tDCS + Cognitive Behavioral Therapy for Postoperative Pain

(tDCS-CBI Trial)

Overseen By Donald (Hugh) L Myrick, MD BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Implanted devices, Pregnant, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 days

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcranial direct current stimulation (tDCS) can reduce pain after knee or hip replacement surgery when combined with Cognitive Behavioral Therapy (CBT). tDCS uses a tiny electric current to stimulate brain areas associated with pain reduction, eliminating the need for medication or needles. The study will examine how tDCS, CBT, and their combination affect pain, opioid use, and daily function in the two days following surgery. Veterans scheduled for knee or hip replacement surgery who can understand instructions are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques without medication.

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 prior data suggests that transcranial direct current stimulation (tDCS) is safe for reducing postoperative pain?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people. One study found no serious side effects from using tDCS. This treatment uses a small electrical current to stimulate parts of the brain, which can help reduce pain. It has been used safely for various long-term pain conditions and may also lessen the need for pain medication after surgeries.

For the Cognitive-Behavioral intervention, studies indicate it is a safe way to manage pain after surgery. Cognitive-Behavioral Therapy (CBT) helps change negative thought patterns that can make pain feel worse. This method is well-tolerated and has improved recovery in many situations, including after surgeries.

Both tDCS and the Cognitive-Behavioral intervention are considered safe options based on existing research. Participants can feel reassured that these treatments have been studied for safety in human trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to managing postoperative pain. Unlike traditional methods like opioids or NSAIDs, this trial combines transcranial direct current stimulation (tDCS) with cognitive-behavioral interventions (CBI). tDCS is a non-invasive technique that uses mild electrical currents to influence brain activity, potentially reducing pain perception. Meanwhile, CBI focuses on changing pain-related thoughts and behaviors to help manage discomfort. This combination could provide a safer and more holistic alternative to typical pain medications, with fewer side effects and the potential for long-lasting relief.

What evidence suggests that this trial's treatments could be effective for reducing postoperative pain?

This trial will evaluate the effectiveness of transcranial direct current stimulation (tDCS) and cognitive-behavioral intervention (CBI) for managing postoperative pain. Research shows that tDCS can reduce pain and decrease the need for pain medication after surgery. Studies have found that tDCS lessens pain perception and improves tolerance to hot and cold temperatures. It is also associated with a reduced need for painkillers, such as morphine, after surgery.

Similarly, CBI, a type of talk therapy, has proven effective in relieving pain after joint surgeries. It can enhance quality of life and reduce pain during recovery. This trial will test the combination of both tDCS and CBI, as using them together might be a powerful approach to managing pain after knee or hip replacements. Participants will be assigned to different groups to receive either real or sham treatments of tDCS and CBI to assess their effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

Jeffrey J Borckardt, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Cognitive-Behavioral Therapy for:

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

Approved in European Union as Cognitive-Behavioural Therapy for:

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

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+

Published Research Related to This Trial

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]

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]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

In a study involving 67 postoperative spine surgery patients, both anodal tDCS applied over the primary motor area and the left dorsolateral prefrontal cortex significantly reduced pain levels and morphine consumption compared to a sham treatment.

While both active tDCS treatments were effective in reducing pain and opioid use, there was no significant difference in efficacy between the two active groups, suggesting that tDCS is a promising non-pharmacological approach for pain management in postoperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation in pain and opioid consumption after spine surgery. Hamed, R., Khedr, EM., Haridy, NA., 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]

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]

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]

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]

Citations

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Cognitive behavioral therapy achieves better benefits in ... This study shows that CBT can relieve pain in patients with total joint arthroplasty in the early postoperative period and improve quality of life to some ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8730643/

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Cognitive Behavioural Therapy to Optimize Post-Operative ... Emerging evidence suggests that cognitive behavioural therapy (CBT) may improve outcomes after fracture repair. We conducted a pilot study to ...

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Evaluation of Cognitive Behavioral Therapy on Improving ... We found low-quality evidence that there was a better effect of CBT on reducing pain compared with other therapies. The effect was statistically ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04814992

Pre-op Cognitive Behavior Therapy to Decrease Chronic ... Describe the effects of a 4-week targeted pre-operative CBT intervention in 45 TKA patients on 48hr post-operative pain severity, and 3- and 6-month rates of ...

6. withpower.com withpower.com/trial/phase-fractures-bone-2021-f19c0

Cognitive Behavioural Therapy for Postoperative Pain · Info ... What safety data exists for CBT in treating postoperative pain? ... Cognitive Behavioral Therapy (CBT) is considered a safe treatment for postoperative pain.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8325315/

A digital health peri-operative cognitive-behavioral ... Beyond the context of surgery, a large body of evidence demonstrates that cognitive-behavioral therapy (CBT) interventions are effective for reducing pain and ...

8. rapm.bmj.com rapm.bmj.com/content/50/2/93

Upskilling pain relief after surgery: a scoping review of ... Cognitive behavioral therapy cannot relieve postoperative pain and improve joint function after total knee arthroplasty in patients aged 70 years and older ...