Clinical Research Directory

SERENITY Study of Chronic Pain Interference in Adults

SERENITY is a remote observational study designed to characterize inter-individual differences in chronic pain among adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain. Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection. Ecological momentary assessment surveys will be completed 4 times per day for at least 3 weeks and will assess pain interference, pain intensity, stress, affect, sleep, body and mind awareness, agency, medication use, manual therapy frequency, and related factors. The study will use Bayesian hierarchical modeling, clustering analyses, and causal discovery approaches to identify person-specific and group-level factors associated with pain interference.

Different Treatments in Chronic Pain Patients.

The goal of this observational study is to compare different treatment options in a chronic pain population. The main questions it aims to answer are: * What is the effectiveness of the different therapy options in the pain center of Sint-Lucas on outcomes related to pain and disability? * What are predictive factors for the different therapy options in the pain center of Sint-Lucas? Which factors predict improvement in pain related outcomes? Participant data will be gathered as part of their routine care. They can be advised to 4 different treatment options: * Consultations with the pain specialist * Interventions by the pain specialist (infiltrations, denervations) * Baxter therapy * Interdisciplinary treatment Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.

Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury

The goal of this clinical trial is to learn whether virtual reality (VR)-based hypnotherapy, added to conventional physiotherapy, improves pain, sleep, mood, and quality of life in adults with chronic spinal cord injury. The main questions it aims to answer are: * Does VR-based hypnotherapy added to physiotherapy reduce pain intensity more than physiotherapy alone? * Does it improve neuropathic pain, sleep quality, anxiety and depression, spasticity, and quality of life? Researchers will compare participants who receive VR-based hypnotherapy in addition to physiotherapy with participants who receive physiotherapy alone. Participants will: * Receive a standard physiotherapy and rehabilitation program 5 days a week for 2 weeks (10 sessions). * If assigned to the VR group, also receive an approximately 20-minute VR-based hypnotherapy session after each physiotherapy session, using a VR headset and headphones. * Complete assessments at the start of the study, at the end of the 2-week treatment period, and 2 weeks after treatment ends.

Pain Self-Management and Treatment Engagement for Patients Taking Opioids

The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder (OUD) The main questions it aims to answer are: * Does PSM help participants manage their chronic pain more effectively? * Does PSM help participants engage in treatment for opioid use? Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment. Participants will: * Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study * Complete surveys every 3 months for 9 months (total of 4 visits) Participants will receive compensation for participating in the study. There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.

Transcranial Direct Current Stimulation for Chemotherapy-Related Chronic Pain in Cancer Survivors

The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) combined with a working-memory task can treat chronic pain and related emotional and cognitive problems after chemotherapy in adult cancer survivors. tDCS is a non-invasive and painless technique that uses a very weak electrical current, applied through two small electrodes on the head, to modulate the activity of certain brain areas. The main questions it aims to answer are: * Does tDCS reduce chronic pain intensity after chemotherapy in cancer survivors? * Does tDCS also reduce anxiety, depression, and cognitive problems, and improve the regulation of cortisol, a stress-related hormone? * Are the effects on pain, anxiety, depression, cognitive problems, and cortisol sustained when treatment continues with a maintenance phase of up to 2 months? Researchers will compare real tDCS to sham (placebo) tDCS, a look-alike procedure that does not deliver effective stimulation, to see if real tDCS works to reduce pain and improve these symptoms. Participants will: * Receive real or sham tDCS (assigned by chance) in 5 daily sessions over 1 week. Each session lasts 20 minutes: 10 minutes at rest and 10 minutes while doing a working-memory task * If they did not respond to sham tDCS, be offered 5 additional daily sessions of real tDCS * If they respond to treatment, continue with real tDCS twice a week for up to 2 months * Complete assessments of pain, mood, memory, attention, and quality of life before treatment, after each phase, and during and at the end of the maintenance phase * Collect saliva samples to measure cortisol

Validation of the Turkish Brief Inventory of Treatment Expectations in Chronic Pain

The purpose of this study is to conduct the Turkish cross-cultural adaptation, validity, and reliability study of the "Brief Inventory of Treatment Expectations in Chronic Pain" (BITEC) scale. Chronic pain is a complex, multidimensional experience that affects a significant portion of the adult population. Treatment expectations play a critical role in predicting clinical outcomes and directly influencing placebo/nocebo responses. While several tools exist to evaluate expectations, there is a lack of a concise, clinician-friendly, and Item Response Theory (IRT)-based instrument adapted for Turkish chronic pain populations. The BITEC is a 9-item scale that evaluates biological, psychological, and social/interactional expectation domains. This methodological and cross-sectional study will be conducted with adult patients diagnosed with chronic pain for at least three months at Bingöl State Hospital. The study will be carried out in four consecutive stages: cross-cultural adaptation (forward and backward translation), comprehensibility pre-testing (with 30-40 volunteers), main data collection (with at least 200 participants), and statistical analyses. Data will be collected through printed forms and an online survey platform (Kobotoolbox), involving no clinical interventions. Participants will complete a sociodemographic information form, the Turkish version of the BITEC (BITEC-TR), the Treatment Expectations in Chronic Pain Scale (TEC-TR), the Pain Catastrophizing Scale (PCS), the Numerical Pain Rating Scale (NPRS), and the Hospital Anxiety and Depression Scale (HADS). Additionally, a subgroup of approximately 60 participants will recomplete the BITEC-TR 7-10 days after the initial session to evaluate test-retest reliability. Psychometric evaluation will include construct validity through exploratory and confirmatory factor analyses, and internal consistency and stability measurements.

Group Acupuncture for Pain

The goal of this study is to learn if group acupuncture is acceptable and feasible as a treatment for chronic pain in adults living in rural North Carolina, with the aim of improving access to equitable pain care. The main questions it aims to answer are: Is group acupuncture acceptable (measured by a questionnaire and semi-structured interviews), feasible (measured by recruitment and retention rates), and delivered with fidelity (measured by the proportion of acupuncture sessions attended) among adults with chronic pain in rural North Carolina (Phase 2)? Adults with chronic pain will: * Attend up to 10 group acupuncture sessions over a 6-week period * Complete a questionnaire about the acceptability of the intervention; a subset of participants will complete qualitative acceptability interviews * Complete self-report measures of pain, anxiety, depression, sleep, fatigue, and quality of life

Probiotics for Inflammation in Pediatric Chronic Pain

To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index \>=85th percentile.

Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients

Prospective observational crossover study of 250 adults undergoing chronic pain management. For insomnia treatment, patients alternate their usual prescribed sedative versus Lemborexant or Clonidine; on alternate nights. Patients use a validated smartwatch and a validated sleep diary to collect data including mood score, sleep score, sleep duration, and adverse effects. Patients complete the diary for 20-25 days. Pain and mood are measured using numeric rating scales. Sleep score is measured using the Likert sleep scale. Within-patient differences are analyzed. Any change in pain, mood, or sleep scores by 2-points is considered significant.

Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity

Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.

Focused Ultrasound Neuromodulation for Chronic Pain

This study will evaluate the feasibility, tolerability, and preliminary analgesic effects of individualized Precision Confidence Mapping-guided low-intensity focused ultrasound neuromodulation in adults with chronic pain. Participants will undergo MRI and resting-state fMRI to identify an individualized SCAN-connected centromedian thalamic target. Participants will then complete two treatment arms in randomized order: focused centromedian thalamic low-intensity focused ultrasound and unfocused control low-intensity focused ultrasound. Each treatment arm includes five consecutive daily stimulation sessions, separated by a washout interval. The primary outcome is change in daily pain intensity measured using Brief Pain Inventory pain intensity items. Secondary outcomes include pain-related symptoms, physical function, fatigue, sleep disturbance, depressive symptoms, anxiety symptoms, pain catastrophizing, pain vigilance, neuropathic pain features, feasibility, tolerability, adverse events, blinding integrity, and exploratory neuroimaging measures.

Turkish Adaptation of the Pain and Smoking Inventory

The purpose of this study is to perform the Turkish cross-cultural adaptation of the Pain and Smoking Inventory (PSI) and to comprehensively evaluate its reliability, validity, and psychometric properties among daily cigarette smokers with chronic pain.

Evaluation of Alexithymia in Chronic Pain Patients With Spinal Cord Stimulation

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.

Pain and Opioids: Integrated Treatment In Veterans

This trial will recruit veterans with chronic pain (N = 160) who are prescribed buprenorphine for the treatment of opioid use disorder (OUD). We seek to: (1) examine the efficacy of an integrated treatment to reduce pain interference (Acceptance and Commitment Therapy and Mindfulness-Based Relapse Prevention \[ACT + MBRP\]) compared to an education control (EC) consisting of a protocol-based series of education sessions concerning chronic pain, opioids, and buprenorphine use and (2) examine how theoretically-relevant treatment mechanisms of pain acceptance, engagement in values-based action, and opioid craving are related to treatment outcomes. Interventions will be delivered via the VA Video Connect telehealth modality.

Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial

This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.

Behavioural Study in Chronic Pain : Creativity and Motivation, and Circuits Involved in Functional MRI

Being creative means having the ability to produce ideas, actions or works that are original and different from what we have already done. This process involves mental flexibility, in particular the association of distant ideas or divergent thinking. This creative potential is complex and depends on a number of factors, both internal (personality, motivation, emotional state, stress) and external to the individual (socio-cultural context). The generation of creative ideas involves the fronto-striatal circuit, with a balance between flexibility and perseverance. The striatum is central to the reward system and mental flexibility, while the prefrontal cortex is involved in executive control, underpinning perseverance functions. Dopamine plays a key role in this balance, and changes in dopamine levels, depending on the type of receptor activated, will have a direct impact on the transition between mental flexibility and perseverance. Furthermore, in the context of chronic pain, changes in connectivity and activity can be observed in neuroimaging in these same regions of the reward circuit. This suggests that the dopaminergic system is also involved in the chronicisation of pain. The creative process would therefore be correlated with the dopaminergic reward system, involving several dimensions, both cognitive in terms of mental flexibility, coping strategies and perseverance, and motivational. In this context, art therapy treatments are beginning to be studied, particularly in patients suffering from Alzheimer's or Parkinson's disease, showing improvements in anxiety and depression. Art therapy has not yet been widely proposed or studied for patients suffering from chronic pain. A more detailed behavioural study would confirm and clarify the clinical benefits for patients, by exploring the neuronal circuits involved, particularly the dopaminergic reward system.

Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain

This is a study evaluating the Scrambler Therapy device as a non-invasive treatment for neuropathic pain in pediatric oncology patients with metastatic bone disease. The primary goal is to assess changes in pain intensity and medication use, aiming to improve quality of life and reduce reliance on systemic pain medications.

Cohort of Chronic Pain Patients

Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5 billion people worldwide. Societal and economic issues are also crucial, as 60% of people with pain are less able or unable to work and 20% say they have lost their jobs because of pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU. Unfortunately, current treatments for chronic pain have limited effectiveness and important adverse effects. Pain clinics, which support the most complex and refractory cases of chronic pain, as well as general practitioners and patients expect improvements, both in terms of therapeutic efficacy and organization of care. In order to allow the characterization and a personalized follow-up of chronic pain patients, we have created e-DOL, a smartphone application for patients and a web platform for healthcare professionals in pain clinics. The purpose of this study is to create an e-cohort for the research, and characterization and follow-up of chronic pain patients.

Assessment and Treatment for Chronic Pain in Veterans With Serious Mental Illness

Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.

Mechanisms of CBD for Chronic Pain

This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.

Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With Fibromyalgia: a Randomized Controlled Trial

This research study aims to investigate whether art and integrative medicine, within a unique setting like a university museum, can offer a new approach to help women suffering from fibromyalgia. Fibromyalgia is a chronic condition causing widespread pain and other symptoms such as fatigue and sleep disturbances. The question this study seeks to answer is: Is an 8-week rehabilitation program, based on mindfulness and body awareness techniques, conducted at the University Museum of the G. d'Annunzio University, effective in reducing pain and improving the quality of life (physical and mental well-being) and coping abilities in female fibromyalgia patients? Participants will be randomly assigned to either receive this program in the museum or to a control group.

Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain

This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain. The Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into the forehead area that measures HRV throughout the use of the device. The system runs for 15 min at a time and is not FDA approved. The trial will last a total of 14 weeks. 50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai.

Reducing Chronic Pain Following Cesarean Delivery

This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and/or pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.

Chronic Pain Assessment Via AI-Powered Game

Pain is an individual experience that has existed throughout human history. Pain is divided into acute and chronic depending on its duration. While acute pain is caused by a specific cause and can be easily treated because it lasts for a short time, the same is not true for chronic pain.