Clinical Research Directory

Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers

The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients.

Safety and PK of Intrathecal CNTX-3001 for Intractable Chronic Low Back Pain

This clinical study is being conducted to evaluate the safety, tolerability, plasma pharmacokinetics and efficacy of an investigational drug called CNTX-3001. This Phase 1 study is the first time that CNTX-3001 will be given to people (first-in-human study). The study is being done to evaluate whether CNTX-3001, given into the intrathecal space by lumbar puncture, can be administered safely to participants who have been diagnosed with intractable chronic moderate to severe low back pain and who have not responded well to other treatments in the past. CNTX-3001 is a novel, non-opioid small molecule

Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy

This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin. If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.

Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques

The study's purpose is to determine the effects of three different dry needling sessions on pain and quality of life for those with chronic low back pain. Dry needling is a therapeutic procedure in which a very thin, monofilament needle is inserted through the skin to reach a target tissue like a muscle to help reduce pain, improve muscle activation, and increase blood flow. Dry needling has also been shown to improve nervous system function.

Low Back and Neck Pain in Nursing Students at The University of The West Indies

The purpose of this study is to identify the prevalence of neck and low back pain in nursing students enrolled at the University of the West Indies, Mona; to assess their knowledge, attitude and practice of good spine health and to determine the outcome of a standardised spine exercise program on nursing students experiencing neck and low back pain, using a prospective randomised control design.

Electronic Approach to the Human Massage Therapist

The purpose of this study is to gather information about patient experience receiving a massage through a robotic EMMA (Expert Manipulative Massage Automation) compared to receiving a massage from a massage therapist.

The Effects of Balanced Seating Pressure on Pelvic Asymmetry: A Pilot Study

The goal of this clinical trial is to learn if the DaSuit® cushion helps reduce discomfort caused by sitting in adults with non-specific low back pain. It will also assess the safety and physical effects of using the DaSuit® cushion. The main questions it aims to answer are: 1. Does the DaSuit® cushion distribute the pressure evenly on both under-buttock pressure compared to a placebo cushion? 2. Does the DaSuit® cushion improve spinal alignment compared to a placebo cushion? 3. What discomfort or adverse events do participants experience when using the DaSuit® cushion? Researchers will compare the DaSuit® cushion to a placebo cushion (a look-alike cushion without therapeutic effect) to see if the DaSuit® cushion works to relieve sitting-induced discomfort. Participants will: 1. Use the DaSuit® cushion or a placebo cushion in a randomized order, with each sitting session lasting 10 minutes 2. Complete both conditions with a 10-minute washout period between sessions 3. Sit on a standardized wooden chair with a pressure sensor mat placed on the cushion surface 4. Keep a fixed posture with hips, knees, and ankles at approximately 90 degrees 5. Watch a 10-minute video on a tablet positioned 30-40 cm in front of them at a 5-10 degree downward angle to maintain a steady gaze 6. Undergo spinal imaging immediately after each session, maintaining the same seated posture 7. Report any discomfort or pain experienced during or after each session

Improving Access to Chiropractic Care in Community Health Centers

The goal of this study is to evaluate the feasibility of new implementation strategies designed to increase the number of Primary Care Providers (PCPs) referrals to chiropractic care for lower back pain (LBP) in underserved populations. The investigators plan to pilot the strategies in three qualified community health centers (CHCs) and compare the number of LBP patients who receive referrals before and after implementation. The implementation strategies involve PCP, patient, and organizational interventions. Patients presenting with LBP will be provided educational materials that focus on the safety and effectiveness of chiropractic care as an evidence-based treatment for LBP. Materials will be available in CHC common areas and may be sent to patients by their PCP via patient portal. PCPs will participate in interactive lunch seminars to allow for inter-professional learning for PCPs. They will also participate in a survey regarding their attitudes and beliefs relating to chiropractic care. Currently, many PCPs cannot make chiropractic care referrals in the electronic health record (EHR). The investigators plan to add this option, or make it easier if the referral is already available. This multi-level, multi-component approach will last two months, and will be rolled out sequentially in three clinics using a stepped-wedge design. The ordering of clinics will be random. The primary outcome is the proportion of patients with LBP who received a referral to chiropractic care before and after the intervention. Secondary outcomes include referral to any non-pharmacologic treatment, use of imaging, and prescribed medications.

Peripheral Nerve Stimulation With the SPRINT® System in Chronic PSIJC Pain

Chronic lower back pain is a significant cause of disability, affecting 21-68% of people 60 years of age and older (source). Of these cases, 15-30% are attributed to posterior sacroiliac joint complex (PSIJC) pain (source), making it a target for treatment. Peripheral Nerve Stimulation (PNS) is a procedure that involves the placement of a lead under the skin with local anesthetic and electrically stimulating designated spinal nerves that deliver pain signals to the brain. It has emerged as a promising alternative to drug, injection, and radioablative therapies. Its use has been supported by previous studies of subjects who received permanent neurostimulation and experienced benefits such as decreased sensation of pain and perceived level of disability. SPRINT is a minimally invasive PNS system of interest due to its ability to provide long-term pain relief after temporary administration of PNS. The aim of this study is to understand whether the FDA-cleared SPRINT PNS system is safe and effective for the treatment of chronic PSIJC pain. This prospective clinical study will assess 10 subjects that meet the inclusion and exclusion criteria across 5 separate time points- 1.) Screening; 2.) Procedure within 3 months of screening; 3.) 12-day post-procedure follow-up; 4.) 3-month post-procedure follow-up; 5.) 3-Month post lead removal follow-up. The subjects will be required to complete physical examinations, and VAS and ODI questionnaires at timepoints 3, 4, and 5.

Effect of Dynamic Sitting on Pain Development - Part 2

As a follow-up project to the Dyn-Sit-Pain study, this research aims to investigate the overall health as well as the physical and mental well-being through dynamic office chairs. The development of an innovative dynamic office chair concept will be professionally and scientifically supported, and the developed prototypes will be examined within the framework of usability studies.

Neck and Low Back Pain in Medical Students at The University of the West Indies, Mona, Jamaica

The purpose of this study is to identify the prevalence of neck and low back pain in medical students enrolled at the University of the West Indies, Mona; to assess their knowledge, attitude and practice of good spine health and to determine the outcome of a standardised spine exercise program on medical students experiencing neck and low back pain, using a prospective randomised control design.

Bone Enhanced Ultrasound (BEUS) Data Library Development Project

A common treatment for low back pain involves fluoroscopy-guided spinal facet joint injections and/or medial branch nerve blocks. Unfortunately, fluoroscopy requires expensive equipment and personnel and exposes patients and healthcare providers to ionizing radiation. Ultrasound offers a safer, lower-cost alternative, but the traditional 2-dimensional (2D) ultrasound systems are limited due to poor image quality, particularly in patients with higher body mass index (BMI). As an alternative, a novel Bone Enhanced Ultrasound (BEUS) technology uses artificial intelligence (AI) to create real-time 3-dimensional (3D) images of the spine to guide needle placement for these injections. The AI software is trained by overlaying computed tomography (CT) and ultrasound images from a patient dataset to recognize anatomical landmarks. BEUS aims to ultimately replace fluoroscopy for spinal injections, reducing radiation exposure, lowering healthcare costs, and improving accessibility, especially in rural settings where CT and fluoroscopy are unavailable. A key limitation, however, is that the current AI system is trained based primarily on patients (mostly pediatric) undergoing perioperative assessment of scoliosis. To address this, the current study aims to develop a new, more clinically relevant training AI dataset by collecting spinal ultrasounds from up to 100 adult participants (most/all of whom are followed at the local chronic pain clinic for low back pain) with existing spinal CT or magnetic resonance imaging (MRI) scans. This dataset will be used to retrain the current AI model to enhance the accuracy of 3D spinal reconstructions, thereby improving the clinical relevance of the BEUS system.

The Effect of Kinesio Taping Applied to Operating Room Nurses on Low Back Pain, Fatigue, and Sleep Quality

This study aims to determine the effects of kinesiology taping applied to operating room nurses on lower back pain, fatigue, and sleep quality. The research will be conducted using a randomized controlled experimental design with pre-test and post-test control groups. The universe of the study will consist of 100 operating room nurses working in a university hospital. The sample size has been calculated as a total of 84 nurses (Intervention group: 42; Control group: 42) based on power analysis calculations. The study will commence after obtaining the necessary permissions. Data collection will involve the use of the Descriptive Information Form, Visual Analog Scale, Quebec Back Pain Disability Scale, Visual Analogue Scale for Fatigue, and the Richards-Campbell Sleep Questionnaire. Participants who consent to the study will be administered the Descriptive Information Form, Visual Analog Scale, Quebec Back Pain Disability Scale, Visual Analogue Scale for Fatigue, and Richards-Campbell Sleep Questionnaire before the application of kinesiology tape. Subsequently, a physiotherapist from the research team will apply kinesiology tape to the paravertebral muscles using the muscle technique. As the literature suggests that the most suitable number of days for kinesiology tape application is four, participants will be instructed not to remove the tapes for four days. Additionally, participants will be informed that they can continue their daily activities and shower with the kinesiology tape on. The Visual Analog Scale will be applied to the participants at the end of the workday on the day of the kinesiology tape application and at the end of the workday for four days. At the end of the fourth day, all data collection tools will be applied. Seven days after the application, the scales will be filled out again by the nurses to determine if the effects of the kinesiology tape persist. Participants in the control group who agree to participate in the study will have data collected at the same time intervals as the intervention group participants using the same data collection tools. The Visual Analogue Scale will be administered to participants at the end of the day the data collection tools are filled out and at the end of the workday for four consecutive days. At the end of the fourth day, all data collection tools will be applied again. Seven days after the application, all scales will be refilled by the nurses..

Anxiety Level Among Patients With Chronic Low Back Pain

The goal of this observational cross-sectional study is to learn about the intensity of anxiety symptoms among Polish people suffering from chronic lower back pain. The main question it aims to answer is: What is the severity of anxiety symptoms among the Polish population of patients suffering from chronic lower back pain?