Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Primary Purpose
Post-Operative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional other trial for Post-Operative Pain
Eligibility Criteria
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
Sites / Locations
- Brain Stimulation Laboratory, Institute of Psychiatry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Real tDCS:Active Comparator
Sham tDCS: Sham Comparator
Arm Description
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).
For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
Outcomes
Primary Outcome Measures
Patient Controlled Analgesia (PCA) Hydromorphone Usage
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01861587
First Posted
April 26, 2012
Last Updated
July 9, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01861587
Brief Title
Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Official Title
Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real tDCS:Active Comparator
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham tDCS: Sham Comparator
Arm Type
Experimental
Arm Description
For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
20 minutes of either real or sham stimulation
Primary Outcome Measure Information:
Title
Patient Controlled Analgesia (PCA) Hydromorphone Usage
Description
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
Time Frame
Participants were followed for the duration of hospital stay, an average of 48 hours.
Title
Average Pain at Least
Description
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.
Time Frame
Baseline and Discharge
Title
Average Pain at Worst
Description
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.
Time Frame
Baseline Only
Title
Average Pain
Description
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.
Time Frame
Baseline Only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Borckardt, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Stimulation Laboratory, Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
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