An interventional study of Active tDCS Stimulation and Sham tDCS Stimulation in Knee Arthroplasty, Transcranial Direct Current Stimulation and Pain, Postoperative, sponsored by Women's College Hospital. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Women's College Hospital · Not applicable, Interventional, and Treatment
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.
Participants will self-administer 15 tDCS sessions using a home-based device during the perioperative period. Feasibility and acceptability will be assessed through device-recorded adherence data, participant diaries completed during the intervention period, and follow-up diary entries on postoperative days 14, 30, and 90. Findings will be used to refine the protocol and inform the design of a future large-scale trial evaluating the efficacy of home-based tDCS for postoperative pain management following TKA.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 70 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Women's College Hospital is the lead sponsor of 83 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Active diagnosis of a sleep disorder, defined as a documented diagnosis of any of the following conditions within the past 12 months, based on patient history or medical record review:
receives active stimulation
Device: Active tDCS Stimulation
receives non-active stimulation
Device: Sham tDCS Stimulation
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.
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.
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
Treatment Acceptability
tDCS Treatment Acceptability Questionnaire
Time frame: Post-op 14 days
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
Participant Blinding Success
Evaluated using the Bang Blinding Index (BBI)
Time frame: Post-op day 1 to 90
Device Related Side Effects
Patient-Reported Side Effect Diary
Time frame: Post-op day 1 to 90
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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