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Behavioural Intervention
Active tDCS for Osteoarthritis
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks and 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 45 years old or older.
Select...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of complete follow up
Secondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
The Arthritis Society, CanadaOTHER
24 Previous Clinical Trials
5,554 Total Patients Enrolled
7 Trials studying Osteoarthritis
1,394 Patients Enrolled for Osteoarthritis
McMaster UniversityLead Sponsor
880 Previous Clinical Trials
2,597,760 Total Patients Enrolled
19 Trials studying Osteoarthritis
901,062 Patients Enrolled for Osteoarthritis
Lisa Carlesso, PhDPrincipal InvestigatorMcMaster University
3 Previous Clinical Trials
140 Total Patients Enrolled
2 Trials studying Osteoarthritis
80 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being actively sought for this ongoing research study?
"Apologies for the confusion. According to the information available on clinicaltrials.gov, this particular study is not currently recruiting participants. It was initially posted on May 15th, 2024 and last updated on January 18th, 2024. However, it's worth noting that there are currently 660 other studies actively seeking patients at this time."
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