Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation: A Randomized Controlled Pilot Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究者
Karim Ladha
MD MSc FRCPC
Women's College Hospital