Complex Regional Pain Syndrome (CRPS)

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 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 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.

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

Researchers are conducting a multi-center clinical longitudinal study to better understand neuropathic pain by examining patients' brain activity and cognitive function. The study collects detailed data on pain levels, sleep quality, social support, anxiety, depression, and cognitive tasks using various scales and imaging techniques. This observational research aims to track changes in these factors during acute pain episodes in adults aged 18 to 85 years. Participants diagnosed with neuropathic pain will join the study and receive standard care from the pain department while being observed over time. The study includes evaluations using pain scales like the Visual Analogue Scale (VAS) and digital pain grading (NRS), as well as assessments of sleep, anxiety, cognitive function, and brain activity through electroencephalogram (EEG) and near-infrared brain imaging (fNIRS). Follow-up continues up to three months after enrollment to monitor changes. During the study, participants will undergo various assessments including pain scoring, cognitive tests, emotional tasks, and questionnaires on sleep and social support. Brain function will be monitored using EEG and fNIRS. Researchers will evaluate measures such as pain intensity, sleep quality, anxiety and depression levels, and cognitive abilities at one month. Participants' progress will be closely observed throughout the study period, which lasts at least three months post-enrollment.

Researchers are evaluating the effects of Problem Adaptation Therapy for Pain (PATH-Pain) on cognitive function, depression, and pain-related disability in older adults who have mild cognitive impairment or early stage Alzheimer's disease, along with chronic pain and depression. The study compares PATH-Pain to Attention Control Usual Care to see which approach leads to better cognitive, emotional, and functional outcomes in this population. This is a randomized control trial with a focus on real-world application in primary care settings. Participants in the PATH-Pain group receive a total of 14 therapy sessions: eight weekly in-office sessions during the first eight weeks, followed by six monthly phone sessions (three individual and three group) from weeks 9 to 36. The therapy teaches emotion regulation, problem-solving skills, and uses compensatory strategies to help manage memory challenges. A tablet app called WellPATH may be used to support emotion regulation techniques. The control group receives usual medical care from their physicians and additional structured interviews and educational sessions unrelated to cognitive impairment, pain, or depression, plus an educational booklet. During the study, participants undergo assessments at the start and at weeks 5, 9, 24, 36, and 52. These include tests of cognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status, evaluations of depressive symptoms, and measures of pain-related disability. Each therapy session lasts about 50 minutes. Caregiver participation is required, and the study monitors cognitive changes, mood, and pain-related functional abilities over one year. The study aims to evaluate the overall impact of PATH-Pain compared to usual care in this group of older adults.

Researchers are evaluating the impact of live and recorded music-based interventions on patients undergoing neurosurgical procedures. The study aims to measure changes in vital signs, stress biomarkers, and self-reported pain, anxiety, and mood before and after the music sessions. It also explores how prior musical experience and preferences might influence responses to music in reducing stress and anxiety. Participants will be randomly assigned to one of three groups: simulated live music, recorded music using a Steinway Spirio M player piano, or no music as a control. The study uses a randomized controlled design to compare these interventions. Each participant will receive their assigned music intervention before surgery, and the study will monitor physiological and psychological responses. During the study, participants will provide demographic information and complete questionnaires, including the Brief Musical Experience Questionnaire (BMEQ), to assess their musical background. Researchers will monitor stress and mood changes as primary outcomes throughout the study, along with serum and plasma stress biomarkers. The study will continue assessing these outcomes through completion, with a focus on understanding the effects of music on preoperative stress and pain.

This research aims to explore the potential use of enalapril to treat painful venous malformations, which are congenital vascular defects that can cause disfigurement and pain, affecting patients' quality of life. The study investigates whether enalapril can reduce the pain and volume of these malformations and improve quality of life in affected patients aged 18 to 70. The trial is a phase 2, single-center, single-arm pilot study led by Oslo University Hospital.

Researchers are evaluating the safety, tolerability, how the body processes, and the effects of food on the oral drug HRS-6257 in healthy adults aged 18 to 55. This phase 1, randomized, single-blind, placebo-controlled study aims to gather detailed information about how single and multiple doses of HRS-6257 behave in the body and their impact on pain tolerance. Participants will receive either HRS-6257 or a placebo in two parts of the study. The drug is given orally in single and repeated doses to assess its pharmacokinetics and pharmacodynamics. The study includes measurements over time to observe the drug's absorption and effects, including the influence of food on its bioavailability. During the study, participants will be monitored for adverse events from the day they sign consent until Day 14, 21, or 27 depending on the study part. Researchers will assess drug levels in the blood up to 72 hours after dosing, measure pain tolerance using the Cold Pain Test, and evaluate responses related to suicide risk. The total participation involves multiple visits for drug administration and safety evaluations to ensure careful monitoring throughout the trial.