search
Back to results

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

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 9, 2019
Last Updated
May 8, 2023
Sponsor
Florida State University
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT04016272
Brief Title
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
Official Title
Self-Administered Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis: A Phase II Randomized Sham-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Title
Sham tDCS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Active tDCS
Other Intervention Name(s)
Soterix 1x1 tDCS mini-CT Stimulator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Other Intervention Name(s)
Soterix 1x1 tDCS mini-CT Stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Clinical Pain as Assessed by the Numeric Rating Scale (NRS) for Pain
Description
The Numeric Rating Scale (NRS) total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Time Frame
baseline, week 3
Secondary Outcome Measure Information:
Title
Change in Pain Related Cortical Response Using a Continuous Wave, Multichannel Functional Near-infrared Spectroscopy (fNIRS) Imaging System
Description
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.
Time Frame
Baseline, week1, week2, and week 3
Title
Acceptability as Measured by the tDCs Experience Questionnaire
Description
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.
Time Frame
week 3
Title
Number of Participants With Possible Side Effects of Treatment
Description
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.
Time Frame
week 3
Title
Feasibility as Assessed by the Number of Participants That Complete the Full tDCS Protocol
Description
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.
Time Frame
week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyochol Ahn, PhD, RN, MSN
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35690388
Citation
Martorella G, Mathis K, Miao H, Wang D, Park L, Ahn H. Self-administered transcranial direct current stimulation for pain in older adults with knee osteoarthritis: A randomized controlled study. Brain Stimul. 2022 Jul-Aug;15(4):902-909. doi: 10.1016/j.brs.2022.06.003. Epub 2022 Jun 8.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs