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tDCS + Mindfulness Meditation for Osteoarthritis

N/A
Recruiting
Led By Hyochol Hyochol, Phd,RN,MSN
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention)
Awards & highlights

Study Summary

This trial is testing if a combination of electrical brain stimulation and mindfulness meditation can help relieve pain and symptoms in people with knee arthritis.

Who is the study for?
This trial is for English-speaking adults with knee pain from osteoarthritis, who've had an average pain score of at least 30 out of 100 in the past three months. Participants should not plan to change their pain medication during the study and must have access to videoconferencing tools.Check my eligibility
What is being tested?
The study tests if a combination of active transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) can reduce knee pain and improve symptoms in osteoarthritis patients compared to placebo treatments.See study design
What are the potential side effects?
Potential side effects may include mild skin irritation or burning sensation on the scalp from tDCS, headache, fatigue, or discomfort during meditation practice. Serious side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have knee pain diagnosed as osteoarthritis.
Select...
I have experienced knee pain due to OA, averaging at least 30 out of 100.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 time points: baseline,after each treatment session during the treatment period, and three follow-up assessments (months 1, 2,and 3 postintervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Numeric Rating Score (NRS) of Pain
Secondary outcome measures
Client Satisfaction Questionnaire (CSQ-8)
Conditioned Pain Modulation (CPM)
Freiburg Mindfulness Inventory (FMI)
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: active tDCS paired with active MBM,Experimental Treatment1 Intervention
Group II: active tDCS paired with sham MBMActive Control1 Intervention
Group III: sham tDCS paired with active MBMActive Control1 Intervention
Group IV: sham tDCS paired with sham MBMPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,760 Total Patients Enrolled
5 Trials studying Osteoarthritis
244 Patients Enrolled for Osteoarthritis
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,394 Total Patients Enrolled
2 Trials studying Osteoarthritis
318 Patients Enrolled for Osteoarthritis
Florida State UniversityLead Sponsor
200 Previous Clinical Trials
31,558 Total Patients Enrolled
2 Trials studying Osteoarthritis
143 Patients Enrolled for Osteoarthritis

Media Library

active tDCS paired with active MBM Clinical Trial Eligibility Overview. Trial Name: NCT04375072 — N/A
Osteoarthritis Research Study Groups: active tDCS paired with active MBM,, active tDCS paired with sham MBM, sham tDCS paired with active MBM, sham tDCS paired with sham MBM
Osteoarthritis Clinical Trial 2023: active tDCS paired with active MBM Highlights & Side Effects. Trial Name: NCT04375072 — N/A
active tDCS paired with active MBM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04375072 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of person do you think would be a good candidate for this trial?

"Eligible individuals for this study are those aged 50 to 85 who have knee osteoarthritis pain that has averaged at least a 30 on a 0-100 NRS in the last 3 months."

Answered by AI

Does the age limit for this clinical trial exclude elderly patients?

"This trial includes patients that are between 50-85 years old."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
The University of Texas Health Science Center at Houston
How many prior treatments have patients received?
1
2
Recent research and studies
clinicaltrials.govStudy
Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms
Hyochol Ahn 2020. "Home-based tDCS and Mindfulness-based Meditation for Self-management of Clinical Pain and Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04375072.
~31 spots leftby Dec 2024
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