55 Clinical Trials for Various Conditions
Purpose and Aims: The purpose of this study is to assess the clinical effectiveness of back and core exercise interventions for low back injury prevention in firefighters. Aim 1. Compare the effectiveness of 2 worksite exercise interventions (supervised, web-based) relative to control to reduce lost work days related to low back injury and illness in firefighters. Relevance: Low back injury is one of the most common and disabling disorders in firefighters. Thus, novel interventions are needed to counteract the adverse consequences of this disorder and its impact on firefighter safety. Methods: A cluster randomized controlled trial will be conducted in career, full active duty firefighters (n = 345) who will be randomly assigned (by fire station) to 1 of 3 intervention groups - 1) supervised exercise (n = 115), 2) web-based exercise (n = 115), or 3) control (n = 115). Participants in the supervised and web-based exercise groups will perform back and core exercises previously tested in our recent FEMA-funded grant (EMW-2009-FP-00418), twice per week for 12 months while on duty, in addition to their usual physical fitness routine - The supervised group will perform exercise under direct supervision of certified exercise specialists, and the web-based group will utilize a web-based exercise system. The control group will not perform back and core exercises, but will continue their usual physical fitness routine and receive brief education on general exercise and physical activity principles. Outcome measures include low back injury and illness data obtained and cross-checked from various sources, other standard clinical outcome measures for low back pain and disability, and validated physical fitness tests. Anticipated Outcomes: We hypothesize that the supervised and web-based interventions will reduce lost work days related to low back injury and illness by 40% compared with control. Assuming positive results, this study will deliver an evidence-based exercise intervention for low back injury prevention specifically designed for firefighters and assessed in a full-scale randomized controlled trial.
The focus of this project is to evaluate the diagnostic utility of Shear Wave Elastography (SWE) in individuals after routine low back injury and begin an initial investigation of it's ability to effectively guide physical therapy treatment with dry-needling as a relevant treatment intervention. Specific Aim #1: Evaluate the diagnostic utility of SWE in differentiating individuals with and without LBP. The investigators will also examine the interaction between tissue change and clinical improvement. The investigators hypothesize that individuals with LBP will have higher muscle stiffness (shear modulus) at rest and impaired (lower) stiffness during contraction than individuals without LBP. Specific Aim #2: Evaluate the effectiveness of dry-needling in decreasing aberrant muscle stiffness in individuals with LBP. The investigators hypothesize that individuals with LBP that receive dry-needling will exhibit larger changes than both individuals with LBP that receive sham dry-needling and than individuals without LBP that receive dry-needling. Specific Aim #3: Evaluate the effectiveness of dry-needling in decreasing pain and disability in individuals with LBP. The investigators hypothesize that individuals with LBP that receive dry-needling will exhibit larger improvements than individuals with LBP that receive sham dry-needling.
The investigators will conduct a controlled clinical trial with U.S. Army soldiers training to become combat medics. The purpose of this study is to determine if a 11-week, high intensity exercise program targeting the low back muscles using specialized equipment will result in a 25% increase in low back muscular strength and endurance compared with a lower intensity general core stability exercise.
This study is one of several initiated by the investigators to reduce musculoskeletal injuries in patient care providers. Nurses have one of the highest incidences of work related back injuries of any profession. Over the past 20 years, efforts to reduce work-related injuries in nursing have been largely unsuccessful.
The study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464).
Transcutaneous Electrical Nerve Stimulation (TENS) devices produce a gentle electrical stimulation that when applied through pads applied directly to the skin, has a noticeable effect in reducing pain associated with various types of injuries and ailments. Several recent studies have shown efficacy when used for acute pain specific to primary dysmenorrhea, renal colic, lower-extremity pain, and pain associated with spinal cord injury, and was achieved without adverse effects. This study is intended to compare the effects of TENS units on acute back pain on ambulatory patients who are awaiting emergency medical treatment, to uncover if a statistically-significant analgesic effect is noted compared to a placebo device.
The present study aims to adapt and modify a brief perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.
This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.
This study will examine the effect of heat stress on factors that influence musculoskeletal injury risk in firefighters. Participants will attend 4 data collection sessions. 1: informed consent, screening, and familiarization. 2: pre-tests (strength, balance, and movement quality). 3: heat stress (rapid or gradual) followed by post-tests (strength, balance, and movement quality). 4: heat stress (rapid or gradual) followed by post-tests.
The goal of this clinical trial is to determine if a wearable back exosuit can make it safer and easier for workers who bend, lift, and lower objects in an industrial setting. Many studies have shown that wearable back exoskeletons or exosuits can provide helpful forces making a person's back muscles work less. It is believed that exosuits can lower a person's level of workplace effort and fatigue, making it less likely for them to have back pain at work. Back exosuits could be a solution to make a job easier, but how well they work in the real-world over a long period of time is unclear. The investigators want to know if workers who wear a back exosuit during the workday will have lower rates of lower back pain or injury than those who are not wearing a back exosuit. The investigators also want to know how well exosuit technology integrates into the workplace (for example, how this technology improves or hinders job performance). Participants will be randomized into an exosuit group or control group. Participants in the exosuit group will be given a back exosuit that they can use as much as they want at work. All participants will complete surveys monthly. Researchers will compare the exosuit group to the control group to see if using a back exosuit in a workplace can reduce a person's risk and impact of low back injury or pain. The investigators also want to see if a back exosuit impacts job productivity and if participants find the exosuit becomes useful or bothersome over time.
This study is designed to track brain functional changes in individuals with i) chronic back pain + opioid use (CBP+O) and individuals with ii) chronic back pain + opioid misuse disorder (CBP+mOUD) following a brief drug delay and re-exposure manipulation. Re-exposure could be placebo, the participant's own opioid dose, or a dopaminergic treatment (DA+NSAID). The participants will be also evaluated for changes in cognition, emotion, and motor abilities with opioid delay and re-exposure to placebo, opioid, or DA+NSAID.
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.
The long-term goal of our research program is to reduce the high incidence of musculoskeletal injury associated with person-handling tasks performed by EMS providers/responders (NORA Public Safety Industry Sector). The literature shows the significant burden of these injuries, many of which affect the back and are debilitating. There is a need for effective ergonomic tools that can assist EMS providers in the patient handling tasks encountered in patient homes, particularly those patient handling situations that include restricted or tight spaces. To address this need, our prior work identified a set of potential ergonomic solutions, using a participatory process with EMS providers, for physically challenging and frequently occurring patient handling tasks that occur in patient homes. A final product of this prior work was the development of the LiftKit, which is a collection of seven tools that were shown in biomechanical validation studies with EMS providers to effectively reduce physical demands during simulated patient handling tasks in a laboratory setting. The overall objective of this proposed research-to-practice application is to evaluate the LiftKit's seven patient handling tools (interventions) in the field to assess their usability, usefulness, and desirability, as well as their impact with regards to preventing musculoskeletal injuries incurred during EMS patient handling tasks. In this field study, 30 LiftKits will be placed on EMS vehicles that service urban, suburban, and rural communities. Given the three-shift operation used by fire-service based EMS departments, there is the potential to recruit between 180 and 270 EMS providers for the study. Immediately following the training on how to use the tools and at 4, 8, and 12 months following the training, participants will be interviewed and questioned about each tools' usability, usefulness, and desirability. Frequency of each tool's use will be assessed with a questionnaire at the time of the interview and a daily Run-Use survey tool. Musculoskeletal injury data due to patient handling tasks during the 12 month follow-up period will be compared with injury data from the three-year period prior to study initiation. The final product of this work will provide the important evidence needed to widely promote the adoption of the ergonomic tools within the LiftKit, in order to reduce MSD injury risk to EMS providers associated with common patient handling tasks.
Back pain is one of the most common of all symptoms. It is also a great cause of days lost from work and visits to health care providers. This study will develop and evaluate an approach to low back pain that allows subjects to talk with each other and with health professionals via an Internet discussion group. Results we will look at include health behaviors, such as exercise; health status, such as pain and disability; and health care use, such as number of visits to doctors and other health care providers. Anyone 18 years old or older who lives in the United States and has ongoing Internet access can take part in the study. All subjects must have back pain and meet the eligibility criteria listed below.
Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing.
Muscle sprains of the back and neck are very common. In addition to pain and antiinflammatory medications the use of either cold or hot packs has been recommended. In the current study we will compare ice packs and heat packs to see which is more effective at relieving pain from back and neck sprains while in the Emergency Department.
To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.
The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.
The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of "smart" electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.
This is a prospective, randomized, double-blinded controlled trial comparing two different techniques for digital blocks. Participants will be physicians who perform digital blocks as part of their everyday duty. Each participant will undergo two digital blocks and will have the opportunity to perform a digital block on another participant. This study follows a two-period cross-over design with four groups that are defined by the sequence of treatments within each group. Participants will receive two digital blocks, one using the traditional dorsal technique and one using the volar technique. Of the two injections, one of the syringes will contain 1% lidocaine without epinephrine and the other will contain sterile normal saline. The injections will be to the index finger on each hand. The hand injected first will be up to the participant. The order in which the dorsal technique versus the volar technique is performed will be randomized. Participants will not be told one of the syringes contains normal saline. Injection pain will be measured by visual analog score and recorded after each injection. Sensation in each of the 12 zones of the finger will be recorded at each minute mark until loss of sensation in all 12 zones is achieved or 15 minutes has passed, whichever comes first.
The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow. Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.
The overall objective of this fully powered clinical trial is to investigate if using a solid backrest on a manual wheelchair (MWC) will improve postural alignment, function and wheelchair mobility, as compared with an upholstery backrest, and to explore the impact of overall back height, contour, and seat gap when using a solid backrest in individuals with spinal cord injury (SCI).
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.
A study to compare electrophysiologic activity of epidural stimulation and dorsal root ganglion stimulation, as well as quantify changes in motor performance with both types of stimulation over the course of 10 rehabilitation sessions.
The purpose of this study is to examine a different way to educate patients about taking care of their wound and see how this method affects patient satisfaction, compliance to the wound care regimen, and patient experience. The teach-back method is delivered using the ask-tell-ask method. Investigators will ask the patient about their knowledge of wound care healing, provide the patient educational component, then ask the patient to repeat what was said. If the answer is wrong or incomplete, the researcher will go over the information again with the patient to clear up any misunderstandings.
This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.
The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in patients undergoing lumbar fusion.
This study will measure the effects of interactive, whole-body video games on movement behavior in people with chronic low back pain.
The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.