Effects of tDCS Combined With CBI on Postsurgical Pain (tDCS-CBI)

VA Office of Research and Development

Status: Enrolling

Conditions: Total Hip Arthroplasty (Postoperative Pain); Total Knee Arthroplasty (Postoperative Pain)

Treatments: Behavioral: Cognitive-Behavioral (CB) intervention; Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04199780

NURB-001-19S

CX001996 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups

Group 1- real tDCS and real CBI

Experimental group

Description:

4 active treatments of tDCS and active cognitive behavioral intervention (CBI)

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Cognitive-Behavioral (CB) intervention

Group 2- real tDCS and sham CBI

Experimental group

Description:

4 active treatments of tDCS and education-only-control cognitive intervention

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Cognitive-Behavioral (CB) intervention

Group 3- sham tDCS and real CBI

Experimental group

Description:

4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Cognitive-Behavioral (CB) intervention

Group 4- sham tDCS and sham CBI

Sham Comparator group

Description:

4 sham treatments of tDCS and education-only-control cognitive intervention

Treatment:

Device: Transcranial Direct Current Stimulation

Behavioral: Cognitive-Behavioral (CB) intervention