Treatment Trials

23 Clinical Trials for Various Conditions

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WITHDRAWN
Naproxen for the Prevention of HO After Complex Elbow Trauma
Description

Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs. Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip. The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.

COMPLETED
Assessment of Gesture Accuracy of a Prosthesis Control System
Description

The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.

COMPLETED
Pocket Sized Ultrasound (PsUS) and Pediatric Elbow Fractures
Description

The main purpose of this project is to investigate the accuracy of pocket-sized ultrasound (PsUS) in the diagnosis of pediatric elbow fractures. The primary research objective is to determine the test performance characteristics of PSUS performed by pediatric emergency medicine physicians compared to radiography for the detection of pediatric elbow fractures. The project will consist of two parts, first involving a feasibility study and followed by an active study. The feasibility study will aim to answer if providers can perform an adequate elbow ultrasound exam after a brief study training. The active study will investigate the initial accuracy of the PsUS. Participants will be asked in either the feasibility or the active phases of the study to undergo a brief pocket-sized ultrasound elbow exam of both elbows. Patient will continue to receive their previously determined clinical ED management. In the active phase of the study, participant's elbow X-rays or if patient underwent bedside nursemaid reduction will be the comparison to pocket-sized ultrasound images.

RECRUITING
The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal
Description

The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow.

Conditions
ENROLLING_BY_INVITATION
MDR ExploR Radial Head System PMCF
Description

The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.

Conditions
COMPLETED
Physical Therapy on Non-structural Medial Elbow Pain
Description

This study is investigating the effect of using a regional interdependence approach of managing non-structural elbow pain with physical therapy.

COMPLETED
Prevention of Ulnar Collateral Ligament (UCL) Injuries in Minor League Pitchers
Description

This is a study of the muscle stabilizers of the elbow with respect to the prevention of Ulnar Collateral Ligament (UCL) injuries in pitchers. Pitchers are assessed at spring training and end of season for approximately 5 years. Pronator, flexor digitoum superficialis (FDS), and wrist flexion strength will be measured and correlated with upper extremity injuries and time missed from pitching. The investigators will also be measuring loss of strength over the season. The goal is to learn whether strength in these muscles prevents UCL injuries and finally whether these muscles can be strengthened to avoid such injuries.

COMPLETED
Preservation of Joint Function Using Postoperative Continuous Passive Motion (CPM) A Pilot Study
Description

This pilot study is designed to determine if the rehabilitative benefits of continuous passive motion (CPM) will help preserve/restore the joint function and significantly improve the rate of recovery of patients after the surgical release of elbow contractures better than standard physiotherapy and static splinting.

Conditions
ACTIVE_NOT_RECRUITING
VR to Evaluate Phantom Limb Pain
Description

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research setting and for at-home use by individuals with upper and lower extremity amputation. We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.

RECRUITING
Evaluating the Experience of Upper Limb Prosthesis Use
Description

The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.

WITHDRAWN
Isometric Intervention for Lateral Elbow Tendinopathy
Description

This study will be looking at people with lateral elbow tendinopathy (elbow pain). The goal is to determine if a one-time isometric intervention will positively change the level of pain and strength as compared to baseline measurements. After determining baseline strength and pain level, an intervention consisting of several trials of isometric hand/wrist contractions will be performed by the participant. Pain and strength will again be assessed immediately after the intervention.

COMPLETED
PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2
Description

PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) is a Phase III randomized, controlled, double blinded multicenter trial with 3 parallel groups (Ketotifen 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks) and a primary endpoint of elbow extension-flexion range of motion (ROM) arc at 12 weeks post-randomization.

TERMINATED
Progressive Splinting Status Post Elbow Fractures and Dislocations
Description

The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.

COMPLETED
Ultrasound Visualization Versus Electrical Nerve Stimulation
Description

Hypothesis and Specific Aims: The investigators hypothesize that ultrasound (US) visualization is as effective as nerve stimulation (NS) for identification of peripheral nervous structures and may be associated with less trauma and patient discomfort. Specifically, the investigators believe that equivalent rates of surgical anesthesia are achievable with non-invasive ultrasonic needle guidance in comparison to needle guidance by intensity of motor fiber response to intermittent electrical nerve stimulation. Specifically, the number of needle sticks to identify the brachial plexus and total time to plexus sheath injection may be reduced while achieving similar efficacy rates. The investigators hypothesize that similar composite safety and efficacy endpoints but improved patient satisfaction and acceptance will favor US over NS guidance of nerve blocks indicated for surgery on the extremity surgery. However, the investigators believe that an economic assessment based upon capital hardware investment, operating room utilization, total block time, and pay for performance patient satisfaction metrics require examination prior to assimilation of new technology into clinical practice.

COMPLETED
Retrospective Study on Myoelectric Elbow-Wrist-Hand Orthosis User Outcomes
Description

The objective of this study is to retrospectively evaluate the outcomes and clinical benefits provided by this brace to adult patients with upper limb impairment or paralysis due to brachial plexus, stroke (CVA), spinal cord injury, or other neurological disease or injury.

ACTIVE_NOT_RECRUITING
Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Description

The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures.

COMPLETED
Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow
Description

The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.

COMPLETED
Comparing Outcomes of Elbow Extension Tendon Transfers
Description

Active elbow extension has significant functional benefits for individuals with tetraplegia. The proposed work will provide information to assess how effectively people are using their elbow extension tendon transfers, and whether one surgery works more effectively than the other. This study will provide recommendations to clinicians about the possibility of improving function after surgery using rehab techniques.

COMPLETED
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
Description

Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.

TERMINATED
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
Description

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee

COMPLETED
Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
Description

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee.

RECRUITING
Cortical Recording and Stimulating Array Brain-Machine Interface
Description

The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.