Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults With Knee Osteoarthritis

NCT ID: NCT03747640

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2019-03-08

Brief Summary

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis (OA).

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS with mindfulness-based meditation

Self Transcranial Direct Current Stimulation (tDCS) with Mindfulness-Based Meditation

Group Type: EXPERIMENTAL

Self Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

tDCS with a constant current intensity of 2 milliamps (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., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.

mindfulness-based meditation

Intervention Type: BEHAVIORAL

The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.

sham tDCS with sham meditation

Sham self Transcranial Direct Current Stimulation (tDCS) with sham Meditation

Group Type: SHAM_COMPARATOR

Sham Self Transcranial Direct Current Stimulation (tDCS)

Intervention Type: DEVICE

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.

sham meditation

Intervention Type: BEHAVIORAL

For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.

Interventions

Self Transcranial Direct Current Stimulation (tDCS)

tDCS with a constant current intensity of 2 milliamps (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., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.

Intervention Type: DEVICE

mindfulness-based meditation

The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.

Intervention Type: BEHAVIORAL

Sham Self Transcranial Direct Current Stimulation (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.

Intervention Type: DEVICE

sham meditation

For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria. According to American College of Rheumatology criteria, participants should meet at least 3 of 6 criteria, including age > 50 years, stiffness < 30 minutes, crepitus, bony tenderness, bony enlargement, and no palpable warmth.
• have had knee OA pain in the past 3 months with an average of at least 30 on a 100 Numeric Rating Scale (NRS) 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 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

• Participants will be excluded if they have concurrent medical conditions that hinder the completion of the protocol, including any of the following
• history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
• serious medical illness, such as uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm Hg), heart failure, or history of acute myocardial infarction
• alcohol/substance abuse
• cognitive impairment
• pregnancy or lactation
• hospitalization within the preceding year for psychiatric illness

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Hyochol Ahn

Associate Professor & Theodore J. and Mary E. Trumble Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyochol Ahn, PhD, RN, MSN

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-SN-18-0885

Identifier Type: -

Identifier Source: org_study_id