Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor Induced Arthralgias Save

Date Added
July 31st, 2017
PRO Number
Pro00056235
Researcher
Steven Corso
Keywords
Cancer/Breast, Drug Studies, Joint, Pain
Summary

It is well known that treatment with an aromatase inhibitor (AI) can cause side effects that result in symptoms such as joint pain and stiffness, which can interfere with activities of daily living. In some patients, the treatment has to be stopped because of these symptoms.

The purpose of this study is to compare the effects, good and/or bad, of the study agent, testosterone, with a placebo (an inactive agent) on joint pain caused by taking aromatase inhibitors. The testosterone/placebo is a gel that will be applied to the body in non-fat pad areas. In this study, patients will receive either the testosterone or placebo. They will not receive both.

The study agent, testosterone, used in this study is considered investigational, which means it has not been approved by the Food and Drug Administration (FDA) for routine clinical use. However, the FDA has allowed the use of this agent for this research study.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients with Osteoarthritis of the Knee Save

Date Added
January 24th, 2017
PRO Number
Pro00062926
Researcher
Shane Woolf
Keywords
Arthritis, Drug Studies, Joint, Pain
Summary

The purpose of this study is to evaluate the safety of repeat administrations of the drug FX006 in patients who suffer from osteoarthritis of the knee. FX006 is a long lasting steroid that is injected into the knee for pain associated with osteoarthritis. Patients will be monitored monthly to ensure that they are benefiting from the injection.

Institution
MUSC
Recruitment Contact
Robert McClam
843-792-7238
mcclamr@musc.edu

Online Pain Management Program for Parents of Preschool-Age Children with Sickle Cell Disease: A Pilot Study Save

Date Added
December 1st, 2016
PRO Number
Pro00055478
Researcher
Jeffrey Schatz
Keywords
Blood Disorders, Pain
Summary

Sickle cell disease (SCD) is a genetic blood disorder present at birth characterized by painful vaso-occlusive episodes. Pain episodes typically result in approximately one to two severe pain crises requiring hospitalization per year along with another ten pain episodes managed at home. Pain crises can emerge as early as six to twelve months and most children with the most common form of the disease (HbSS), experience a pain episode requiring hospital care by the age of five years. Promoting better coping with pain in preschool age children likely requires additional adaptation of methods and consideration of a developmental framework. Very young children have limited coping skills, a limited ability to communicate pain, and it is up to the primary caregiver to correctly interpret and treat the pain that a child may be experiencing. Despite the frequency of painful episodes early in life in SCD, there has been little work to-date addressing pain management in young children with SCD. Management of pain episodes early in life by parents may be an important developmental context for later child and family coping with pain, as well as coping with other aspects of this chronic health condition. Consequently, the current study will target parents of preschool age children with SCD through an online video-based platform in order to teach pain management skills to help to identify and manage SCD-related pain episodes.

Institution
Palmetto
Recruitment Contact
Kelsey Smith
803-563-7931
smithk88@email.sc.edu

The effect of early versus late urinary catheter removal on post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI) rates in patients with POUR risk factors receiving thoracic epidural analgesia (TEA) for post-operative thoracic surgery pain control Save

Date Added
November 15th, 2016
PRO Number
Pro00058458
Researcher
Michaella Prasad
Keywords
Bladder, Infectious Diseases, Pain, Spinal Cord, Surgery, Urinary
Summary

Patients scheduled for thoracic surgery will be identified as potential candidates and recruited by a research coordinator before surgery. Research subjects will be randomized to either early or late post-operative urinary catheter (a thin flexible tube placed into the bladder to drain urine) removal. Thoracic epidural analgesia (TEA), a thin tube placed near the spinal cord, will remain functioning after urinary catheter removal for the early group. The study group randomized to early catheter removal will have urinary catheters removed 24 hours after surgery is completed. Study subjects that are randomized to late removal of urinary catheter will have urinary catheters removed after TEA is discontinued as routine clinical care (usually 4-5 days). Determination of bladder urine volume will be made by sound wave examination (ultrasound) by appropriately-trained staff. Following indwelling urinary catheter removal, research subjects may receive a brief urine drain tube as standard clinical care. Laboratory urine analysis will be obtained from urine following removal of urinary catheter and assessed for urinary tract infection (UTI).

Institution
MUSC
Recruitment Contact
Bill Rawls
9196360725
rawlsw@musc.edu

Looseners versus Tighteners: Histopathology Analysis of Arthrofibrosis in Total Knee Replacement (TKA) Save

Date Added
November 3rd, 2016
PRO Number
Pro00052283
Researcher
Jacob Drew
Keywords
Aging, Arthritis, Bone, Joint, Pain, Physical Therapy
Summary

All primary total knee replacement patients will undergo the surgical procedure per the surgeon's standard technique. Samples of tissue that is ordinarily removed and discarded as a part of the procedure will be sent to the pathology lab, where the pathologist will prepare and stain the tissue sample to assess for levels of a specific protein thought to be a marker for the likelihood of the soft tissues to form dense versus loose scar tissue. We will then follow each patient's postoperative course to determine if levels of the protein in question, alpha smooth muscle actin (ASMA) correlate with outcomes. Outcomes will include postoperative pain, range of motion, as well as patient-reported satisfaction and function scores.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@musc.edu

The effects of electroacupuncture on pain and shoulder range of motion (ROM) in patients with shoulder impingement syndrome. Save

Date Added
August 16th, 2016
PRO Number
Pro00053521
Researcher
Emily Darr
Keywords
Pain
Summary

This research study is designed to examine the effects of a single treatment of electroacupuncture (EA) on shoulder pain and range of motion in patients who have ben diagnosed with shoulder impingement syndrome. Patients with shoulder impingement syndrome will be recruited from orthopedic and physical therapy offices in Charleston, SC. If they are determined to be eligible for the study, the patients will receive informed consent. If the patient chooses to participate in the study, they will have their shoulder pain and range of motion in their shoulder assessed. The patient will then receive one treatment of EA. EA is a roughly 15 minute acupuncture-like procedure where thin needles (about the diameter of a thick human hair) will be placed in the muscle tissue surrounding your shoulder. A small electric current will be applied to the needles while they are inserted. Generally, acupuncture does not hurt. Some people feel the needles as they go in, and some people feel nothing Following the treatment, the patient will have their shoulder pain and range of motion assessed again.

Institution
MUSC
Recruitment Contact
Emily Darr
(843) 792-1414
darr@musc.edu

A Novel Approach to Reduce Pain, Prescription Opioid Use & Misuse in Pregnancy Save

Date Added
March 1st, 2016
PRO Number
Pro00052361
Researcher
Constance Guille
Keywords
Pain, Pregnancy
Summary

Pregnant women using prescription opioid medication (pain medications) are invited to take part in a program for the reduction of pain and prescription opioid misuse.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

RELIEF A Global Registry to Evaluate the Long-Term Effectiveness of Neurostimulation Therapy for Pain Save

Date Added
October 27th, 2015
PRO Number
Pro00044796
Researcher
Michael Hillegass
Keywords
Pain
Summary

This is a registry to investigate the outcomes of participants with commercially available Boston Scientific neurostimulators for pain. This study will also assess the economic value and technical performance of these devices for pain.

Institution
MUSC
Recruitment Contact
Wanda Jones
843-792-1869
joneswr@musc.edu

Evaluation of Pain in Healthy Volunteers Save

Date Added
October 6th, 2015
PRO Number
Pro00047310
Researcher
Kelly Barth
Keywords
Healthy Volunteer Studies, Pain
Summary

This study will evaluate pain laboratory testing in healthy volunteers on two sequential days (Day 1 and Day 2). Pain laboratory testing is non-invasive and will last about 1.5 hours on Day 1 and 1.5 hours on Day 2. The study will also involve filling out questionairres.

Institution
MUSC
Recruitment Contact
Kelly Barth
843-792-0686
stephen@musc.edu

Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper Save

Date Added
September 1st, 2015
PRO Number
Pro00046473
Researcher
Kelly Barth
Keywords
Pain
Summary

Chronic opioid therapy for pain can be associated with significant risks, and a significant number of patients maintained on chronic opioids have continued pain and/or poor functioning. When patients need to or want to come off their opioid pain medications, there is little to guide physicians as to how to best help them do so, and it is not known how patients do after coming off opioid medications. The goals of this study are (1) to evaluate two medications in assisting patients in coming off their opioid pain medications and (2) determining outcomes after discontinuing opioids.

Institution
MUSC
Recruitment Contact
Kelly Barth
843-792-0686
stephen@musc.edu

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