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

Primary Purpose

Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty (Postoperative Pain)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Cognitive-Behavioral (CB) intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty (Postoperative Pain) focused on measuring total knee arthroplasty, pain, postsurgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Ralph H. Johnson VA Medical Center, Charleston, SCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Group 1- real tDCS and real CBI

Group 2- real tDCS and sham CBI

Group 3- sham tDCS and real CBI

Group 4- sham tDCS and sham CBI

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

postoperative opiod pain medication use
Patient controlled analgesic medication usage (the morphine equivalent dose (MED); mg of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).

Secondary Outcome Measures

Long term outcomes of patient reported pain ratings
long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale.
Long term outcomes of patient reported pain ratings
long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable).
Long term outcomes of patient reported pain ratings
long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable).

Full Information

First Posted
December 6, 2019
Last Updated
March 24, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04199780
Brief Title
Effects of tDCS Combined With CBI on Postsurgical Pain
Acronym
tDCS-CBI
Official Title
tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: Group1- real tDCS + real CB intervention Group2- real tDCS + education-only-control intervention Group3- sham tDCS + real CB intervention 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1- real tDCS and real CBI
Arm Type
Experimental
Arm Description
4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
Arm Title
Group 2- real tDCS and sham CBI
Arm Type
Experimental
Arm Description
4 active treatments of tDCS and education-only-control cognitive intervention
Arm Title
Group 3- sham tDCS and real CBI
Arm Type
Experimental
Arm Description
4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
Arm Title
Group 4- sham tDCS and sham CBI
Arm Type
Sham Comparator
Arm Description
4 sham treatments of tDCS and education-only-control cognitive intervention
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Transcranial direct current stimulation (tDCS), stimulates specific areas of the brain via electric current passed through electrodes placed on the scalp. During tDCS, low amplitude direct currents penetrates the skull to enter the brain and modulates neuronal activity.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral (CB) intervention
Other Intervention Name(s)
CBI
Intervention Description
CBI generally consist of cognitive coping strategies (e.g., distraction, relabeling, reducing pain-catastrophizing) and self-management (e.g., relaxation strategies, guided imagery) designed to enhance perceived control and reduce sympathetic nervous system tone.
Primary Outcome Measure Information:
Title
postoperative opiod pain medication use
Description
Patient controlled analgesic medication usage (the morphine equivalent dose (MED); mg of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Long term outcomes of patient reported pain ratings
Description
long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale.
Time Frame
1 month
Title
Long term outcomes of patient reported pain ratings
Description
long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable).
Time Frame
3 months
Title
Long term outcomes of patient reported pain ratings
Description
long-term outcomes of post-operative tDCS and a cognitive-behavioral intervention on pain rating assessed using a visual analog scale (minimum value =0, no pain at all; maximum value =10, worst pain imaginable).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey J Borckardt, PhD
Phone
(843) 577-5011
Ext
5854
Email
Jeffrey.Borckardt@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Donald (Hugh) L Myrick, MD BS
Phone
(843) 789-7316
Email
Donald.Myrick@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Borckardt, PhD
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Borckardt, PhD
Phone
843-577-5011
Ext
5854
Email
Jeffrey.Borckardt@va.gov
First Name & Middle Initial & Last Name & Degree
Donald (Hugh) L Myrick, MD BS
Phone
(843) 789-7316
Email
Donald.Myrick@va.gov
First Name & Middle Initial & Last Name & Degree
Jeffrey J Borckardt, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of tDCS Combined With CBI on Postsurgical Pain

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