Clinical Research Directory

Prevalence of Fabry's Disease in a Population of Patients With Chronic Pains

Fabry disease (FD) is a rare X-linked multisytemic lysosomal disorder caused by alpha-galactosidase deficiency. Globotriaosylcéramide (Gb3) deposits are observed in almost all tissues examined. Signs of the disease appear earlier and are more severe in affected males than in females. Myocardiopathy, renal failure and neurological signs including chronic pain and peripheral neuropathies are the most frequent signs. The availability of two enzymatic replacement therapies now provides a specific and effective treatment for patients. The prevalence of FD is estimated between 1/40,000 and 1/117,000. The frequency of Fabry disease has previously been estimated in several series of patients presenting one single sign, ie renal failure, hypertrophic myocardiopathy and early onset stroke. However, no data are available about the prevalence of FD in populations of patients suffering from chronic pains of unknown origin. The diagnosis of FD will be performed by standard procedures following international recommendations. These require the search for a deficiency of alphagalactosidase A activity on leucocytes in males and genetic analysis of the GLA gene in females (Lidove et al. 2007). The patients in whom the diagnosis of FD is established during this study, will be call in for an additional visit in the Investigating Centre in order to confirm the diagnosis and propose suitable assessment and care.

Sociocultural & Biobehavioral Influences on Pain Expression and Assessment

Objective The current proposal investigates behavioral, psychophysiological, and social processes that may help explain biases and disparate outcomes in pain. Health disparities, or health outcomes that adversely affect disadvantaged populations, are pervasive and apparent in many diseases and symptoms, including pain. Pain is the number one reason individuals seek medical treatment. Health disparities in pain encompass both differences in pain experience and treatment for pain. For instance, research indicates that Black individuals report increased pain and have reduced pain tolerance relative to White individuals, yet doctors are less likely to treat minority patients pain and underestimate their pain experience. This project aims to address this systemic discrepancy by focusing on interpersonal processes that may contribute to these disparities, including socially-relevant responses to pain (i.e. pain expression) and pain assessment (e.g. visual attention). The proposed research aims to determine whether the study of pain expressions and their assessment can yield insights on how social factors shape pain and its treatment. Further, we test the efficacy of potential interventions designed to improve accuracy and reduce biases in pain assessment. If successful, this work will form the foundation of a new research program that will link the field of pain research with the field of social neuroscience, and forge new insights on the critical problem of health disparities in pain. Study population We will accrue up to 700 total healthy volunteers to target 240 completers Design Our overall aim is to understand how social factors influence the assessment and management of pain, and to gain insight into psychosocial processes that may underlie health disparities in pain. We propose a series of studies designed to test these links. First, we will measure pain perception and physiological responses to painful stimuli in a diverse group of individuals to test for sociocultural and biological influences on pain and pain-related responses. In subsequent studies, new participants ("perceivers") will view images of these initial participants ("targets") and will provide estimates of 'targets' pain experience. We will measure a) whether perceivers can accurately estimate 'targets' pain experience; b) whether accuracy differs as a function of similarity between target and perceiver (ingroup vs outgroup); and c) whether individuals can improve accuracy through feedback. Outcome measures Primary outcome measures for all experiments will be decisions about pain (experienced by self or other) measured with visual analogue scales, reaction time, and/or categorical judgments (pain/no pain). We will also measure physiological responses (e.g., facial muscle response, skin conductance, pupil dilation) and brain responses using functional magnetic resonance imaging (fMRI) as secondary outcome measures. We will test whether pain and pain-related responses varies as a function of sociocultural/demographic factors (e.g. race, ethnicity, sex) and whether accuracy in assessing others' pain is influenced by group similarity (i.e. ingroup vs. outgroup) and training (e.g. performance-related feedback)....

Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty

Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.

Photo-biomodulation Therapy for Pain Relief After Caesarean Section

C-sections may result in a lot of pain that is distressing to the mother, and can impact bonding with the baby. Although there are medications used to treat strong pain, they are not good to use after C-sections because they can affect the baby. There is a need for a pain management option that can reduce the use of medications. The investigators are testing the effects of a combined light and laser device (photo-biomodulation therapy; PBMT), used on the wound twice daily, with respect to pain right after surgery, and pain that lasts longer than 6 weeks after surgery.

13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain. Purpose: To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability. Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006. The Swedish Ethical Review Authority approved the study. Dnr: 2019-01944, 2019-05-21.

The Effect of Smoking in Women

This study aims to investigate the effects of smoking on pain threshold, cervical position sense, and grip strength in women. Measurements will include pressure pain threshold (PPT), cervical position sense (CPS), grip strength, and pinch strength.

Chronic Pain in Rheumatoid Arthritis

The objective is to identify modifiable clinical factors and neurobiological pathways that lead to the development of chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing, a type of testing that involves assessing response to well-defined, quantifiable painful stimuli, at 0, 3, and 12 months. A subset of participants will also undergo magnetic resonance imaging at 0 and 12 months to assess neuroimaging markers that have previously been shown to be involved in chronic pain.

Sensory Distribution and Postoperative Analgesia of Ultrasound-Guided Interfascial Plane Blocks in Living Liver Donors

Living liver donor hepatectomy at our institution routinely includes ultrasound-guided interfascial plane blocks as part of postoperative analgesia. Although these blocks have become increasingly used in donor hepatectomy, their cutaneous sensory distributions and block-related dermatomal coverage have not been systematically evaluated, with only anecdotal reports available in the literature. This prospective observational study aims to assess both the sensory blockade patterns and the early postoperative analgesic performance of interfascial plane blocks administered to living liver donors. Following surgery, all consenting donors receive the institution's standard block protocol. Cutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Pain intensity and analgesic requirements within the first 24 hours are also recorded. The study is designed to provide objective data on the dermatomal coverage and postoperative analgesic effects of contemporary ultrasound-guided interfascial plane blocks used in living liver donor surgery.

Constructivist Prenatal Education Effects

The Effect of a Constructivist-Based Prenatal Education Program on Pregnant Women's Fear of Childbirth, Pain Beliefs, and Self-Efficacy for Normal Delivery: A Randomized Controlled Trial.

Anatomical Axis on X-Ray and Its Relationship With Pain and Kinesiophobia in Knee Osteoarthritis

Knee osteoarthritis is a common joint disease that causes pain, stiffness, and limitations in daily activities, especially in older adults. Changes in the alignment of the lower limb, called the anatomical axis, can increase the mechanical load on the knee joint and may affect pain and mobility. This study aims to investigate the relationship between the anatomical axis measured on knee X-rays and patients' pain levels, functional status, quality of life, and fear of movement (kinesiophobia). This is a single-center, observational, cross-sectional study. Adult patients diagnosed with knee osteoarthritis who have a standard knee X-ray taken within the last 6 months and who volunteer to participate will be included. Pain will be measured with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the 36-Item Short Form Health Survey (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). The femoro-tibial angle and joint space width will be measured on X-rays by two independent observers. By examining the relationship between radiographic alignment and clinical findings, this study may provide new insights into the comprehensive evaluation of knee osteoarthritis and help guide treatment planning for patients.

Active vs. Passive VR During Office-based ENT Procedures

The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars Sinai.

Comparison of Treatment Modalities in Myofascial Pain Syndrome

The aim of this study is to evaluate the effects of classical massage on pain, muscle sensitivity, muscle activity, functional status, and quality of life in individuals with myofascial pain syndrome, and to compare the effectiveness of classical massage applied alone versus in combination with a conventional physiotherapy program.

Trauma-adapted Yoga in Child & Adolescent Psychiatry.

The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice. Within and between group (yoga group vs waiting list) analyses will be performed.

Music and VR Effects on Pain, Anxiety, and Fear During Oral Mucositis Care in Leukaemic Children

Children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. Mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. Although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. The pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. Since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. In this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. Block randomisation (gender (F/M) and age groups (6-9/10-12) will be used to identify participants. Five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the Child Anxiety Scale-Disposition (CAS-D), Child Fear Scale and Visual Analogue Scale (VAS). The study will be conducted in three groups as control group, VR group and music group. Descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. In examining the relationship between dependent and independent variables, Mann Whitney-Kruskal Wallis or Student t-Anova analyses will be performed according to the result of the analysis of conformity to normal distribution. Bonferroni analysis will be used for pairwise comparisons and Covariance analysis will be used to investigate the effect of variables with children.

Ketamine and Propofol NeuroImaging

This is a multi-visit which will collect MRI (pictures of the brain) and EEG (brain waves) data to determine changes in brain connectivity and brain activity for memory formation and pain perception while receiving the commonly-used anesthetic agents ketamine and propofol, both alone and in combination.

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

Box Breathing for Anxiety, Pain and Nausea in ERCP Patients

This study aims to evaluate the effects of a non-pharmacological breathing technique, known as box breathing, on anxiety, pain, and nausea in adult patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). ERCP is an invasive endoscopic procedure that may cause significant physical and psychological discomfort, including increased anxiety, pain, and nausea. Participants are randomly assigned to either an intervention group receiving standard care plus box breathing training or a control group receiving standard care alone. The box breathing technique consists of four equal phases of breathing (inhale, hold, exhale, hold), each lasting four seconds. Anxiety, pain, and nausea levels are assessed before ERCP and within the first 24 hours after the procedure. The results of this study may contribute to improving patient comfort and supporting the use of simple, nurse-led interventions in clinical practice.

IceBath: NOICE vs Nothing

This prospective, randomized, 2-period crossover study seeks to evaluate the effect of the non-visual immersive technology-based audio biofeedback intervention, delivered through devices such as NOICE device or Quest 3, on cold pain threshold within participants.

Effects of a Machine Learning-based Lower Limb Exercise Training System for Knee Pain

The goal of the study is to confirm the idea of AI-powered Technological Surrogate Physiotherapist (TSP), by demonstrating its effectiveness and value as a new technology-based contribution to OA healthcare. Participants will be randomized to one of two groups: (1) the conventional PT group receiving the exercise program delivered through in-person sessions; or (2) the AI-guided group following the program through the TSP after an initial PT session. All individuals will take part in the study for 12 weeks, and data will be collected at baseline and 12 weeks after randomization.

ShotBlocker, Cold Needling, and Both Methods in Combination Pain and Satisfaction

Intramuscular (IM) injections are one of the most frequently used pharmacological treatment methods in nursing practice. Reducing the pain experienced by patients during this procedure and ensuring patient satisfaction are important indicators of treatment quality. Reducing injection-related pain should be a priority in nursing care for both patient safety and the effectiveness of the treatment process. This study is a trpile-blind, randomized, controlled trial. It was designed to evaluate the effects of ShotBlocker, cold needle, and a combination of both methods during intramuscular injection on patient pain levels and satisfaction. The research will be conducted in the injection unit affiliated with the Adult Emergency Department of Konya City Hospital, Ministry of Health of the Republic of Turkey. The study population will consist of patients who presented for cyanocobalamin injections, and the sample will consist of 132 individuals who voluntarily agreed to participate in the study and met the inclusion criteria. Before conducting the study, ethical approval will be obtained from the Necmettin Erbakan University Health Sciences Ethics Committee and from the Konya City Hospital of the Ministry of Health of the Republic of Turkey. Collected data will be analyzed using the SPSS statistical package program (version 22.0; SPSS Inc., USA). The Kolmogorov-Smirnov test will be used to assess whether the data exhibit a normal distribution; statistical significance will be accepted as p\<0.05.

Neural and Psychological Mechanisms of Pain Perception

Background: \- Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision. Objectives: \- To better understand how pain and emotions are processed and influenced by psychological factors. Eligibility: \- Healthy volunteers ages 18-50. Design: * This study requires 1 to 2 clinic visits that last 1 to 3 hours. * Participants will be screened with medical history and physical exam. * Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs. * Participants' heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored. * Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI. * Participants will fill out questionnaires. * The study will last 3 years.

Analgesic and Subjective Effects of Terpenes

The purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of THC.

Using a Stress Ball With Music During Colonoscopy

This study aims to evaluate whether using a stress ball together with listening to music during a colonoscopy procedure can reduce patients' pain and anxiety and improve their overall experience of the procedure. Colonoscopy is an important method for diagnosing and preventing colorectal diseases, but it can often cause discomfort, pain, and anxiety in patients. In this randomized controlled study, 100 patients undergoing colonoscopy without sedation are divided into two groups. One group receives the intervention, which includes listening to relaxing music and using a stress ball starting before the procedure and continuing throughout it. The other group receives standard care without any additional intervention. Pain levels, anxiety levels, and patients' perceptions of the procedure are measured before and after the colonoscopy using validated assessment tools. Patient satisfaction with the intervention is also evaluated. The study investigates whether simple, low-cost, and non-invasive methods such as music and stress ball use can improve patient comfort and experience during colonoscopy. The findings may help healthcare providers, especially nurses, to enhance patient-centered care practices.

Pain Outcomes Associated With Exogenous Hormone Therapy in Adults

TRANSPIRE is an observational study of \~200 individuals who (1) will be initiating gender-affirming hormone therapy (GHT) or (2) are gender minority individuals who do not use GHT. The primary outcome will be to identify how the presence of chronic pain changes overtime with GHT through the use of surveys, quantitative sensory testing (QST), brain MRIs, and qualitative interviews. Following recruitment and consent, participants will complete baseline survey measures and will repeat those measures at 1 months, 3 month, 6 months, and 12 months. QST measures, brain MRIs, and Qualitative Interviews will be offered to participants in cohort (1) and will be completed at baseline and 12 months.