Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
132 participants
INTERVENTIONAL
2021-01-11
2026-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Group 1- real tDCS and real CBI
4 active treatments of tDCS and active cognitive behavioral intervention (CBI)
Transcranial Direct Current Stimulation
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.
Cognitive-Behavioral (CB) intervention
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.
Group 2- real tDCS and sham CBI
4 active treatments of tDCS and education-only-control cognitive intervention
Transcranial Direct Current Stimulation
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.
Cognitive-Behavioral (CB) intervention
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.
Group 3- sham tDCS and real CBI
4 sham treatments of tDCS and active cognitive behavioral intervention (CBI)
Transcranial Direct Current Stimulation
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.
Cognitive-Behavioral (CB) intervention
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.
Group 4- sham tDCS and sham CBI
4 sham treatments of tDCS and education-only-control cognitive intervention
Transcranial Direct Current Stimulation
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.
Cognitive-Behavioral (CB) intervention
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.
Interventions
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Transcranial Direct Current Stimulation
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.
Cognitive-Behavioral (CB) intervention
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.
Other Intervention Names
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Eligibility Criteria
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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
* pregnant
* history of seizures
* allergic to latex rubber
* psychiatric conditions except for depression and/or anxiety disorders (commonly seen in this population).
18 Years
90 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Jeffrey J Borckardt, PhD
Role: PRINCIPAL_INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Locations
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Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CX001996
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NURB-001-19S
Identifier Type: -
Identifier Source: org_study_id
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