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Behavioural Intervention

Brain Stimulation + Yoga for Osteoarthritis

N/A

Recruiting

Led By Lisa Carlesso, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥45 years of age

Diagnosis of Knee osteoarthritis OR having movement-related joint pain with either no morning knee stiffness or stiffness of 30 minutes or less AND experiencing an average pain intensity of ≥3 /10 in the past month

Must not have

Contraindications to tDCS such as neurological or neuropsychiatric conditions

Systemic inflammatory arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks and 3 months

Summary

This trial aims to find a new approach to manage knee arthritis pain, which is currently not effectively treated. The researchers want to combine a brain stimulation technique called Transcranial Direct Current Stimulation (t

Who is the study for?

This trial is for individuals with knee osteoarthritis who often deal with persistent pain and are looking for new ways to manage it. The study is open to those willing to try a combination of brain stimulation and yoga, but specific inclusion and exclusion criteria details were not provided.

What is being tested?

The trial tests a novel approach combining Transcranial Direct Current Stimulation (tDCS), which alters brain activity to reduce pain, with yoga that promotes overall well-being. Participants will be randomly assigned to receive either real tDCS or sham tDCS along with yoga sessions.

What are the potential side effects?

Potential side effects were not explicitly mentioned; however, tDCS can sometimes cause mild discomfort, itching or tingling at the electrode sites on the scalp. Yoga is generally safe but may include muscle soreness or strain if not practiced carefully.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 45 years old or older.

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I have knee pain from arthritis or joint pain with little to no morning stiffness and it's been a 3/10 or more in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any brain or mental health conditions that prevent tDCS treatment.

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I have been diagnosed with systemic inflammatory arthritis.

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I cannot get up and down from the floor by myself.

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I use devices to help me move around.

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I have had brain surgery or a brain tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of complete follow up

Secondary study objectives

Acceptability of the delivery of the brain stimulation on a 5 point Likert scale

Acceptability of the delivery of the yoga session of the program on a 5 point Likert scale

Adverse events

+20 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCSExperimental Treatment1 Intervention

Active tDCS Arm: In Week 1, participants in the Active tDCS arm will undergo five in-person visits for the administration of active transcranial Direct Current Stimulation (tDCS). Subsequently, from Weeks 2 to 9, participants will receive weekly active tDCS sessions preceding the scheduled yoga sessions. For the active tDCS sessions, a constant current stimulator will be employed to deliver direct current through a pair of surface sponge electrodes (5×7 cm) soaked in saline. Participants will undergo anodal stimulation targeting the primary motor cortex (M1) contralateral to the most painful site (C3 or C4 based on the electroencephalogram 10/20 system). The cathodal electrode will be positioned on the supraorbital area contralateral to the anode. During active tDCS, a constant anodal current of 2 mA will be administered for 20 minutes, a duration known to enhance cortical excitability and alleviate pain. T

Group II: Sham tDCSPlacebo Group1 Intervention

Sham tDCS Arm: tDCS: In Week 1, participants in the Sham tDCS arm will attend five in-person visits for the administration of sham transcranial Direct Current Stimulation (tDCS). From Weeks 2 to 9, participants will receive weekly sham tDCS sessions before the scheduled yoga sessions. Constant current stimulator will be used to deliver direct current through a pair of surface sponge electrodes (5×7 cm) soaked in saline. Participants will undergo sham stimulation targeting the primary motor cortex (M1) contralateral to the most painful site (C3 or C4 based on the electroencephalogram 10/20 system). During sham tDCS, the electrodes will be placed in the same montage as the active tDCS; however, current will only be applied for the initial and final 30 seconds of the 20-minute session. Consequently, participants will experience the sensation of current ramping up and down but will receive no current for the remaining stimulation period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Yoga

2008

Completed Phase 3

~3830

0 / 7Eligibility criteria met