Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016272
• Other study ID #: HSC-SN-19-0469
• Secondary ID: R15NR018050
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: November 5, 2021

Study information

• Verified date: May 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 5, 2021
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Active tDCS
tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY) with headgear and saline-soaked surface sponge electrodes.
• Sham tDCS
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain	The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).	baseline, week 3
Secondary	Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System	Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal and punctate pain stimulation and correlation values will be presented in the form of figures.; Specify the full scale: Pearson correlation coefficient (r) between pairs of brain regions (fNIRS channels).; A value of r=0 indicates that two brain regions were functionally disconnected.; Greater absolute r values denote stronger connections. However, this does not indicate a better or worse result but only a different type of connectivity on a macroscale (when considering several fNIRS channels).; We used |r|>0.3 (absolute value of r greater than 0.3) to extract meaningful functional connections.	Baseline, week1, week2, and week 3
Secondary	Acceptability as Measured by the tDCs Experience Questionnaire	The tDCS experience questionnaire contains 10 questions based on a scale from 0-10, 0 being strongly disagree and 10 being strongly agree.; Higher scores indicating greater acceptability for 7 questions and lower scores indicating greater acceptability for 3 questions resulting most desirable score of a 70.	week 3
Secondary	Number of Participants With Possible Side Effects of Treatment	If any side effects are reported, the degree of relatedness to the intervention will be assessed on a 10-point scale, from 0 (not at all) to 10 (to a high degree). The questionnaire ask to what extend did the participant experienced symptoms like, tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, or mood change.	week 3
Secondary	Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol	We will calculate the percentage of participants who a) meet the inclusion criteria, b) agree to be randomly assigned, c) complete the full tDCS protocol, and d) attend the follow-up assessment.	week 3