Treatment Trials

30 Clinical Trials for Various Conditions

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UNKNOWN
A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries
Description

Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a commercially available centrifuge. The sample then contains a high concentration of growth factors and has been used for numerous indications in a number of joints. This process has not yet been proven for non-operative management of the Triangular FibroCartilage Complex (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks to determine the efficacy of PRP for TFCC injuries.

WITHDRAWN
Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
Description

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.

COMPLETED
Proximal Strengthening for the Management of Wrist Pain
Description

This study will be a randomized controlled trial comparing proximal strengthening vs. traditional hand therapy for patients with wrist pain. Patients will attend 2 hand therapy sessions per week for 4 weeks. Change in patient function and pain as measured by the patient rated wrist evaluation will be the primary outcome of interest

Conditions
TERMINATED
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
Description

To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

UNKNOWN
Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
Description

The purpose of this study is to review the clinical outcomes following hand ligament reconstruction surgery using allograft (cadaveric) knee collateral ligaments. Currently, there is no standard procedure or devices used for hand ligament reconstruction surgery, although most techniques use some form of autograft (patients' own tissue) for the reconstruction. We believe that the use of allograft ligaments in reconstruction may eliminate the pain associated with procuring the patients' own tissue for the procedure, and prove to be a viable and preferred alternative to the multiple techniques currently used. The main procedures of this study include wrist and hand ligament reconstruction surgery (for wrist scapholunate (SL) ligaments, thumb ulnar collateral ligaments (UCL), and finger proximal interphalangeal (PIP) joint collateral ligaments) using allograft ligament, and subsequent follow up appointments where measurements and questionnaires will be completed to evaluate how hand function is doing after surgery.

COMPLETED
Comparing Two Injection Sites of Local Anesthetic for Hand Surgery
Description

The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.

TERMINATED
Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery
Description

The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.

COMPLETED
4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries
Description

The study seeks to determine whether the 4DCT imaging technique can be used to replace current invasive diagnostic tests for ligament injuries of the wrist.

COMPLETED
Biomechanical Evaluation of Wrist Ligament Injuries: Diagnostic Tool to Detect Wrist Instability
Description

Damage to the ligaments of the wrist occurs frequently, however, it is not well publicized or understood. Our previous and current biomechanical studies have shown that damage to certain wrist ligaments is the likely cause of wrist instability and pain. Based on our three dimensional models and animations of actual cadaver motions with various ligaments intact or sectioned, we have identified several changes in how the carpal bones move and are positioned relative to the radius with various levels of instability. Using this information, we have developed a mathematical model that can predict in cadaver wrists which groups of ligaments have been injured. We started, under IRB approval, a prospective clinical study to evaluate the reliability of this mathematical model. During the past 5 years we have studied 13 patients with suspected wrist ligament injuries who were previously scheduled for surgical treatment. CT scans have been performed of the injured wrist and for comparison purposes, the contralateral, uninjured wrist. During these 5 years, there were no problems with the conduct of the study. During these 5 years the only changes to the original study application were * a) to include a CT scan of the contralateral wrist for comparison purposes * b) a paper handout given to potential subjects * c) to add additional people to the study team. The principal investigator, blinded to the results of the CT scan, surgically explores and treats these patients in the same manner that he would for any patient with suspected wrist ligament injuries. During the surgery, the investigator determines the integrity of the various wrist ligaments. The prediction of which ligaments are damaged, based upon the CT scan information and mathematical model is compared to the actual surgical findings. The importance of this study is to develop a tool that will allow one to rapidly and non invasively diagnose wrist instability and initiate treatment before further damage is done.

COMPLETED
Virtual Reality for Pain in Acute Orthopedic Injuries
Description

The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.

COMPLETED
Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration
Description

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).

RECRUITING
Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery
Description

Does a difference in patient satisfaction and cosmetic outcome exist between wound closure with absorbable or non-absorbable sutures.

COMPLETED
Virtual Reality to Enhance Upper Extremity Physical Therapy and Recovery
Description

This is a descriptive study assessing the feasibility of using VR rehabilitation with unilateral (or bilateral) impairment of the arm, wrist and or hand resulting in reduced range of motion, dexterity, and/or strength of the hand.

UNKNOWN
Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
Description

This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.

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.

RECRUITING
Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury
Description

The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm. It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI). This study requires 30 visits, and each visit will last approximately 1.5 hours.

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.

TERMINATED
Does Addition of a Vessel Loop in Wound Closure Improve Suture Removal?
Description

This study will investigate whether adding a vessel loop under sutures after elective carpal tunnel release increases patient satisfaction with suture removal.

COMPLETED
The Effects of Postoperative Physician Phone Calls for Hand and Wrist Fractures
Description

This study seeks to determine if postoperative phone calls by a physician affect outcomes in hand surgery.

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
Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome
Description

The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome.

COMPLETED
Protective Brace to Prevent Hand and Arm Injuries
Description

When people use hand-held power tools, their hands and arms vibrate along with the tool they are holding. People who frequently use hand-held power tools may develop injuries related to this vibration. This study will evaluate a protective brace designed to prevent vibration-related hand and arms injuries.

COMPLETED
Sonographic Measurement of Intraneural Blood Flow in the Median Nerve
Description

Carpal tunnel syndrome (CTS) is the most common nerve compression disease and the most expensive upper-extremity work-related musculoskeletal disorder, affecting approximately 10 million people in the US. To understand the clear etiology and mechanism of carpal tunnel syndrome, the measurement of median nerve intraneural blood flow needs to be further scrutinized as the common fluctuating physiological conditions and functional hand activities might contribute to the fluctuation of the measurement and serve as measurement error. This study aims to examine how intraneural blood flow within the median nerve is affected by physiological factors (i.e., body temperature and blood pressure) and functional hand activities (i.e., typing, using a mouse, and cooking).

COMPLETED
Non-invasive CTS Device Clinical Trial
Description

Sham-controlled, multi-center and remote patient-centered randomized controlled clinical trial to investigate the efficacy of a novel non-invasive, unobtrusive study device in reducing symptoms of carpal tunnel syndrome (CTS). Daily wear of the study device is expected to significantly reduce symptom severity (evaluated by the Boston Carpal Tunnel Questionnaire) in mild to severe CTS-diagnosed patients. Subjects are randomized into the active device group or sham group for 8 weeks, then followed for 12 weeks post-treatment.

COMPLETED
Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals
Description

Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal disorder, impacting 10 million people annually and costing employers up to $113,695 per incident. There is currently no established method to detect this disorder prior to the onset of symptoms and nerve damage. Preliminary research suggests that sonography-a relatively inexpensive, widely available, increasingly portable technology-can provide a non-invasive and pain-free method of early detection that could reduce incidence, improve targeted interventions and ultimately reduce costs. The primary aims of this study are to establish predictive validity of a novel method for early detection using sonographic imaging and to identify task components of intensive functional hand activity associated with morphologic changes.

COMPLETED
Sham Device, Pill Placebo or Treatment For Arm Pain
Description

This study investigates the role of two active interventions and their placebo effects in randomized control trials. The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture device and placebo pill.

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.

COMPLETED
Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Description

The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.

COMPLETED
Work and Health Disparities Among Rural Women
Description

This is a study of the effects of fast paced assembly line work on women. We are studying problems women in poultry processing have with their muscles, tendons, and nerves as well as acute injuries they have in the workplace. We are also studying how their work affects the quality of their lives.