Wednesday, May 24, 2017

Featured Clinical Trials: December 2015

Clinical Trials-Dec 2015 Sustained acoustic medicine for chronic low back pain secondary to herniated nucleus pulposus or other conditions
Purpose: ZetrOZ’s Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with chronic low back pain, a subset of which will have chronic low back pain due to a herniated disc, over an 8-week treatment period.
Sponsor: ZetrOZ, Inc.

Bioequivalence study of fentanyl transdermal system compared with DURAGESIC fentanyl transdermal patch in healthy participants
Purpose: The purpose of this study is to evaluate the bioequivalence of the new formulation of fentanyl transdermal system (JNJ-35685-AAA-G021) compared with DURAGESIC fentanyl in healthy participants.
Sponsor: Janssen Research & Development, LLC

Biopsychosocial influence on shoulder pain
Purpose: Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the investigators identified a genetic and psychological subgroup that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study the investigator proposes to test how interventions tailored to the high risk subgroup affect pain responses in a pre-clinical cohort.
Sponsor: University of Florida

Efficacy and safety of pregabalin in treatment of neuropathic pain in patients with idiopathic small fiber neuropathy
Purpose: The purpose of this study is to assess safety and efficacy of treatment with pregabalin in patients with idiopathic small fiber neuropathy proven by skin biopsy.This is an enriched enrollment randomized withdrawal study that comprises 4 phases: a screening and selection phase, a washout period from previous pain medication for enriched enrollment, an 8 week single blind pregabalin treatment phase; and a 4 week randomized withdrawal phase.
Sponsor: Johns Hopkins

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The American Academy of Pain Management improves the lives of people with Pain by advancing a person-centered, integrative model of pain care through evidence-guided education, credentialing, and advocacy.