Effects of tDCS Combined With CBI on Postsurgical Pain
tDCS-CBI
tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
2 other identifiers
interventional
132
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
CompletedJuly 30, 2025
July 1, 2025
5 years
December 6, 2019
July 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative opioid pain medication use
Patient controlled analgesic medication usage (the morphine equivalent dose (MED); mg of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).
48 hours
Secondary Outcomes (3)
Long term outcomes of patient reported pain ratings
1 month
Long term outcomes of patient reported pain ratings
3 months
Long term outcomes of patient reported pain ratings
6 months
Study Arms (4)
Group 1- real tDCS and real CBI
EXPERIMENTAL4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
Group 2- real tDCS and sham CBI
EXPERIMENTAL4 active treatments of tDCS and education-only-control cognitive intervention
Group 3- sham tDCS and real CBI
EXPERIMENTAL4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
Group 4- sham tDCS and sham CBI
SHAM COMPARATOR4 sham treatments of tDCS and education-only-control cognitive intervention
Interventions
Transcranial direct current stimulation (tDCS), stimulates specific areas of the brain via electric current passed through electrodes placed on the scalp. During tDCS, low amplitude direct currents penetrates the skull to enter the brain and modulates neuronal activity.
CBI generally consist of cognitive coping strategies (e.g., distraction, relabeling, reducing pain-catastrophizing) and self-management (e.g., relaxation strategies, guided imagery) designed to enhance perceived control and reduce sympathetic nervous system tone.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- implanted medical devices above the waist
- pregnant
- history of seizures
- allergic to latex rubber
- psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey J Borckardt, PhD
Ralph H. Johnson VA Medical Center, Charleston, SC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2019
First Posted
December 16, 2019
Study Start
January 11, 2021
Primary Completion
January 1, 2026
Study Completion
July 31, 2026
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share