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          Grants & Funding: The NIAMS Extramural Program
          Clinical Trials in the Spotlight
          Clinical Trials in the Spotlight - Completed Recruitment








Clinical Trials in the Spotlight - Completed Recruitment FacebookEmailPrintFacebookEmail     
    Studies That Have Completed Recruitment

Trials that are no longer recruiting but remain active to complete other study activities are found here. Click on a disease/condition below to learn more about a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal and skin diseases.

**Please check other clinical trials supported by the NIAMS that are actively recruiting or have completed with published results following the links below.**View Actively Recruiting StudiesView Completed Studies with Published Results

For questions, please contact the NIAMS Clinical Trials team at: NIAMSclinicaltrials@mail.nih.gov

Disease / Condition

Achilles
	Anterior Cruciate Ligament (ACL) Injury
	Atherosclerosis
	Atopic Dermatitis
	Chronic Pain
	Duchenne Muscular Dystrophy (DMD)
	Fibromyalgia
	Knee Arthroplasty
	Knee Osteoarthritis
	Osteoporosis
	Osteosarcopenia
	Osteogenesis Imperfecta
	Pompe Disease
	Rheumatoid Arthritis
	Spinal Cord Injury
	Systemic Lupus Erythematosus (SLE)
	Ventilator-Induced Diaphragm DysfunctionAchilles Tendinopathy

**Tendinopathy Education on the Achilles, A Clinical Trial (TEACH)**

The standard of care for chronic tendinopathy primarily targets a localized area of tendon pain, but this strategy is ineffective for up to 40% of patients with chronic Achilles tendinopathy. An emerging field of research indicates that changes in the central nervous system (CNS) contribute to pain in patients with orthopaedic injuries, such as tendinopathy. Yet the current standard of care for Achilles tendinopathy does not evaluate or treat CNS pain mechanisms. This study proposes a more global approach by evaluating and treating alterations in how the central nervous system processes chronic tendinopathy pain.

View more about this trial in ClinicalTrials.gov

Anterior Cruciate Ligament (ACL) Injury

**Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST)**

Over the last four decades, these debilitating Injuries have occurred at a 2 to 10-fold greater rate in female compared to male athletes with the highest prevalence occurring between the ages of 16-18 years. As a consequence, there is a large population of females that endure significant pain, functional limitations and knee osteoarthritis (OA) as early as 5 years after the initial unintentional injury. To reduce the burden of OA, The National Public Health Agenda for Osteoarthritis recommends both expanding and refining evidence-based prevention of ACL injury. There currently is a gap in knowledge regarding how to maximize the effectiveness of injury prevention training in young female athletes. The long-term goal is to reduce the ACL injuries in young female athletes. The objective of this study is to increase the efficacy of biofeedback training to reduce the risk of ACL injury. This study tests the central hypothesis that biofeedback methodology is needed to maximize the effectiveness of neuromuscular prophylactic interventions.

View more about this trial in ClinicalTrials.gov

**Real-time Sensorimotor Feedback for Injury Prevention Assessed in Virtual Reality**

Traumatic and debilitating anterior cruciate ligament (ACL) injuries occur at a 2- to 10-fold greater rate in female than male athletes, and 50-100% of females develop knee osteoarthritis within 12-20 years of initial injury. The National Public Health Agenda for Osteoarthritis recommends expanding and refining evidence- based prevention of ACL injury to reduce this burden. The study team has identified modifiable risk factors that predict ACL injury in young female athletes. The lab-based neuromuscular training targets modifiable risk factors and shows statistical efficacy in high-risk athletes, but a meaningful risk re-categorization to "low-risk" has not been achieved.  The overall objective of this proposal is to implement and test innovative augmented neuromuscular training (aNMT) methods to enhance sensorimotor learning and more effectively reduce biomechanical risk factors for ACL injury.

View more about this trial in ClinicalTrials.gov



Atherosclerosis

**Treatments Against RA and Effect on FDG-PET/CT (The TARGET Trial)**

Rheumatoid arthritis (RA) is a chronic inflammatory disease, causing joint damage and disability. While remarkable progress in the treatment of RA over the past two decades has improved many outcomes, mortality rates in RA remain 1.5-3-fold above non-RA controls. Cardiovascular disease (CVD) is the leading cause of excess deaths in RA.  Most experts believe that enhanced vascular inflammation underpins accelerated atherosclerosis and CV events yet, there has been no direct proof for this hypothesis. If this is true, then RA therapies that reduce joint inflammation might also reduce CV risk. The lack of an RA-specific CV risk tool hampers evidence-based guidelines, as general population tools perform poorly in RA. These gaps in knowledge create uncertainty for patients and providers in managing RA and its comorbidities. This study proposes to use 18fluoro-deoxyglucose by positron emission tomography/computed tomography (FDG PET/CT) as a novel imaging modality to detect baseline, and disease-modifying antirheumatic drug (DMARD)-associated changes in, vascular inflammation in RA.

View more about this trial in ClinicalTrials.gov

Atopic Dermatitis

**Team-Based Connected Health to Improve Access and Outcomes in Atopic Dermatitis**

Skin diseases account for 30% of all physician office visits. In the United States, access to dermatologists remains a significant challenge for those in underserved or rural communities. To increase access to specialists and improve patient outcomes, this study will evaluate a team-based connected health (TCH) model that enables structured asynchronous online interactions among patients, primary care providers (PCPs), and dermatologists. The goal of TCH is to enable effective management of chronic skin diseases via high-quality and efficient online care between providers and patients. TCH purports to bring direct and expedient specialist care to patients and PCPs in a location-independent and asynchronous manner. Specifically, TCH offers several ways that patients and providers can communicate online asynchronously to manage skin diseases: (1) PCP-dermatologist, (2) patient-dermatologist, and (3) patient-PCP interactions. With PCP-dermatologist interactions, PCPs can access dermatologists online asynchronously for consultations or to request a dermatologist to assume care of patient’s skin disease. With patient-dermatologist interactions, patients can upload clinical images and history online and obtain asynchronous evaluation and recommendations from dermatologists directly. Finally, PCPs have the option of managing their patients’ skin diseases online. Importantly, TCH applies efficient workflow that maximally supports providers and fosters multi-directional, informed communication among patients, PCPs, and dermatologists.

View more about this trail in ClinicalTrials.gov

**A Community-based Assessment of Skin Care, Allergies, and Eczema: The CASCADE Trial**

Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.

This study hypothesizes that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.

View more about this trial in ClinicalTrials.gov

Chronic Pain

**GET Living: Graded Exposure Treatment for Children and Adolescents with Chronic Musculoskeletal Pain**

With up to a third of adolescents reporting recurrent or chronic musculoskeletal pain, it is a critical national health problem. The experience of chronic pain in adolescence negatively impacts overall health during this important life period and increases the risk of pain and mental health problems in adulthood. Pain-related fear is repeatedly identified as an important factor that increases the likelihood of poor outcomes among adolescents with pain, and yet pain-related fear is rarely targeted in typical pain management (TPM). Perhaps unsurprisingly, TPM yields no change in pain-related fear, and modest improvements in functional disability. To overcome limitations of TPM for pain-related fear, graded in-vivo exposure treatment (GET) was developed. While TPM focuses on pain control via pain management psychology and impairment-based physical therapy, GET is jointly delivered by a pain psychologist and physical therapist targeting functional improvement, through exposing patients to activities previously avoided due to fear of pain. GET is successful in adults with chronic musculoskeletal pain! and our pilot data of GET for adolescents with chronic pain (GET Living) is robust, with significant declines in patient fear, activity avoidance, and disability. Uniquely, GET Living also targets parent distress and behavior, and our pilot data demonstrate decreases in parent fear, avoidance, and protective behavior. GET Living also distinguishes itself with an innovative assessment approach to patient progress and clinical endpoints. In addition to standard assessment tools, GET Living utilizes electronic daily diary technology to identify exactly when improvements in outcomes are occurring/not occurring, and objective biomechanical assessment using motion analysis and physical activity monitoring via Actigraphy.

View more about this trial in ClinicalTrials.gov

Duchenne Muscular Dystrophy (DMD)

**Phase I Gene Transfer Clinical Trial for Duchenne Muscular Dystrophy Using rAAVrh74.MCK.GALGT2**

The study aims to develop a rAAVrh74.MCK.GALGT2 as a surrogate gene therapy that can provide significant clinical benefit to boys affected by Duchenne muscular dystrophy (DMD). The study objective is to perform first-in-human studies demonstrating the safety and expression of the vector following intramuscular injection. The central hypothesis is that following intramuscular injection into the extensor digitorum brevis (EDB) muscle, CT antigen expression will be widely identifiable at the sarcolemmal membrane, and no significant inflammation will be seen.  The study's specific aims are to perform a first-in-human safety study of intramuscular gene transfer of rAAVrh74.MCK.GALGT2 and to assess the degree of and the effects of CT antigen expression in EDB muscles.

View more about this trial in ClinicalTrials.gov

Fibromyalgia

**Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia**

Chronic pain is an international health problem that imposes costs of over 600 billion dollars per year. This study focuses on fibromyalgia (FM), which is characterized by persistent, widespread body pain, with significant evidence of altered brain function. One of the few effective treatments for FM is cognitive-behavioral therapy (CBT), which has been shown to reduce pain intensity and pain-related disability, potentially via reductions in catastrophizing, an important psychosocial factor that plays a crucial role in shaping individual differences in pain-related outcomes.

The investigator’s previous study in FM patients confirmed that patients who are high in catastrophizing show enhanced pain-related activation in brain areas that process emotional aspects of pain (e.g., anterior insula and medial thalamus). In addition, catastrophizing was associated with altered pain-evoked functional connectivity between thalamus, anterior insula, and default mode network (DMN) structures such as medial prefrontal cortex. This study hypothesizes that CBT-produced improvements in pain will be anticipated and mediated by reductions in catastrophizing and their associated effects on pain-related brain functioning.

View more about this trial in ClinicalTrials.gov

Knee Arthroplasty

**A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial**

Total Knee Replacement (TKR) is the most successful intervention to address pain from knee osteoarthritis. However, most resume a sedentary lifestyle gain weight and subsequently remain at high risk for poor health outcomes after surgery. There is a critical need for people after TKR to adopt an active lifestyle. Outpatient Physical therapy (PT) is an ideal, low-cost setting for a physical activity intervention for people after TKR given that physical therapists are experts at prescribing and personalizing exercises to meet patients' abilities over multiple outpatient visits. Unfortunately, little study has been devoted to the efficacy of a physical therapist delivered physical activity intervention.
The objective of this study is to evaluate the preliminary efficacy over 3 months of a physical therapist-delivered physical activity intervention. The intervention starts with providing a FitbitTM monitor at admission to PT. Next, the physical therapist provides face-to-face feedback on current activity levels and recommends step goals personalized to previous activity levels, a process that takes < 5 minutes at each visit. The intervention is integrated into standardized outpatient PT for TKR.

View more about this trial in ClinicalTrials.gov

Knee Osteoarthritis

**Weight Loss and Exercise for Communities with Arthritis in North Carolina (WE-CAN)**

This study aims to develop and to demonstrate the effectiveness of a systematic, practical, cost-effective diet-induced weight loss and exercise intervention that communities can implement to reduce pain and improve other clinical outcomes in knee OA patients. The primary objective is to determine whether a pragmatic, community-based 18-month diet-induced weight loss and exercise intervention implemented in three North Carolina counties with diverse residential (from urban to rural) and socioeconomic composition significantly decreases knee pain in overweight and obese adults with knee OA relative to an attention control group. Secondary aims will determine whether this intervention improves self-reported function, health-related quality of life, and mobility.

View more about this trial in ClinicalTrials.gov

Osteoporosis

**Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration**

One in three women and one in five men will experience an osteoporotic fracture during their lifetime. Currently, available medications reduce fracture risk but are unable to fully restore skeletal integrity. Thus, there remains an urgent need for osteoporosis treatments that rapidly and effectively restore bone strength. Unlike most chronic conditions, osteoporosis has historically been treated with only one drug at a time. Attemps to combine anabolic agents with the most commonly used antiresorptive agents (bisphosphonates) did not prove efficacious. In contrast, we recently reported that the combination of teriparatide and the receptor activator of nuclear factor-kB ligand (RANKL) inhibitor, denosumab, increases bone density and improves bone microarchitecture and estimated strength more than either drug alone and more than any vailable therapy. The study team has hypothesized that the efficacy of this combination is dependent on denosumab's capacity to fully block teriparatide's stimulation of bone resorption while allowing for teriparatide-induced stimulation of bone formation (modeling-based bone formation). In this proposal, the study team will directlyl assess the ability of teriparatide to stimulate modeling-based bone formation with bone resorption is blocked by denosumab.

View more about this trial in ClinicalTrials.gov

Osteosarcopenia

Effect of a Ghrelin Receptor Agonist on Muscle and Bone

Adults with low muscle mass also usually have low bone mass, making them vulnerable to falls, fractures, and other injuries. This study will determine the effectiveness of treatment with a ghrelin receptor agonist in improving short term indicators of muscle and bone health in adults with low bone and muscle mass. The results of this trial will inform the design of a larger definitive randomized trial designed to establish efficacy.

View more about this trial in ClinicalTrials.gov

Osteogenesis Imperfecta

**Rare Diseases Clinical Research Network Brittle Bone Disease Consortium Longitudinal Study of Osteogenesis Imperfecta**

Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and, in adult years, hearing loss. The purpose of this natural history study is to perform a long-term follow-up of a large group of people with osteogenesis imperfecta (OI) to improve the health and quality of life of people with OI.  The study team will collect information on medical history, number of broken bones, surgeries done, medications taken, ability to walk, pain, lung function and breathing, hearing, and bone mineral density. This study aims to perform DNA testing and collect natural history data on all individuals enrolled in this longitudinal study, see how often people with type I OI have vertebral compression fractures of the spine, follow people with all forms of OI to see how often they develop scoliosis (curvature of the spine), and look at dental health in people with OI.

View more about this trial in ClinicalTrials.gov

Pompe Disease

**A Phase 1 Study of the Safety of AAV2/8-LSPhGAA in Late-onset Pompe Disease**

The development of gene therapy has advanced to a point where a cure for Pompe disease can be foreseen. Pompe disease (glycogen storage disease type II; acid maltase deficiency) is a devastating muscle disease resulting from acid alpha-glucosidase (GAA) deficiency in striated and smooth muscle. Despite the availability of enzyme replacement therapy (ERT) with recombinant human (rh) GAA, many patients have poor outcomes including death due to clinically significant anti-GAA antibody response. The limitations of ERT have prompted the preclinical development of gene therapy for Pompe disease. Clinical translation of efficacious gene therapy will greatly advance treatment for Pompe disease by correcting GAA deficiency and suppressing immune responses against rhGAA.

The long-term goal of the study is to develop curative therapy for Pompe disease. Toward this end we have developed gene therapy with an adeno-associated virus (AAV) vector that expresses GAA specifically in the liver accompanied by GAA secretion and receptor-mediated uptake of GAA in the heart and skeletal muscle. It is the central hypothesis that continuous GAA production from a liver depot will surpass the benefits achieved with ERT in Pompe disease.

View more about this trial in ClinicalTrials.gov

Rheumatoid Arthritis

**Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)**

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease, with a prevalence of 1% worldwide. Nearly two-thirds of RA patients suffer from loss of skeletal muscle mass, which often co-occurs with central obesity, a feature of metabolic syndrome. Lower muscle mass leads to muscle weakness, a major contributor to physical impairment in patients with RA, even after multivariate adjustment for demographic and disease variables. The overarching goal is to understand at a mechanistic level the metabolic and physiologic abnormalities of skeletal muscle in patients with RA and to use that knowledge to improve therapy for skeletal muscle dysfunction in RA.  Thus, this study hypothesizes that increased lipid content in skeletal muscle contributes to insulin resistance and impaired skeletal muscle homeostasis and function in RA and that treatment with pioglitazone will improve muscle function by decreasing lipid deposition in skeletal muscle, restoring the anabolic effects of insulin and attenuating inflammation.

View more about this trial in ClinicalTrials.gov

**Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial**

Rheumatoid Arthritis (RA) affects adults in the prime of their life and their career with two peaks of onset, the first in the mid-life around the age of forty and the second in the sixties. RA affects women more frequently than men with up to 1% of the population affected. The burden to society includes but is not limited to the potential loss of individuals who are at the peak of their careers themselves who may be affected by RA or who may be responsible for caring for a family member with RA. This Phase I clinical trial in which RA patients have had an incomplete response to methotrexate receive add on therapy with a single infusion of adult bone marrow stem cells (or placebo infusion) from a healthy donor to “quiet” the immune system. If successful, cell-based therapy would represent a paradigm shift in the treatment of RA. Studies have demonstrated that early treatment of new-onset RA improves outcomes, but therapies are most often life long, expensive and have undesirable side effects. If immune tolerance can be induced and the immune system "reset" to its "pre-RA" condition, then environmental, and other lifestyle changes (e.g., quitting smoking) could be used to reduce the chance of recrudescence of RA and increase the interval to "flare."

View more about this trial in ClinicalTrials.gov

Spinal Cord Injury

**Exploration of blood flow regulation to bone in humans**

Without blood flow, bone cannot maintain its integrity. Bone blood flow responds to various local and systemic factors, however, bone perfusion in humans remains relatively unstudied. This study will investigate key mechanisms that regulate bone perfusion in able-bodied and contrast responses to those with spinal cord injury (SCI). SCI is a model of chronic reduced loading with loss of sympathetic regulation.

In tibial cortical bone, the study team will: 1) determine the impact of compressive loading with and without muscle contractions; 2) determine the impact of vascular sympathetic activity and systemic perfusion pressure; 3) compare the response between able-bodied and those with SCI

View more about this trial in Clinical Trials.gov

Systemic Lupus Erythematosus (SLE)

**Study of Anti-Malarials in Incomplete Lupus Erythematosus**

Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidence-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE).

The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE. The secondary objectives are to determine whether HCQ treatment 1) lessens lupus disease activity as measured by standard scoring indices, 2) improves patient-reported outcomes, 3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines, and 4) has an acceptable toxicity profile.

View more about this trial in ClinicalTrials.gov

Ventilator-Induced Diaphragm Dysfunction

**The Effect of Intermittent Hemidiaphragm Stimulation During Surgery on Mitochondrial Function, Single Fiber Contractile Force and Catabolic Pathways in Humans**

This study proposes to test the hypothesis that intermittent electrical stimulation (ES) of the human hemidiaphragm during prolonged cardiac surgeries with mechanical ventilation (MV) support prevents/attenuates ventilator-induced diaphragm dysfunction (VIDD) in the active hemidiaphragm.  Using a within-subjects experimental design, muscle samples from a stimulated hemidiaphragms will be compared with samples from the unstimulated hemidiaphragm. The study team will investigate mitochondrial dysfunction and oxidative stress during prolonged CTS/MV, and the potential of ES to attenuate or prevent VIDD, investigate the effects of ES on single fiber contractile properties and Titin integrity, and study the effect of ES on proteolytic pathways (caspase, calpain, and ubiquitin-proteasome) and ribosomal RNA markers of decreased protein synthesis implicated in VIDD.

View more about this trial in ClinicalTrials.gov


Last Updated: August 2022


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