tDCS + Cognitive Behavioral Therapy for Postoperative Pain

(tDCS-CBI Trial)

Overseen by Jeffrey J Borckardt, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Implanted devices, Pregnant, Seizures, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for postoperative pain?

Research shows that transcranial direct current stimulation (tDCS) can help reduce pain and the need for pain medication after surgeries, like spine surgery and thoracotomy. Studies also suggest that tDCS can improve pain control in conditions like spinal cord injury, indicating its potential to help with postoperative pain. ^{1 2 3 4 5}

Is tDCS combined with Cognitive Behavioral Therapy safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe, but it can cause mild skin irritation and occasional skin injuries. Studies have used tDCS for various pain conditions, and while it shows promise, these minor side effects should be considered. ^{2 3 4 6 7}

How is the tDCS + Cognitive Behavioral Therapy treatment different from other treatments for postoperative pain?

This treatment is unique because it combines transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive-behavioral therapy (CBT), a psychological approach, to manage postoperative pain. Unlike traditional pain management methods that often rely on medications like opioids, this approach aims to reduce pain and opioid consumption by directly stimulating the brain and addressing psychological aspects of pain. ^{2 3 4 7 8}

Research Team

Jeffrey J Borckardt, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

This trial is for veterans who can read, write, consent, and follow instructions. They must be cleared for and scheduled to have knee or hip replacement surgery at the Ralph H. Johnson VAMC in Charleston SC. Participants should understand English as the CB intervention is delivered through headphones.

Inclusion Criteria

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

You have an allergy to latex rubber.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 treatments of tDCS and CBI or control interventions over 2 days during the perioperative period

2 days

4 visits (in-person)

Postoperative Monitoring

Participants' perioperative medication usage and pain ratings are tracked during postoperative hospital stay

48 hours

Follow-up

Follow-up data regarding pain and opioid use is collected at 1, 3, and 6 months

6 months

Treatment Details

Interventions

• Cognitive-Behavioral (CB) intervention (Behavioral Intervention)
• Transcranial Direct Current Stimulation (Procedure)

Trial Overview The study tests if transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique using mild electrical currents, combined with Cognitive-Behavioral interventions (CB) can reduce pain and opioid use after knee or hip replacement surgeries.

Participant Groups

Group I: Group 3- sham tDCS and real CBI Experimental Treatment 2 Interventions

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

Group II: Group 2- real tDCS and sham CBI Experimental Treatment 2 Interventions

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

Group III: Group 1- real tDCS and real CBI Experimental Treatment 2 Interventions

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

Group IV: Group 4- sham tDCS and sham CBI Placebo Group 2 Interventions

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

Cognitive-Behavioral (CB) intervention is already approved in Canada for the following indications:

Approved in Canada as Cognitive-Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Post-traumatic stress disorder
• Substance use disorders
• Pain management

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Transcranial direct current stimulation (tDCS) significantly improved pain control in patients with central pain from traumatic spinal cord injury, showing effectiveness compared to sham stimulation.

The study found no negative effects on cognitive performance or confounding factors like depression and anxiety, suggesting that tDCS is a safe and effective method for pain management in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Fregni, F., Boggio, PS., Lima, MC., et al.[2022]

In a study of 62 lung cancer patients undergoing thoracotomy, transcranial direct current stimulation (tDCS) significantly reduced cumulative morphine consumption in the first 120 hours post-surgery compared to sham stimulation, indicating its potential efficacy in managing acute postoperative pain.

On postoperative day 5, patients receiving tDCS reported lower pain scores and less pain interference with cough, suggesting that tDCS can improve pain management shortly after surgery, although no long-term benefits were observed one year later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation Combined With Patient-Controlled Intravenous Morphine Analgesia on Analgesic Use and Post-Thoracotomy Pain. A Prospective, Randomized, Double-Blind, Sham-Controlled, Proof-of-Concept Clinical Trial. Stamenkovic, DM., Mladenovic, K., Rancic, N., et al.[2022]

This randomized control trial involves 84 participants and aims to assess the efficacy of transcranial direct current stimulation (tDCS) as an adjunctive treatment for chronic pain, focusing on improving pain tolerance and subjective pain experiences.

Active tDCS, which delivers a 2mA current to specific areas of the brain, is being tested against a sham treatment over 10 sessions, highlighting its potential as a non-invasive option to enhance the effectiveness of existing non-opioid pain management therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management. Janice Jimenez-Torres, G., Weinstein, BL., Walker, CR., et al.[2018]

Preemptive Transcranial Direct Current Stimulation (tDCS) effectively managed postoperative pain in rats, as evidenced by changes in neurochemical markers and reduced inflammation, suggesting its potential as a pain management strategy.

The study showed that tDCS not only alleviated pain but also promoted tissue repair and prevented chronic inflammation, indicating its dual role in enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preemptive transcranial direct current stimulation induces analgesia, prevents chronic inflammation and fibrosis, and promotes tissue repair in a rat model of postoperative pain. Zancanaro, M., Stein, DJ., Lopes, BC., et al.[2023]

In a study involving 50 patients undergoing total knee arthroplasty, transcranial direct current stimulation (tDCS) significantly reduced opioid consumption by 59% compared to sham treatment, indicating its potential as an effective pain management tool.

While the Visual Analogue Scale (VAS) scores remained constant between groups, the tDCS treatment showed promise in reducing the need for opioids, suggesting it can provide similar analgesia with less reliance on pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of transcranial direct current stimulation on reduction of postsurgical opioid consumption and pain in total knee arthroplasty: Double randomized clinical trial. Khedr, EM., Sharkawy, ESA., Attia, AMA., et al.[2022]

Transcranial direct current stimulation (tDCS) has shown promising results in reducing postoperative pain and opioid consumption based on a systematic review of eight studies.

The review suggests that tDCS may also help decrease cravings for opioids, indicating its potential as a non-pharmacological alternative for managing pain and preventing opioid dependence after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to prevent and treat surgery-induced opioid dependence: a systematic review. Gallucci, A., Lucena, PH., Martens, G., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation Combined With Patient-Controlled Intravenous Morphine Analgesia on Analgesic Use and Post-Thoracotomy Pain. A Prospective, Randomized, Double-Blind, Sham-Controlled, Proof-of-Concept Clinical Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation in pain and opioid consumption after spine surgery. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A study protocol for a single-blind, randomized controlled trial of adjunctive transcranial direct current stimulation (tDCS) for chronic pain among patients receiving specialized, inpatient multimodal pain management. [2018]

5. Ireland pubmed.ncbi.nlm.nih.gov

Preemptive transcranial direct current stimulation induces analgesia, prevents chronic inflammation and fibrosis, and promotes tissue repair in a rat model of postoperative pain. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Role of transcranial direct current stimulation on reduction of postsurgical opioid consumption and pain in total knee arthroplasty: Double randomized clinical trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to prevent and treat surgery-induced opioid dependence: a systematic review. [2019]