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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01861587
Other study ID # HR18682
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date October 2014

Study information

Verified date July 2018
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.


Description:

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18 years-75 years of age

- surgery at Medical University of South Carolina

- at least 2 days of post-operative stay

Exclusion Criteria:

- history of seizures or epilepsy

- family history of seizures

- taking any medications shown to lower seizure threshold

- metal implants above the waist

- pregnant

- brain tumors or lesions

- pacemaker

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS
20 minutes of either real or sham stimulation

Locations

Country Name City State
United States Brain Stimulation Laboratory, Institute of Psychiatry Charleston South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Controlled Analgesia (PCA) Hydromorphone Usage The PCA pump usage was downloaded from the PCA pump after discharge from the hospital. Participants were followed for the duration of hospital stay, an average of 48 hours.
Primary Average Pain at Least To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain. Baseline and Discharge
Primary Average Pain at Worst To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain. Baseline Only
Primary Average Pain To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain. Baseline Only
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