Clinical trials

The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.

This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.

This study plans to use systems that have been developed by Medtronic to investigate the use of cervical spinal cord stimulation to treat adults with upper limb hemiparesis resulting from a stroke. The spinal cord stimulation (SCS) will be combined with physical training to improve arm and hand motor control. The study is divided into three phases. In the first phase, after baseline assessments, participants will undergo a Physical Training Protocol (PTP) for 6 weeks including 3 sessions of 90 mins/session per week. After receiving the Medtronic implantable system, in Phase 2, they will then repeat the same PTP program in combination with spinal cord stimulation during the entirety of each of the rehabilitation sessions. Finally, in Phase 3, participants will go home, will not be able to use the stimulation at home but will participate in monthly assessments in the laboratory in which the functionality of the Medtronic system and their motor performances will be assessed for up to 6 months.

To our knowledge, no studies have been conducted in the literature investigating the relationship between the success of physical therapy programs applied in knee osteoarthritis and patients' pre-treatment expectations. The rationale for this study is to demonstrate the possible relationship between treatment expectations and the benefits seen from conventional physical therapy programs in patients with knee osteoarthritis, and to provide clinicians with a different perspective in knee osteoarthritis treatment planning.

Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.

The goal of this clinical trial is to learn whether starting rehabilitation earlier after surgery can improve recovery and is feasible and acceptable for adults with degenerative cervical myelopathy (DCM) undergoing cervical spine surgery. The main question it aims to answer is: Does starting rehabilitation earlier improve walking, balance, physical activity, quality of life, and nervous system function after surgery? Researchers will compare participants who begin rehabilitation two weeks after surgery with participants who begin rehabilitation six weeks after surgery to see if earlier rehabilitation leads to better recovery outcomes and participation. Participants will: Be randomly assigned to begin rehabilitation either two weeks or six weeks after surgery. Attend physical therapy sessions twice per week for eight weeks focused on strength, balance, and walking. Complete assessments of walking ability, balance, physical activity, quality of life, and nervous system function over several months after surgery. Provide feedback about their experience with the rehabilitation program, including satisfaction and any side effects or challenges related to participation.

This clinical trial tests two different physical therapy and relaxation interventions, one in-person and at-home called Resiliency and Operative Success for Adults Receiving Lung Cancer Surgery (ROAR-LCS) and one virtually called BeFitMe. These programs that take place before and after standard of care lung cancer surgery, called prehabilitation programs, promote resiliency and patient outcomes (operative success) for adults receiving lung cancer surgery. Lung cancers occur in the chest and often cause symptoms for patients. Poor physical performance and negative mood are two risk factors for a decline in functional status after surgery. Physical therapy and relaxation interventions (i.e. progressive muscle relaxation) are two such interventions that may improve physical and emotional recovery including a potential shortened hospital stay for patients receiving surgery for lung cancer. Starting these intervention programs early alongside cancer treatment can improve symptoms, improve functional status and quality of life, help with emotional needs of patients, improve recovery time, and may even prolong life. ROAR-LCS and BeFitMe may promote resiliency and operative success for adults receiving lung cancer surgery.

This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.

This is a pragmatic, open label, randomized controlled trial with 1:1:1 allocation to 12 weeks of: (1) onsite yoga at opioid treatment programs (OTPs), (2) onsite physical therapy (PT) at OTPs, or (3) treatment as usual (TAU). Participants will be 180 individuals with chronic back pain receiving treatment for opioid use disorder (OUD) in community-based OTPs. Through research visits at screening, baseline, and months 1, 2, 3, 6, and 9, the investigators will evaluate pain and opioid use outcomes and implementation outcomes.

The goal of this clinical trial is to learn whether Neuromodulation-Induced-Cortical-Prehabilitation (NICP)-using physical therapy (constraint-induced movement training, CIM) alone or combined with repetitive transcranial magnetic stimulation (rTMS)-can promote motor-cortex neuroplasticity before surgery in adults with high-grade gliomas near the motor pathway. It will also learn about the feasibility and safety of these prehabilitation strategies around the time of surgery. The main questions it aims to answer are: 1. Does CIM (with or without rTMS) produce measurable motor-cortex plasticity from baseline to pre-surgery as assessed by neuronavigated TMS (nTMS)? 2. Does adding rTMS to CIM lead to greater neuroplastic changes than CIM alone? 3. What clinical, radiological, and neurophysiological outcomes are observed after surgery in participants who receive prehabilitation compared with controls? Researchers will compare standard care (control) vs CIM-based physical therapy vs CIM plus rTMS to see if these approaches induce preoperative neuroplastic changes that may support better surgical outcomes. Participants will: 1. Be randomized to one of three groups: control, CIM physical therapy, or CIM + rTMS• Undergo nTMS motor mapping and excitability testing at baseline (T0) and the day before surgery (T1) 2. Undergo planned tumor surgery (according to standard methods of care) and complete postoperative clinical, imaging, and neurophysiological follow-up assessments.

This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.

This study is testing the effectiveness of "dry needling" for pain management and on muscle strength and leg function for those with knee pain. Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function.

This clinical trial tests how well a psychosocial oncology intervention during neoadjuvant therapy works for patients with pancreatic cancer that has not spread to other parts of the body (localized). Chemotherapy and/or radiation therapy is often recommended prior to surgeryf or patients with pancreatic cancer; this is known as neoadjuvant therapy (NT). The primary advantages of NT include: reducing the size of the cancer mass and/or reducing the spread of cancer, to improve the likelihood of getting all the cancer during surgery, and because receiving chemotherapy after pancreas surgery can be challenging. Other research has shown that NT can lead to improved survival and a lower rate of the cancer returning. Despite these positive effects, NT can be associated with significant physical and emotional side effects. To prepare patients for future surgery and maintain health during chemotherapy and/or radiation, prehabilitation is often recommended. This can include nutritional and physical therapy to help with physical health. An oncology (cancer) psychosocial intervention during NT may be feasible and helpful to patients with localized pancreatic cancer.

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

This study aims to evaluate the effectiveness of a telerehabilitation protocol utilizing the Band Connect platform in patient recovery following rotator cuff repair surgery. This will be a randomized control trial with patients assigned into a traditional rehabilitation or a telerehabilitation protocol.

The investigators hypothesize that a myoelectric (EMG) controlled virtual reality (VR) interface allows for effective upper limb motor recovery of stroke patients. EMG control offers the possibility to alter visual feedback according to the recorded muscle activity in real-time. By manipulating the motion of a virtual hand associated with the recorded muscle patterns, assistance can be provided to stroke patients by correcting the error between the actual (dysfunctional) and a reference (functional) muscle pattern. Thus, through such an assistive EMG control algorithm, patients will be able to perform reaching movements with the virtual hand despite their motor impairment. By gradually reducing assistance, it is hypothesized that the salient error in the task space provided as visual feedback will systematically change the muscle patterns, thereby driving adaptation of the dysfunctional muscle patterns, enhancing motor recovery. Moreover, due to its relevant role in motor learning, it is expected that cerebellar stimulation will favor the underlying processes of adapting cerebello-cortical plasticity involved in motor learning. Therefore, it is hypothesized that an assistive EMG control algorithm in combination with cerebellar transcranial magnetic stimulation will further enhance upper limb recovery.

This study investigates sleep quality in patients with Rotator Cuff Syndrome (RCS) undergoing physical therapy treatment. Existing literature presents a gap regarding longitudinal studies evaluating the impact of physical therapy and different sleeping positions on sleep quality within this specific population. The central hypothesis is that physical therapy, combined with guidance on the best sleeping positions, reduces pain, improves shoulder function, and consequently promotes an improvement in sleep quality for RCS patients over time. The justification for this research lies in the need to better understand the relationship between physical therapy and sleep quality in RCS patients, aiming for the development of more effective and less invasive interventions. Previous studies have demonstrated that chronic pain, a common symptom of RCS, is intrinsically linked to sleep disturbances, which can lead to deleterious effects such as dopamine reduction, alterations in the descending pain modulation system, and central sensitization. Improvements in sleep quality have been observed after surgical procedures such as shoulder arthroscopy and arthroplasty, often associated with improved function and pain reduction. Thus, this study seeks to longitudinally evaluate whether physical therapy is capable of promoting a sustained improvement in sleep quality for patients with RCS

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain and function at 12 weeks and 6 months compared to physical therapy with sham inserts (PT+Sham) and physical therapy (PT) alone. In addition, we hypothesize that the addition of a neutral shoe insert in the involved limb will immediately improve biomechanics and pain with the single-leg stance test.

This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.

The goal of this clinical trial is to learn whether a pain-management program called a Transitional Pain Service can help prevent long-term pain and reduce opioid needs after surgery in adult surgical patients who may be at higher risk for developing persistent pain. The main questions this trial aims to answer are: 1) Does the Transitional Pain Service help high-risk surgical patients manage pain better after surgery? 2) Can a computer tool (an algorithm) improve screening of patients for long-lasting pain after surgery? The investigators will compare patients who continue with their usual care to patients who receive support from the Transitional Pain Service to see if the program leads to better pain control and lower opioid use. Participants will share information about their pain levels and the pain-relief treatments they are using before and after surgery so researchers can better understand how the program affects recovery. Patients assigned to the Transitional Pain Service will also be offered additional coordinated support before and after their surgery to help optimize their pain control and overall recovery.

The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.

This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.

Hip pathologies that cause pain and functional limitations are common in the general population. These can include femoroacetabular impingement (FAI), labral tears and mild osteoarthritis (OA) among others. While more severe and symptomatic cases may require surgical intervention, the treatment of mild-to-moderate cases is often treated without surgery to relieve pain, improve function, and delay surgical intervention. Non-operative treatments of hip pathologies consist of a multitude of options. A common non-operative intervention includes intra-articular injections, including corticosteroids and hyaluronic acid. Evidence has demonstrated that corticosteroids have fast acting effects which tend to diminish within a few months, while hyaluronic acid has a delayed time of onset and demonstrates clinical benefit for a longer period of time. Studies have evaluated combinations of corticosteroid and hyaluronic acid, hoping to take advantage of the fast-acting relief of corticosteroid and the longer lasting benefits of corticosteroid. Physiotherapy is also a frequent non-operative intervention used to relieve pain and increase function in patients with hip pathologies. While many studies have looked at intra-articular injections and physiotherapy as independent non-operative possibilities for hip conditions, the combined effect of these two have not received much evaluation. The purpose of this study is to evaluate the effect of physiotherapy in conjunction with a combined corticosteroid and hyaluronic acid intraarticular injection on patient outcomes when compared to a corticosteroid and hyaluronic acid intraarticular injection alone.

The purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." This type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. This study is also exploring a possible way to treat somatosensory tinnitus.

Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated, and painless lumbosacral transcutaneous electrical stimulation strategy was demonstrated to be effective in improving lower limb motor function in participants with spinal cord injury. Our current project, cervical transcutaneous electrical stimulation and intensive exercise for arms and hands are also revealing a significant improvement in upper extremity function. Additionally, the subject and caregiver noted that stair climbing ability has been substantially enhanced starting from the first week of cervical stimulation treatment and continues to date. This study is a prospective efficacy trial of combined transcutaneous cervical and lumbosacral electrical stimulation with physical therapy for improving locomotion in people with anatomically incomplete tetraplegia and paraplegia. This experiment design consists of testing walking function with and without transcutaneous spinal cord stimulation. A two to four-phase intervention program will include physical therapy and spinal cord stimulation with physical therapy. The length of any intervention phase, and number of measurements performed during that phase, will be determined by multiple factors, including participants' health condition, availability, and response to intervention. Between each intervention, washout periods of up to one month may be used to determine any after-effects of the interventions. The intervention arms will be repeated if the functional improvement does not reach a plateau during the first two months of intervention. Physical therapy will include functional training (e.g., walking training) and strength training. Each spinal cord stimulation with physical therapy intervention block can use transcutaneous lumbosacral stimulation or cervical and lumbosacral stimulation. Both immediate and lasting improvements in lower extremity function and autonomic function via transcutaneous spinal cord stimulation and intensive physical therapy may be evaluated.