Skip to main content
OpenTrials
Completed

NCT Number: NCT04199780

Effects of tDCS Combined With CBI on Postsurgical Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Arthroplasty (Postoperative Pain) Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Total Hip Arthroplasty (Postoperative Pain)

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

About this study

The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS, brief Cognitive-Behavioral (CB) intervention and their combination on pain among Veterans undergoing unilateral TKA or THA. 132 patients undergoing TKA/THA will be randomly assigned to one of four groups:

  • Group1- real tDCS + real CB intervention
  • Group2- real tDCS + education-only-control intervention
  • Group3- sham tDCS + real CB intervention
  • Group4- sham tDCS +education-only-control intervention

Participants will receive 2 tDCS/CBI treatments on the day of their surgery, and 2 tDCS/CBI treatments the day after their surgery. Participants' perioperative medication usage and pain ratings will be tracked during postoperative hospital stay. Follow-up data regarding pain and opioid use will be collected at 1, 3 and 6-months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing total knee arthroplasty (TKA) or total hip arthroplasty (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 Cognitive-Behavioral (CB) intervention and understand educational materials through headphones in English

Exclusion criteria

  • 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)

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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.

Other names: tDCS

Cognitive-Behavioral (CB) intervention

Behavioral

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.

Other names: CBI

Primary outcomes

  1. postoperative opioid pain medication use

    Time frame: 48 hours

    Patient controlled analgesic medication usage (the morphine equivalent dose (MED); milligrams (mg) of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).

Secondary outcomes

  1. Long term outcomes of patient reported pain ratings

    Time frame: 1 month

    long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale.

  2. Long term outcomes of patient reported pain ratings

    Time frame: 3 months

    long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable).

  3. Long term outcomes of patient reported pain ratings

    Time frame: 6 months

    long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: tDCS-CBI

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2019
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.