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

NCT01861587 | Completed Results

• 1 other identifier: HR18682
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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

• 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

Study Arms (2)

Real tDCS:Active Comparator

EXPERIMENTAL

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).

Device: tDCS

Sham tDCS: Sham Comparator

EXPERIMENTAL

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

Device: tDCS

Interventions

tDCS DEVICE

20 minutes of either real or sham stimulation

Real tDCS:Active Comparator; Sham tDCS: Sham Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years-75 years of age
• surgery at Medical University of South Carolina
• at least 2 days of post-operative stay

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Brain Stimulation Laboratory, Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Jeffrey Borckardt, Ph.D
• Organization: Medical University of South Carolina

borckard@musc.edu

843-792-3295

Study Officials

• Jeffrey Borckardt, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 23, 2013
• Study Start: October 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 7, 2018
• Results First Posted: July 10, 2018

Record last verified: 2018-07

Locations

US (1)