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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at day 5 of intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analgesic consumption

Secondary outcome measures

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor

200 Previous Clinical Trials

31,718 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

Frequently Asked Questions

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

Could individuals under 40 years old potentially participate in this research?

"Individuals aged between 50 and 85 years old are being considered for enrolment in this clinical trial."

Answered by AI

Could people currently participate in this trial?

"Affirmative. The information available on clinicaltrials.gov confirms that this scientific trial, which was initially revealed on February 10th 2023, is actively seeking individuals to join the study. Approximately 40 patients must be recruited from a single site for successful completion of the project."

Answered by AI

How many patients is this research opportunity accommodating?

"Affirmative. Clinicaltrials.gov reveals that the study is currently seeking to recruit patients, with first posting of February 10th 2023 and latest update on same date. Its recruitment goal consists of 40 participants from a single trial site."

Answered by AI

What characteristics should potential participants possess for this research endeavor?

"This clinical trial is recruiting 40 qualified candidates aged 50-85 with a diagnosis of osteoarthritis in the knee. Qualified participants must also demonstrate: voluntary unilateral knee replacement, mental capacity for reading and comprehending directions, fluency in English, non-pregnant status."

Answered by AI