Chronic Pain

Researchers are evaluating the PerQdisc Nucleus Replacement System in patients with degenerative disc disease (DDD) affecting one or more lumbar discs. This prospective, open-label, multi-center study aims to collect additional safety and effectiveness data for this minimally invasive device. The PerQdisc is designed to replace the nucleus pulposus in lumbar discs between L1 and S1, offering an alternative to spinal fusion surgery by aiming to preserve disc height and maintain spinal motion to reduce chronic low back pain. The study involves surgical implantation of the PerQdisc device using standard anterior, lateral, or minimally invasive posterolateral approaches. All patients who meet inclusion criteria and have no exclusions will be considered for nucleus replacement surgery following review by a Medical Advisory Board. The device replaces the disc nucleus at a single level of the lumbar spine, intending to preserve spinal movement and reduce pain. Participants will be monitored for safety and performance outcomes over time, including pain and disability scores at 6 and 12 months. Researchers will assess device expulsion, failure, revision surgeries, disc height, range of motion, neurological status, analgesic use, and serious adverse events up to 5 years after surgery. The study includes clinical evaluations, imaging, and questionnaires to track progress and safety, with total follow-up extending to 5 years post-implantation.

Researchers are evaluating the effects of a single infusion of (2R,6R)-hydroxynorketamine (HNK) compared to ketamine and saline in adults with chronic neuropathic pain of the extremities lasting more than 3 months. This randomized, double-blind, three-way crossover trial aims to study the pain relief effectiveness and duration of these treatments, as well as their impact on pain qualities, physical function, pain interference, sleep disturbance, and quality of life. Participants will receive three different treatments—ketamine 0.5mg/kg, (2R,6R)-HNK 0.5mg/kg, and saline—each as a 45-minute infusion given in random order with a 5-week interval between infusions over a 15-week period. Five subjects will be assigned to each possible treatment sequence. The study includes a pretreatment evaluation and follow-up assessments at 7, 14, 21, and 35 days after each infusion. During the study, participants will undergo detailed sensory and pain evaluations and complete questionnaires to report their pain and related symptoms. Safety assessments include vital signs, medical history, blood tests, liver function tests, and electrocardiograms before and after each treatment. Participants will continue their usual pain medications and record any additional medication use. The main outcome measured is pain intensity over 35 days, with secondary outcomes including pain qualities and analgesic consumption.

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis (RA). This study focuses on understanding two main factors influencing pain relief: brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinib's impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

Researchers are investigating whether touch sensation can be restored to the breast after mastectomy using neural stimulation. This trial aims to gather information to guide future studies on the safety, effectiveness, and acceptability of this approach. The study focuses on women undergoing bilateral mastectomy with two-stage reconstruction for certain types of breast cancer or breast cancer risk reduction. Participants will receive a small medical device called the Bionic Breast implant, temporarily placed in one breast during the mastectomy. This device sends tiny electrical currents to nerves to create sensory stimulation in response to touch or pressure. The device will later be removed, and the study will assess the sensations produced by the stimulation. During the study, participants will complete psychophysical tasks seven months after mastectomy, implantation, and device removal to evaluate sensation and stimulation levels. Researchers will measure outcomes such as stimulation intensity, ability to distinguish different stimuli, and mapping of sensation areas. Participants will be monitored throughout for safety and adherence, with the total study duration spanning several months post-surgery.

Researchers are evaluating the safety and effectiveness of the drug LY4065967 for treating diabetic peripheral neuropathic pain (DPNP), which is pain caused by nerve damage due to diabetes. This trial is part of a larger chronic pain master protocol aimed at speeding up the development of new treatments for chronic pain conditions. The study is a randomized, placebo-controlled Phase 2 clinical trial sponsored by Eli Lilly and Company. Participants in this study will be randomly assigned to receive either LY4065967 or a placebo, both taken by mouth. The treatment period includes regular dosing, and the study compares the effects of the drug against placebo to assess its impact on pain relief. The trial uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the trial, participants will have their pain intensity tracked using the Numeric Rating Scale, along with other assessments such as sleep quality, emotional functioning, and pain interference with daily activities. These evaluations will occur from baseline through week 8 to monitor changes. Researchers will also measure the use of rescue medication and overall patient improvement. Safety monitoring and follow-up will be part of the study to ensure participant well-being throughout the trial duration.

Researchers are evaluating the analgesic effect and safety of a mixed reality (MR) based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups: the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale (VAS) to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are evaluating the effects of different exercise programs on pain and function in adults with chronic low back pain. This randomized controlled trial includes otherwise healthy participants aged 18 to 45 who experience pain or functional limitations due to low back pain lasting more than 3 months. The study aims to understand how various exercise types impact pain levels and physical ability. Participants are randomly assigned to one of three groups: a control group that continues their usual exercise routine, a running-based intervention group, or a swimming/cycling-based intervention group. The two intervention groups will follow an 8-week combined exercise program consisting of aerobic training (running or swimming/cycling), progressive resistance exercises, and flexibility exercises. The program gradually increases in intensity over the 8 weeks to encourage adherence and reduce injury risk. Throughout the study, participants will be assessed using validated measures of pain and disability at three points: before starting (baseline), after 8 weeks of exercise, and at 12 months to evaluate long-term effects. Researchers will collect self-reported pain scores and functional questionnaires to analyze changes over time. The total study duration allows for monitoring both immediate and lasting impacts of the exercise interventions on low back pain management.

Researchers are evaluating a combined lifestyle intervention integrated into standard care for patients with persistent low back pain (LBP) who are overweight or obese and referred back to primary care from the hospital. The study aims to improve physical functioning and physical activity over 36 months, while also reducing healthcare and societal costs. Lifestyle factors like physical inactivity, stress, sleep quality, excess weight, and diet are addressed because they contribute to LBP and related health risks such as diabetes and cardiovascular disease. The intervention is delivered by certified physio/exercise therapists following Dutch clinical guidelines. It includes a two-year program where the first six months focus on behavioral change, and the next 18 months focus on maintaining new healthy habits. The program uses group and individual sessions with techniques such as motivational interviewing and self-monitoring. Patients set their own goals and treatment is tailored to their lifestyle risks and LBP clinical factors. The comparison group receives usual care as prescribed by medical specialists, which may include education, exercise therapy, pain medication, or referral back to primary care. Participants will attend scheduled assessments at baseline and multiple follow-up points over 36 months. Researchers will measure physical activity using a device that tracks daily steps and assess physical functioning with a disability questionnaire. Additional evaluations include pain intensity, weight, sleep quality, diet, inflammation markers, quality of life, healthcare costs, and overall perceived effect. These measurements will help determine the effectiveness and cost-effectiveness of the combined lifestyle intervention compared to usual care in this patient group.

Researchers are investigating treatments for temporomandibular disorders (TMD), which are increasingly common and affect jaw function and cause pain. This study aims to evaluate whether combining manual therapy with vagus nerve stimulation, a nerve linked to pain and jaw function, offers better relief and improved quality of life than manual therapy alone. The study involves 20 participants diagnosed with myogenic TMD, focusing on pain, jaw movement, and distress. Participants are randomly assigned to one of two groups: one receiving manual therapy combined with vagus nerve stimulation and the other receiving only manual therapy. Both groups undergo four physiotherapy sessions, one per week over a month, and are trained to continue treatment exercises at home over two months. The manual therapy includes joint manipulation and soft tissue techniques for the jaw. Throughout the study, an independent evaluator will assess participants monthly using questionnaires to measure chronic pain, jaw function, physical symptoms, range of motion, and distress. The main outcomes are changes in health status and chronic pain after two months. This double-blind, randomized study ensures unbiased results by keeping evaluators unaware of group assignments. Participant involvement spans two months of treatment and assessments.