Muscle Strain

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 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.

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 a new way of providing physical therapy directly in the emergency department (ED) for adults with low back pain. This multi-site feasibility trial compares this embedded ED physical therapy model to usual care at two hospital EDs within the Northwestern Medicine and University of Utah Health systems. The study aims to test if this approach can be successfully implemented, including enrolling patients and collecting long-term outcome data, as a step toward a larger future trial focused on pain and opioid use outcomes. The trial randomly assigns two hospital EDs to either have a physical therapist available on-site to start timely care for low back pain patients or to continue with usual care, which may include imaging, education, and medications but no ED physical therapist involvement. The intervention period lasts 9 months, followed by 12 months of collecting patient-reported outcomes and electronic health record data. A third hospital ED will contribute baseline data without participating in the intervention or enrollment. Participants are adult patients visiting the ED with low back pain lasting up to 30 days during daytime hours. They will complete surveys over 12 months to measure pain interference and other health outcomes. Researchers will also review health records and survey clinicians to assess how well the intervention is adopted and delivered. The study monitors participant retention and data completeness to inform future research. Overall participation lasts 21 months, including intervention and follow-up phases.

Low back pain is a leading cause of disability worldwide and a common reason for primary care visits. This research aims to improve how low back pain is managed in primary care by testing a multilevel intervention developed with general practitioners, physiotherapists, and occupational therapists. The study evaluates the effectiveness of this new care approach compared to usual care, focusing on cost-effectiveness, imaging rates, and patient disability over time. The intervention includes training general practitioners, sending reminders, providing patient education, and using a clinical pathway based on risk of chronicity. Patients may receive education and self-management support, individual physiotherapy sessions after a specialized two-day workshop, and multidisciplinary group management if needed. Care pathways involve screening, follow-up questionnaires assessing risk and work ability, and tailored treatment steps over several weeks, with coordination among healthcare providers encouraged. Participants will be monitored for 12 months through questionnaires at multiple time points and administrative data. Outcomes measured include back-related disability, imaging referrals, opioid and sick leave prescriptions, pain intensity, quality of life, work participation, and beliefs about back pain. Healthcare professionals' confidence and beliefs will also be assessed. Implementation outcomes such as acceptability and feasibility will be explored via interviews and focus groups with patients and practitioners to understand integration into routine care.

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.