Transcranial Direct Current Stimulation and Yoga for Knee Osteoarthritis

NCT06228573 | Recruiting

• 1 other identifier: 23-0000000177
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of complete follow up

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

  9 weeks and 3 months

Secondary Outcomes (23)

• Brief Pain Inventory - Numeric Rating Scale

  9 weeks and 3 months

• Modified Charlson Comorbidity Index (CCI)

  9 weeks and 3 months

• Endogenous pain modulation

  9 weeks

• Pain interference

  9 weeks and 3 months

• Pain catastrophizing

  9 weeks and 3 months

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Procedure: Yoga

Sham tDCS

SHAM COMPARATOR

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.

Procedure: Yoga

Interventions

Yoga PROCEDURE

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.

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Experiencing an average pain intensity of ≥3 /10 in the past month

You may not qualify if:

• 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.
• Current participation in another OA clinical trial.
• Use of mobility aids.
• Currently receiving care for KOA pain (e.g., physiotherapy).
• Planned absences exceeding 1 week.
• Contraindications to transcranial direct current stimulation (tDCS) such as neurological or neuropsychiatric conditions.
• History of brain surgery or tumor.
• Metallic implants.
• Epilepsy or history of substance abuse or dependence.
• Cochlear or ocular implant.
• Presence of a pacemaker or cardiac defibrillator.
• Eczema on the scalp.

Sponsors & Collaborators

• McMaster University: lead
• The Arthritis Society, Canada: collaborator

Study Sites (3)

McMaster University

Hamilton, Ontario, L8S1C7, Canada

RECRUITING

University of Western Ontario

London, Ontario, N6A 3K7, Canada

RECRUITING

Université de Sherbrooke

Sherbrooke, Quebec, J1K 2R1, Canada

RECRUITING

Related Publications (40)

• Wallis JA, Taylor NF, Bunzli S, Shields N. Experience of living with knee osteoarthritis: a systematic review of qualitative studies. BMJ Open. 2019 Sep 24;9(9):e030060. doi: 10.1136/bmjopen-2019-030060.

  PMID: 31551381 BACKGROUND

• Calders P, Van Ginckel A. Presence of comorbidities and prognosis of clinical symptoms in knee and/or hip osteoarthritis: A systematic review and meta-analysis. Semin Arthritis Rheum. 2018 Jun;47(6):805-813. doi: 10.1016/j.semarthrit.2017.10.016. Epub 2017 Oct 31.

  PMID: 29157670 BACKGROUND

• Kendzerska T, Juni P, King LK, Croxford R, Stanaitis I, Hawker GA. The longitudinal relationship between hand, hip and knee osteoarthritis and cardiovascular events: a population-based cohort study. Osteoarthritis Cartilage. 2017 Nov;25(11):1771-1780. doi: 10.1016/j.joca.2017.07.024. Epub 2017 Aug 9.

  PMID: 28801210 BACKGROUND

• Arthritis Alliance of Canada. The Impact of Arthritis in Canada: Today and over the Next 30 years. Executive Summary. 2011.

  BACKGROUND

• Sharif B, Kopec JA, Wong H, Anis AH. Distribution and Drivers of Average Direct Cost of Osteoarthritis in Canada From 2003 to 2010. Arthritis Care Res (Hoboken). 2017 Feb;69(2):243-251. doi: 10.1002/acr.22933.

  PMID: 27159532 BACKGROUND

• Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.

  PMID: 23973124 BACKGROUND

• Fingleton C, Smart K, Moloney N, Fullen BM, Doody C. Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Jul;23(7):1043-56. doi: 10.1016/j.joca.2015.02.163. Epub 2015 Mar 5.

  PMID: 25749012 BACKGROUND

• Carlesso LC, Segal NA, Frey-Law L, Zhang Y, Na L, Nevitt M, Lewis CE, Neogi T. Pain Susceptibility Phenotypes in Those Free of Knee Pain With or at Risk of Knee Osteoarthritis: The Multicenter Osteoarthritis Study. Arthritis Rheumatol. 2019 Apr;71(4):542-549. doi: 10.1002/art.40752. Epub 2019 Feb 7.

  PMID: 30307131 BACKGROUND

• O'Leary H, Smart KM, Moloney NA, Blake C, Doody CM. Pain sensitization associated with nonresponse after physiotherapy in people with knee osteoarthritis. Pain. 2018 Sep;159(9):1877-1886. doi: 10.1097/j.pain.0000000000001288.

  PMID: 29794610 BACKGROUND

• Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

  PMID: 31278997 BACKGROUND

• Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, Callahan L, Copenhaver C, Dodge C, Felson D, Gellar K, Harvey WF, Hawker G, Herzig E, Kwoh CK, Nelson AE, Samuels J, Scanzello C, White D, Wise B, Altman RD, DiRenzo D, Fontanarosa J, Giradi G, Ishimori M, Misra D, Shah AA, Shmagel AK, Thoma LM, Turgunbaev M, Turner AS, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Rheumatol. 2020 Feb;72(2):220-233. doi: 10.1002/art.41142. Epub 2020 Jan 6.

  PMID: 31908163 BACKGROUND

• Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.

  PMID: 23595142 BACKGROUND

• Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24.

  PMID: 26405113 BACKGROUND

• Hall M, Dobson F, Plinsinga M, Mailloux C, Starkey S, Smits E, Hodges P, Vicenzino B, Schabrun SM, Masse-Alarie H. Effect of exercise on pain processing and motor output in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2020 Dec;28(12):1501-1513. doi: 10.1016/j.joca.2020.07.009. Epub 2020 Aug 9.

  PMID: 32783909 BACKGROUND

• Ahn H, Sorkpor S, Miao H, Zhong C, Jorge R, Park L, Abdi S, Cho RY. Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study. J Clin Neurosci. 2019 Aug;66:61-65. doi: 10.1016/j.jocn.2019.05.023. Epub 2019 May 29.

  PMID: 31153751 BACKGROUND

• Ahn H, Suchting R, Woods AJ, Miao H, Green C, Cho RY, Choi E, Fillingim RB. Bayesian analysis of the effect of transcranial direct current stimulation on experimental pain sensitivity in older adults with knee osteoarthritis: randomized sham-controlled pilot clinical study. J Pain Res. 2018 Sep 27;11:2071-2082. doi: 10.2147/JPR.S173080. eCollection 2018.

  PMID: 30310309 BACKGROUND

• Tavares DRB, Okazaki JEF, Santana MVA, Pinto ACPN, Tutiya KK, Gazoni FM, Pinto CB, Santos FC, Fregni F, Trevisani VFM. Motor cortex transcranial direct current stimulation effects on knee osteoarthritis pain in elderly subjects with dysfunctional descending pain inhibitory system: A randomized controlled trial. Brain Stimul. 2021 May-Jun;14(3):477-487. doi: 10.1016/j.brs.2021.02.018. Epub 2021 Mar 5.

  PMID: 33684598 BACKGROUND

• Pinto CB, Teixeira Costa B, Duarte D, Fregni F. Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. J ECT. 2018 Sep;34(3):e36-e50. doi: 10.1097/YCT.0000000000000518.

  PMID: 29952860 BACKGROUND

• Lee PG, Jackson EA, Richardson CR. Exercise Prescriptions in Older Adults. Am Fam Physician. 2017 Apr 1;95(7):425-432.

  PMID: 28409595 BACKGROUND

• Solomon DH, Schneeweiss S, Glynn RJ, Kiyota Y, Levin R, Mogun H, Avorn J. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation. 2004 May 4;109(17):2068-73. doi: 10.1161/01.CIR.0000127578.21885.3E. Epub 2004 Apr 19.

  PMID: 15096449 BACKGROUND

• Pearson N, Prosko S, Sullivan M, Taylor MJ. White Paper: Yoga Therapy and Pain-How Yoga Therapy Serves in Comprehensive Integrative Pain Management, and How It Can Do More. Int J Yoga Therap. 2020 Jan 1;30(1):117-133. doi: 10.17761/2020-D-19-00074.

  PMID: 32412808 BACKGROUND

• MacKay C, Jaglal SB, Sale J, Badley EM, Davis AM. A qualitative study of the consequences of knee symptoms: 'It's like you're an athlete and you go to a couch potato'. BMJ Open. 2014 Oct 16;4(10):e006006. doi: 10.1136/bmjopen-2014-006006.

  PMID: 25324325 BACKGROUND

• Nyvang J, Hedstrom M, Gleissman SA. It's not just a knee, but a whole life: A qualitative descriptive study on patients' experiences of living with knee osteoarthritis and their expectations for knee arthroplasty. Int J Qual Stud Health Well-being. 2016 Mar 31;11:30193. doi: 10.3402/qhw.v11.30193. eCollection 2016.

  PMID: 27036130 BACKGROUND

• Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.

  PMID: 28665989 BACKGROUND

• Ahn H, Zhong C, Miao H, Chaoul A, Park L, Yen IH, Vila MA, Sorkpor S, Abdi S. Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study. J Clin Neurosci. 2019 Dec;70:140-145. doi: 10.1016/j.jocn.2019.08.047. Epub 2019 Aug 14.

  PMID: 31421990 BACKGROUND

• Cardenas-Rojas A, Pacheco-Barrios K, Giannoni-Luza S, Rivera-Torrejon O, Fregni F. Noninvasive brain stimulation combined with exercise in chronic pain: a systematic review and meta-analysis. Expert Rev Neurother. 2020 Apr;20(4):401-412. doi: 10.1080/14737175.2020.1738927. Epub 2020 Mar 14.

  PMID: 32130037 BACKGROUND

• Sefat O, Salehinejad MA, Danilewitz M, Shalbaf R, Vila-Rodriguez F. Combined Yoga and Transcranial Direct Current Stimulation Increase Functional Connectivity and Synchronization in the Frontal Areas. Brain Topogr. 2022 Mar;35(2):207-218. doi: 10.1007/s10548-022-00887-z. Epub 2022 Jan 29.

  PMID: 35092544 BACKGROUND

• Lauche R, Hunter DJ, Adams J, Cramer H. Yoga for Osteoarthritis: a Systematic Review and Meta-analysis. Curr Rheumatol Rep. 2019 Jul 23;21(9):47. doi: 10.1007/s11926-019-0846-5.

  PMID: 31338685 BACKGROUND

• Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

  PMID: 26978655 BACKGROUND

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

• Moonaz S, Nault D, Cramer H, Ward L. CLARIFY 2021: explanation and elaboration of the Delphi-based guidelines for the reporting of yoga research. BMJ Open. 2021 Aug 5;11(8):e045812. doi: 10.1136/bmjopen-2020-045812.

  PMID: 34353794 BACKGROUND

• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Roizenblatt S, Fregni F, Gimenez R, Wetzel T, Rigonatti SP, Tufik S, Boggio PS, Valle AC. Site-specific effects of transcranial direct current stimulation on sleep and pain in fibromyalgia: a randomized, sham-controlled study. Pain Pract. 2007 Dec;7(4):297-306. doi: 10.1111/j.1533-2500.2007.00152.x. Epub 2007 Nov 6.

  PMID: 17986164 BACKGROUND

• Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.

  PMID: 16564618 BACKGROUND

• Kim YJ, Ku J, Kim HJ, Im DJ, Lee HS, Han KA, Kang YJ. Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Ann Rehabil Med. 2013 Dec;37(6):766-76. doi: 10.5535/arm.2013.37.6.766. Epub 2013 Dec 23.

  PMID: 24466511 BACKGROUND

• Mori F, Codeca C, Kusayanagi H, Monteleone F, Buttari F, Fiore S, Bernardi G, Koch G, Centonze D. Effects of anodal transcranial direct current stimulation on chronic neuropathic pain in patients with multiple sclerosis. J Pain. 2010 May;11(5):436-42. doi: 10.1016/j.jpain.2009.08.011. Epub 2009 Dec 16.

  PMID: 20018567 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

• Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

  PMID: 16427357 BACKGROUND

• Kessler SK, Turkeltaub PE, Benson JG, Hamilton RH. Differences in the experience of active and sham transcranial direct current stimulation. Brain Stimul. 2012 Apr;5(2):155-62. doi: 10.1016/j.brs.2011.02.007. Epub 2011 Mar 27.

  PMID: 22037128 BACKGROUND

• Palm U, Reisinger E, Keeser D, Kuo MF, Pogarell O, Leicht G, Mulert C, Nitsche MA, Padberg F. Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials. Brain Stimul. 2013 Jul;6(4):690-5. doi: 10.1016/j.brs.2013.01.005. Epub 2013 Feb 8.

  PMID: 23415938 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Yoga

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Lisa Carlesso, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Carlesso, PhD

CONTACT

2896805640; carlesl@mcmaster.ca

Guillaume Leonard, PhD

CONTACT

(819) 780-2220; Guillaume.Leonard2@USherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 29, 2024
• Study Start: October 20, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)