RECRUITING

Effects of tDCS Combined With CBI on Postsurgical Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI). This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles. This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). The Veteran may benefit in the form of decreased pain and opioid requirements following knee or hip replacement surgery. However, benefit is only likely if Veterans are randomized to one of the 3 (out of 4) groups. This study hopes to determine the effects of these interventions and combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Official Title

tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

Quick Facts

Study Start:2021-01-11
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04199780

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mentally capable of reading, writing, giving consent, and following instructions
  2. * Cleared for, and scheduled for unilateral TKA or THA surgery
  3. * Able to hear CB intervention and understand educational materials through headphones in English
  1. * implanted medical devices above the waist
  2. * pregnant
  3. * history of seizures
  4. * allergic to latex rubber
  5. * psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population).

Contacts and Locations

Study Contact

Jeffrey J Borckardt, PhD
CONTACT
(843) 577-5011
Jeffrey.Borckardt@va.gov
Donald (Hugh) L Myrick, MD BS
CONTACT
(843) 789-7316
Donald.Myrick@va.gov

Principal Investigator

Jeffrey J Borckardt, PhD
PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC

Study Locations (Sites)

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Jeffrey J Borckardt, PhD, PRINCIPAL_INVESTIGATOR, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-11
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2021-01-11
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • total knee arthroplasty
  • pain
  • postsurgical pain
  • opioid
  • transcranial direct current stimulation
  • tDCS
  • brain stimulation
  • total hip arthroplasty
  • TKA
  • THA

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty (Postoperative Pain)
  • Total Hip Arthroplasty (Postoperative Pain)