Treatment Trials

2,078 Clinical Trials for Various Conditions

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RECRUITING
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
Description

The investigators propose to conduct a dose-escalation trial of an FDA-approved antiepileptic drug, lacosamide, added to opioid therapy in patients with chronic abdominal pain from chronic pancreatitis (CP). This pilot trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of lacosamide used concomitantly with opioids in this patient population to reduce the condition known clinically as opioid-induced hyperalgesia (OIH).

ENROLLING_BY_INVITATION
ESWL vs. Pancreatoscopy-guided Lithotripsy for Painful Chronic Calcific Pancreatitis
Description

This is a multi-center randomized controlled trial comparing extracorporeal shock-wave lithotripsy (ESWL) with per-oral pancreatoscopy-guided lithotripsy (PPL) in the treatment of patients with chronic pancreatitis and refractory main pancreatic duct stones. This study will be comparing the two treatment options for patients who have stones that fail initial endoscopic therapy via endoscopic retrograde pancreatography (ERCP). The study will look at the stone clearance rates and patient-centered outcomes including quality of life and pain.

COMPLETED
Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee
Description

Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.

RECRUITING
BioPoly® Partial Resurfacing Knee Implant IDE
Description

The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: * no secondary surgical intervention (SSI) and * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement). Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.

NOT_YET_RECRUITING
Home-based Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for IBS Pain
Description

The goal of this clinical trial is to learn the feasibility and safety of using home-based taVNS in young adults with IBS to manage their IBS-related pain and symptoms. It will also learn about participants' experience in using the home-based taVNS intervention. The main questions it aims to answer are: * Is it feasible to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? * Is it safe and reported satisfactory to use a home-based taVNS intervention for pain and symptom management among YAs with IBS? Researchers will compare Active to Sham taVNS (a look-alike intervention that contains minimal stimulation) to see if Active taVNS works on managing IBS-related pain and symptoms. Participants will: * Take Active or Sham taVNS intervention for a 6-week treatment (twice daily, 30 minutes per session) * Visit the research lab at the initial setup and the end of the 6-week treatment for checkups and tests * Keep a diary of their symptoms and the number of times they use the taVNS.

RECRUITING
Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain
Description

The purpose of this study is to determine whether exposure to prescription opioids is associated with brain structural changes on magnetic resonance imaging (MRI), with the primary outcome of white matter integrity as measured by fractional anisotropy of the corpus callosum.

Conditions
RECRUITING
Pain Reprocessing Therapy in Post-Operative Knee Pain
Description

The goal of this clinical trial is to learn whether Pain Reprocessing Therapy (PRT) can help adults with knee pain after knee replacement surgery. The study is comparing PRT to usual care (the regular treatment people get after surgery) to see which works better for relieving pain. The main questions the study aims to answer are: 1. Does PRT help lower pain in people who have chronic knee pain after knee surgery? 2. How do the effects of PRT compare with usual care in terms of pain relief and other factors such as anxiety, depression, and sleep? 3. How does PRT impact the brain? Participants will: 1. Be randomly assigned to receive either PRT or usual care. 2. Complete questionnaires about their pain and health. 3. If in the PRT group, have eight weekly therapy sessions over video calls with a therapist. 4. If interested, may also take part in an optional EEG test to measure brain activity related to pain.

RECRUITING
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Description

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain. The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.

Conditions
NOT_YET_RECRUITING
Developing a Nonpharmacological Pain Intervention for Community-dwelling Older Adults With Dementia
Description

The purpose of this study is to develop an exercise treatment program for knee osteoarthritis that works well for people with memory problems. This study will include two parts. Participants can choose to participate in either or both parts. In Part 1 (not a clinical trial) - The investigators are inviting the following people to participate in an interview: 1. Individuals aged 60 years or older who do not live in a nursing home and have both memory issues and knee pain. 2. Care partners of people with knee pain and memory issues. A care partner can be a family member or friend who helps regularly. 3. Clinicians (exercise physiologists or rehabilitation therapists like physical and occupational therapists) who have worked with older adults with memory issues and knee pain. The goal of these interviews is to learn from the experiences of people with memory issues and knee pain and those who care for them. From these interviews, the investigators hope to design a non-drug, tailored physical activity program that will be interesting and helpful in managing knee pain for older adults with memory problems. For people with memory problems and knee pain and their care partners: The investigators will ask some questions to determine eligibility to participate in the study. Those who qualify for the study will be invited to participate in an interview that could be completed online or in person (Philadelphia, PA). The interview could last up to 90 minutes (1 and a half hours) and can be completed as one or multiple sessions. For clinicians: Participants will engage in a 90-minute focus group with other clinicians where lunch will be served if in person. Those participating in an online focus group will receive a gift card equal to the value of lunch. In Part 2 (a clinical trial) - The program developed in Part 1 will be tested. The program will be physical activity-based. Specific program details for part 2 will be provided as they emerge. Participants can choose to sign up for either or both parts. Signing up for Part 1 does not mean participants have to sign up for Part 2. Please contact us for any questions.

RECRUITING
MIVetsCan: Cannabidiol (CBD)-Care Trial
Description

This research is studying the effects of cannabidiol (CBD), an active component from cannabis (a.k.a. marijuana), on Veterans' chronic pain. The purpose of this study is to better understand if CBD can improve pain symptoms in Veterans with chronic pain. Eligible participants will be randomly assigned to receive either placebo medication (not active) or CBD during the study period. The study hypotheses: - CBD would improve overall pain symptoms compared to placebo

Conditions
RECRUITING
Transcranial Direct Current Stimulation in Conjunction with Individualized Physical Therapy for Individuals with Chronic Knee Pain
Description

Background: There is a high prevalence of chronic pain in the US, with nearly half of adults experiencing chronic pain. Chronic pain is associated with impaired mobility, specifically ambulation. Treatment for chronic knee pain is complex given that pain is not only due to peripheral sources, but also due to alterations of the central nervous system (CNS). Majority of physical therapy (PT) interventions involve a bottom-up approach targeting the peripheral pain sources and many patients (\~66%) do not respond to this treatment approach. Noninvasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) is a novel and promising option for a top-down intervention that can have neuromodulatory effects on the CNS and may better target central factors associated with chronic pain. Purpose: To determine if tDCS delivered to the primary motor cortex in conjunction with individualized PT will result in greater improvements in pain and function compared to sham tDCS with individualized PT in individuals with chronic knee pain. Methods: This study will be performed at outpatient PT clinics at the University of Illinois Hospital. Eligible participants will include patients with chronic knee pain (duration \> 3 months) who have not undergone surgery to this area and are scheduled to receive formal PT intervention. Subjects will be randomized to the active tDCS + PT group or sham tDCS + PT group and will receive the intervention for 8 sessions. Outcomes include pain ratings, pressure pain thresholds, patient specific functional scale, lower extremity functional scale, quadriceps strength, knee range of motion, 2-minute walk test, 5 time sit to stand, patient health questionnaire-2, and Central Sensitization Inventory. Impact: The use of adjuvant therapies such as tDCS have the potential to optimize rehabilitation treatment for individuals with chronic pain by offering a more comprehensive treatment that targets peripheral and central sources of pain.

RECRUITING
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
Description

This study examines the relationship between central nervous system (CNS) mechanisms of pain inhibition and the pain relief that occurs following a lumbar medial branch block (MBB).

COMPLETED
Empowered Relief Delivered by Nurses
Description

This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it \[Empowered Relief (ER)\], as a single-session video-conferenced program. The primary objective is to evaluate the effects of ASPMN nurse-provided ER versus waitlist control (WLC) on pain catastrophizing, pain bothersomeness, pain intensity, pain interference, sleep disturbance, physical function, depression, anxiety, and social isolation for patients with persistent pain. Secondarily, feasibility and acceptability of the ER program will be assessed through recruitment and retention data and qualitative satisfaction data.

Conditions
TERMINATED
The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
Description

This is a research study to evaluate the effectiveness of daily supplementation with Root.Health, a plant-based dietary supplement, on reducing levels of 11 abnormal urine biomarkers associated with chronic pain. Biomarkers are molecules found in blood, tissues, or other body fluids (such as urine) that indicate normal or abnormal processes.

COMPLETED
Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults
Description

This study is designed to test if the use of virtual reality (VR) can improve chronic pain related to CRPS. One way is to use virtual reality. Virtual reality involves looking into a set of goggles and interacting with a computer-simulated world. The use of VR has been shown to be an effective treatment for other pain conditions (Hoffman et al., 2019) and is inexpensive and noninvasive.

Conditions
RECRUITING
The Effectiveness of Immersive Virtual Reality as a Pain Control Modality After Hip Arthroscopy
Description

1. The purpose of the research is to assess the efficacy of postoperative immersive virtual reality (iVR) compared to a standard multimodal pain regimen including opioids and a local block on acute postoperative pain management following hip arthroscopy 2. The primary research procedures are medical record review for demographic information, head-mounted immersive virtual reality experience in PACU, and pre-operative and post-operative surveys 3. The study will enroll adult patients of all ages undergoing elective hip arthroscopy procedures for any diagnosis

RECRUITING
Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain
Description

The goal of this clinical trial is to learn about resilience coaching in adolescents with chronic musculoskeletal pain. The main questions it aims to answer are to 1) determine how helpful resilience coaching is for teens with chronic musculoskeletal pain, 2) which participants are best suited for resilience coaching, and 3) barriers and facilitators to implementing resilience coaching as part of routine clinical care. Participants will complete survey measures and participate in the resilience coaching intervention called Promoting Resilience in Stress Management (PRISM). Researchers will compare youth in PRISM to those receiving usual care to determine whether PRISM leads to greater improvements in functional disability, psychological distress, and pain intensity than usual care alone.

RECRUITING
Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
Description

The goal of this clinical trial is to learn which treatment works better for adults with chronic pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain). The study's main questions are: * Does PRT work well for adults with chronic pain? * Which treatment works better for lowering pain: PRT, CBT, or usual care? This study will compare PRT, CBT, and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain can have.

COMPLETED
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Description

This project will develop and test a wearable breathing monitor that will measure the synchrony in breathing between the diaphragm and chest of children with a pain diagnosis while receiving yoga therapy. Specifically, we will develop a biofeedback system to help improve breathing in pain patients.

Conditions
RECRUITING
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Description

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

WITHDRAWN
Tranexamic Acid (TXA) in Hip Arthroscopy
Description

The primary goal of this study will be to determine if perioperative IV Tranexamic Acid (TXA) administration will reduce intra-operative bleeding and subsequently improve visual clarity during surgery and reduce operative traction time in patients undergoing hip arthroscopy. Additionally, this study aims to determine whether IV TXA injections will reduce post-operative pain and affect hip-specific patient-reported outcomes in patients undergoing hip arthroscopy.

RECRUITING
Randomized Trial for cLBP (Gokhale Project)
Description

The study aims to compare the effectiveness of the Gokhale Method posture therapy for low back pain (LBP) management to standard physical therapy (PT) with posture training. The second aim of this study is to evaluate usability and user adherence of the online/digital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App). The investigator hopes to learn: The effectiveness of the Gokhale Method posture therapy for low back pain management, in comparison to the effectiveness of standard physical therapy with posture training. the usability and user adherence of the online/digital intervention through the Gokhale Method Foundation Class (online delivery with smartphone App).

RECRUITING
Cemented vs Cementless Persona Keel RCT
Description

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.

ACTIVE_NOT_RECRUITING
Pain Reduction Through Empowered Recovery (PRIME) Study
Description

Chronic pain and depression or low mood are often experience by women who age with or into disabilities. Due to various factors women with disabilities often experience this cycle of pain and depression. Both of these conditions can be debilitating and lead to declines in health. Treating these conditions simultaneously, particularly , in older adults can be complicated due to side effects, risks of poor access to pain management and mental health care , and complications from other co occuring conditions. In order to address this cycle in older women with disabilities the investigators are testing the Women in Pain Reduction through Improved Mood and Empowerment (PRIME) study. The PRIME intervention includes four in person visits by a nurse to the women's homes where the participants set goals regarding pain and depression and the nurse helps the participants strategize ways to meet these goals. The second component of the study will be eight group sessions virtually with other participants in the study. The group sessions will be led by a clinical psychologist who will engage in Acceptance Commitment Therapy with the women.

RECRUITING
Comparative Effectiveness of Online 8-session CBT Vs. 1-Session Empowered Relief for Chronic Pain - the PROGRESS Study
Description

The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness of: (1) 8-week cognitive behavioral therapy for chronic pain (pain-CBT; sixteen hours total treatment time); and (2) a 1-session pain relief skills intervention for chronic pain (Empowered Relief; two hours total treatment time).

WITHDRAWN
Study on the Use of Intraoperative Neurophysiological Monitoring in Spinal Cord Stimulator Trials
Description

This is an observational pilot study. The spinal cord stimulator (SCS) procedure and neuromonitoring device is not under investigation. Neuromonitoring is typically performed on this patient population receiving SCS trials here. This study is collecting the data that is transmitted into EPIC from the device that is being collected as part of the patients standard of care. This study will specifically look at Boston Scientific SCS trials as those are the majority of SCS devices that are used here at this medical center Primary Objective - To evaluate the difference between observed intraoperative neuromonitoring readings and patient reported coverage for spinal cord stimulator trials and Secondary Objective(s) - 1. To evaluate the safety and tolerability of intraoperative neuromonitoring during spinal cord stimulator trials and via documented adverse events and patient elicited feedback on follow up questionnaires. 2. Patient satisfaction using PGIC from one week to 6-months post procedure 3. Change in pain intensity using NRS from baseline to 6-months post procedure This study will follow subjects in conjunction with thier standard of care SCS clinic visits. This includes the one week wound check at the pain clinic and then a 2 week end of study phone call.

COMPLETED
The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
Description

Approximately 24% of community-dwelling older adults are socially isolated, and over 40% of adults 60 and older report feeling lonely. Over 50% of midlife and older adults who perceive their health as fair or poor are lonely in contrast to 27% percent who believe their health to be excellent or very good. Loneliness has been associated with high mortality and inflammation which can influence symptoms such as pain. Social isolation and pain further contribute to loneliness. Studies have reported one and a half greater odds of being socially isolated among older adults with clinical osteoarthritis (OA) of the hip and/or knee than someone with similar characteristics without OA. Pain is significant because it is highly prevalent among older adults and is associated with disability, social isolation, and greater costs and burden to health care systems. A recent review of the literature found that several interventions influence social isolation and loneliness. As these interventions require in-person interaction, those who are socially isolated or distanced due to pain may not benefit due to a lack of access. Current advancements in technology and social media may provide opportunities to reduce loneliness and pain due to social isolation. Online and technology-based interventions have shown potential to engage older adults to improve communication and social connection. Given that socialization with these approaches are supportive only when the other person is available for that interaction. An intervention that utilizes technology to incorporate solitary interventions may be efficacious. Studies found a trend for a positive relationship between the use of a voice assistant and loneliness in aging adults living alone. Building upon this evidence on loneliness and pain research, conversational voice assistant (CVA) technology and personalized persuasion, investigators will conduct a 12-week randomized control pilot with older adults that live alone and self-report pain. Participants will interact with a standard or a personally enhanced loneliness routine delivered through a CVA. Investigators will explore intervention feasibility and examine the efficacy of both standard and personalized interventions on loneliness and secondary outcomes.

RECRUITING
iCanCope With Post-Operative Pain (iCanCope PostOp)
Description

There are few applications available in the community to help teenagers manage pain after surgery. The focus of this study is to better understand the pain experience of children after having surgery and to design a Smartphone app called "iCanCope with Post-Operative Pain" (iCanCope PostOp), to help children and parents to better manage pain at home after surgery. The app will help keep track of pain, provide information about the teenager's surgery and provides "in-the-moment" advice wherever and whenever the patient needs it.

COMPLETED
Examining the Effects of Float-REST for Recovery in Individuals With Chronic Lower Back Pain
Description

Researchers at the West Virginia University Rockefeller Neuroscience Institute are looking for volunteers to participate in a research study to evaluate what effects Float-REST (Restricted environmental Stimulation Technique) has on the stress response caused by chronic lower back pain.

Conditions
WITHDRAWN
Genicular Artery Embolization (GAE) for the Treatment of Chronic Post Knee Arthroplasty Pain
Description

This study seeks to evaluate the safety and efficacy of genicular artery embolization (GAE) as a treatment for patients with chronic pain following primary total knee arthroplasty (TKA) or revision TKA at 6 months as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS).