N/A
Completed N=20
Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Source: ClinicalTrials.gov NCT03425019 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) — 55.23 units on a scale
Summary
The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS) |
24.85 | — |
| SECONDARY Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale |
5.75 | — |
| SECONDARY Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale |
2.90 | — |
| SECONDARY Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale |
20.85 | — |
| SECONDARY Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale |
22.75 | — |
| SECONDARY Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale |
14.05 | — |
| SECONDARY Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale |
12.90 | — |
| SECONDARY Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale |
8.2 | — |
| SECONDARY Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale |
5.75 | — |
| SECONDARY Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH) |
37.3; 40.1 | — |
| SECONDARY Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO) |
43.2; 44.6 | — |
| SECONDARY Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT) |
3.7; 4.4; 3.9 | — |
| SECONDARY Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP) |
67.4; 54.6 | — |
| SECONDARY Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM) |
1.3 | — |
| SECONDARY Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS) |
20 | — |
| SECONDARY Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device |
9.75 | — |
| SECONDARY Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device |
9.75 | — |
| SECONDARY Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time |
6.75 | — |
| SECONDARY Tolerability as Assessed by Number of Participants With Side Effects |
— | — |
| SECONDARY Anxiety as Assessed by the PROMIS Anxiety-short Form |
12.05 | — |
| SECONDARY Depression as Assessed by the PROMIS Depression-short Form |
11.85 | — |
| SECONDARY Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form |
19.85 | — |
Eligibility Criteria
Inclusion Criteria
- have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria
- have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) for pain
- can speak and read English
- have a device with internet access that can be used for secure video conferencing for real-time remote supervision
- have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit
- have no plan to change medication regimens for pain throughout the trial
- are able to travel to the coordinating center
- are willing and able to provide written informed consent prior to enrollment.
Exclusion Criteria
- previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee
- history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation
- systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
- uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg)
- heart failure
- history of acute myocardial infarction
- peripheral neuropathy
- alcohol/substance abuse
- cognitive impairment (i.e., Mini-Mental Status Exam score ≤ 23)
- pregnancy or lactation
- hospitalization within the preceding year for psychiatric illness
Data sourced from ClinicalTrials.gov (NCT03425019). 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.