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59 recruiting in CA
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Brain Imaging Biomarkers for Response to Spinal Cord Stimulation in Patients With Chronic Low Back Pain

Chronic Low-back Pain

In this protocol, "Brain imaging biomarkers for response to Spinal Cord Stimulation in patients with chronic low back pain," the investigators plan to perform brain mapping studies in 42 patients who are undergoing spinal cord stimulation (SCS) for chronic low back pain (CLBP) as part of the participants normal clinical care during a 2-year period. This imagining study is completed for research purposes. There is no standard of care imaging for the participants. This study requires two visits in total. During the baseline visit, participants will undergo imaging acquisition protocol and corresponding assessments. Participants will have another follow-up visit (potentially remotely) for final assessments two weeks after the SCS treatment. The objective of the study is to investigate potential imaging biomarkers that can predict response to the SCS treatment. Specifically, the investigators hypothesize that the connectivity of a certain region of the brain (specifically the subgenual cingulate) prior to SCS may serve as a possible pre-operative imaging-based biomarker on response to SCS. The findings of the study may further enhance investigators understanding of the connectivity between brain areas that are critical to the therapeutic response to SCS in CLBP patients and that can be used as a putative biomarker to select patients who may respond to SCS.

Los Angeles, CA21+ yrsAll genders
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Exactech Shoulder Post Market Clinical Follow-up Study

Osteo Arthritis Shoulders ยท Osteonecrosis ยท Rotator Cuff Tears

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

Laguna Woods, Redwood City +more, CA21+ yrsAll genders
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Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee

Osteoarthritis, Knee ยท Osteoarthritis, Hip ยท Osteo Arthritis Shoulders

In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.

Palo Alto, CA25โ€“80 yrsAll genders
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Trial to Test the Efficacy of Using Magnetic Fields to Stimulate the Back to Treat Chronic Lower Back Pain.

Lower Back Pain Chronic

The goal of this study is to see if a new way to treat back pain without the use of medications is effective. We plan use Transcranial Magnetic Stimulation (TMS), a wand-like device, to excite the nerves of people with lower back pain to see if we can decrease pain and improve quality of life. This study will have two groups and randomly assign participants to a group. One group will have their back nerves stimulated with the TMS device and the other group will not. Participants will also need to do back exercises at home once a day, and complete questionnaires at each visit before and after each treatment. The total time commitment will be 5 to10 visits with one visit occurring each weekday and each visit lasting up to 30 minutes.

Edwards Air Force Base, CA18โ€“64 yrsAll genders
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Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

Osteo Arthritis Knee

The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.

La Jolla, CA45โ€“75 yrsAll genders
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The Effects of Tranexamic Acid on Joint Inflammation and Cartilage Health in Anterior Cruciate Ligament Injured Patients

Anterior Cruciate Ligament Reconstruction

Patients who tear their ACL are at high risk for developing arthritis (post-traumatic osteoarthritis-PTOA) just 10 years later. Joint bleeding and inflammation contribute to deterioration of joint health. This study will determine whether treatment with Tranexamic Acid (TXA), an FDA approved medication that reduces bleeding right after ACL injury and reconstructive surgery reduces inflammation and improves joint health as a new strategy to prevent or delay the onset of PTOA.

Stanford, CA18โ€“30 yrsAll genders
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A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Osteoarthritis, Knee ยท Diabetic Neuropathic Pain ยท Chronic Low-back Pain

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Irvine, Palm Springs +more, CA18+ yrsAll genders
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AETOS Shoulder System

Shoulder Osteoarthritis ยท Shoulder Arthritis

The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects in 2 cohorts (anatomic and reverse) at up to 15 sites. No intra-study comparator group will be included, and there will be no randomization

San Francisco, CA18+ yrsAll genders
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Brain Mechanisms Supporting Cannabis-induced Pain Relief

Sciatica ยท Lumbar Radiculopathy ยท Lower Back Pain

Chronic low back pain is a common and disabling condition that affects millions of people in the United States. Many people with chronic low back pain do not get enough relief from current treatments. Cannabis may help reduce pain, but researchers do not fully understand how it affects the brain in people with chronic pain. The purpose of this study is to examine how inhaled cannabis changes brain activity and reduces pain in people with chronic low back pain. Results from this study may help researchers better understand how cannabis works for pain and support the development of improved pain treatments.

La Jolla, CA21โ€“65 yrsAll genders
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Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome

Myofascial Pain Syndrome (MPS) ยท Chronic Low-back Pain (cLBP)

This study will evaluate the clinical and biological effects of acupuncture for chronic low back pain associated with myofascial pain syndrome (MPS). In this randomized, participant- and assessor-blinded clinical trial, 64 adults with chronic low back pain due to MPS will be assigned to receive either true acupuncture or sham acupuncture for eight weeks. Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging and complete standardized pain and functional questionnaires at baseline and after treatment. The study will evaluate whether acupuncture improves pain and function compared with sham treatment and whether TB-PET/CT imaging can detect changes in myofascial tissue metabolism and perfusion that correspond with clinical outcomes.

Sacramento, CA18+ yrsAll genders
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FDG PET/MRI Imaging of Patellofemoral Joint Osteoarthritis

Patellofemoral Osteoarthritis ยท Knee Osteoarthritis ยท Knee Pain

This project aims to develop an \[18F\] fluorodeoxyglucose (FDG) positron emission tomography (PET) / magnetic resonance imaging (MRI) method to locate the painful inflammation in PFJ OA associated with joint loading. \[18F\] FDG PET/MRI is an emerging pain imaging approach with enhanced sensitivity to painful hypermetabolic inflammation through evaluation of intracellular glucose utilization rate via (\[18F\]FDG PET) and fine anatomy details (MRI). The investigative group has shown its promise in revealing previously unidentified or unspecified pain generators in various musculoskeletal pain conditions. The investigators have also demonstrated the feasibility of visualizing the structural changes between unloaded and loaded knee joints with MRI, which can be easily adopted in the current PET/MRI setting. The main challenge in the proposed \[18F\]FDG PET/MRI approach is to differentiate the normal uptake of FDG for metabolic changes by weight-bearing from abnormal changes indicating eventual pain aggravation by weight-bearing and knee-flexion. The investigators have garnered the following two aims to validate the proposed method by comparing unloaded and loaded knee imaging results between PFJ OA pain patients and asymptomatic, matched controls.

San Francisco, CA18+ yrsAll genders
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The Effect and Safety of Anti-inflammatories and Dextrose Prolotherapy Injections in Treating Knee Osteoarthritis

Knee Osteoarthritis (OA)

Our purpose is to expand upon the results of the pilot study performed at David Grant Medical Center (DGMC) which showed that concomitant non-steroidal NSAID use in adults with knee osteoarthritis (OA) undergoing a three-shot dextrose prolotherapy (DPT) injection series did not negate the efficacy of DPT. Additionally, it showed that giving both treatments simultaneously is safe and efficacious. The small sample size and design of the pilot study limited the conclusions that can be drawn on the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) during DPT treatment. This is a double-blinded, randomized, controlled trial that includes a subject population of males and females between the ages of 45-75 years who are DoD beneficiaries empaneled at DGMC with a history of chronic, symptomatic knee osteoarthritis in one or both knees, that meet study criteria. Participants will have study inclusion/exclusion and knee films (within the past 2 years) reviewed by a study investigator to confirm eligibility to participate in the study. Eligible participants will be consented then randomized into treatment groups (ibuprofen, placebo) by the pharmacy. Participants will provide a baseline assessment of pain and dysfunction using the Numeric Pain Rating Scale (NPRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Participants will then have a series of three injections of 4mL of 25% dextrose mixed with 1% lidocaine into the knee under ultrasound guidance, performed at 0, 4 and 8 weeks (+/- 1 week) in addition to a 7-day supply of the study drug (ibuprofen, placebo) at these time points. NPRS and KOOS scores will be collected at 0, 4, 8 and 12 weeks. During the study period, participants will be counseled to avoid oral analgesics (other than what has been prescribed for them as part of the study) including NSAIDs, acetaminophen, or opioids, in addition to other procedures to treat their knee pain to include other injections, acupuncture, physical therapy, and surgery. The primary outcome is to determine the effect of concomitant oral ibuprofen vs. placebo use on intra-articular knee injections using hypertonic dextrose and the determine the short and long-term outcomes in each treatment group (ibuprofen, placebo) using the NPRS and KOOS questionnaires to assess pain and function.

Travis AFB, CA45โ€“75 yrsAll genders
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Recruiting

A Study to Evaluate the Efficacy and Safey of PTP-001 (MOTYSโ„ข) in Knee Osteoarthritis Patients

Knee Osteoarthritis

This is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of intra-articular administration of PTP-001 (MOTYS) for the treatment of knee osteoarthritis. The purpose of the trial is to evaluate the efficacy, safety, and tolerability of a single intra-articular injection of PTP-001 compared to placebo over a 52-week period in participants with radiographic and symptomatic knee OA.

La Mesa, West Hills, CA40โ€“80 yrsAll genders
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Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

Chronic Low Back Pain

VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers.

Loma Linda, Long Beach +more, CA18+ yrsAll genders
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Effects of Movement Retraining on Knee Loading in Individuals With Knee Osteoarthritis

Osteoarthritis, Knee

This study investigates how well individuals with knee osteoarthritis can learn to alter their calf muscle activation using haptic biofeedback while walking and evaluates how these changes affect knee loading. Prior research has utilized musculoskeletal simulations to determine that reducing the activation of one of the calf muscles, the gastrocnemius, can have a large impact on reducing knee loading. However, this has not been tested in individuals with knee osteoarthritis. In this study, participants will be trained to alter the activation of their gastrocnemius muscle, by receiving haptic feedback after each step. The feedback will indicate how the participant changed their muscle activation relative to baseline. Some participants will train on a treadmill in the laboratory for up to two sessions, with 30 minutes of walking with feedback in each session. If a participant can learn to adjust their muscle activation in the first training session, they will be able to complete the second training session. Other participants will train outside the laboratory for one session with 30 minutes of walking with feedback to investigate changes in knee loading while using the new walking strategy during over-ground walking. The movement data collected during the training sessions will be used as inputs to computer simulations of the musculoskeletal system to determine if walking with the new muscle activation strategy reduces knee loading.

Stanford, CA18+ yrsAll genders
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A Study to Investigate the Treatment Effect of Subcutaneous Injections of Pentosan Polysulfate Sodium Compared With Placebo in Adult Participants With Knee Osteoarthritis Pain.

Osteoarthritis, Knee

The purpose of this study is to measure the change in pain and function with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with subcutaneous injections of placebo in participants with knee OA pain. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be 6 weeks. * The visit frequency will be twice weekly during treatment. * The visit/contact frequency will be every 4-6 weeks during the 52-week Follow-up period. * Approximately 466 participants will be enrolled into this study.

Anaheim, Cerritos +more, CA18+ yrsAll genders
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Phase 3 Pivotal Trial Comparing CARTISTEMยฎ and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis

Knee Cartilage Defects

To establish the efficacy and safety of CARTISTEMยฎ, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEMยฎ compared to the surgical comparator of debridement in Subjects with knee cartilage lesions and osteoarthritis. This trial is intended to provide evidence of the superiority of CARTISTEMยฎ to reduce knee pain and improve knee function compared to debridement for Subjects with knee cartilage lesions and osteoarthritis at 2-years post-treatment. Additionally, this trial is intended to intended to explore whether CARTISTEMยฎ may have disease-modifying effects on osteoarthritis progression through the use of semi-quantitative MRI assessment.

El Cajon, La Jolla +more, CA18โ€“75 yrsAll genders
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