Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms

Not Applicable

Completed

• Conditions: Osteo Arthritis Knee

• Registration Number: NCT04375072
• Lead Sponsor: University of Arizona

Brief Summary

This clinical trial aims to evaluate whether a 2 week regimen of transcranial direct current stimulation (tDCS) paired with mindfulness-based meditation (MBM) can improve pain modulation, reduce clinical pain, and alleviate osteoarthritis (OA)-related symptoms in patients with knee OA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-05
• Study Start: 2020-08-13
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Status Verified: 2025-10
• Results First Submitted: 2025-10-08
• Results First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Results First Posted: 2025-11-12
• Last Update Posted: 2025-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

• 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
• diminished cognitive function that would interfere with understanding study procedures (i.e., Mini-Mental Status Exam score ≤ 23)
• pregnancy or lactation
• prosthetic knee replacement or non-arthroscopic surgery to the affected knee
• hospitalization within the preceding year for psychiatric illness
• no access to a device that can be used for secure videoconferencing for real-time remote supervision.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Numeric Rating Score (NRS) of Pain	baseline, week 2 (after 10 tDCS sessions)	The Numeric Rating Scale (NRS) is a subjective measure of pain intensity. The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable). Change in NRS = Week 2 (post-intervention) NRS - Baseline (pre-intervention) NRS. A decrease in NRS score indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).	baseline, week 2 (after 10 tDCS sessions)	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): 26 question index to assess knee OA pain (0-20 scale), function (0-68 scale), and stiffness (0-8 scale). The total WOAMC score is the sum of the 3 sub scales for a total score range from 0-96. Change in total WOMAC score = Week 2 total WOMAC score - Baseline (pre-intervention) total WOMAC score. The lower change scores represents improvement in pain, movement, and stiffness.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States