Radiculopathy

Researchers are evaluating the accuracy of the straight leg raise test in adults suspected of having lumbosacral radicular pain, which often results from lumbar disc herniation and causes pain radiating from the lower back or buttock to the leg. This observational study uses diagnostic transforaminal epidural steroid injection or selective nerve root block as reference standards to measure the tests sensitivity, specificity, and overall diagnostic performance. Participants will undergo clinical evaluation including the straight leg raise test followed by diagnostic injections targeting the L4, L5, or S1 nerve roots. Only selective injections performed without sedation and with a low volume of short-acting local anesthetic are included. The study will analyze the diagnostic value of the straight leg raise test compared to these injections, helping to determine when the test alone is sufficient or when further diagnostics are necessary. During the study, participants will be assessed before and one hour after the diagnostic injection using the straight leg raise test, pain intensity scales, and the Bragard test. Additional evaluations include questionnaires, lumbar MRI analysis for disc degeneration and nerve root compression, and monitoring of any changes in symptoms. The study aims to provide detailed diagnostic insights, with participation expected to cover assessments during the diagnostic procedure and related clinical evaluations.

Researchers are evaluating the effects of two different techniques, Facilitated Positional Release Technique FPRT and Manual Myofascial Release Technique, in female patients with Piriformis Syndrome. This randomized control trial aims to compare these treatments to see how they impact hip range of motion and pain levels in affected individuals. The study focuses on women aged 25 to 50 who have experienced Piriformis Syndrome symptoms for at least two months. Participants are divided into two groups a treatment group receiving the Facilitated Positional Release Technique and a control group receiving Manual Myofascial Release. The FPRT involves applying pressure over tender muscle areas while maintaining specific positions, with five repetitions. The control group undergoes 3 to 5 repetitions of manual myofascial release, applying ischemic pressure directly on the piriformis muscle for 90 seconds before release. At the start, baseline measurements of hip range of motion including abduction, adduction, internal and external rotation, pain levels using the Numeric Pain Rating Scale NPRS, and functional ability via the Lower Extremity Functional Scale LEFS are taken. After two weeks of treatment, these assessments are repeated to compare changes. The primary outcome measured is the change in range of motion after two weeks. The study is sponsored by Foundation University Islamabad and plans to conclude by April 2025.

Researchers are evaluating the safety and effectiveness of the PerQdisc Nucleus Replacement Device NRD for patients with degenerative disc disease DDD causing chronic low back pain. This prospective, open-label, multi-center study involves 72 patients who have DDD in one or more lumbar discs between L1 and S1. The study aims to collect additional data on this minimally invasive device, which is designed to maintain disc height and preserve spinal motion compared to the current standard spinal fusion surgery. Participants will undergo nucleus replacement surgery using the PerQdisc device via standard anterior, lateral, or minimally invasive posterolateral surgical approaches to replace the single nucleus pulposus in the affected lumbar disc. All surgeries require approval from a Medical Advisory Board. The study focuses on patients who have exhausted at least six months of conservative treatments for their back pain and meet specific criteria, including disc height and pain scores. During the study, participants will be monitored closely with evaluations at multiple time points up to five years. Researchers will assess performance outcomes such as disability Oswestry Disability Index, pain levels Visual Analog Scale, disc height, and range of motion, as well as safety outcomes including device expulsion, failure, neurological status, revision surgeries, and serious adverse events. Follow-up visits will include questionnaires, imaging, and clinical assessments to track the devices impact over time.

Researchers are evaluating the effects of two different voltage settings, 45 V and 60 V, for pulsed radiofrequency PRF treatment applied to the cervical dorsal root ganglion DRG in patients experiencing cervical radicular pain. This condition involves nerve pain radiating from the neck due to nerve root compression, often following inadequate response to conservative treatments. The study aims to compare pain relief and functional improvement between these two PRF voltage groups, while also monitoring any procedure-related side effects. Participants receive PRF treatment targeted at the cervical DRG under fluoroscopic guidance. Both groups undergo a similar procedure involving local anesthesia and sensory stimulation to confirm correct needle placement. The PRF is then applied for 240 seconds at a maximum temperature of 42C, with either 45 V or 60 V applied depending on the assigned group. After the procedure, patients are observed for 60 minutes before discharge. The study uses a randomized, parallel design to compare these two active treatment groups. Participants pain levels are measured using the Numerical Rating Scale NRS, and functional disability is assessed with the Neck Disability Index NDI before treatment and at 3 and 6 months afterward. Researchers also record any adverse events related to the procedure throughout the follow-up period. This allows assessment of both the effectiveness and safety of each voltage setting. The total study duration spans from the initial treatment through the 6-month follow-up assessments.

Researchers are evaluating the clinical effects and biomechanical impacts of different trigger modes of lever positioning manipulation LPM for treating lumbar disc herniation LDH. This study aims to clarify the clinical efficacy of LPM, analyze the mechanical and spatial motion characteristics of its two trigger modes, and explore how these modes influence the stress-strain and flow-solid coupling effects on the lumbar intervertebral discs, particularly at the L45 segment. The investigation also uses 3D finite element technology combined with dynamic capture and mechanical sensing systems to better understand these effects. Participants include 64 LDH patients and 64 healthy volunteers divided into four groups two patient groups receiving either unilateral or bilateral LPM or sham manipulation, and two healthy volunteer groups receiving unilateral or bilateral LPM. Treatments are administered every two days for a total of six sessions over two weeks. During manipulation, mechanical and kinematic data are collected using sensing gloves and motion capture systems. Additionally, a virtual simulation model is built from imaging data to analyze biomechanical loading and stress on the intervertebral discs under different LPM modes. Participants will complete clinical questionnaires such as the Visual Analog Scale VAS and Japanese Orthopaedic Association JOA scoring system to assess pain and function. Mechanical parameters and motion characteristics are recorded during manipulation sessions. Researchers will use these data alongside imaging and individual patient features to study correlations. The primary outcome is the overall clinical efficacy after two weeks. Secondary outcomes include pain and functional scores, as well as detailed mechanical and kinematic measurements during treatment.

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 physioexercise 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 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.

Researchers are evaluating a multicomponent mindfulness and movement program called Move-MORE designed for patients with lumbosacral radiculopathy, a condition causing pain, weakness, and numbness in the lower limbs often known as sciatica. The study aims to develop this non-invasive, non-drug treatment by combining mindfulness training, gentle physical activity, and motivational interviewing to help manage pain and improve function. The study will assess the programs feasibility, acceptability, and preliminary effects on pain, disability, and psychological factors. Participants will engage in the Move-MORE program remotely, attending weekly virtual classes for eight weeks. The program includes mindfulness practice, physical activity, and motivational interviewing based on self-determination theory. Between sessions, participants will track their home practice, pain levels, and any adverse events through daily surveys. The intervention is specifically tailored for those with lumbosacral radiculopathy, using feedback from patients and physicians to guide program design. During the study, participants will complete online surveys at baseline, midpoint, post-intervention, and three-month follow-up, including daily pain ratings via ecological momentary assessment. They will wear an activity monitor continuously to measure movement and undergo quantitative sensory testing to assess pain sensitivity. At the end, participants will share their experiences in interviews to help refine the program. The primary outcome measured is disability related to back pain, with additional assessments of pain characteristics and satisfaction.

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 studying the safety and effectiveness of a single dose of nexiguran ziclumeran NTLA-2001 compared to a placebo in people with hereditary transthyretin amyloidosis with polyneuropathy ATTRv-PN. This phase 3, multinational, randomized, double-blind, placebo-controlled trial involves about 60 participants with this nerve disease and genetic condition affecting the peripheral nervous system. Participants will be randomly assigned to receive a single intravenous infusion of either nexiguran ziclumeran 55 mg or a placebo of normal saline. To give everyone a chance to receive the study drug, participants may switch to the other treatment group at either 12 or 18 months, depending on specific study criteria. The study is designed to compare the effects of the drug and placebo over time. During the study, participants will be monitored for nerve function using the Modified Neuropathy Impairment Score 7 mNIS7 over 18 months and blood levels of serum transthyretin at 29 days and 18 months. Quality of life, body mass index, and other health measures will also be evaluated. The study includes careful safety monitoring and will last up to 18 months with ongoing assessments to track participants nerve health and overall well-being.