Clinical trial NCT04199780: Effects of tDCS Combined With CBI on Postsurgical Pain
Official title: tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty (Postoperative Pain)
Total Hip Arthroplasty (Postoperative Pain)
Keywords: total knee arthroplasty
pain
postsurgical pain
opioid
transcranial direct current stimulation
tDCS
brain stimulation
total hip arthroplasty
TKA
THA
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-12-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: postoperative opioid pain medication use
timeFrame: 48 hours
Secondary outcomes:
measure: Long term outcomes of patient reported pain ratings
timeFrame: 1 month
measure: Long term outcomes of patient reported pain ratings
timeFrame: 3 months
measure: Long term outcomes of patient reported pain ratings
timeFrame: 6 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Jeffrey J Borckardt, PhD
role: PRINCIPAL_INVESTIGATOR
References: