTC-146 to look for signs of pain generating nerve irritation or injury that may not be visible on convention imaging tests. Participants whose pain-generating nerve can be identified may undergo a diagnostic nerve block and, if successful, a standard clinical procedure called cryoneurolysis will be used to temporarily interrupt pain signals.

The focus of this study is to determine whether adding Whole Health Coaching (WHC) improves pain care among adults with chronic pain and who are currently working with a pain management team (PMT) at the VA.

Phase 1 (started in July 2019): Central Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant factors for CPHP that can be reliably assessed preoperatively. === Phase 2 (anticipated start May 2022): In addition to above factors, the association between heart rate variability (HRV) parameters, anxiety level, anticipated pain, and anticipated analgesia requirement with significant postoperative pain and CPHP will be investigated.

YOGENDOCHIR is a multicentre, prospective, randomised, controlled, parallel-group study involving 188 adult women scheduled to undergo surgery for endometriosis. The study compares standard surgical management alone with the same management combined with a structured perioperative yoga therapy programme comprising 32 guided sessions (16 before and 16 after surgery), supplemented by a secure digital platform supporting independent practice and adherence monitoring. The primary objective is to assess the effect of yoga therapy on endometriosis-related pain, as measured by the pain subscale of the Endometriosis Health Profile-30 (EHP-30). Participants are assessed before surgery and at 3, 6, and 12 months after the procedure. Secondary outcomes include quality of life, pain characteristics, fatigue, sleep, anxiety and depressive symptoms, sexual health, kinesiophobia, activities of daily living, medication use, healthcare utilisation, absenteeism, adherence, satisfaction, and the participants' ability to use the platform independently.

The purpose of this study is to investigate the relationship between alexithymia levels and clinical parameters, including pain intensity and quality of life, in chronic pain patients treated with spinal cord stimulation (SCS). Chronic neuropathic pain can lead to psychological distress and decreased quality of life. While SCS is an effective neuromodulation therapy for managing refractory pain, patient outcomes vary significantly, suggesting that biomedically similar patients experience different levels of relief due to psychosocial factors. Alexithymia, characterized by difficulties in identifying and describing emotions, may significantly influence the individual pain experience and treatment outcomes. In this cross-sectional observational study, patients who underwent SCS implantation for clinical indications will be evaluated. Clinical data regarding pain history will be collected retrospectively from patient files, while psychosocial profiles will be assessed at a single time point using validated psychometric questionnaires. The study aims to contribute to a better understanding of psychosocial variables in neuromodulation outcomes, potentially aiding in improved patient selection and expectation management.

Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

This study will examine the effects of brain stimulation on pain symptoms associated with Major depressive disorder. This study will enroll 54 Subjects. Study subjects will be asked to complete surveys about their mood and well-being, 2 blood draws, 2 MRIs, 3 electroencephalograms, and receive 30 treatments of blinded transcranial magnetic stimulation. There is no control group as all subjects will receive some form of active treatment. Subjects are required to participate in 30-33 study visits and volunteer 40 hours of their time. Compensation for this study is $150 for completing all study activities.

The goal of this clinical trial is to examine the effects of duloxetine on walking ability and physical activity in patients with knee osteoarthritis. Researchers will compare duloxetine to a placebo (a look-alike substance that contains no drug) to see if duloxetine works to improve walking ability in patients with knee osteoarthritis. At study visits, participants will complete surveys, perform physical function tasks, undergo non-invasive brain imaging, and undergo sensory testing.

Conduct a feasibility randomized controlled trial (N = 130, 65 per group) comparing the POPSINGER music therapy (MT) intervention to yoga.