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

NCT03747640 | Completed Results FDA Device

• 1 other identifier: HSC-SN-18-0885
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Pain as Assessed by a Numeric Rating Scale for Pain (NRS)

  The NRS assess average pain over the past 24 hours from 0 (no pain) to 100 (most intense pain imaginable).

  baseline, 2 weeks

Secondary Outcomes (17)

• Change in Clinical Pain as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  baseline, 2 weeks

• Psychosocial Symptoms as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety-short Form

  baseline

• Psychosocial Symptoms as Assessed by the PROMIS Anxiety-short Form

  2 weeks

• Psychosocial Symptoms as Assessed by PROMIS Depression-short Form

  baseline

• Psychosocial Symptoms as Assessed by PROMIS Depression-short Form

  2 weeks

Study Arms (2)

tDCS with mindfulness-based meditation

EXPERIMENTAL

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

Device: Self Transcranial Direct Current Stimulation (tDCS); Behavioral: mindfulness-based meditation

sham tDCS with sham meditation

SHAM COMPARATOR

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

Device: Sham Self Transcranial Direct Current Stimulation (tDCS); Behavioral: sham meditation

Interventions

Self Transcranial Direct Current Stimulation (tDCS) 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.

tDCS with mindfulness-based meditation

mindfulness-based meditation 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.

tDCS with mindfulness-based meditation

Sham Self Transcranial Direct Current Stimulation (tDCS) 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 tDCS with sham meditation

sham meditation 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.

sham tDCS with sham meditation

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Hyochol Ahn, PhD, MSN, MS-ECE, MS-CTS, APRN, ANP-BC, FAAN
• Organization: Florida State University

hahn@fsu.edu

850-644-2647

Study Officials

• Hyochol Ahn, PhD, RN, MSN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Theodore J. and Mary E. Trumble Professor

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 20, 2018
• Study Start: November 28, 2018
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: March 25, 2022
• Results First Posted: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)