Dysmenorrhea (Painful Periods)

This research aims to evaluate knee joint position sense, pain, and dynamic balance in females with primary dysmenorrhea, a common menstrual condition affecting many adolescent girls and women of reproductive age. The study is observational and focuses on young adult females aged 18 to 25 years. It addresses a gap in understanding how primary dysmenorrhea impacts physical therapy-relevant factors such as knee joint function and balance. Participants will be grouped based on their dysmenorrhea severity: those with no or mild symptoms and those with moderate to severe symptoms. There is no intervention applied during the study; instead, measurements are taken to compare these groups. The study observes participants during their menstrual cycle at specific times to assess balance and knee joint sense. During the study, researchers will measure overall stability indexes including antero-posterior and medio-lateral stability, as well as knee joint position sense and pain on the first and fourth days of menstruation. These assessments will help understand the effects of primary dysmenorrhea on physical balance and knee function. The total study duration includes these menstrual cycle assessments, with no additional intervention or treatment.

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 vipoglanstat on non-menstrual pelvic pain (NMPP) related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are evaluating GenSci048 for treating moderate to severe pain associated with endometriosis in pre-menopausal women. This randomized, double-blind, placebo-controlled Phase IIa study aims to assess the safety and effectiveness of GenSci048 in relieving endometriosis-related pain. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on women aged 18 to 49 who have been diagnosed with endometriosis within the past 10 years. Participants will receive either GenSci048 or a placebo by subcutaneous injection every four weeks. The treatment period includes regular dosing and monitoring over several months. Researchers will compare changes in pain levels, including menstrual pain and non-menstrual pelvic pain, using a numeric rating scale from baseline through week 24 and up to 52 weeks for secondary outcomes. During the study, participants will attend scheduled visits for assessments of pain, use of rescue medications, and overall health evaluations. Safety will be monitored through adverse event reporting for up to approximately 56 weeks. Pain changes will be measured with standardized scales, and participants will be asked about their impressions of change at multiple time points. Total participation may last over one year, including treatment and follow-up periods.