MedTrace Logo

Effects of tDCS Combined With CBI on Postsurgical Pain

NCT04199780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Transcranial Direct Current Stimulation

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.

BEHAVIORAL

Cognitive-Behavioral (CB) intervention

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2026-01-01
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04199780 on ClinicalTrials.gov