Treatment Trials

15 Clinical Trials for Various Conditions

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WITHDRAWN
The Use of PET/CT to Evaluate Synovitis in the Temporomandibular Joint (TMJ)
Description

Temporomandibular joint disorders (TMD) are a common musculoskeletal problem with an estimated 40-75 percent of the population reporting at least one sign. Up to fifteen percent of the patients who seek care for one of these conditions, will go on to develop chronic pain. The two most common TMD conditions include myofascial pain disorder and internal derangement of the Temporomandibular Joint (TMJ). These two conditions have similar clinical presentations, making an accurate diagnosis difficult. Currently, there is no accurate exam or test to differentiate between these two conditions. Internal derangement of the TMJ is a condition with disk displacement, pain, and dysfunction, which may progress to localized osteoarthritis. Fortunately, this condition is self-limiting for the majority of the patients afflicted, with a small minority progressing to advanced joint destruction, disability and chronic pain.18 Currently there are no prognostic indicators to identify these individuals. There are three hypothesis of degenerative TMJ disease, they include: direct mechanical trauma, hypoxia reperfusion injuries, and neurogenic inflammation. All involve parafunctional habits such as clenching or grinding by the patient and a low-grade inflammatory response/synovitis. 18-fluorodeoxyglucose (18-FDG), a radioisotope used with positron emission tomography (PET) and paired with a CT scan (PET/CT), may have a role in imaging inflammation in arthritis as recently demonstrated in several pilot studies involving osteoarthritis of the knee and shoulder. 18-FDG accumulates in areas of increased metabolism, particularly activated leukocytes, as measured by increased standardized uptake value.2 PET/CT offers the unique advantage of showing active disease before anatomic damage is evident. Our hypothesis is that there is an increased uptake of 18-FDG on PET/CT in synovitis of the TMJ.

COMPLETED
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
Description

The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA) treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For the purposes of the study infants will be enrolled if they are delivered before 28 weeks gestation and have a moderate/large PDA present at 5-7 days after birth. The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease the time needed for assisted respiratory support, diuretic therapy, and gavage feeding assistance, in addition to decreasing the incidence of ductus ligations or need for future outpatient cardiology follow-up appointments. The investigators hypothesize that one or more of these benefits will occur without an increase in the time taken to achieve full enteral feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal perforations (SIP).The investigators will be comparing the effectiveness of early pharmacologic treatment with a control group of conservatively managed infants who will only receive treatment if they meet specific criteria for "rescue treatment".

TERMINATED
Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
Description

The purpose of this study is to evaluate the effectiveness of cooled radiofrequency denervation of the sacroiliac region using the SInergy System compared to conservative treatment in the treatment of sacroiliac joint pain.

RECRUITING
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
Description

The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years. The main questions this study aims to answer are: 1. Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage. 2. Is the device safe and effective compared to the sham group? Participants will: 1. Be randomly assigned to an active or sham control group in a blinded, multicenter study. 2. Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals. 3. Enter a 3-month, treatment-free follow-up phase, with SUI assessment. 4. Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit. The total study duration will last approximately 18 months, with each individual's participation lasting approximately 6-8 months. This study aims to provide robust data on the effectiveness, safety, and durability of the SUI-100 device for treating female Stress Urinary Incontinence.

COMPLETED
Conservative Treatment of Mallet Finger Injury
Description

Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ.

COMPLETED
Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
Description

Thoracolumbar (TL) burst fractures in neurologically intact patients account for approximately 45% of all TL spine injuries. Despite being common fractures, there is significant variability in treatment recommendations encompassing surgery and non-surgical treatment options. The controversy regarding optimal treatment for these injuries is fueled by several studies which suggest a potential benefit to surgical treatment in the realm of patient satisfaction, and the overall socio-economic burden of treatment while other studies demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study aims to perform a prospective cohort analysis investigating the clinical outcome of various treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A cost-effectiveness analysis will also be performed to identify costs and benefits of each treatment option. More specifically a sub-group analysis will be performed for this group of patients, which have equipoise in regards to patients treatment, as decided by a blinded review panel.

TERMINATED
Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
Description

The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Whole-body vibration combined with un-weighting traction and specific manual mobilization plus active therapeutic exercise seems to treat chronic low back pain by non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such therapy reduces the need for surgery and significantly out performs traditional physical as the preferred conservative treatment.

COMPLETED
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Description

The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.

WITHDRAWN
Clinical Evaluation of Placement of Radiofrequency-based Plasma Microdebridement in the Treatment Algorithm for Foot and Ankle Tendinosis and Plantar Fasciosis
Description

To determine the magnitude of improvement for pain and function symptoms over a two year period after enrollment into the registry study in patients presenting with chronic heel pain and receiving standard of care treatment. Standard of care will include traditional conservative care measures, ESWT, radiofrequency-based plasma microdebridement, scalpel debridement and/or surgical release.

COMPLETED
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Description

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \>/= 65 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

COMPLETED
Treatment of Type II Odontoid Fractures Among the Elderly
Description

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \> 64 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

COMPLETED
Enhancing Conservative Treatment for Urge Incontinence
Description

The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.

COMPLETED
Conservative Treatment of Postprostatectomy Incontinence
Description

The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

TERMINATED
Surgical Plate Osteosynthesis of Distal Radius Fractures
Description

Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.

RECRUITING
The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema
Description

The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)