Effects of tDCS Combined With CBI on Postsurgical Pain

Total Knee Arthroplasty (Postoperative Pain) Clinical Trial

— tDCS-CBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199780
• Other study ID #: NURB-001-19S
• Secondary ID: CX001996
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: July 31, 2026

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Jeffrey J Borckardt, PhD
• Phone: (843) 577-5011
• Email: Jeffrey.Borckardt[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. Group1- real tDCS + real CB intervention

2. Group2- real tDCS + education-only-control intervention

3. Group3- sham tDCS + real CB intervention

4. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: July 31, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

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).

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Long term outcomes of patient reported pain ratings	long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale.	1 month
Secondary	Long term outcomes of patient reported pain ratings	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 months
Secondary	Long term outcomes of patient reported pain ratings	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).	6 months