Using brain stimulation and therapy to reduce pain after knee or hip surgery
tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
This study is testing if combining brain stimulation with therapy can help veterans feel less pain after knee or hip surgery and reduce their need for pain medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04199780 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcranial direct current stimulation (tDCS) combined with a Cognitive-Behavioral intervention (CBI) in reducing postoperative pain for veterans undergoing total knee or hip arthroplasty. A total of 132 participants will be randomly assigned to one of four groups to receive either real or sham tDCS and either a real or education-only CBI. The study aims to assess pain levels and opioid usage during the hospital stay and at follow-up intervals of 1, 3, and 6 months post-surgery. The goal is to determine if this combined approach can lead to better pain management outcomes without the need for additional medication.
Who should consider this trial
Good fit: Ideal candidates are veterans scheduled for unilateral total knee or hip arthroplasty who can understand and follow instructions.
Not a fit: Patients with implanted medical devices above the waist, pregnant individuals, or those with a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid use for veterans after knee or hip surgeries.
How similar studies have performed: While the combination of tDCS and CBI is a novel approach, previous studies have shown promise in using tDCS for pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Charleston, South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey J Borckardt, PhD — Ralph H. Johnson VA Medical Center, Charleston, SC
- Study coordinator: Jeffrey J Borckardt, PhD
- Email: Jeffrey.Borckardt@va.gov
- Phone: (843) 577-5011
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.