Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation

ConditionsKnee Arthroplasty Transcranial Direct Current Stimulation Pain, Postoperative

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorWomen's College Hospital

About this trial

Total knee arthroplasty (TKA) is widely performed to reduce pain from advanced osteoarthritis, yet many patients experience severe postoperative pain and up to 25-44% develop chronic postsurgical pain (CPSP). Transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique, has shown promise in reducing pain and opioid use in early studies but has not been evaluated using comprehensive perioperative, home-based protocols. This study will test whether a home-based tDCS intervention delivered before and after TKA can improve acute pain management and reduce the development of CPSP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older.

American Society of Anesthesiologists (ASA) Physical Classification Status I-III.

Scheduled to undergo unilateral elective primary total knee arthroplasty for advanced osteoarthritis of the knee.

Access to a device running iOS Version 10.0 or above, or Android Version 5.0 or above that can connect to the internet.

Disqualifiers

History of brain surgery, central nervous system tumors, seizures (including epilepsy), stroke or intracranial implants (e.g plates, screws, deep brain stimulators)

Have vascular, traumatic, infectious, or metabolic lesions or diseases of the brain

Insomnia disorder (e.g., difficulty initiating or maintaining sleep, early morning awakening)

Obstructive sleep apnea (OSA)

Trial design

Design model

Parallel

Treatments tested in this trial

Active tDCS Stimulation
Device
Participants will have electrodes positioned on their scalp at C3, C4 (primary motor cortices) and Oz (occipital cortex) according to the international 10-20 EEG system. They will receive active transcranial direct current stimulation (tDCS) to the primary motor cortex (M1) opposite the surgical site, with the Oz electrode serving as the return. Stimulation will be delivered at 2 mA for 20 minutes, including a 15-second ramp-up at the start and a 15-second ramp-down at the end. The PlatoWork 2.0 tDCS Neurostimulator headset will be used to administer the stimulation.
Sham tDCS Stimulation
Device
Participants will receive sham (inactive) transcranial direct current stimulation (tDCS) using the PlatoWork 2.0 tDCS Neurostimulator headset at home. The headset is identical to the active device but does not deliver electrical stimulation. This allows for blinding of participants to the intervention condition while maintaining the same study procedures and device usage as the active tDCS group.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Home-based tDCSExperimental treatment 1 intervention

Group B: Sham tDCSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility outcomes

Enrollment: number of patients enrolled per week (proceed if ≥1/wk; modify protocol if 0.5-1/wk; fail to proceed if \<0.5/wk) Intervention Adherence: percent of randomized participants completing all stimulation sessions (proceed if \>80%; modify protocol if 50-80%; fail to proceed if \<50%) Data Completeness: percent of randomized participants completing the Numeric Rating Scale pain score at end of tDCS treatment; (proceed if \>85%; modify protocol if 60-85%; fail to proceed if \<60%)

Time frame

Pre-op Days -5 to +90 days

Secondary outcomes

Treatment Acceptability

tDCS Treatment Acceptability Questionnaire

Time frame

Post-op 14 days

Other outcomes

Pain Intensity

Assessed using Numeric Rating Scale (NRS)

Time frame

Post-op day 1 to 90

Knee-Specific Pain, Function, and Quality of Life

Measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time frame

Post-op day 1 to 90

Postoperative Analgesic Medication and Opioid Use

Self-reported and converted to oral morphine equivalents

Time frame

Post-op day 1 to 90

Quality of Life Assessment

Assessed using PROMIS-29 domain scores

Time frame

Post-op day 1 to 90

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's College Hospital

Lead sponsor

AFP Innovation Fund

Collaborator

University Health Network, Toronto

Collaborator

Source ClinicalTrials.gov

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