Pain

Many patients suffer from traumatic burns, and current treatments mainly focus on infection prevention and fluid management without improving the skin's ability to regenerate. This research aims to evaluate the role of 4-aminopyridine (4-AP), a promising agent with a good safety profile, in accelerating burn wound healing in patients with second-degree burns. The study addresses the need for new regenerative treatments that can speed up recovery while allowing existing protocols to continue. Participants will be randomly assigned to receive either 4-aminopyridine capsules (10 mg every 12 hours) or a placebo capsule on the same schedule. This phase 2 study will compare these two groups over a 12-month period to assess the treatment's effect on the healing process. The study uses triple masking to ensure unbiased results. During the study, participants will be monitored for healing rate, skin graft requirements, scar formation, and scar sensitivity over 12 months. They will provide informed consent and attend scheduled follow-up visits where researchers will evaluate wound healing through sensory and motor assessments and calibrated wound photographs. Safety and adherence will be closely tracked to evaluate the treatment's impact and patient outcomes throughout the study period.

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.

Burn injuries can cause long-lasting physical and mental effects due to scarring and painful dressings. The usual treatment involves antibiotic topical dressings while waiting to determine the depth of the burn, followed by surgery for deeper burns. Assessing burn depth is difficult, and surgical removal of damaged tissue may remove some healthy tissue. New methods like hydro-dissection devices and enzymatic treatments like Bromolein have been explored but lack clear proof of benefit and may sometimes cause harm. This research compares PluroGel®, a special gel that helps soften and remove dead tissue while keeping the wound moist, to the standard antibiotic ointment and gauze dressings. PluroGel® is applied in a 0.5 cm layer with moist gauze twice daily, alongside the standard dressing applied three times a week. The study will assess if PluroGel® improves wound healing and reduces the need for surgery. Participants will receive either the standard dressing or PluroGel® treatment and will be followed for up to 14 days. Researchers will monitor wound healing, pain levels, satisfaction of patients and caregivers, and whether surgery is needed. The study uses a randomized, double-blind design and aims to provide evidence on the effectiveness of PluroGel® in burn care.

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 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 investigating the effects of an investigational cold treatment device called ETX-4143 on the eye's surface anatomy and inflammatory response in people with chronic ocular surface pain (COSP). This study aims to understand changes to corneal surface nerves and inflammatory mediators after treatment, while also evaluating the safety of this cooling device. The study involves detailed imaging and tear sample analysis to learn more about the condition and treatment impact. The ETX-4143 Device is a handheld cooling tool containing a frozen mixture that cools metallic probes touching the eye's conjunctival surface without direct contact with the frozen mixture. Before treatment, local anesthesia and a corneal shield are applied to protect the eye. Participants will receive a 4-minute cold treatment to the worse eye using this device. This single-center study will treat 5 adults with chronic ocular surface pain and follow them for 12 weeks. Participants will be screened for chronic ocular surface pain and will complete weekly eye pain questionnaires for 12 weeks. Clinic visits at 2, 6, and 12 weeks after treatment will include corneal surface imaging and tear sample collection. Both eyes will be assessed with confocal microscopy and tear osmolarity tests, using the untreated eye as a control. The main measurement is corneal nerve imaging analysis over the 12-week period, alongside safety monitoring by the medical team.

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.

Researchers are evaluating a new program called Strengthening COnnections to Overcome Pain (SCOOP) designed for older adults living in rural areas who experience chronic pain and loneliness. This program aims to teach strategies for managing these conditions and to determine whether participation reduces pain interference in daily life and decreases feelings of loneliness. The study also looks at how engaged participants are with the SCOOP program compared to those who do not participate. The SCOOP program lasts for 7 weeks and is mainly delivered over the telephone by community health workers. Participants in the intervention group watch brief weekly videos that teach pain management and social connection skills, followed by coaching sessions to support goal-setting in these areas. Community health workers also screen for unmet social needs and connect participants to resources. Those in the control group receive usual care and after the 8-week follow-up, are offered an educational workshop and access to the intervention materials. Participants will be involved in two telephone interviews, one at the start and another 2 months later, to assess their health, mental health, and functioning. Researchers will measure engagement by counting the number of sessions completed and will evaluate changes in loneliness using the UCLA 8-item Loneliness Scale and changes in pain interference with the PROMIS-43 Adult Profile pain subscale. Satisfaction with the SCOOP program will also be assessed. The total participation period covers baseline through 8 weeks with follow-up assessments.

Researchers are conducting a first-in-human, randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TT5 given at different doses in healthy volunteers and surgical patients. This phase 1 trial includes both single and multiple ascending dose parts and involves healthy and surgical participants aged 18 to 55 years. The study aims to explore TT5's effects, including psychological responses and potential fluid biomarkers. The study consists of three parts: Part A tests single ascending intravenous doses of TT5 in healthy participants across up to five dose levels; Part B evaluates multiple ascending doses over seven days in healthy participants with up to three dose levels; and Part C administers intravenous doses on the same day to surgical patients in up to three dose levels. Both TT5 and placebo (vehicle) are given intravenously, and dosing schedules vary according to the study part. Participants will be monitored for adverse events, vital signs, physical exams, laboratory tests, and psychological responses using tools like the Bond and Lader Visual Analog Scale. Pharmacokinetic measurements will include plasma and urine analysis over specified days. Safety and tolerability will be assessed through day 8 for single doses and day 14 for multiple doses. The total study duration varies by cohort, with close follow-up during and after dosing to evaluate TT5's effects and safety.

Researchers are studying whether the handheld device called Grasp can help reduce pain and distress in children and adolescents aged 8 to 15 during small needle procedures. These procedures include venous puncture, insertion of a peripheral venous catheter, and local anesthesia injections before dental treatment. The study aims to compare the effects of using Grasp during these procedures with standard care to see if it helps improve the experience for young patients. Grasp is a soft silicone ball with pressure sensors that detect squeezes of different strengths and durations. When squeezed, it provides real-time visual and auditory feedback through an iPad application, playing melodies and showing dynamic curves. Participants in the intervention group will squeeze the Grasp ball repeatedly, starting at least 10 seconds before and continuing throughout the needle procedure. The control group will receive standard care without Grasp. In addition to the randomized trial, six children with type 1 diabetes will use Grasp during blood sugar measurements or insulin injections as part of exploratory use. During the study, participants will fill out questionnaires about their pain and distress before and after the procedure, as will their parents or guardians. Some participants at the dental clinic will use Grasp during further dental treatment and complete additional forms afterward. The main measure is self-reported pain immediately after the procedure, with secondary measures including distress reported by both children and parents. The study includes interviews with some participants to explore their experiences, and statistical analyses will assess the impact of using Grasp.