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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

⁃ Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.

• Mentally capable of reading, writing, giving consent, and following instructions

• Cleared for, and scheduled for unilateral TKA or THA surgery

• Able to hear CB intervention and understand educational materials through headphones in English

Locations
United States
South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITING
Charleston
Contact Information
Primary
Jeffrey J Borckardt, PhD
Jeffrey.Borckardt@va.gov
(843) 577-5011
Backup
Donald (Hugh) L Myrick, MD BS
Donald.Myrick@va.gov
(843) 789-7316
Time Frame
Start Date: 2021-01-11
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 132
Treatments
Experimental: Group 1- real tDCS and real CBI
4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
Experimental: Group 2- real tDCS and sham CBI
4 active treatments of tDCS and education-only-control cognitive intervention
Experimental: Group 3- sham tDCS and real CBI
4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
Sham_comparator: Group 4- sham tDCS and sham CBI
4 sham treatments of tDCS and education-only-control cognitive intervention
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov