Toronto Western Hospital (UHN)
Toronto, Ontario, M5G 2C4, Canada
NCT Number: NCT07351578
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2C4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Pre-op Days -5 to +90 days
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: Post-op 14 days
tDCS Treatment Acceptability Questionnaire
Time frame: Post-op day 1 to 90
Assessed using Numeric Rating Scale (NRS)
Time frame: Post-op day 1 to 90
Measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Post-op day 1 to 90
Self-reported and converted to oral morphine equivalents
Time frame: Post-op day 1 to 90
Assessed using PROMIS-29 domain scores
Time frame: Post-op day 1 to 90
Evaluated using the Bang Blinding Index (BBI)
Time frame: Post-op day 1 to 90
Patient-Reported Side Effect Diary
Contact information is provided by the study sponsor or research team.
Women's College Hospital
Other
Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation: A Randomized Controlled Pilot Trial
Acronym: KART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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