Total Knee Arthroplasty (Postoperative Pain)Phase 1tDCS-TKANCT02241967

Dose Dependent Effects of tDCS on Post-Operative Pain

A Phase 1 study testing 4 Real sessions of Transcranial Direct Current Stimulation, 2 Real Sessions of Transcranial Direct Current Stimulation and 1 Real Session of Transcranial Direct Current Stimulation 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty(Postoperative Pain)
What is being tested?: 4 Real sessions of Transcranial Direct Current Stimulation, 2 Real Sessions of Transcranial Direct Current Stimulation and 1 Real Session of Transcranial Direct Current Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 1 siteUnited States
Study dates: 7 Jan 2016to 2 Jul 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.
Between the ages of 19 and 90
Mentally capable of reading, writing, giving consent, and following instructions
Cleared for and scheduled for unilateral TKA or THA surgery

Who cannot join

Implanted medical devices above the waist
Pregnant
History of seizures
Allergic to latex rubber
Psychiatric conditions other than for depression and/or anxiety disorders

Trial locations and contacts

1 site in 1 country.

United States1 site

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799

Other trials in United States

About this study

The proper control of acute and chronic pain is one of the most important areas in health care. Despite the profound advances in neuroscience over the past 20 years, the investigators still largely use opiate narcotics, much as was done in the Civil War. Total knee arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee pain is often a complaint that precedes TKA, the procedure itself is associated with considerable post-operative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery time and hospital length of stay. New analgesic strategies are needed that can be used adjunctively to existing strategies with the potential to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety of pain conditions. Electricity has no metabolite or other residue, and can be delivered with minimal discomfort and without problems associated with drug-drug interactions. In two independent preliminary pilot studies, the Investigators have shown that tDCS can reduce post-operative PCA use by as much as 46% while simultaneously reducing subjective pain ratings. The present study aims to determine the effects of transcranial direct current stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and post-surgical complications during the 48-hour post-operative period following total knee arthroplasty.

Read the detailed description

The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS. Real tDCS was administered at 2mA whereas sham tDCS delivered none.

120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have 4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 - 1 session of real tDCS (+ 3 sham-sessions). Group 4 is "Sham" tDCS, which does not involve any real stimulation. The participants will receive 2 tDCS treatments on the day of their surgery, and 2 tDCS treatments the day after their surgery.

Conditions: Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty(Postoperative Pain)
Being tested: 4 Real sessions of Transcranial Direct Current Stimulation, 2 Real Sessions of Transcranial Direct Current Stimulation, 1 Real Session of Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
Keywords: total knee arthroplasty, pain, post-surgical 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.

4 Real sessions of Transcranial Direct Current StimulationDevice
Also called tDCS Full Dose
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.
2 Real Sessions of Transcranial Direct Current StimulationDevice
Also called tDCS Half Dose
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.
1 Real Session of Transcranial Direct Current StimulationDevice
Also called tDCS Minimal Dose
Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.
Sham Transcranial Direct Current StimulationDevice
Also called Sham tDCS
Four sessions of sham tDCS; control intervention.

Study groups in NCT02241967
Study group	Role	What they receive
tDCS Full Dose	Experimental	4 active treatments Receives: Device: 4 Real sessions of Transcranial Direct Current Stimulation
tDCS Half Dose	Experimental	2 active treatments Receives: Device: 2 Real Sessions of Transcranial Direct Current Stimulation
tDCS Minimal dose	Experimental	1 active treatment Receives: Device: 1 Real Session of Transcranial Direct Current Stimulation
Sham tDCS	Sham comparator	no active treatments Receives: Device: Sham Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-operative Opioid Pain Medication Dose
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Measured: 2-Days
Patient-reported Pain Intensity Ratings
Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.
Measured: 2-Days

Secondary outcomes (1)

Patient-reported Average Pain Ratings
Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: "0- no pain," "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.

7 Jan 20162 Jul 2020

First posted16 Sep 2014 (estimated)
Study start7 Jan 2016
Primary completion2 Jul 2020
Study completion2 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02241967
Sponsor's protocol ID: CLIN-005-13F
Other IDs: CX001078
Acronym: tDCS-TKA
Status last verified: Jun 2022
First submitted: 2 Sep 2014
Last updated: 13 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Total Knee Arthroplasty (Postoperative Pain) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Dependent Effects of tDCS on Post-Operative Pain
ClinicalTrials.gov ID: NCT02241967
Acronym / sponsor ID: tDCS-TKA / CLIN-005-13F
Conditions: Total Knee Arthroplasty (Postoperative Pain), Total Hip Arthroplasty(Postoperative Pain)
Keywords: total knee arthroplasty, pain, post-surgical pain, opioid, transcranial direct current stimulation, tDCS, brain stimulation, total hip arthroplasty
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 7 Jan 2016 (actual)
Primary completion: 2 Jul 2020 (actual)
Study completion: 2 Jul 2020 (actual)
First posted: 16 Sep 2014 (estimated)
Results: Posted 7 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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
tDCS Full Dose	Experimental	Device: 4 Real sessions of Transcranial Direct Current Stimulation4 active treatments
tDCS Half Dose	Experimental	Device: 2 Real Sessions of Transcranial Direct Current Stimulation2 active treatments
tDCS Minimal dose	Experimental	Device: 1 Real Session of Transcranial Direct Current Stimulation1 active treatment
Sham tDCS	Sham comparator	Device: Sham Transcranial Direct Current Stimulationno active treatments

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson VAMC in Charleston SC.
Between the ages of 19 and 90
Mentally capable of reading, writing, giving consent, and following instructions
Cleared for and scheduled for unilateral TKA or THA surgery

Key exclusion criteria (5 listed)

Implanted medical devices above the waist
Pregnant
History of seizures
Allergic to latex rubber
Psychiatric conditions other than for depression and/or anxiety disorders

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
4 Real sessions of Transcranial Direct Current StimulationAlso: tDCS Full DoseStimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.	Device	tDCS Full Dose
2 Real Sessions of Transcranial Direct Current StimulationAlso: tDCS Half DoseStimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.	Device	tDCS Half Dose
1 Real Session of Transcranial Direct Current StimulationAlso: tDCS Minimal DoseStimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.	Device	tDCS Minimal dose
Sham Transcranial Direct Current StimulationAlso: Sham tDCSFour sessions of sham tDCS; control intervention.	Device	Sham tDCS

Primary outcome

Post-operative Opioid Pain Medication Dose
Time frame: 2-Days
Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
Patient-reported Pain Intensity Ratings
Time frame: 2-Days
Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.

1 secondary outcome

Patient-reported Average Pain Ratings
Time frame: 6 Months

Results and safety

Results posted to the registry on 7 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
tDCS Full Dose	30	30
tDCS Half Dose	30	30
tDCS Minimal Dose	30	30
Sham tDCS	29	29

Primary outcome: Post-operative Opioid Pain Medication Dose

Time frame: 2-Days. Mean (Standard Error). Unit: mg of morphine equivalent dose (MED)

Measure	tDCS Full Dose n = 30	tDCS Half Dose n = 30	tDCS Minimal Dose n = 30	Sham tDCS n = 29
Value	26.99 (2.99)	31.12 (3.73)	28.65 (31.12)	33.15 (5.60)

Primary outcome: Patient-reported Pain Intensity Ratings

Time frame: 2-Days. Mean (Standard Error). Unit: score on a scale

Measure	tDCS Full Dose n = 29	tDCS Half Dose n = 28	tDCS Minimal Dose n = 29	Sham tDCS n = 27
Value	5.33 (.44)	5.59 (.43)	5.84 (.48)	5.33 (.56)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2-Days during the routine post-operative hospital stay; the duration in which tDCS was delivered.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tDCS Full Dose	0 of 30 (0%)	0 of 30 (0%)	0 of 30
tDCS Half Dose	0 of 30 (0%)	0 of 30 (0%)	0 of 30
tDCS Minimal Dose	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Sham tDCS	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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?

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 13 Jul 2022. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post-operative Opioid Pain Medication Dose (time frame: 2-Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02241967.

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 13 Jul 2022.