Health TrialsbyHealthPanel

Transcranial Direct Current Stimulation and Yoga for Knee Osteoarthritis

ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorMcMaster University

About this trial

People with knee arthritis often experience constant pain, and current treatments aren't very effective. This can lead to limited movement and more health problems. Knee arthritis is a big part of healthcare costs in Canada, and its pain is a major reason people see doctors. The pain is linked to complex nervous system changes, making current treatments, like exercise, not very successful.

To address this, researchers suggest a new approach combining two things: a brain stimulation technique called Transcranial Direct Current Stimulation (tDCS) and yoga. TDCS helps with pain by changing how the brain works, and yoga, a safe practice, focuses on overall well-being. Together, the investigators aim to improve how the nervous system works from top to bottom.

The research project wants to change how the arthritis pain is being managed by focusing on how it works. The investigators plan to test this combo in a study comparing real tDCS plus yoga with fake tDCS plus yoga. The investigators will look not only at pain but also at other measures related to pain and how the nervous system works. This new mix could be a meaningful way to reduce pain for people with knee arthritis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

community dwelling adults from Sherbrooke, Quebec, Hamilton and London, Ontario fulfilling the NICE criteria for KOA

≥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

Disqualifiers

Systemic inflammatory arthritis.

Any knee injection in the past 3 months.

Inability to independently get up and down from the floor.

Lower limb trauma or surgery within the last 6 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yoga

    Procedure/Surgery

    Yoga program: In weeks 2-9, participants will attend twice weekly 1-hour sessions of yoga led by a certified yoga instructor trained in the intervention by collaborator Pearson. Videos will be provided for completion of home sessions. The yoga program is based on the Pain Care Aware certification program.38 Details of the program as well as the training of instructors are provided in the appendices. Briefly, classes will consist of 3 parts: centring and warming up aimed at regulating physiology prior to beginning the yoga postures; yoga postures and guided relaxation.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of complete follow up

Percentage rate measured by those at baseline completing study follow up measures

Time frame
9 weeks and 3 months

Secondary outcomes

1

Brief Pain Inventory - Numeric Rating Scale

The BPI uses 4 questions to ask about worst and least pain intensity in the past 24 hours, pain on average and pain right now. Questions are rated on an 11-point scale where patients select a rating between 0-10 with zero representing 'no pain' and 10 representing the 'worst imaginable pain'. The Numeric Rating Scale is reported to have excellent inter-rater reliability and acceptable validity in people with KOA.

Time frame
9 weeks and 3 months
2

Modified Charlson Comorbidity Index (CCI)

To assesses the presence of 19 comorbidities in participants. The CCI has been used in many patient populations including knee osteoarthritis

Time frame
9 weeks and 3 months
3

Endogenous pain modulation

CPM will be assessed in the following steps: 1) at the anterior shin on the unaffected knee, an ascending measure of pressure pain threshold (PPT) will be evaluated, inducing a pain rating of 3/10. 2) At the opposite volar forearm, a conditioning stimulus in the form of forearm ischemia using a blood pressure cuff and squeezing a stress ball until a pain rating of 5/10 is reached, 3) PPT at the anterior shin will be repeated with the cuff remaining inflated2, 4) an index will be created by calculating the percent efficiency of CPM (%CPM) as PPT2/PPT1, multiplied by 100; whereby %CPM ≤ 100 indicates inefficient pain modulation. CPM testing has demonstrated good intra-session reliability.

Time frame
9 weeks
4

Pain interference

The Brief Pain Inventory5 assesses pain interference through 7 items general activity, mood, walking, normal work, relations with others, sleeping, enjoyment of life rated from 0 (does not interfere) to 10 (completely interferes).

Time frame
9 weeks and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

The Arthritis Society, Canada

Collaborator

Source ClinicalTrials.gov
Apply now