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

Intrathecal Morphine versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial

Date Added
June 21st, 2022
PRO Number
Pro00121082
Researcher
Natalie Barnett

List of Studies

Keywords
Adolescents, Kidney, Pediatrics, Urinary
Summary

Patients between the ages of 12 months and 11 years who are undergoing lower abdominal laparotomy will be randomized to receive intrathecal morphine, or bilateral quadratrus lumborum block. We will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.

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

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

Date Added
December 5th, 2023
PRO Number
Pro00131771
Researcher
Haley Burdge

List of Studies

Keywords
Breastfeeding
Summary

This study aims to improve the breastfeeding skills of premature or sick term infants with non-invasive, transcutaneous vagus nerve stimulation (taVNS). taVNS is microcurrent stimulation to the ear, which targets a vagus nerve branch. Pairing taVNS with motor activity, such as breast feeding, may help with motor learning in infants as it does in adults with stroke. Ten premature infants older than or equal to 35 weeks gestational age, or convalescing sick term infants whose mothers want to breastfeed will participate in this study with parental consent. Infants will receive 1 taVNS treatment paired with breastfeeding per day for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort. This level of electrical stimulation will be delivered by a TENS unit (Transcutaneous elecrical nerve stimulation) and neonatal electrodes applied just in front of the ear and our custom made carbon electrode used in the BabyStrong studies (#10881, #67997). Stimulation will be timed with latching and sucking for the duration of the feed and will be on with sucking and off with rest. Pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow efficiency will be recorded. Parental satisfaction will be assessed by questionnaires at the beginning, after 1 and 2 weeks, and 3 months after the end of treatment to assess infants' progress in and maintenance of breastfeeding abilities.
If pairing breastfeeding with taVNS is able to improve effective breastfeeding in infants in the neonatal intensive care units, it might help premature and sick term infants to successfully breastfeed at the time of discharge and maintain breast feeding at home after discharge. Premature infants may benefit from longer time receiving maternal breastmilk.

Institution
MUSC
Recruitment Contact
Haley Burdge
843-214-4089
burdge@musc.edu



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