N/A
Completed N=123
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Osteo Arthritis Knee
Source: ClinicalTrials.gov NCT04016272 ↗
Enrolled (actual)
123
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain — -24.07; -1.08 score on a scale
Summary
The purpose of this study is to assess the feasibility, acceptability, and efficacy of self-administered transcranial direct current stimulation (tDCS) in older adults with knee osteoarthritis (OA)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain |
-24.07; -1.08 | — |
| SECONDARY Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System |
0.18; 0.12; 0.10; 0.09; -0.12; -0.12 | — |
| SECONDARY Acceptability as Measured by the tDCs Experience Questionnaire |
62.93; 64.93 | — |
| SECONDARY Number of Participants With Possible Side Effects of Treatment |
0; 0 | — |
| SECONDARY Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol |
60; 60 | — |
Eligibility Criteria
Inclusion Criteria
- have symptomatic knee OA based on American College of Rheumatology Clinical criteria
- have had knee OA pain in the past 3 months with an average of at least 30 on a 0-100 NRS for pain
- can speak and read English
- have no plan to change medication regimens for pain throughout the trial
Exclusion Criteria
- prosthetic knee replacement or nonarthroscopic surgery to the affected knee
- history of brain surgery, brain tumor, seizure, stroke or intracranial metal implantation
- systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- alcohol/substance abuse
- current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
- diminished cognitive function that would interfere with understanding study procedures(i.e., Mini-Mental Status Exam score ≤ 23)
- pregnancy or lactation
- hospitalization within the preceding year for psychiatric illness
- no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Data sourced from ClinicalTrials.gov (NCT04016272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.