The purpose of this study is to determine the clinical efficacy of a novel, bioresorbable hydrogel sheet and wetting solution, VersaWrap®, in surgeries of the foot and ankle. This is a prospective, multi-center, controlled case series with patients identified by the Investigator in his practice. Patients who are scheduled to have procedures of the Achilles tendon will be reviewed to determine if they meet the inclusion/exclusion criteria. If eligible, patients may be enrolled in the study, and the operative surgeon will use VersaWrap® during the procedure. Patients are considered enrolled when VersaWrap® is placed intraoperatively. VersaWrap® has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1-2 years. All subjects will be followed for 1 year post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 6 weeks, 3 months, 6 months, and 1 year after surgery. Patients enrolled in this study are receiving a standard of care surgical procedure (with or
without VersaWrap) and therefore there is no increased risk of the surgical procedure when participating in the study. The study collects patient data, and therefore there is a risk data privacy loss. Patients will also receive remuneration for their participation.

We are looking to examine the various factors that contribute to the changes seen with Physical Therapy for chronic neck pain. These factors include the components of care involving the way a patient perceives their pain or disability, as well as the interaction with their care giver, which contribute to the effect of the Physical Therapy (PT) treatment. The study will assign subjects to one of three groups. The first group will receive a manual therapy treatment approach, the second will receive a simulated manual therapy treatment approach and the third will receive no treatment and act as a waitlist control. This design will allow us to tease out the effects of the treatment itself compared with the other factors which may contribute to change as well as any improvement which occurs as result of natural history. You will be seen for an initial assessment where you will complete surveys and measurements will be performed looking at how far you can move and the way that you move your neck. You will then be seen for 3 additional visits weekly over the next three weeks if you are assigned to the manual therapy or simulated manual therapy group. You will be seen for an initial visit and a follow up after three weeks if you are assigned to the waitlist/control group. All groups will complete the surveys and have repeat measurements performed at the final follow up visit.

The purpose of this study is to study the effectiveness of steroids after sleep surgery in improving pain, reducing difficulties in swallowing, and reducing the amount of narcotic pain medication after surgery. This study also want to see what dosage of steroids, whether intravenous or oral, are more effective at reducing these symptoms and providing a more effective surgical procedure for your sleep apnea. Anyone planning to undergo sleep surgery for your obstructive sleep apnea at the recommendation of the Sleep Surgery Division here at MUSC is invited to participate in this study. The study will be using both intravenous and oral dexamethasone, a very common and widely used steroid. This steroid has been FDA approved for many medical indications.

This study aims to determine if photo biostimulation with Nd-YAG laser improves wound healing following tooth extraction and alveolar ridge preservation. The impact of laser treatment on wound healing will be evaluated by levels of salivary inflammatory biomarkers, gingival wound size, and surveying for pain reduction and patient satisfaction. The intervention group will receive standard-of-care extraction and alveolar ridge preservation with adjunct Nd-YAG laser photobiostimulation on days 1, 3, and 7, while the control group will receive the standard-of-care extraction and alveolar ridge preservation only.

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution) and the current treatment of TCA-IR (Triamcinolone Acetonide, immediate release). The study drug is administered through an ultrasound-guided injection to the affected shoulder. Forty percent of subjects will receive Zilretta, forty percent will receive TCA-IR and twenty percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-85 years of age, BMI under 40, who have been diagnosed with Osteoarthritis of the shoulder by x-ray and has had pain for over 15 days out of the past month. The study has 10 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.

This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to your skin.

If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they will be treated with Qutenza 8% capsaicin topical system and can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if you will need to be retreated at each visit based on your symptoms). This is an open-label study and all participants will receive Qutenza 8% capsaicin topical system. The study visits are estimated to take 90 minutes upwards to 120 minutes.

The APEX 3D™ Total Ankle Replacement System is intended to reduce pain and restore motion to a failing ankle joint due to rheumatoid, post-traumatic, or degenerative arthritis. In 2020, the APEX 3D™ Total Ankle Replacement System received 510(K) clearance from the FDA, demonstrating that the device is marketed as safe and effective. The primary objective of this research study is to determine implant survivorship. Enrollment is expected to take approximately one to two years. All subjects will be followed for ten years post-operatively. Study follow-up visits will occur at 6-weeks, 6-months, and annually for ten years after surgery. During the pre-operative visit and each follow-up visit, subjects will be asked to complete a series of questionnaires that assess their levels of pain, function, mobility, and quality of life. Comparison of pre-operative scores to post-operative scores can be used to assess the improvement in patient function, thus supporting the benefit and clinical performance of the intervention. As with any clinical research study, there is a risk of unintended personal health information disclosure.

The goal of this randomized controlled trial is to analyze return to pre-injury activity level on subjects with lateral ankle instability undergoing a modified Broström reconstruction procedure for repair of the anterior talofibular ligament (ATFL). The subjects undergoing ATFL reconstructive procedure using the Artelon FLEXBAND® system as an augmentation device will be compared to subjects undergoing a standard modified Broström procedure alone. Artelon FLEXBAND is a commercially available, polycaprolactone (PCL) polyurethane urea (PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. Artelon FLEXBAND has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1 year. All subjects will be followed for 2 years post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 2-, 6-, 12-, 18- and 26-weeks, and 1- and 2-years after surgery. Possible, anticipated procedure-related risks associated with using the FLEXBAND device include, but are not limited to, infections, both deep and superficial, allergies or other reaction to device materials, dislocation, subluxation or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant, bone fractures as a result of one-sided overload or weakened bone structure, temporary or permanent nerve damage as a result of pressure or hematoma, wound hematoma, and delayed wound healing. Benefits include improvement in function, including return to pre-injury activity levels.

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.

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.