Clinical trial NCT03425019: Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Official title: Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Knee Pain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Chronic Pain
Keywords: Knee Osteoarthritis
Chronic Pain
Osteoarthritis
Transcranial Direct Current Stimulation
tDCS
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale
timeFrame: 2 weeks
measure: Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale
timeFrame: 2 weeks
measure: Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale
timeFrame: 2 weeks
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale
timeFrame: 2 weeks
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale
timeFrame: 2 weeks
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale
timeFrame: 2 weeks
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale
timeFrame: baseline
measure: Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale
timeFrame: 2 weeks
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
timeFrame: baseline
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)
timeFrame: 2 weeks
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
timeFrame: baseline
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)
timeFrame: 2 weeks
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
timeFrame: baseline
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)
timeFrame: 2 weeks
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)
timeFrame: baseline
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)
timeFrame: 2 weeks
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
timeFrame: baseline
measure: Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)
timeFrame: 2 weeks
measure: Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)
timeFrame: 2 weeks
measure: Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device
timeFrame: 2 weeks
measure: Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device
timeFrame: 2 weeks
measure: Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time
timeFrame: 2 weeks
measure: Tolerability as Assessed by Number of Participants With Side Effects
timeFrame: 2 weeks
measure: Anxiety as Assessed by the PROMIS Anxiety-short Form
timeFrame: baseline
measure: Anxiety as Assessed by the PROMIS Anxiety-short Form
timeFrame: 2 weeks
measure: Depression as Assessed by the PROMIS Depression-short Form
timeFrame: baseline
measure: Depression as Assessed by the PROMIS Depression-short Form
timeFrame: 2 weeks
measure: Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form
timeFrame: baseline
measure: Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Hyochol Ahn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahn H, Sorkpor S, Miao H, Zhong C, Jorge R, Park L, Abdi S, Cho RY. Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study. J Clin Neurosci. 2019 Aug;66:61-65. doi: 10.1016/j.jocn.2019.05.023. Epub 2019 May 29.