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Behavioural Intervention

Brain Stimulation + Meditation for Post-Knee Replacement Pain

N/A
Recruiting
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at day 5 of intervention

Summary

This trial found that a combination of electric brain stimulation and mindfulness can reduce pain after knee replacement surgery.

Who is the study for?
This trial is for adults who can communicate in English, are mentally able to read and consent, not pregnant, and scheduled for elective knee replacement surgery. It's not suitable for those on certain heart or brain medications, with recent severe psychiatric issues, substance abuse history, past major brain procedures or metal implants in the head.
What is being tested?
The study tests a combination of brain stimulation (tDCS) and mindfulness-based meditation (MBM) to see if they help reduce pain after knee surgery. Some participants will get the real treatments while others will receive non-active versions as a comparison.
What are the potential side effects?
Potential side effects may include discomfort at the site of tDCS electrode placement, headache during or after treatment sessions, fatigue following meditation practice, and possible skin irritation from electrode use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at day 5 of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at day 5 of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Analgesic consumption
Secondary study objectives
Brief Pain Inventory (BPI)
Change in descending pain modulation (CPM) as measured by the quantitative sensory testing
Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: preoperative active tDCS+MBIExperimental Treatment1 Intervention
Active tDCS with simultaneous meditation intervention will be applied.
Group II: preoperative sham tDCS+MBIPlacebo Group1 Intervention
Sham tDCS with simultaneous sham MBM intervention will be delivered.

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
220 Previous Clinical Trials
36,431 Total Patients Enrolled
3 Trials studying Osteoarthritis
343 Patients Enrolled for Osteoarthritis

Media Library

MBM (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05673720 — N/A
Osteoarthritis Research Study Groups: preoperative active tDCS+MBI, preoperative sham tDCS+MBI
Osteoarthritis Clinical Trial 2023: MBM Highlights & Side Effects. Trial Name: NCT05673720 — N/A
MBM (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05673720 — N/A
~17 spots leftby Nov 2025
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