Knee Arthroplasty, Pain, Postoperative, Transcranial Direct Current Stimulation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActive 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.
DEVICESham tDCS 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.
Sponsors
Women's College Hospital
AFP Innovation Fund
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
As noted above, only the company created the randomization will be aware of allocation assignment. The participant, Investigator, surgeon and outcomes assessors will be blinded to minimize bias.
Intervention model description
This study will be a randomized, double-blinded, active-placebo controlled trial with two parallel arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older. 2. American Society of Anesthesiologists (ASA) Physical Classification Status I-III. 3. Scheduled to undergo unilateral elective primary total knee arthroplasty for advanced osteoarthritis of the knee. 4. Access to a device running iOS Version 10.0 or above, or Android Version 5.0 or above that can connect to the internet.
Exclusion criteria
1. History of brain surgery, central nervous system tumors, seizures (including epilepsy), stroke or intracranial implants (e.g plates, screws, deep brain stimulators) 2. Have vascular, traumatic, infectious, or metabolic lesions or diseases of the brain 3. 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: * Insomnia disorder (e.g., difficulty initiating or maintaining sleep, early morning awakening) * Obstructive sleep apnea (OSA) * Central sleep apnea * Narcolepsy * Restless legs syndrome * REM sleep behavior disorder * Circadian rhythm sleep-wake disorders * Parasomnias (e.g., sleepwalking, night terrors) 4. Active diagnosis of alcohol use disorder, defined as meeting DSM-5 criteria or documented in the patient's medical record within the past 12 months. 5. Patients taking opioid medications with a daily Oral Morphine Equivalent (OME) of ≥ 80 mg 6. Current use of medications or substances known to alter cortical excitability or possess psychoactive properties (e.g., antiepileptics, benzodiazepines, antidepressants, antipsychotics, hallucinogens, dissociatives), as determined by review of the patient's medication list, chart review, and patient history. This includes prescribed medications and illicit substances used within the past 30 days. 7. Have metallic implants or objects in or on the head, including mouth (e.g. electrodes, stents, clips, pins, braces, shrapnel, jewellery (unremovable) 8. Use passive or active implanted medical devices (e.g., pacemakers, defibrillators, cochlear implants, natural implants or active body-worn medical devices (e.g., neural stimulation or medication infusion devices) 9. Have defects in the neurocranium (e.g., post-skull trepanation) 10. Have large vessel occlusions (e.g., complete blockage of the internal carotid artery or other conditions affecting brain perfusion 11. Have skin diseases of the scalp 12. Are using other brain stimulation devices concurrently 13. Are pregnant 14. Are unable to provide informed consent 15. Are unable to wear or tolerate the study device 16. Unable to speak or read English, or understand device operation instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility outcomes | 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability | Post-op 14 days | tDCS Treatment Acceptability Questionnaire |
Countries
Canada
Contacts
CONTACTDidem Bozak
PRINCIPAL_INVESTIGATORKarim Ladha, MD, FRCPC
Women's College Hospital
Outcome results
None listed