Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Real tDCS:Active Comparator

For Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system).

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

20 minutes of either real or sham stimulation

Sham tDCS: Sham Comparator

For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

20 minutes of either real or sham stimulation

Interventions

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tDCS

20 minutes of either real or sham stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No