Clinical Trials in the Spotlight - Completed Studies with Published Results

Completed Studies with Published Results

This page features extramurally funded clinical trials supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) that are complete and have published results. Click on a disease/condition below to learn more about a range of clinical trials that NIAMS supported and how they contributed to generating new knowledge about prevention and treatment of arthritis, musculoskeletal and skin diseases. Please note that this page does not include the full portfolio of completed trials with results supported by the NIAMS. Studies with results that completed as of May 2019 are added to this page.

Please check other clinical trials supported by the NIAMS that are actively recruiting or have completed recruitment following the links below.
View Actively Recruiting Studies
View Active Studies with Completed Recruitment

For questions, please contact the NIAMS Clinical Trials team at: [email protected]

Disease / Condition

Achilles 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

Actinic Neoplasia

Photodynamic Therapy-Induced Immune Modulation: Part III

This study is designed as a double-blinded proof of concept of feasibility study to define if the immunosuppression associated with photodynamic therapy (PDT) can be blocked by treatment with cyclo-oxygenase-2 (COX-2) inhibitor celecoxib in comparison to placebo. PDT consists of application of the photosensitizer 5-aminolevulinic acid followed by treatment with a blue light. PDT is used to treat pre-cancerous actinic keratosis on large areas of skin. These studies are a continuation of ongoing studies that indicate that the lipid mediator platelet-activating factor (PAF) is generated in skin following PDT, and that PDT suppresses the immune system. It is hypothesized that PDT-generated PAF results in the immunosuppression associated with PDT. Therefore, it is proposed that a treatment to block that immunosuppression could protect the patient undergoing PDT. Blockers of the PAF system are not currently commercially available. However research studies done at Wright State University using mice indicate that PAF- and PDT-induced immunosuppression is blocked by treatment with COX-2 inhibitors. This study is conducted as a proof of concept.

View more about this trial in ClinicalTrials.gov

Anterior Cruciate Ligament (ACL) Injury

Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST)

This study will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for anterior cruciate ligament (ACL) injury. A six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. The investigators will also determine the effects of hip strategy on retention of decreased knee abduction load with focused biofeedback. A six-month follow-up design will be used to test retention of real-time biofeedback intervention.

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

Chronic Pain

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

The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain at the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the effectiveness and acceptability of this intervention for children with high levels of pain-related fear and functional disability. If proven efficacious, it will allow for the dissemination of this innovative treatment model to others working with children and adolescents with chronic pain.

View more about this trial in ClinicalTrials.gov

Chronic Refractory Gout

REduCing Immunogenicity to PegloticasE (RECIPE) Study

Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of immune modulating therapy with mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase and ensure patients afflicted with chronic refractory gout have better treatment outcomes and improved quality of life.

View more about this trial in ClinicalTrials.gov

Fibromyalgia

Multi-site Randomized Clinical Trial of FIT Teens for Juvenile Fibromyalgia

This study evaluates whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants will receive the FIT Teens training; one third will receive CBT training; and one third of participants will receive the GAE training.

View more about this trial in ClinicalTrials.gov

Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

This study design has two components: 1) a cross-sectional assessment of brain connectivity and response to pain in healthy controls and demographically matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.

The investigators will evaluate a group of fibromyalgia patients who will receive CBT treatment once a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from pain-free controls and a group of education program controls. Participants will undergo experimental pain assessments as well as brain neuroimaging.

View more about this trial in ClinicalTrials.gov

Granulomatosis with Polyangiitis (GPA)

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)

This is a multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA). Participants will be randomized 1:1 to receive either abatacept 125 mg or a placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare.

Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.

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 Fitbit™ 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

Improving Physical Activity and Gait Symmetry After Total Knee Arthoplasty

The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.

View more about this trial at 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

Low Back Pain

Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity

Chronic low back pain is a prevalent and costly condition that impairs physical, emotional, and social function. Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for acute and chronic pain. This study will test the impact of VR on chronic lower back pain management and measure whether it can improve pain, reduce opioid use, and improve quality of life.

View more about this trial in ClinicalTrials.gov

Osteoporosis

Bone Modeling Effects of Combined Anabolic/​Antiresorptive Administration

The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.

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

Pelvic Fractures

PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial

This randomized, double-blind, placebo-controlled 3-month study tests the efficacy of teriparatide (TPTD) to accelerate fracture healing in women and men ≥ 65 years of age with acute fractures of the pelvis. The investigator hypothesizes that TPTD for 3 months as an adjunctive therapy in addition to standard of care will accelerate radiographic evidence of fracture healing and functional recovery and that differences between TPTD and placebo groups documented at 3 months of treatment will persist when evaluated up to 12 months.

View more about this trial in ClinicalTrials.gov

Rheumatoid Arthritis

Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)

Muscle strength helps determine a person's quality of life and functional independence. Patients with rheumatoid arthritis often suffer from muscle weakness and a pre-diabetic condition called insulin resistance. By doing this study, the investigators hope to learn why patients with rheumatoid arthritis (RA) suffer from muscle weakness.

View more about this trial in ClinicalTrials.gov

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

In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

View more about this trial in ClinicalTrials.gov

Weight loss and exercise to improve rheumatoid arthritis cardiovascular risk (SWET/ CHAT)

This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training (SWET) program.

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

Statin-induced Inhibition of Skeletal Muscle Adaptation to Exercise

Impact of Statin Therapy on Muscle Mitochondrial Function and Aerobic Capacity

More than 40 million Americans currently take statins for the treatment or prevention of hyperlipidemia and cardiovascular disease (CVD). Patients taking statins are also commonly advised to exercise regularly to further lower the risk for metabolic and cardiovascular disease. However, recent evidence suggests that statins can impair important exercise adaptations and that this, again, may occur as a result of statins negatively impacting mitochondria in skeletal muscle. Understanding how long-term statin therapy affects mitochondrial function in skeletal muscle is extremely important clinically, given the critical role skeletal muscle plays in maintaining metabolic and cardiovascular health. Therefore, the objectives of this study are to determine the impact of statin therapy on skeletal muscle mitochondrial function, cardiorespiratory fitness, and metabolism in humans.

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

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