Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)

Date Added
January 2nd, 2024
PRO Number
Pro00130123
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Pain, Psychiatry, Substance Use
Summary

This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.

Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.

Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.

Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.

In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.

It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.

Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.

Institution
MUSC
Recruitment Contact
Georgia Mappin
843-764-7316
mappin@musc.edu

STEMCAP-1: Safety and Efficacy of Mesenchymal Stem Cells Associated with Chronic Pancreatitis Pain

Date Added
December 19th, 2023
PRO Number
Pro00132905
Researcher
Hongjun Wang

List of Studies


Keywords
Pain
Summary

Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of donor derived mesenchymal stem cells to relieve chronic pain. After cell infusion into the vein, the participant will be followed for 6 months to evaluate their pain and other outcomes. There are a total of 5 clinic visits with a total study participation of up to 7 months.

Institution
MUSC
Recruitment Contact
Leah Benn
843-792-2813
bennle@musc.edu

A randomized, parallel-group, 24 week, double-blind, placebo-controlled, multicenter Phase 3 study to assess the efficacy and safety of secukinumab compared to placebo in adult patients with active rotator cuff tendinopathy.

Date Added
September 12th, 2023
PRO Number
Pro00128912
Researcher
Josef Eichinger

List of Studies


Keywords
Drug Studies, Joint, Muscle, Pain
Summary

Patients greater than/equal to 18 years of age who are diagnosed with unilateral rotator cuff tendinopathy (with MRI confirmation) will be recruited. The purpose of the study is to measure the safety and efficacy of the drug secukinumab, 300mg s.c. (subcutaneous) compared to placebo. The use of secukinumab for the treatment of tendinopathy is investigational in this study, but FDA approved for other indications. The study will be a randomized, double-blind study. This means the participant, nor the researchers will know if the drug or placebo is administered. The treatment period will last 16 weeks, during which the patient will receive 7 doses of the study drug (2 injections per dose) over 12 weeks. Participants will continue follow-up until week 24. A total of 11 visits are required for the study, each will take approximately 3 hours to complete. These visits will be at the following timepoints: Screening visit, Baseline visit, and visits at weeks 1,2,3,4,8,12,16, 20, and the end of the study visit. The location of the injection will be the affected shoulder.

Risks include but are not limited to upper respiratory tract infections, with symptoms such as sore throat and stuffy nose. Common risks include Cold sores, Athletes foot, runny nose, diarrhea, itchy rash (urticaria). Rare and serious risks include Severe allergic reaction with shock (anaphylactic reactions). A blood draw may cause fainting, pain, and/or bruising, dizziness, and in rare cases, infection.

Institution
MUSC
Recruitment Contact
Maggie Schiessl
843-792-7534
schiessl@musc.edu

Novel Cellular Therapy for the Treatment of Pain Associated with Chronic Pancreatitis

Date Added
July 18th, 2023
PRO Number
Pro00127525
Researcher
Hongjun Wang

List of Studies


Keywords
Pain
Summary

Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of the patient's own stem cells to relieve chronic pain. The stem cells will be isolated from the patient's bone marrow and grown in the clean lab to be used for treatment. After infusion into the vein, the participant will be followed for 12 months to evaluate their pain and other outcomes.

Institution
MUSC
Recruitment Contact
Leah Benn
843-792-2813
bennle@musc.edu

POST-APPROVAL STUDY 2: HINTERMANN SERIES H3® TOTAL ANKLE REPLACEMENT SYSTEM

Date Added
June 12th, 2023
PRO Number
Pro00127864
Researcher
Christopher Gross

List of Studies


Keywords
Arthritis, Joint, Pain
Summary

Total ankle replacement has become an increasingly recommended treatment option for endstage ankle osteoarthritis over the last decades. As a result of this progress, a large variety of implant systems exist.

The Hintermann Series H3 Total Ankle Replacement System (H3) is a three-piece, mobile-bearing implant. The H3 is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease.

The purpose of this study is to investigate long-term (up to 5 years) how the H3 implant is performing, collect information about the device through x-rays of the joint, document any complications from the device implant, see how the device affects patient quality of life.

Institution
MUSC
Recruitment Contact
Joshua Morningstar
843-792-1383
Morninjo@musc.edu

Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial

Date Added
April 4th, 2023
PRO Number
Pro00127137
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Minorities, Pain, Pediatrics, Rare Diseases
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms. 272 teens and adults with SCD will be enrolled in this study which is being conducted at the Medical University of South Carolina in Charleston SC., East Carolina University in Greenville NC., University of Miami in Miami FL., and the University of Alabama in Birmingham AL.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

REAL Answers (Registry Expansion Analysis to Learn Answers)

Date Added
November 16th, 2022
PRO Number
Pro00124358
Researcher
Hermes Florez

List of Studies

Keywords
Anxiety, Blood Disorders, Cardiovascular, Genetics, Hypertension/ High Blood Pressure, Pain, Stroke, Stroke Recovery
Summary

Over 2400 people who have sickle cell disease and are between the ages of 15 and 45 have been enrolled into the National Registry (SCDIC-I) of patients with Sickle Cell Disease (SCD). A rich resource of natural history data, the SCDIC-I Registry has longitudinal data collected yearly since 2016 from patient surveys (e.g. self reported pain incidences, sleep, barriers to care, experiences during and after pregnancy), medical record abstraction (e.g. medications, transfusion history, co-morbidities) and laboratory results. The 150 patients (or 1200 among the 8 sites) will be selected from both MUSC adult and pediatric SCD clinics starting at 12 years of age; those not previously enrolled in the SCDIC National Registry will be offered the possibility to enroll in SCDIC-II.
We will look at the following:
1- Compare the effect of new SCD medications – crizanlizumab, voxelotor, and L-glutamine – on clinical outcomes in individuals with SCD.
2 - Identify genetic and genomic predictors of response to crizanlizumab, voxelotor, and L-glutamine
3 - Integrate study data into the CureSCi metadata catalog (MDC) to enhance future cross-study analyses.

Institution
MUSC
Recruitment Contact
Jayla Moss
843-792-4653
mossjay@musc.edu

Sickle Cell Disease Patient Registry

Date Added
August 23rd, 2022
PRO Number
Pro00122740
Researcher
Hermes Florez

List of Studies

Keywords
Anxiety, Blood Disorders, Cardiovascular, Genetics, Hypertension/ High Blood Pressure, Pain, Stroke, Stroke Recovery
Summary

Over 2400 people who have sickle cell disease and are between the ages of 15 and 45 have been enrolled into the National Registry (SCDIC-I) of patients with Sickle Cell Disease (SCD). A rich resource of natural history data, the SCDIC-I Registry has longitudinal data collected yearly since 2016 from patient surveys (e.g. self reported pain incidences, sleep, barriers to care, experiences during and after pregnancy), medical record abstraction (e.g. medications, transfusion history, comorbidities) and laboratory results. The SCDIC-II Registry will continue follow-up of this patient cohort and enroll new patients of all ages to enrich the data resource as a natural history study.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-876-8652
bourne@musc.edu

Studying the effects of iPACK blocks with adductor canal blocks for postoperative analgesia following ACL reconstruction

Date Added
June 21st, 2022
PRO Number
Pro00121103
Researcher
Carey Brewbaker

List of Studies


Keywords
Joint, Pain, Physical Therapy
Summary

This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.

Institution
MUSC
Recruitment Contact
Haley Nitchie
843-792-1869
nitchie@musc.edu

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Date Added
May 17th, 2022
PRO Number
Pro00117916
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Exercise, Pain, Physical Therapy
Summary

The purpose of this research study is to study four treatments for chronic low-back pain to learn whether or not certain treatments work better for people with certain characteristics.The study's main goal is to find a way to match treatments to low-back pain patients based on their characteristics and how they responded to treatments they have used before.

This study is a multi-site, sequential, multiple assignment randomized trial (SMART) designed to meet the primary objective of estimating an algorithm for optimally assigning evidence-based interventions for chronic low-back pain. The trial is based on an individual patient's phenotypic markers and response to treatment. Interventions being evaluated in this trial are: (1) acceptance and commitment therapy (ACT), (2) duloxetine, (3) enhanced self-care (ESC), and (4) evidence-based exercise and manual therapy (EBEM).

Institution
MUSC
Recruitment Contact
Haley Schiek
843-764-7309
schiek@musc.edu



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