Total Knee Arthroplasty (Postoperative Pain)tDCS-CBINCT04199780
Effects of tDCS Combined With CBI on Postsurgical Pain
A study testing Transcranial Direct Current Stimulation and Cognitive-Behavioral (CB) intervention in people with Total Knee Arthroplasty (Postoperative Pain) and Total Hip Arthroplasty (Postoperative Pain), run by VA Office of Research and Development at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty (Postoperative Pain)
- What is being tested?
- Transcranial Direct Current Stimulation and Cognitive-Behavioral (CB) intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing total knee arthroplasty (TKA) or total hip arthroplasty (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 Cognitive-Behavioral (CB) intervention and understand educational materials through headphones in English
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
About this study
Official title: tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
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.
Read more
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.
Read the 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.
- Being tested
- Transcranial Direct Current Stimulation, Cognitive-Behavioral (CB) intervention
- Keywords
- total knee arthroplasty, pain, postsurgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty, TKA, THA
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
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) interventionBehavioural
Also called CBI
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- real tDCS and real CBI | Experimental | 4 active treatments of tDCS and active cognitive behavioral intervention (CBI) Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Cognitive-Behavioral (CB) intervention |
| Group 2- real tDCS and sham CBI | Experimental | 4 active treatments of tDCS and education-only-control cognitive intervention Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Cognitive-Behavioral (CB) intervention |
| Group 3- sham tDCS and real CBI | Experimental | 4 sham treatments of tDCS and active cognitive behavioral intervention (CBI) Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Cognitive-Behavioral (CB) intervention |
| Group 4- sham tDCS and sham CBI | Sham comparator | 4 sham treatments of tDCS and education-only-control cognitive intervention Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Cognitive-Behavioral (CB) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid pain medication use
Patient controlled analgesic medication usage (the morphine equivalent dose (MED); milligrams (mg) of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).
Measured: 48 hours
Secondary outcomes (3)
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.
Measured: 1 month
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).
Measured: 3 months
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start11 Jan 2021
- Primary completion1 Jan 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (Postoperative Pain)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jeffrey J Borckardt, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199780
- Sponsor's protocol ID
- NURB-001-19S
- Other IDs
- CX001996
- Acronym
- tDCS-CBI
- Status last verified
- Aug 2026
- First submitted
- 6 Dec 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS Combined With a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans
- ClinicalTrials.gov ID
- NCT04199780
- Acronym / sponsor ID
- tDCS-CBI / NURB-001-19S
- Keywords
- total knee arthroplasty, pain, postsurgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- real tDCS and real CBI | Experimental | Device: Transcranial Direct Current Stimulation, Behavioral: Cognitive-Behavioral (CB) intervention4 active treatments of tDCS and active cognitive behavioral intervention (CBI) |
| Group 2- real tDCS and sham CBI | Experimental | Device: Transcranial Direct Current Stimulation, Behavioral: Cognitive-Behavioral (CB) intervention4 active treatments of tDCS and education-only-control cognitive intervention |
| Group 3- sham tDCS and real CBI | Experimental | Device: Transcranial Direct Current Stimulation, Behavioral: Cognitive-Behavioral (CB) intervention4 sham treatments of tDCS and active cognitive behavioral intervention (CBI) |
| Group 4- sham tDCS and sham CBI | Sham comparator | Device: Transcranial Direct Current Stimulation, Behavioral: Cognitive-Behavioral (CB) intervention4 sham treatments of tDCS and education-only-control cognitive intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be 120 patients (132 recruited to account for 10% drop-out rate) undergoing total knee arthroplasty (TKA) or total hip arthroplasty (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 Cognitive-Behavioral (CB) intervention and understand educational materials through headphones in English
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSTranscranial 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. | Device | 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 |
| Cognitive-Behavioral (CB) interventionAlso: CBICBI 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. | Behavioural | 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 |
Primary outcome
postoperative opioid pain medication use
Time frame: 48 hours
Patient controlled analgesic medication usage (the morphine equivalent dose (MED); milligrams (mg) of morphine) during the acute 48-hour post-operative period following total knee arthroplasty (TKA) or total hip arthroplasty (THA).
3 secondary outcomes
Long term outcomes of patient reported pain ratings
Time frame: 1 month
Long term outcomes of patient reported pain ratings
Time frame: 3 months
Long term outcomes of patient reported pain ratings
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty (Postoperative Pain)
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Borckardt, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Cognitive-Behavioral (CB) intervention in people with Total Knee Arthroplasty (Postoperative Pain) and Total Hip Arthroplasty (Postoperative Pain), run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid pain medication use (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.